吲哚布芬预防心脑血管事件效果和安全性的Meta分析  

Effectiveness and safety of indobufen in preventing cardiovascular and cerebrovascular events:a Meta-analysis

作　　者：徐荣彬[1] 杨俊[2] 韩晟[3] 孙凤[2] 马军[1] 

机构地区：[1]北京大学儿童青少年卫生研究所,北京100191 [2]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [3]北京大学药学院药事管理与临床药学系,北京100191

出　　处：《中国循证心血管医学杂志》2017年第5期532-538,共7页Chinese Journal of Evidence-Based Cardiovascular Medicine

基　　金：国家自然科学青年基金(81302508)

摘　　要：目的系统评价吲哚布芬预防心脑血管事件的效果和安全性。方法计算机检索CBM、CNKI、WanFang Data、VIP、PubMed、EMbase、Cochrane Library、ClinicalTrail.gov等数据库,关于吲哚布芬预防心脑血管事件且对照药物为阿司匹林或华法林的临床试验或队列研究,检索时限均从建库至2016年10月10日。由2人独立进行文献筛选、资料提取和质量评价,使用R 3.3.1软件进行分析。结果最终纳入11项RCT研究和2项有对照的临床试验,吲哚布芬组合计1043例,对照组合计1040例。有10项研究的对照药为阿司匹林,随访时间为2周~6月,其中4项为高质量研究。3项研究的对照药为华法林,随访时长为6~12月,仅1项为高质量研究。Meta分析结果显示:吲哚布芬在预防心脑血管疾病患者全死因死亡、心血管死亡、脑卒中、心肌梗塞、肺栓塞及全身栓塞方面,与阿司匹林、华法林差异无统计学意义(P>0.05)。吲哚布芬导致的总不良事件要少于阿司匹林[OR=0.26(95%CI:0.16,0.42)]和华法林[OR=0.54(95%CI:0.32,0.91)];其中吲哚布芬发生总出血事件要少于阿司匹林[OR=0.35(95%CI:0.17,0.73)]、华法林[OR=0.17(95%CI:0.07,0.41)];吲哚布芬发生胃肠道反应要少于阿司匹林[OR=0.25(95%CI:0.13,0.49)],而与华法林差异无统计学意义(P>0.05)。结论吲哚布芬预防心脑血管事件的效果与阿司匹林和华法林无差异,而安全性优于阿司匹林和华法林。但受纳入研究质量和数量的限制,对本研究结论的运用需谨慎。Objective To review systematically the effectiveness and safety of indobufen in preventing cardiovascular and cerebrovascular events. Methods The databases of CBM, CNKI, WanFang Data, VIP, PubMed, EMbase, Cochrane Library and ClinicalTrail.gov were retrieved with computer for searching the clinical trials or cohort studies on indobufen and control drugs-aspirin or warfarin in preventing cardiovascular and cerebrovascular events from the establishing time of the databases to Oct. 10, 2016. The literature was screened, data was extracted and quality was reviewed by 2 researchers independently and all materials were analyzed by using R 3.3.1 software. Results There were finally 11 RCT and 2 clinical trials with controls included, and 1043 cases in indobufen group and 1040 cases in control group. There were 10 studies with aspirin as control drug, the follow-up time was from 2 w to 6 m, and among them 4 were high-quality studies. There were 3 studies with warfarin as control drug, the follow-up time was 6～12 m, and only 1 was high-quality study. The results of Meta-analysis showed that the differences in all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, pulmonary infarction and whole body infarction had no statistical significance among indobufen, aspirin and warfarin （P〉0.05）. The adverse events induced by indobufen were less than those induced by aspirin [OR=0.26 （95%CI： 0.16, 0.42）] and warfarin [OR=0.54 （95%CI： 0.32, 0.91）]. The total bleeding events induced by indobufen were less than those induced by aspirin [OR=0.35 （95%CI： 0.17, 0.73）] and warfarin [OR=0.17 （95%CI： 0.07, 0.41）]. The gastrointestinal reactions induced by indobufen were less than those induced by aspirin [OR=0.25 （95%CI： 0.13, 0.49）] and had no statistical significance compared with warfarin （P〉0.05）. Conclusion The effectiveness of indobufen in preventing cardiac-cerebral vascular events has no difference compared with aspirin and warfarin, while its safety i

关 键 词：吲哚布芬 心血管疾病 有效性比较研究 安全性 META分析 

分 类 号：R541[医药卫生—心血管疾病]