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532 ?中国循证心血管医学杂志2017年5月第9卷第5期 Chin J Evid Based Cardiovasc Med,May,2017,Vol.9,No.5
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循证理论与实践·论著 ?
吲哚布芬预防心脑血管事件效果和安全性的Meta分析
徐荣彬1，杨俊2，韩晟3，孙凤2，马军1
【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。
【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
【中图分类号】R541 【文献标志码】 A 【文章编号】1674-4055(2017)05-0532-07Effectiveness and safety of indobufen in preventing cardiovascular and cerebrovascular events: a Meta-Peking University, Beijing 100191, China.
Corresponding authors: SUN Feng, E-mail:sunfeng@bjmu.edu.cn; MA Jun, E-mail:majunt@bjmu.edu.cn
[Abstract] 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 is higher. However, the conclusion should be considered with caution due to the limited quality and quantity of included studies.
[Key words] Indobufen; Cardiovascular diseases; Comparative-effectiveness research; Safety; Meta-analysis
基金项目：国家自然科学青年基金(81302508)
作者单位：1 100191 北京,北京大学儿童青少年卫生研究所;2 100191 北京,北京大学公共卫生学院流行病与卫生统计学系; 3
100191 北京,北京大学药学院药事管理与临床药学系
共同通讯作者：孙凤,E-mail:sunfeng@bjmu.edu.cn; 马军,E-mail:majunt@bjmu.edu.cn
doi：10.3969/j.issn.1674-4055.2017.05.06
analysis XU Rong-bin*, YANG Jun, HAN Sheng, SUN Feng, MA Jun. *Institute of Child and Adolescent Health of
抗血小板治疗可预防动脉血栓、混合性血栓、静脉血栓等等导致的缺血性心血管疾病，如冠心病，缺血性脑血管疾病等[1]。吲哚布芬是一种抗血小板药物，最早于1984年8月在意大利上市[2]，对于治疗及预防血栓栓塞性疾病具有一定的疗效，可作为不能接受一线抗栓方案的患者的
吲哚布芬预防心脑血管事件效果和安全性的Meta分析
