Risks of harms using antifibrinolytics in cardiac surgery: systematic review and network meta-analysis of randomised and observational studies.
Risks of harms using antifibrinolytics in cardiac surgery: systematic review and network meta-analysis of randomised and observational studies.
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DOI：
10.1136/bmj.e5798
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发表时间：
2012-09-11
期刊：
影响因子：
--
通讯作者：
Tinmouth A
中科院分区：
文献类型：
--
作者：
Hutton B;Joseph L;Fergusson D;Mazer CD;Shapiro S;Tinmouth A
目的 评估 2008 年出于安全原因将抑肽酶从市场上暂停以及最近在欧洲和加拿大重新引入后，抗纤溶药物与不治疗之间死亡、心肌梗塞、中风、肾衰竭或功能障碍的相对风险。设计系统回顾和网络荟萃分析。数据来源 选择抗纤维蛋白溶解治疗的 Cochrane 综述作为本次系统评价的起点。对 Medline、Embase 和 Cochrane 试验登记册进行了检索，对观察证据没有日期限制。研究选择 在接受心脏手术的患者中进行的倾向匹配或调整观察性研究，涉及两种或多种感兴趣的干预措施（抑肽酶、氨甲环酸、ε-氨基己酸和不治疗）。数据分析 使用网络荟萃分析来比较治疗方法，并估计 95% 可信区间的比值比。对单独的随机对照试验和带有观察性研究的随机对照试验进行了荟萃分析。结果 纳入了 106 项随机对照试验和 11 项观察性研究（43-270 名患者）。根据随机对照试验的分析结果，与抑肽酶相比，氨甲环酸平均可降低死亡风险（比值比 0.64，95% 可信区间为 0.41 至 0.99）。当纳入观察数据时，比较显示，相对于氨甲环酸（比值比 0.71，95% 可信区间 0.50 至 0.98）和 ε-氨基己酸（0.60，0.43 至 0.87），抑肽酶平均死亡风险增加，相对于所有比较者，平均肾衰竭或功能障碍风险增加：比值比 0.66与未治疗相比（95%可信区间为0.45至0.88），与氨甲环酸相比为0.66（0.48至0.91），与ε-氨基己酸相比为0.65（0.45至0.88）。结论 尽管随机对照试验的荟萃分析在很大程度上没有结论，但观察数据的纳入表明人们仍然对抑肽酶的安全性感到担忧。氨甲环酸和ε-氨基己酸是有效的替代品，对患者来说可能更安全。
Objective To estimate the relative risks of death, myocardial infarction, stroke, and renal failure or dysfunction between antifibrinolytics and no treatment following the suspension of aprotinin from the market in 2008 for safety reasons and its recent reintroduction in Europe and Canada. Design Systematic review and network meta-analysis. Data sources A Cochrane review of antifibrinolytic treatments was chosen as the starting point for this systematic review. Medline, Embase, and the Cochrane register of trials were searched with no date restrictions for observational evidence. Study selection Propensity matched or adjusted observational studies with two or more of the interventions of interest (aprotinin, tranexamic acid, epsilon-aminocaproic acid, and no treatment) that were carried out in patients undergoing cardiac surgery. Data analysis Network meta-analysis was used to compare treatments, and odds ratios with 95% credible intervals were estimated. Meta-analyses were carried out for randomised controlled trials alone and for randomised controlled trials with observational studies. Results 106 randomised controlled trials and 11 observational studies (43 270 patients) were included. Based on the results from analysis of randomised controlled trials, tranexamic acid was associated on average with a reduced risk of death compared with aprotinin (odds ratio 0.64, 95% credible interval 0.41 to 0.99). When observational data were incorporated, comparisons showed an increased risk of mortality with aprotinin on average relative to tranexamic acid (odds ratio 0.71, 95% credible interval 0.50 to 0.98) and epsilon-aminocaproic acid (0.60, 0.43 to 0.87), and an increased risk of renal failure or dysfunction on average relative to all comparators: odds ratio 0.66 (95% credible interval 0.45 to 0.88) compared with no treatment, 0.66 (0.48 to 0.91) versus tranexamic acid, and 0.65 (0.45 to 0.88) versus epsilon-aminocaproic acid. Conclusion Although meta-analyses of randomised controlled trials were largely inconclusive, inclusion of observational data suggest concerns remain about the safety of aprotinin. Tranexamic and epsilon-aminocaproic acid are effective alternatives that may be safer for patients.
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