Hugo R. Rosen, M.D.
N Engl J Med 2011; 364:2429-2438June 23, 2011
This Journal feature begins with a case vignette highlighting a common clinical problem. Evidence supporting various strategies is then presented, followed by a review of formal guidelines, when they exist. The article ends with the author's clinical recommendations.
FDA表示，根據大型隨機分派研究結果，使用ESA可能增加心血管疾病風險，他們的建議是:
- 尚未接受透析的CKD患者: 僅當血紅素低於10 g/dl時才考慮開始使用ESA，如果治療後血紅素超過10 g/dl，應該考慮減少或暫停使用ESA (很硬!)
- 已經接受透析的CKD患者: 當血紅素低於10 g/dl時開始使用ESA，如果治療後血紅素超過11 g/dl，應該考慮減少或暫停使用ESA
在FDA的聲明中表示，仿單中移除了之前治療目標 (target) 的概念 (因為會讓人聯想這樣才會有效)，而改採治療建議
The US Food and Drug Administration (FDA) today urged more conservative dosing guidelines for erythropoiesis-stimulating agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD).
The US Food and Drug Administration (FDA) has approved fentanyl nasal spray (Lazanda) for the management of breakthrough pain in adults with cancer. It is indicated for patients aged 18 years and older who are already receiving opioid therapy but who have developed resistance to their regimen.
The US Food and Drug Administration (FDA) has approved nitroglycerin ointment 0.4% (Rectiv, ProStrakan Group) for the treatment of moderate to severe pain associated with chronic anal fissures, the company announced today.
The US Food and Drug Administration (FDA) late yesterday approved the first autologous aesthetic cell therapy to improve the appearance of moderate to severe nasolabial fold wrinkles in adults.
John P. Christodouleas, M.D., M.P.H., Robert D. Forrest, C.H.P., Christopher G. Ainsley, Ph.D., Zelig Tochner, M.D., Stephen M. Hahn, M.D., and Eli Glatstein, M.D.
N Engl J Med 2011; 364:2334-2341
Patients with ulcer bleeding who have failed endoscopic hemostasis gain relief from transarterial embolization (TAE). The procedure leads to fewer surgeries, has fewer associated complications, and does not increase overall mortality, according to a study published in the May issue of Gastrointestinal Endoscopy.
Aspirin and simvastatin, which have been shown to be beneficial in the treatment of cardiovascular disease, are ineffective at improving functional capacity in patients with pulmonary arterial hypertension (PAH), according to a multicenter study, sponsored by the National Institutes of Health (NIH), presented here at the American Thoracic Society 2011 International Conference.
The following test-and-teach case makes up an educational activity modeled on the interactive grand rounds approach. The questions within the case are designed to test your current (ie, baseline) knowledge. After each question, you will be able to see whether you answered correctly and can then read evidence-based information that supports the most appropriate answer choice. Please note that these questions are designed to challenge you; you will not be penalized for answering the questions incorrectly. At the end of the activity, there will be a short post-test assessment based on material covered in the case.
The US Food and Drug Administration (FDA) approved ezogabine (Potiga, Valeant Pharmaceuticals and GlaxoSmithKline [GSK]) as an add-on medication to treat seizures associated with epilepsy in adults.
During the second and third trimester of pregnancy, sulfonamides and nitrofurantoins may be used as first-line agents for urinary tract and other infections, but in the first trimester, these agents may be used when no alternatives are available, according to a Committee Opinion from the American College of Obstetricians and Gynecologists (ACOG).
The US Food and Drug Administration (FDA) today approved a sterile, injectable gel called Solesta (Oceana Therapeutics) to treat fecal incontinence in patients after other remedies have failed.
荷蘭葛蘭素史克藥廠公司（ GSK ）「安滅菌糖漿用粉劑（ Augmentin for syrup ）」 156m g/5ml ，以及 457 m g/5ml 二項藥品，經食品藥物管理局檢驗結果，確認含有 DIDP (di-"isodecyl" phthalate) 鄰苯二甲酸二異癸酯。為確保民眾用藥安全，食品藥物管理局已要求 GSK 公司將該二產品下架、回收，直至釐清產品含有塑化劑的原因為止。另外，抗生素治療有一定的療程，正在使用「安滅菌糖漿用粉劑」的民眾，建議儘速回診原處方醫師，由醫師依據醫療專業考量，並充份告知民眾用藥訊息，做必要之調整用藥。
The US Food and Drug Administration has issued an alert about medication error reports in which patients were mistakenly given the antipsychotic risperidone (Risperdal, Johnson & Johnson) instead of the dopamine agonist ropinirole (Requip, GlaxoSmithKline) and vice versa.
An FDA review launched in the wake of a controversial 2010 meta-analysis by DrIlke Sipahi (University Hospitals Case Medical Center, Cleveland, OH) et al [1] suggesting an increased risk of cancer among patients taking angiotensin-receptor blockers (ARBs) has concluded that the drugs do not pose a cancer risk to patients [2]. But reacting to the FDA alert to heartwire , Sipahi said he was disappointed with how the FDA conducted its review and, in particular, its failure to do a patient-level analysis.
Gradual increases in dietary calcium intake above the first quintile in a large female cohort are not associated with further reductions in fracture risk or osteoporosis, according to the results of a prospective longitudinal cohort study reported in the May 24 issue of the BMJ.
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