环加氧酶2抑制剂对肾脏和心律失常事件的不良影响:随机试验的meta分析。
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张军，丁磊，宋勇
环加氧酶2抑制剂对肾脏和心律失常事件的不良影响:随机试验的meta分析。
《美国医学协会杂志》上。2006年10月4日;296(13):1619-32。Epub 2006 9月12日。
- PubMed ID
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16968832 (查看PubMed］
- 摘要
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背景:选择性环氧合酶2 (COX-2)抑制剂对肾脏事件和心律失常的不良影响一直存在争议，有一类效应的建议。目的:定量评估肾脏事件(肾功能障碍、高血压和外周水肿)和心律失常事件的不良风险，并探索COX-2抑制剂罗非昔布、塞来昔布、瓦尔德考昔布、帕瑞考昔布、埃托瑞昔布和鲁米拉昔布的药物类效应和明显效应的时间趋势。数据来源:系统检索EMBASE和MEDLINE(截止2必威国际app006年6月)、书目、美国食品和药物管理局报告和制药行业临床试验数据库。研究选择:从相关报道中，纳入114项随机双盲临床试验。数据提取:使用标准化协议提取有关发表年份、参与者特征、试验持续时间、药物、对照、剂量和事件的信息。数据综合:通过随机效应模型和元回归汇集结果。来自114个试验报告的11694名参与者，包括127个试验人群(40个罗非昔布，37个塞来昔布，29个伐尔德昔布+帕瑞昔布，15个依特瑞昔布，6个鲁米昔布)，总共有6394例复合肾脏事件(2670例外周水肿，3489例高血压，235例肾功能障碍)和286例心律失常事件。结果显示不同药物对肾脏的影响具有显著的异质性(相互作用P = 0.02)，表明没有分类效应。与对照组相比，罗非昔布与心律失常风险增加相关(相对风险[RR]， 2.90;95%置信区间[CI]， 1.07-7.88)和复合肾脏事件(RR, 1.53; 95% CI, 1.33-1.76); adverse renal effects increased with greater dose and duration (both P< or =.05). For all individual renal end points, rofecoxib was associated with increased risk of peripheral edema (RR, 1.43; 95% CI, 1.23-1.66), hypertension (RR, 1.55; 95% CI, 1.29-1.85), and renal dysfunction (RR, 2.31; 95% CI, 1.05-5.07). In contrast, celecoxib was associated with lower risk of both renal dysfunction (RR, 0.61; 95% CI, 0.40-0.94) and hypertension (RR, 0.83; 95% CI, 0.71-0.97) compared with controls. Other agents were not significantly associated with risk. Time-cumulative analyses indicated that for rofecoxib the adverse risks for peripheral edema and hypertension were evident by the end of year 2000 and for risk of arrhythmia by 2004. CONCLUSIONS: In this comprehensive analysis of 114 randomized trials with 116,094 participants, rofecoxib was associated with increased renal and arrhythmia risks. A COX-2 inhibitor class effect was not evident. Future safety monitoring is warranted and may benefit from an active and continuous cumulative surveillance system.
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