美国胃肠病学会(AGA)有关开据 NSAIDs处方的建议

2006-09-23 00:00 来源:丁香园 - 医药生命科学动态跟踪 作者:cplamst 译
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非甾体类抗炎药的应用伴随高发胃肠道并发症
专家组合意制定推荐方案来减小风险

据美国胃肠病学会召集的多学科专家组介绍,非甾体类抗炎药给有适应症的患者提供了广阔的益处,但是保健部门在给病人开据这类药物前,需要仔细考虑它的伴随风险。胃肠道病变是使用非类固醇类抗炎药的最常见的不良反应,包括上消化道和下消化道的并发症。严重的胃肠道并发症,如潜在的致命性出血性溃疡,年发生率为使用者的1-4%。

专家组的讨论结果“关于制定非甾体类抗炎药包括环氧化酶-2抑止剂和阿司匹林的应用方案讨论会的共识”发表在美国胃肠病学会出版的9月份的《临床胃肠病学与肝脏病学》杂志上。

“非甾体类抗炎药是全世界应用最广泛的药物,而且广泛的应用证实了它的功效和相对安全性” 据阿拉巴马大学伯明翰分校内科学教授,论文的主要作者C. Mel Wilcox博士介绍。“但是,过去虽然充分认识了胃肠道并发症,而没有认识到其心脏危险,美国胃肠病学会召集协商会议来增加对应用该类药物的益处和胃肠道及心血管毒性的风险,从而改进对该类药物的应用。”

估计全世界每年消耗500亿阿司匹林片,其中美国大约6000万份处方开据了阿司匹林,并主要给老年病人。这类药物对急、慢性疼痛和骨骼肌肉炎症等方面有效。但是,非甾体类抗炎药的使用伴随着严重的危险,包括胃肠道、肾脏和心血管并发症,甚至包括心力衰竭和心肌梗死。

“我们高兴地看到非甾体类抗炎药的胃肠道并发症和死亡已经从1992年开始下降,我们认为这种状况归功于一下方面:小剂量使用非甾体类抗炎药;降低了幽门螺杆菌的流行;增加了质子泵抑止剂的应用;以及引进对胃肠道更安全的非甾体类抗炎药的应用,如昔布类药物。” Wilcox博士说。“但是,保健部门和病人需要了解该类药物的相关风险来制定非甾体类抗炎药的最佳应用方案。

专家组为保健部门制定了当他们在决定是否给病人开非甾体类抗炎药时的以下建议:

评价治疗的适应症和病人发生胃肠道和心血管并发症的潜在危险因子,并和病人讨论心血管疾病的潜在危险因子。

对风险和益处进行分析来衡量个体胃肠道和心血管危险后,开据低风险的药物。胃肠道出血发生危险大的患者需要应用胃肠道风险低的非甾体类抗炎药,例如非选择性非甾体类抗炎药;心血管事件发生风险大的患者需要接受环氧酶-2抑止剂治疗;有已知心血管疾病或心血管病风险的病人需要接受小剂量阿司匹林。

限制所开非甾体类抗炎药的持续时间和剂量,以及征询并建议病人进行非甾体类抗炎药的联合治疗。

在应用非甾体类抗炎药治疗前,先处理幽门螺杆菌的感染,以致不增加并发消化性溃疡的风险。

针对胃肠道并发症风险大的患者制定胃肠保护方案,如应用米索前列醇或质子泵抑止剂。

“非甾体类抗炎药的应用伴随低胃肠道并发症在诊断和治疗上很重要,” Wilcox博士解释说。“更好地理解低胃肠道出血发生的风险和机理是减少非甾体类抗炎药的使用危险所需要的。”

在协商会议期间讨论的药剂都是非类固醇类抑止炎症反应的药物,因此在学术上被认为是非甾体类抗炎药。非选择性的非甾体类抗炎药,包括布洛芬、依托度酸和萘丁美酮,它们比其他非甾体类抗炎药,例如舒林酸、吲哚美辛、吡罗昔康和酮咯酸对胃肠道具有更高的安全性。昔布类药物是选择性环氧化酶-2抑制剂。在标准剂量下,扑热息痛不是非甾体类抗炎药。

美国胃肠病学会专家组由胃肠病学、风湿病学、心脏病学和内科学医师组成,他们在小组讨论后,以当前科研报告为基础制定了这个方案。

美国胃肠病学会举办的“关于非甾体类抗炎药的应用的协商会议”由TAP药品公司提供的一项无限教育基金资助。与会者的财政开销公布包含在原稿内,在www.cghjournal.org.




Nonsteroidal anti-inflammatory drugs use associated with higher gastrointestinal complications
Consensus panel develops recommendations to minimize risks

Nonsteroidal anti-inflammatory drugs (NSAIDs) provide a broad range of benefits for patients who require their use, but health care providers need to carefully consider the associated risks before prescribing these drugs for their patients, according to a multi-disciplinary panel of experts convened by the AGA Institute. Gastrointestinal (GI) morbidities are the most common adverse events associated with NSAID use, including complications in both the upper- and lower-GI tracts; serious GI complications, such as potentially fatal bleeding ulcers, occur in one to four percent of NSAID users annually.

The findings of the panel, "Consensus Development Conference on the Use of Nonsteroidal Anti-Inflammatory Agents, Including Cyclooxygenase-2 Enzyme Inhibitors and Aspirin," were published in the September issue of Clinical Gastroenterology and Hepatology, published by the American Gastroenterological Association (AGA) Institute.

"NSAIDs are the most widely used medications in the world, and the broad use of these drugs confirms their effectiveness and relative safety," according to C. Mel Wilcox, MD, professor of medicine, University of Alabama at Birmingham, and lead author of the paper. "However, well-recognized GI complications and previously unrecognized cardiac risks have caused great concern about the use of these drugs among healthcare professionals. The AGA Institute convened the consensus conference to increase awareness about the benefits and the risks of GI and cardiovascular toxicities associated with these medications and to improve their use."

An estimated 50 billion aspirin tablets are consumed worldwide and approximately 60 million prescriptions are written for NSAIDs each year in the U.S., predominantly for older patients. These drugs are effective in acute and chronic treatment of painful and inflammatory musculoskeletal conditions, among others. However, NSAID use is associated with several risks including GI, renal and cardiovascular complications, including heart failure and myocardial infarction.

"We were pleased to note that both NSAID-associated GI complications and death have been decreasing since 1992, which we believe can be attributed to several factors: use of lower-dose NSAIDs; decreasing prevalence of H. pylori; increasing use of proton-pump inhibitors; and the introduction of NSAIDs with greater GI safety, such as coxibs," said Dr. Wilcox. "However, healthcare providers and patients need to be aware of the risks associated with these drugs to develop the best plan for using NSAID therapy."

The panel developed the following recommendations for healthcare providers to use when determining whether to prescribe NSAID treatment to their patients:

◎Review the treatment indication and potential patient risk factors, both for GI and cardiovascular complications, and discuss potential cardiovascular risk factor modifications with their patients.
◎Prescribe lower-risk agents after conducting a risk-benefit analysis to determine the GI versus cardiovascular risks for each individual. Patients who are at greater risk of GI bleeding should receive NSAIDs with lower GI risks, such as nsNSAIDs; patients with a greater risk of cardiovascular events should not receive COX-2 inhibitors; and patients with known or a high risk of cardiovascular disease should receive low-dose aspirin.
◎Limit the duration and dosage of the prescribed NSAID and ask about and advise their patients on combination NSAID therapy.
◎Treat patients with H. pylori infection prior to beginning NSAID therapy so as not to increase the risk of complicated ulcers.
◎Institute gastroprotection methods, such as misoprostol or proton pump inhibitors (PPIs), for patients at high-risk of GI complications.

"The association of NSAID use with lower-GI tract complications is important diagnostically and therapeutically," explained Dr. Wilcox. "A better understanding of risk factors for and mechanisms of lower-GI tract bleeding in NSAID users will be required to address risk reduction."

All agents discussed during the consensus conference were nonsteroidal, inhibit inflammation, and thus are technically considered NSAIDs. Nonselective NSAIDs include ibuprofen, etodolac and nabumetone, which may have superior GI safety than other nsNSAIDs, such as sulindac, indomethacin, piroxicam and ketorolac. Coxibs are selective NSAIDs. In standard doses, acetaminophen is not an NSAID.

The AGA Institute panel was comprised of physicians in gastroenterology, rheumatology, cardiology and internal medicine who developed the statement based on presentations of current scientific knowledge followed by group discussion.

The AGA Institute "Consensus Development Conference on the Use of Nonsteroidal Anti-Inflammatory Agents" was supported though an unrestricted educational grant from TAP Pharmaceutical Products Inc. Financial disclosures for conference participants are included in the manuscript at www.cghjournal.org.


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