Category Archives: Promkes

Bagaimana perkembangan penatalaksanaan penderita asma terkini?

NEJM baru saja menerbitkan artikel review tentang perkembangan penatalaksanaan pasien asma. artikel lengkapnya sbb”

A Patient with Asthma Seeks Medical Advice in 1828, 1928, and 2012″

People have suffered from asthma for millennia.1 Although the clinical presentation of asthma has probably changed little, there are many more people who now bear its consequences than there were 200 years ago. As a result of an intense interest in the condition, our understanding of its pathobiology, how to diagnose it, and — most important — how to treat it has evolved dramatically over the past two centuries. To illustrate this change, we provide three fictional reports of consultations performed for essentially the same patient, who has what we in 2012 would refer to as asthma. (A timeline of the major advances in the treatment of asthma from 1812 through 2012 is available with the full text of this article at NEJM.org.)

The first report is from 1828, the year that the New England Journal of Medicine and Surgery and Collateral Branches of Science joined with the Medical Intelligencer to form the Boston Medical and Surgical Journal. The second is from 1928 when the title of the publication was changed to the New England Journal of Medicine, and the third report is from the present.

The three accounts reflect the way in which care was delivered at the time. The first account is in the voice of a general practitioner who was contacted for consultation about a woman with intermittent episodes of dyspnea. The second is in the voice of a generalist who works in a private practice and has an interest in asthma; the patient has been referred to this physician by her own general physician. The third account is in the voice of a sub-subspecialty physician whose practice is limited to the care of patients with asthma. The contemporary patient identified this physician as a specialist in asthma through an Internet search and is consulting him for a second opinion about the appropriateness of her asthma care. She brings to the consultation a detailed history that she wrote, as well as notes from her primary care physician and an allergist.

Our three views of this medical consultation for a patient with asthma are not meant to provide a history of asthma but rather to offer a set of snapshots of the care that the same patient might have received had she sought medical advice in these distinct epochs. There are many diagnostic and therapeutic techniques that we do not mention; this does not mean that they are not important; it simply means that their use does not fit the time frame of our fictitious consultations. Finally, since this article is meant to contribute to the celebration of the Journal‘s 200th anniversary, we have largely, but not exclusively, used literature from the Journal; our apologies to others who claim primacy.

1828

Office Note on Mrs. A. Smith

I attended at the home of a woman aged 35 years who had just moved with her family to Boston. Her household includes herself and her husband of 17 years, four children, a cook, two maids, a stable boy, and a footman. She sent for me with a complaint of repeated shortness of breath.

The History of Her Illness

When a fit of dyspnea occurs, the patient hears a musical noise in her chest, and she must labor to draw and expel a full breath. When she is stricken, it is her custom to stop all her activities and to inhale the steam coming from the spout of a kettle that her cook keeps always at the ready. With such treatment, she usually recovers within one or two days. Once or twice a year she has a severe fit, which may last for a week, and she is confined to her sick bed.

She has suffered such fits of laborious breathing since her childhood. They occur at any time of the year but are more common in the spring, when the trees bloom, and in the late summer than at other times. In the winter she reports that it is common for her to be so stricken when she walks from the harbor to her home, a distance of nearly a mile along a path that ascends steeply. This difficulty of respiration has become such a frequent occurrence that she now routinely calls for her coach even for very short journeys outside her home. During each of her periods of confinement for childbearing, the fits were far less numerous and severe in character, but within a few months after she had given birth, they returned.

Often, even when she is not suffering from laborious breathing, she will arise in the dark of the night and stand at the open window, gasping for air. By the time that dawn arrives she has usually regained control of her breathing and returns to sleep.

Her difficulty of respiration is accompanied by itchy eyes and a runny nose. She has a cough with these fits, but she does not produce phlegm. She does not have hemoptysis. No one among her family or close acquaintances has died from consumption. Her weight has been stable, and when she is not suffering from laborious breathing, her strength is good. She has not had rheumatic fever.

Her mother, now deceased, also suffered from difficulty of respiration; her father did not. Of her four children, ages 14, 12, 9, and 7, her two eldest, both boys, have suffered from the same symptoms, although her oldest son has not had a fit of laborious breathing for more than a year.

My Examination

Observation of her breathing on the occasion of my consultation revealed nothing far out of the ordinary. Her speech was full and normal. The movements of her chest were full. I could palpate nothing abnormal in her heart motion. There was no swelling of her liver or her legs. I used a newly acquired stethoscope to examine her chest. Although the patient could not hear the musical sounds that have been termed “wheezes,” I was able to hear them.

My Opinion

The patient clearly suffers from an asthma; she may also have what has been described as “hay fever” in the spring and fall.2 I believe her fits of laborious breathing are similar to the asthmatic fits that Sir John Floyer suffered from and described in his “Treatise of the Asthma.”3 He describes this type of asthma as follows: “[T]he expiration is very slow and leisurely and wheezing, and the asthmatic can neither cough, sneeze, spit nor speak freely; and in the asthmatic fit, the muscular fibres of the bronchia and vesiculae of the lungs are contracted, and that produces the wheezing noise which is most often observable in expiration.” I have no concern that she suffers from consumption or from conditions of the heart that may lead to dropsy.

I think that she may benefit from smoking the leaf of Datura stramonium, also known as the thorn-apple plant. Many asthma sufferers have tried this remedy, and it seems to provide relief from a fit, even though it will not prevent a recurrence. Several years ago, Dr. Bree reported in the New England Journal of Medicine and Surgery that such smoking had a deleterious effect on a number of patients suffering from difficulty of respiration.4 However, in my experience, patients such as this woman will derive benefit from such treatment in that it shortens the duration of their indisposition from an asthmatic fit. I recommended this treatment to my patient, and she tells me that she has benefited from it.

Comment: In the early 1800s, there were many “asthmas,” since this was the term for any episodic shortness of breath. The physician needed to be sure that the primary cause was not tuberculosis or cardiac disease (e.g., mitral stenosis); both were very common at the time. Once a diagnosis of asthma (as we know it now) was established, the number of effective treatments was quite limited; inhalation of smoke from burning Datura stramonium was probably the best. This agent had anticholinergic properties and was the forerunner of the currently used antimuscarinic agents, such as ipratropium and tiotropium.5 There were numerous other treatments, such as inhalation of the fumes of hydrocyanic acid6 or inflation of the lungs with a bellows.7 Fortunately, such treatments and many others that produced no benefit and probably caused harm are no longer used.

1928

Letter Regarding Mrs. A. Smith

Dear Dr. Jones,

Thank you for referring your patient, Mrs. A. Smith, for evaluation concerning a possible diagnosis of asthma. I found the patient’s history, as recounted in your office notes, to be complete and accurate.

History

The critical feature of her case is that Mrs. Smith, age 35, has been having “asthma attacks” since her early childhood. Her attacks are characterized by the relatively sudden onset of dyspnea; they are more frequent in the spring and fall, when they are often preceded by symptoms of rhino-conjunctivitis. If untreated, an attack will last for a few days, but if she is treated with a subcutaneous injection of adrenaline, as you have administered at your office, she often has relief from acute symptoms, and the attack may or may not recur. Recently, her attacks have been more frequent, and she does not feel that her breathing is improved to the point where she can carry out her responsibilities as a wife and mother.

Her mother carried a diagnosis of asthma, as do two of her children. She is currently not using any medications.

Physical Examination

Her physical examination, at a time when she was not having acute asthmatic symptoms, showed normal body temperature, blood pressure, and pulse. She had no rashes. Her nasal passages were closely examined and showed inflammation and edema but no polyps. Her respirations were 24 and slightly labored. She had diminished tactile fremitus. Expiratory wheezing of modest profusion was audible in all lung fields. Her cardiac examination was normal. There was no clubbing, cyanosis, or edema.

Laboratory Studies

I examined the radiograph of the chest that she brought with her, which was taken within the last month. It showed hyperinflation of the lungs, but there were no abnormal shadows; there were no findings that would suggest tuberculosis. Her cardiac silhouette did not show any abnormalities.

A blood smear was made, showing 14 per cent eosinophils; in a normal person this is most often less than 5 per cent. A sputum sample was also examined, and all the polymorphonuclear leukocytes observed were eosinophils. Specialized skin testing was performed. She had positive reactions to extracts of ragweed and horse dander.

My Opinion

Your diagnosis of asthma is correct. The episodes are characteristic, and there is no other likely cause suggested by her medical history or the physical examination and laboratory findings. In fact, the presence of eosinophils in the blood and sputum makes the diagnosis virtually certain. The positive skin tests make this case one of extrinsic asthma. Hypersensitivity to proteins is the likely physiological basis of asthma, although the exact mechanisms leading to sensitization are not clear.

Treatment is difficult. Your use of adrenaline injections for acute attacks is appropriate8; there is reason to believe that treatment with oral ephedrine may also help with her asthmatic episodes.9 The relief is of longer duration than with injected adrenaline and the patient can administer it herself. Ephedrine is not a substitute for injections of adrenaline when the patient is in extremis.

The critical factor in treatment is removing the patient from exposure to the proteins to which she is sensitive. Her positive skin test to ragweed pollen extract is in agreement with the clinical history of worsening disease in the autumn. However, there may be proteins to which she is allergic that were not included in our skin test panel. In my experience, removing a protein from a patient’s exposure is very hard to accomplish. One strategy, which I am loath to suggest unless there is no other hope, is a move to a climate where there are fewer proteins in the air to which the patient would be exposed.10

Comment: By 1928, the differential diagnosis of asthma was well established, and diagnostic techniques were available that made it possible to be reasonably certain that patients did not have heart disease or pneumonia when they were labeled as asthmatic.11 Physicians of the time often used the term “asthma” to refer to episodic dyspnea, but qualifiers such as “cardiac” were used. By 1928, eosinophils in the blood and sputum were known to be characteristic of asthma.12 Skin tests for allergies had been developed and were used clinically to help clinicians identify specific offending environmental proteins. The issues that plague us today — allergies to multiple allergens and difficulty in interpreting skin tests — were of concern to physicians in 1928.

There was not much available in the way of treatment. Ephedrine, an orally active sympathomimetic agent, had been discovered in China9 and used in asthma treatment, but other than allergen removal and adrenaline injections, there was little to offer patients with asthma beyond advising them to smoke “asthma cigarettes” (made from the leaves of D. stramonium [Figure 1Figure 1Asthma Cigarettes.]). Theophylline was available but was used as a diuretic; its value in the treatment of asthma had not yet been discovered. Aerosol inhalation therapy had not been widely adopted by 1928, but by the 1940s an inhaled formulation of epinephrine was marketed for asthma treatment (Figure 2Figure 2Personal Inhaler.).

2012

E-Mail Message to Ms. Smith

Dear Ms. Smith,

Thank you for asking me to provide you with a direct personal consultation concerning your asthma and your asthma care. I will summarize the salient facts from the detailed written history and physician’s note you kindly provided.

As pointed out in your written history, you have had asthma since childhood. Among your earliest recollections is receiving injection treatments and later inhalation treatments for asthma in an emergency room. In your early teenage years you started treatment with inhaled Vanceril (beclomethasone), two puffs twice a day; 10 years ago, you switched to inhaled Qvar (beclomethasone driven by a hydrofluoroalkane [an ozone-layer–friendly] propellant), and Singulair (montelukast) was added to your regimen. Over the past 10 years, you have tried two different “combination inhalers,” containing both inhaled glucocorticoids and long-acting β2-agonists — namely, Advair (fluticasone propionate and salmeterol) and Symbicort (budesonide and formoterol fumarate dehydrate). These medications did not improve your symptoms or lung function as compared with inhaled beclomethasone alone, and you switched backed to Qvar.

Even with this regimen, however, your asthma symptoms are still present and bothersome. For example, two to three times a month you are awakened from your sleep between 3 a.m. and 4 a.m. by shortness of breath and cough; you can hear yourself wheeze. If you use your rescue albuterol inhaler, you are usually able to get back to sleep by 5 a.m.

Two years ago, skin tests were performed, and your total IgE level was measured. Your only positive skin tests were for house-dust mites and ragweed. Your total IgE level was 75 IU per milliliter. The allergist who did the testing suggested that you add a nonsedating antihistamine, such as loratadine, to your treatment during the times of year when you are most susceptible to symptoms; the loratadine was of some small help in controlling your runny nose, but there was no change in your asthma symptoms. Your allergist also referred you to a gastroenterologist, who performed 24-hour esophageal pH monitoring and found no abnormalities.

In the past decade, you have required treatment with oral prednisone on three occasions; the last instance was in 2009. Each of these exacerbations occurred during your allergy season. You have a peak-flow meter, which you use occasionally. Your best reading is 500 liters per minute; on most days, your peak-flow values are between 350 and 400 liters per minute.

You work in an office. You live with your husband and two children in a single-family home heated and air-conditioned with forced air. You have taken extensive measures to remove allergens from your home, including having the air ducts cleaned and tested for allergens. You have no pets. You have never smoked, and the same is true for your husband and your children. Smoking has not been allowed in your workplace for more than a decade. Your mother had asthma.

Your current medications are Qvar, 80 μg per puff, two puffs twice a day; Singulair, 10 mg per day, taken at night; and one multivitamin per day.

You would like a single consultation and confidential second opinion as to how your asthma has been managed and how to improve your asthma control.

On physical examination today, you looked well. Your weight was 135 lb [61.2 kg]. Your blood pressure was 110/75 mm Hg, and your pulse was 77 beats per minute according to the pulse oximeter, which also indicated that your hemoglobin saturation while you were breathing ambient air was 95%. Your physical examination was largely normal. No abnormalities were noted in your eyes, nose, or ears. Your chest examination was normal except for the presence of scattered expiratory wheezes, which were heard best during rapid, shallow breathing. There were no abnormalities in your extremities. Your neurologic examination was normal as well. Lung-function testing was performed in our laboratory; the results are attached to this letter (Figure 3Figure 3Spirometric Results for Ms. Smith.).

I think that the diagnosis of asthma is well established. You have a long history of asthma and have had salutary symptomatic responses to asthma treatments, your lung-function tests still show reversibility of airway obstruction of more than 15% with albuterol, and no other competing diagnosis has emerged over many years. The major issue now is to determine whether there are additional treatments that could help suppress your asthmatic symptoms without increasing the treatment burden.

You and your physicians have done an excellent job of managing your asthma. The treatments you are using now are well established and known to be effective. There are three treatments that could be added to your regimen, but it is difficult to be certain that they would be effective. First, oral theophylline could be added to your regimen. Although you cannot recall having received treatment with theophylline, given your age and asthma history, it is likely that you were treated with this agent as a child. This therapy could be of value, but it is necessary to monitor blood levels of the drug to obtain an optimum response, and some patients find testing to be burdensome. There is a small chance that theophylline could make your asthma worse by relaxing the muscle that separates your stomach from your esophagus; if this occurred, the treatment would be stopped.

Second, Singulair could be replaced with Zyflo CR (zileuton, controlled release). The active ingredient in Singulair is montelukast, which blocks the action of the cysteinyl leukotrienes at the CysLT1 receptor, whereas zileuton prevents the synthesis of both cysteinyl leukotrienes and dihydroxy leukotrienes. There are theoretical reasons to believe that controlled-release zileuton would yield a clinical benefit, but there are no compelling data to support this approach. Monitoring of liver function is required during initiation of treatment with zileuton.

Third, Xolair (omalizumab) could be added to your regimen. This anti-IgE monoclonal antibody is given once a month by injection. There is clearly an allergic component of your disease; your total IgE level is elevated, but it is not so high as to preclude the use of omalizumab.

As we discussed, I think your primary care physician has done an excellent job in designing your asthma treatment. You should discuss our consultation with her and decide what is in your best interest.

Comment: There have been three major changes in our understanding of asthma between 1928 and 2012. First, spirometry, which had been invented in the 1840s,13 was refined by adding time to volume output, and between the late 1940s and early 1950s, measurements made from forced exhalations were used in the diagnosis and treatment of asthma.14 Other lung-function tests were developed and used, and the relationships between clinical physiology and symptoms were delineated.15 Second, glucocorticoids were identified as an effective and useful asthma treatment. They were first used systemically in the early 1950s16 and were subsequently made available in inhaled form17,18,; these agents remain the standard of care today. Third, our understanding of the immunobiology of asthma progressed beyond the view that the essential mechanism was an immediate hypersensitivity reaction.19,20, Unfortunately, these advances in understanding the cell biology of asthma have not yet been translated into new therapies, although new therapies have been derived from our improved understanding of immediate hypersensitivity responses — notably, the use of leukotriene modifiers21 and anti-IgE antibodies.22

Our patient is current in her medical knowledge and is using medical information widely available on the Internet to help in the management of her chronic condition. The consultant used measures of lung function to quantify her physiological deficit. The consultant also measured the patient’s IgE level, which was consistent with allergic asthma, and provided the information needed for anti-IgE treatment, should the patient elect this approach. The patient has used all the standard asthma therapies but has residual symptoms. The consultant outlines other asthma treatments that the patient could try, highlighting the need to try different treatments to see whether one or another will work. Sadly, we still do not have a way to predict a given patient’s response to therapy.

Conclusions

These three case histories illustrate that asthma as a disease has not changed for two centuries. We have made real progress in identifying patients with asthma and in understanding its biologic basis and its treatment. Progress has also been made in diagnostic testing, which has been refined to measure lung function with great accuracy and repeatability. In addition, we can measure the lung’s responsiveness to triggering agents and thereby obtain objective indications of disease activity, in addition to the patient’s history. We have come to realize that allergic responses often substantially contribute to both chronic persistent asthma and acute exacerbations of asthma symptoms, although this association may have been overemphasized. The current focus is on immune responses in affected patients; we believe that airway inflammation plays a critical role in asthma, but the precise nature of that inflammation remains a mystery. The knowledge that asthma runs in families has become the basis for very sophisticated studies of the genetics of asthma, but not much of its heritability can be explained by all the genes identified to date. In spite of all the progress achieved over the past two centuries, we still do not understand the fundamental causes of asthma. Hence, we do not have therapies that address the underlying mechanisms; we have no cure for asthma. The medications at hand provide relief of symptoms and improve lung function and airway responsiveness, but they do not prevent exacerbations or progression of disease, and the most desirable accomplishment, the primary prevention of asthma, is a vision that has not yet become a reality.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Source Information

From the Division of Pneumology–Allergology, University Children’s Hospital, Munich, Germany (E.M.); and the Pulmonary Division, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston (J.M.D.).

Address reprint requests to Dr. von Mutius at Pneumologie and Allergologie, Dr. von Haunersches Kinderspital, Lindwurmstr. 4, D-80337 Munich, Germany.

Apakah obat herbal tanpa efek samping?

Sering diperbandingkan keamanan obat herbal dengan obat sintetik. Obat herbal dianggap oleh sebagian masyarakat lebih aman jika dibandingkan dengan obat sintetik. Alasan yang selalu menjadi dasar pijakan rasionalisasi berfikir mereka adalah bahwa obat herbal adalah obat alamiah, sesuatu yang alamiah adalah asli sesuai dengan pemberian pembuatnya sehingga tetap murni, artinya tidak kotor atau terkotori atau tercampuri.  Sebagian masyarakat bahkan berkeyakinan bahwa obat herbal pasti aman dan pasti tanpa efek samping. Benarkah anggapan seperti itu? Anda berpendapat bagaimana? Tuangkan pendapat Saudara di media ini sebagai bahan diskusi. Ayo siapa mencoba?

Kiat mencegah membengkaknya korban gangguan stroke dan jantung

NEJM edisi 13 september 2011 memuat artikel perspektif tentang stroke dan penyakit jantung. Tidak dapat dipungkiri bahwa stroke dan jantung telah menjadi momok yang menakutkan di seantero jagad raya. Stroke dan penyakit jantung telah menjadi penyebab kematian terbesar. Di Amerika, stroke dan penyakit kardiovaskuler diidap lebih dari 2 juta dengan 800.000 atau lebih penderita berakhir dengan kematian. Bagaimana kiat untuk mengerem laju perkembangan kedua penyakit pembunuh ini, baca Berita selengkapnya sebagai berikut:
Perspective
The “Million Hearts” Initiative — Preventing Heart Attacks and Strokes

Thomas R. Frieden, M.D., M.P.H., and Donald M. Berwick, M.D., M.P.P.

September 13, 2011 (10.1056/NEJMp1110421)

Article
References

Each year, more than 2 million Americans have a heart attack or stroke, and more than 800,000 of them die; cardiovascular disease is the leading cause of death in the United States and the largest cause of lower life expectancy among blacks. Related medical costs and productivity losses approach $450 billion annually, and inflation-adjusted direct medical costs are projected to triple over the next two decades if present trends continue.1

To reduce this burden, the Department of Health and Human Services (DHHS), other federal, state, and local government agencies, and a broad range of private-sector partners are today launching a “Million Hearts” initiative to prevent 1 million heart attacks and strokes over the next 5 years by implementing proven, effective, inexpensive interventions (see tableThe Million Hearts Initiative: Principles and Examples of Interventions.).

Cardiovascular prevention works in two realms: the clinic and the community. Clinical and community interventions each contributed about equally to the 50% reduction in U.S. mortality due to heart attacks between 1980 and 2000.2 If used consistently, proven interventions could prevent more than half of heart attacks and strokes. It’s time to take the next big step.

In the clinical realm, Million Hearts will improve management of the “ABCS” — aspirin for high-risk patients, blood-pressure control, cholesterol management, and smoking cessation. As for community-based prevention, the initiative will encourage efforts to reduce smoking, improve nutrition, and reduce blood pressure. It will implement the cardiovascular-disease–prevention priorities of the National Quality and National Prevention Strategies and help in meeting targets set by Healthy People 2020.

Improving management of the ABCS can prevent more deaths than other clinical preventive services.3 Patients reduce their risk of heart attack or stroke by taking aspirin as appropriate. Treating high blood pressure and high cholesterol substantially and quickly reduces mortality among high-risk patients. Even brief smoking-cessation advice from clinicians doubles the likelihood of a successful quit attempt, and the use of medications increases quit rates further.

Currently, less than half of people with ischemic heart disease take daily aspirin or another antiplatelet agent; less than half with hypertension have it adequately controlled; only a third with hyperlipidemia have adequate treatment; and less than a quarter of smokers who try to quit get counseling or medications. As a result, more than 100 million people — half of American adults — smoke or have uncontrolled high blood pressure or cholesterol; many have more than one of these cardiovascular risk factors. Increasing utilization of these simple interventions could save more than 100,000 lives a year.3 Measuring and monitoring can encourage providers to improve preventive care.4

Improving care is particularly critical in light of increases in the prevalence of obesity and diabetes. Obesity and physical activity are currently being addressed by complementary efforts designed to improve understanding, implement pilot or community-based programs, and evaluate outcomes. The First Lady’s “Let’s Move” campaign is a comprehensive initiative with the goal of ending childhood obesity — a precursor to cardiovascular disease — within a generation by fostering environments that support increased physical activity and improved nutrition for children and families. And public and private partners are working to expand the Diabetes Prevention Program, which promotes weight loss, improved nutrition, and increased physical activity among people at highest risk.

The Affordable Care Act (ACA) provides a strong foundation for Million Hearts by increasing coverage and facilitating improved care. It waives patient cost sharing for preventive services, including blood-pressure and cholesterol screening and smoking-cessation counseling and treatment, for enrollees in new private insurance plans. The new annual wellness visit for Medicare beneficiaries will help physicians focus on reducing cardiovascular risk and target interventions appropriately. Eliminating Medicare’s “doughnut hole” in prescription-drug coverage will increase access to blood-pressure, cholesterol-lowering, and smoking-cessation medications. Covering 32 million currently uninsured Americans will reduce financial barriers to preventive care, and expanding community health centers will increase access to care and reduce health disparities. In addition, electronic health records (EHRs) will support improved clinical decision making.

Additional means of increasing control of the ABCS include reducing or eliminating copayments for medications, once-a-day dosing, team-based care approaches, stepwise care management, and new forms of payment and delivery for higher-quality, higher-value, and coordinated care, such as those envisioned for accountable care organizations.

Expanding use of prevention-oriented EHRs will enable providers and health systems to track and improve management of the ABCS. Incorporating core ABCS-related quality measures and decision-support tools into the 2013–2014 criteria for “meaningful use” of information technology and providing technical assistance through quality-improvement organizations in all states, the 62 Health Information Technology Regional Extension Centers (which reach nearly 100,000 primary care doctors), and Beacon Communities will reach more than 100 million patients within the next few years.

Million Hearts will work to standardize core ABCS indicators across medical practices, insurers, institutional providers, and systems in public and nonpublic settings. Standardization will facilitate public reporting and identification and diffusion of best practices and will reduce providers’ burden by streamlining quality measurement and improvement. The initiative will be linked to quality-recognition programs (e.g., the Physician Quality Reporting System and star ratings for Medicare Part D and Medicare Advantage plans) and may eventually support approaches in which providers are paid more for better preventive care.

Community-based prevention works by facilitating healthy choices. Important community-based prevention initiatives include those funded by the American Recovery and Reinvestment Act’s Communities Putting Prevention to Work program and programs supported by the ACA’s Prevention and Public Health Fund, including Community Transformation Grants, initiatives for tobacco control and chronic-disease prevention and control, many National Prevention Strategy initiatives, and state and local actions addressing tobacco use, nutrition, and the linkage between clinical and community-based prevention.

Reductions in smoking, sodium consumption, and trans fat consumption can substantially and rapidly improve cardiovascular health. Warning people about the harms of tobacco use through mass media and other measures, as well as package labeling as enabled by the Family Smoking Prevention and Tobacco Control Act, and creating smoke-free public places and workplaces, as detailed in the National Prevention Strategy and facilitated through ACA-funded community grants, should further reduce smoking rates by discouraging smoking initiation and encouraging cessation.

Reducing sodium intake, another key National Prevention Strategy intervention, reduces risks of hypertension and cardiovascular disease. Because most dietary sodium comes from processed and restaurant foods, it’s difficult for Americans to limit their sodium consumption. Procurement guidelines from the DHHS and the General Services Administration and proposed school-food standards from the Department of Agriculture include a focus on sodium reduction. Menu-labeling requirements in chain restaurants will help people make more informed choices. The Centers for Disease Control and Prevention (CDC) is increasing public and professional education regarding sodium, and the CDC’s National Health and Nutrition Examination Survey (NHANES) will begin collecting information on sodium consumption.

Consumption of artificial trans fat increases the risk of cardiovascular disease by raising low-density lipoprotein (LDL) cholesterol levels and lowering high-density lipoprotein (HDL) cholesterol levels. Replacing artificial trans fat with heart-healthy oils is feasible and does not increase the cost or change the flavor or texture of foods. Since the Food and Drug Administration began requiring listing of trans fat content on food labels, the industry has voluntarily reformulated foods, and according to CDC data, Americans’ trans fat consumption has decreased by at least half. Elimination of such consumption could prevent 50,000 deaths per year.5

Million Hearts will leverage, focus, and align existing investments and generally not require new public spending. Voluntary initiatives will simplify, harmonize, and automate clinicians’ reporting requirements, decrease administrative burden, improve the quality of prevention and care, and inform the public more fully. Improvements in control of the ABCS, nutrition, and smoking are projected to prevent more than a million heart attacks and strokes over the initiative’s first 5 years. By focusing our initial efforts where they will save the most lives, we aim to make progress toward a health system that will serve Americans’ needs in the 21st century.

ADR Zolendronic Acid

zolendronic acid

zolendronic acid

Zolendronic acid dapat menimbulkan gagal ginjal. Berita selengkapnya sebagai berikut:

FDA Drug Safety Communication: New contraindication and updated warning on kidney impairment for Reclast (zoledronic acid)

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
References

 

Safety Announcement

[09-01-2011] The U.S. Food and Drug Administration (FDA) has approved an update to the drug label for Reclast (zoledronic acid) to better inform healthcare professionals and patients of the risk of kidney (renal) failure. Kidney failure is a rare, but serious, condition associated with the use of Reclast in patients with a history of or risk factors for renal impairment. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA.

 

Facts about Reclast (zoledronic acid)

  • Used to treat or prevent osteoporosis in women after menopause. Reclast helps reduce the chance of having a hip or spinal fracture (break).
  • Used to increase bone mass in men with osteoporosis.
  • Used to treat or prevent osteoporosis in either men or women who take corticosteroid medications for at least one year.
  • Used to treat men and women who have Paget’s disease of the bone.
  • Given as an intravenous infusion in a single dose, once every 1 to 2 years. The infusion time should be no less than 15 minutes.
  • Marketed under the brand name Aclasta outside the United States.

These labeling changes are being made to the Reclast label only, although zoledronic acid, also sold as Zometa, is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the Zometa label as well as in the Reclast label. Dose reductions for Zometa are provided for patients with renal impairment.

Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

The revised drug label will enhance the safe use of Reclast by providing healthcare professionals updated instructions for prescribing and patient monitoring. The revised label states that Reclast should not be used (is contraindicated) in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Reclast (see Additional Information for Healthcare Professionals below).

The Reclast Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the manufacturer of Reclast will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.

 

Additional Information for Patients 

  • Kidney failure is a rare, but serious, side effect associated with the use of Reclast.
  • Your healthcare professional will order a serum creatinine level (a blood test) before and after each dose of Reclast to assess how well your kidneys are functioning.
  • If you have kidney disease, discuss the necessity of Reclast treatment with your healthcare professional. There may be other treatment choices available to you.
  • Make sure your healthcare professional knows about all the medications you are taking. It is helpful to keep a list of all your current medications in your wallet or another location where it is easily retrieved.
  • Report any side effects with Reclast to FDA’s MedWatch program using the information at the bottom of the page in the “Contact Us” box.

 

Additional Information for Healthcare Professionals 

  • Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment.
  • Continue to screen patients prior to each administration of Reclast to identify those with underlying acute or chronic renal impairment, advanced age, or dehydration. Patients with underlying renal impairment appear to be at highest risk for kidney failure. Reclast should be used with caution in this population.
  • The risk of acute renal failure may increase with underlying renal disease and dehydration secondary to fever, sepsis, gastrointestinal losses, diuretic therapy, etc. The risk of developing renal failure in patients with renal impairment also increases with age.
  • Calculate creatinine clearance before each dose of Reclast. Interim monitoring of creatinine clearance should be performed after Reclast dosing in at-risk patients. Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula.
  • Report any adverse events with Reclast to FDA’s MedWatch program using the information at the bottom of the page in the “Contact Us” box

 

Data Summary 

A January 2009 FDA post-market safety review identified five deaths from acute renal failure following Reclast infusion. Based on that review, the Warnings and Precautions section of the Reclast label was updated in March 2009, with a recommendation to monitor serum creatinine before each dose of Reclast and included reports of renal impairment from clinical studies. An FDA Drug Safety Newsletter article was also published in 2009 reporting the post-marketing cases of renal impairment and acute renal failure.

FDA continued to note reports of renal failure to the Agency’s Adverse Event Reporting System (AERS) after the March 2009 label revision. A follow-up review in April 2011 showed an additional 11 cases of fatal acute renal failure and nine cases of renal injury requiring dialysis after Reclast infusion.

Based on the available information provided in the AERS cases, FDA concluded that several risk factors identified as promoting nephrotoxicity with the use of Reclast should be added to the label. Appropriate selection of patients and patient monitoring by healthcare professionals can reduce the likelihood of adverse events occurring and help ensure the safe use of Reclast.

 

References 

  1. National Center for Biotechnology Information. U.S. National Library of Medicine. PubMed Health Diseases and Conditions Monograph Kidney Failure. Available at: http://www.nlm.nih.gov/medlineplus/kidneyfailure.html. Accessed July 10, 2011

 

Contact Us

    • Report a Serious Problem
    • 1-800-332-1088
    • 1-800-FDA-0178 Fax

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857

ADR Asenapin Maleat

asenapin maleat

asaenapin maleat

Data dari FDA menunjukkan bahwa Asenapin maleat dapat menimbulkan reaksi alergi. Asenapin malet merupakan salah satu obat antipsikosis. Penggunaan bahan ini pada sebagian pasien terbukti dapat menimbulkan reaksi alergi. Berita selengkapnya sebagai berikut:

FDA Drug Safety Communication: Serious allergic reactions reported with the use of Saphris (asenapine maleate)

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
References

 

Safety Announcement

[09-01-2011] The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate). The Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections of the Saphris drug label have been revised to include information about this risk and to inform healthcare professionals that Saphris should not be used in patients with a known hypersensitivity to the drug.

 

Facts about Saphris (asenapine maleate)

  • In a class of medications called atypical antipsychotics.
  • Used to treat symptoms of schizophrenia and bipolar disorder.
  • From approval in August 2009 to June 2011, approximately 235,000 prescriptions were dispensed for Saphris and approximately 87,000 patients received a dispensed prescription for Saphris from U.S. outpatient retail pharmacies.1,2

A search of the FDA’s Adverse Event Reporting System (AERS) database identified 52 cases of Type I hypersensitivity reactions (allergic reactions) with Saphris use (see Data Summary below). Hypersensitivity reactions can be classified into four categories (Type I to Type IV). Signs and symptoms of Type I hypersensitivity reactions may include anaphylaxis (a life-threatening allergic reaction), angioedema (swelling of the deeper layers of the skin), low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. These signs and symptoms are consistent with the reactions reported in the 52 cases. Several cases reported multiple hypersensitivity reactions occurring at the same time, with some of these reactions occurring after the first dose of Saphris.

Healthcare professionals should be aware of the risk of hypersensitivity reactions with Saphris and counsel patients who are receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction. Saphris should not be used in patients with a known hypersensitivity to the drug.

Patients should seek emergency medical attention immediately if they develop any signs and symptoms of a serious allergic reaction while taking Saphris.

 

Additional Information for Patients

  • Serious allergic reactions have been reported in patients treated with Saphris.
  • Patients should seek emergency medical attention immediately if they develop any signs and symptoms of a serious allergic reaction such as:
    • Difficulty breathing
    • Swelling of the face, tongue or throat
    • Feeling lightheaded
    • Itching
  • Serious side effects from the use of Saphris should be reported to the FDA MedWatch program, using the information in the “Contact Us” box at the bottom of this page.

 

Additional Information for Healthcare Professionals

  • Type I hypersensitivity reactions, including anaphylaxis and angioedema, have been observed in patients treated with Saphris. In several cases, these reactions occurred after the first dose.
  • The hypersensitivity reactions included: anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash.
  • Saphris is contraindicated in patients with a known hypersensitivity to the product.
  • Patients should be educated to recognize the signs and symptoms of a serious allergic reaction and advised to contact a healthcare professional immediately if they experience any of these symptoms while taking Saphris.
  • Adverse events involving Saphris should be reported to the FDA MedWatch program using the information in the “Contact Us” box at the bottom of this page.

 

Data Summary

Saphris (asenapine maleate) was FDA-approved on August 13, 2009. A search of the AERS database from approval through September 7, 2010 identified 52 cases that reported Type I hypersensitivity reactions associated with Saphris use. Reported signs and symptoms included anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash. Some of the cases reported the occurrence of more than one hypersensitivity reaction following Saphris use. Eight cases reported hypersensitivity reactions after just one dose of Saphris. The reactions reported following one dose included possible angioedema, respiratory distress, and possible anaphylaxis.

Type I hypersensitivity reactions typically require a history of previous exposure to the drug. However, the absence of a known prior exposure does not exclude the reaction, because sensitization may have occurred to a cross-reactive compound in the past even if the patient showed no signs of allergy to the sensitizing product. To date, no specific drug has shown cross-reactivity with Saphris.

Of the 52 cases, 15 reported a resolution of symptoms following Saphris discontinuation, while two of these cases reported a reappearance of symptoms upon reintroduction of Saphris. Nineteen of the cases resulted in hospitalization or emergency room visits, and therapeutic interventions were reported in seven cases.

Although many of the cases have limited information, the findings from the cases are consistent with hypersensitivity reactions, including anaphylaxis, and support a temporal association between the onset of the reactions and Saphris use.

 

References

  1. SDI, Vector One®: National (VONA). August 2009-June 2011. Data extracted August 2011.
  2. SDI, Vector One®: Total Patient Tracker (TPT). August 2009-June 2011. Data extracted August 2011.

Edukasi kesehatan tentang upaya pencegahan bahaya rokok dalam rumah pada ibu-ibu rumah tangga

pembuka mata kesadarandengan penurunan aktivitas merokok dalam rumah di Bantul Yogyakarta

Titiek Hidayati dan Akrom

Fakultas Kedokteran dan Ilmu Kesehatan UMY dan Kepala Pusat Informasi Obat Fakultas Farmasi UAD

Pendahuluan dan tujuan penelitian: Merokok tak langsung telah terbukti berhubungan dengan permasalahan kesehatan utama baik pada orang dewasa maupun anak-anak. Dalam struktur masyarakat Jawa, seorang ibu memegang peran kunci untuk mengendalikan aktivitas, termasuk aktivitas merokok dalam rumah.  Di Yogyakarta lebih dari 80% kepala keluarga perokok melakukan aktivitas merokok di dalam rumah, sehingga upaya membatasi aktivitas merokok dalam rumah merupakan salah satu cara yang dipandang efektif untuk menghindarkan bukan perokok dari paparan asap rokok. Telah dilakukan survey di kawasan semi urban Kab. Bantul pada Desember – Februari 2010 dimana  prevalensi aktivitas merokok dalam rumah sebesar 67%, lebih dari 53% responden menyatakan bahwa Ibu rumah tangga merupakan orang yang tepat untuk membantu upaya mengurangi kebiasaan merokok di dalam rumah, jika diminta istrinya 57% responden kepala keluarga perokok menyatakan bersedia tidak merokok di dalam rumah dan 70% responden ibu rumah tangga menyatakan siap membantu upaya pembatasan kebiasaan merokok dalam rumah. Di Yogyakarta sampai saat ini belum ditemukan metode yang tepat untuk pembatasan aktivitas merokok di dalam rumah. Penelitian pendahuluan ini bertujuan untuk mengetahui bagaimana hubungan edukasi kesehatan tentang upaya pencegahan bahaya rokok dalam rumah pada Ibu-ibu tokoh masyarakat terhadap perubahan aktivitas merokok di dalam rumah.

Metode: Penelitian kuasi eksperimental pre and post controlled design ini dilakukan pada 40 keluarga dengan kepala keluarga perokok di kawasan semi urban di Kab. Bantul Yogyakarta periode Februari – Mei 2011. Sebanyak 40 ibu-ibu sukarelawan dari 40 keluarga sebagai subjek penelitian, dari 40 relawan tersebut, 20 relawan diberi edukasi kesehatan tentang upaya pencegahan bahaya rokok dalam rumah sebagai kelompok perlakuan dan 20 relawan lainnya tanpa perlakuan sebagai kelompok kontrol. Edukasi tentang upaya pencegahan bahaya rokok dalam rumah dilakukan 2x selama periode penelitian oleh fasilitator terlatih dengan struktur materi yang sudah dibakukan dan disesuaikan kondisi subjek penelitian. Dilakukan pengukuran terhadap tingkat pengetahuan dan sikap subjek penelitian tentang upaya pencegahan bahaya rokok dalam rumah sebelum dan setelah perlakuan dengan skala pengukuran yang telah divalidasi. Aktivitas merokok di dalam rumah sebelum dan setelah perlakuan pada kedua kelompok juga diukur dengan menghitung persentase keluarga dengan aktivitas merokok dalam rumah. Dilakukan analisis statistic Wilcoxon untuk melihat perbedaan persentase keluarga dengan aktivitas merokok dalam rumah, tingkat pengetahuan dan sikap sebelum dan setelah perlakuan antar dan intern kelompok dilanjutkan dengan uji Mann-Whitney. Hubungan edukasi upaya pencegahan bahaya rokok dalam rumah dengan penurunan aktivitas merokok dalam rumah dianalisis dengan chi square dan dinyatakan dengan OR.

Hasil: Edukasi tentang upaya pencegahan bahaya rokok dalam rumah menaikkan tingkat pengetahuan dan sikap Ibu rumah tangga terhadap upaya pencegahan bahaya rokok dalam rumah. Perbandingan persentase tingkat pengetahun cukup dan baik tentang upaya pencegahan bahaya rokok dalam rumah sebelum perlakuan antara kelompok perlakuan dengan kontrol adalah  60% dan 40% v.s. 65% dan 35% (p>0.05). Perbandingan persentase tingkat pengetahuan cukup dan baik tentang upaya pencegahan bahaya rokok dalam rumah setelah perlakuan antara kelompok perlakuan dengan control adalah 5% dan 95% v.s. 60% dan 40% (p<0.05). Perbandingan persentase skala sikap cukup dan baik terhadap upaya pencegahan bahaya rokok dalam rumah sebelum perlakuan antara kelompok perlakuan dengan kelompok control adalah 45% dan 55% v.s. 50% dan 50% (p>0.05). Perbandingan persentase skala sikap cukup dan baik terhadap upaya pencegahan bahaya rokok dalam rumah setelah perlakuan antara kelompok perlakuan dan kelompok control adalah 5% dan 95% v.s. 40% dan 60% (p<0.05). Persentase aktivitas merokok dalam rumah sebelum perlakuan baik pada kelompok perlakuan maupun kelompok control adalah 100% (p>0.05). Perbandingan persentase aktivitas merokok dalam rumah setelah perlakuan antara kelompok perlakuan dengan kontrol adalah 5% v.s. 30% (p<0.05). Hasil uji chi square hubungan edukasi upaya pencegahan bahaya rokok dalam rumah pada ibu rumah tangga dengan aktivitas merokok dalam rumah didapatkan OR=0,06 (CI=0.01 – 0.43;p<0.05).

Kesimpulan: Data hasil penelitian ini menunjukkan bahwa edukasi tentang upaya pencegahan bahaya rokok dalam rumah dapat meningkatkan pengetahuan dan sikap ibu rumah tangga terhadap upaya pencegahan bahaya rokok dalam rumah. Edukasi upaya pencegahan bahaya rokok dalam rumah pada ibu rumah tangga berhubungan dengan penurunan aktivitas merokok dalam rumah (OR=0.06, CI=0.01 – 0.43, p<0.05). Edukasi upaya pencegahan bahaya rokok dalam rumah dapat diterapkan sebagai upaya membatasi kebiasaan merokok dalam rumah di Bantul Yogyakarta.

Kata kunci: edukasi upaya pencegahan bahaya rokok; pembatasan aktivitas merokok dalam rumah; ibu rumah tangga; pre and post controlled design