抑肽酶与赖氨酸类药物在心脏手术中疗效比较的Meta分析

The comparison of aprotinin compared to lysine analogues in cardiac surgical patients: meta-analysis

目的：比较抑肽酶与赖氨酸类药物对心脏手术疗效的影响。方法：检索电子数据库，检索时限为1990年1月-2015年8月，全面搜集比较抑肽酶与赖氨酸类药物对心脏手术疗效的研究，并用RevMan5．0．2软件对其进行Meta分析。结果：纳入31项研究共33501例患者。在低风险组和中级风险组中，抑肽酶均可显著增加心脏手术的早期病死率[RR=1．86，95％CI（1．53～2．25），P〈0．00001；RR=1．40，95％（1．18～1．66），P=0．0001]。而在高危组，抑肽酶和赖氨酸类药物相比较，死亡风险比较差异无统计学意义[RR=1．03，95％（0．67—1．58），P=0．90]，但抑肽酶能够减少高等风险心脏手术后的输血和出血并发症的风险[RR=0．79，95％CI（0．70～0．89），P〈0．01]。结论：抑肽酶与赖氨酸类药物比较，会增加低危和中等风险的心脏手术病死率的风险，但可减少高危组的心脏手术输血和出血并发症的风险，而对其早期病死率没有影响。

Objective：To compare the effect of aprotinin with lysine analogues on cardiac surgical patients. Methods：To perform a meta - analysis of randomised controlled trials and observational studies with the following data sources August 2015, and reference lists of identified articles. Results：Thirty - one studies included 33 501 patients. Early mortality was significantly increased after aprotinin vs lysine analogues [ RR = 1.86,95% CI （ 1.53 - 2.25 ）, P 〈 0. 000 01 ] in the low and the intermediate risk subgroup[ RR = 1.40,95% （ 1.18 - 1.66 ）, P = 0. 000 1 ], respectively. Contrarily, the mortality did not significantly differ between aprotinin and lysine analogues in the high risk subgroup [ RR = 1.03,95% （0.67 - 1.58 ）, P =0.90 ]. Meanwhile, the aprotinin could decrease the risk of transfusion and bleeding complications [ RR = 0.79,95 % CI （0.70 - 0.89 ）, P 〈 0.01 ]. Conclusion：Aprotinin may be associated with an increased risk of mortality in low and intermediate risk cardiac surgery, but presumably may has no effect on early mortality in a subgroup of high risk cardiac surgery compared to lysine analogues. Thus, decisions to relicense aprotinin in lower risk patients should critically be debated. In contrast, aprotinin might probably be beneficial in high risk cardiac surgery as it reduces risk of transfusion and bleeding complications.