通心络联合氯吡格雷治疗冠心病心绞痛疗效与安全性的Meta分析

目的:系统评价通心络联合氯吡格雷治疗冠心病心绞痛的有效性与安全性。方法:计算机检索CBM,CNKI和Wanfang Data等数据库,检索相关随机对照试验,按纳入与排除标准筛选文献、提取数据和评价纳入研究的方法质量后,采用Rev Man 5.2.6软件进行Meta分析。结果:共纳入10篇文献,包含867例患者。通心络联合氯吡格雷优于氯吡格雷的心绞痛疗效OR=4.01,95%CI(2.68,5.99)],两组差异有统计学意义(P0.000 01)。通心络联合氯吡格雷与氯吡格雷的心电图疗效差异没有统计学意义OR=1.67,95%CI(0.94,2.98),P=0.08]。根据对照组用药不同进行亚组分析,Meta分析结果显示,通心络联合氯吡格雷组的心绞痛疗效高于氯吡格雷组,两组差异有统计学意义OR=6.95,95%CI(3.87,12.69),P0.000 01]。通心络联合氯吡格雷组的心绞痛疗效高于氯吡格雷联合肌苷组,两组差异有统计学意义OR=2.61,95%CI(1.06,6.40),P0.05]。间接比较表明,单用氯吡格雷组与单用通心络组心绞痛疗效差异没有统计学意义OR=1.19,95%CI(0.42,3.39),P0.05]。结论:现有证据表明,通心络联合氯吡格雷可有效改善心绞痛且安全性总体可接受。限于纳入研究的文献质量总体一般,笔者建议上述结论有待今后进一步开展高质量临床随机对照双盲试验加以证实。

Evaluation and Meta-analysis of Tongxinluo Capsule Combined with Clopidogrel in Treatment of Angina Pectoris

Objective: To systemically assess the efficacy and safety of Tongxinluo capsule combined with clopidogrel in treatment of angina pectoris. Method: Such databases as CBM, CNKI and Wanfang data were electronically searched to collect relevant randomized controlled trials (RCTs). According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data, and assessed the methodological quality of included studies. Then, Meta-analysis was conducted using RevMan 5.2.6 software. Result: The 10 RCTs with 867 patients were included. Tongxinluo capsule combined with clopidogrel had a better efficacy on angina pectoris than clopidogrel alone OR=4.01, 95%CI (2.68, 5.99)], with statistically significant difference between the two groups (P<0.000 01). There was no statistically significant difference in electrocardiography (ECG) efficacy between Tongxinluo capsule combined with clopidogrel and clopidogrel alone OR=1.67, 95%CI (0.94, 2.98), P=0.08]. The subgroup analyses based on regimen in the control group showed that, compared with clopidogrel alone group, the Tongxinluo capsule combined with clopidogrel group had a higher efficacy on angina pectoris, with statistically significant difference between the two groups OR=6.95, 95%CI (3.87, 12.69), P<0.000 01]. Compared with clopidogrel combined with inosine group, the Tongxinluo capsule combined with clopidogrel group had a higher efficacy on angina pectoris, with statistically significant difference between the two groups OR=2.61, 95%CI (1.06, 6.40), P<0.05]. Indirect treatment comparison showed that there was no significant difference in efficacy on angina pectoris between clopidogrel alone group and Tongxinluo capsule alone group OR=1.19, 95%CI (0.42, 3.39), P>0.05]. Conclusion: Existing evidences suggest that Tongxinluo capsule combined with clopidogrel is effective and safe in improving angina pectoris. However, the quality of RCTs is not high, so more randomized double-blind clinical trials with high quality are still needed for further verification.