基于meta分析的复方丹参注射液治疗不稳定型心绞痛的临床评价

Meta-analysis on the randomized controlled trials of Fufang-Danshen injection in the treatment of unstable angina pectoris

目的：系统评价复方丹参注射液（FD）治疗不稳定型心绞痛（UAP）的临床疗效及安全性。方法计算机检索中国期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、中文科技期刊全文数据库（VIP）、万方数据库、PubMed、Embase和Cochrane Library等，全面搜集有关FD治疗UAP的随机对照试验和半随机对照试验，采用 Cochrane 风险评价表评价其研究质量，提取资料并通过RevMan5.2进行数据分析。结果共纳入13篇研究，共计受试者1156例。Meta分析的结果显示：①心绞痛疗效总有效率：FD＋常规治疗（WM）对WM，两组差异有统计学意义[RR＝1.32，95%CI（1.21，1.43）， P＜0.01]；FD＋低分子肝素＋WM对WM，两组差异有统计学意义[RR＝1.29，95%CI（1.17，1.42）， P＜0.01]，均表明治疗组疗效优于对照组。其余干预措施，FD＋WM对低分子肝素＋WM与FD对WM的治疗组与对照组间差异无统计学意义。②心电图疗效总有效率：FD＋WM对WM，两组差异有统计学意义[RR＝1.34，95% CI（1.14，1.57），P＜0.01]；FD对WM，两组差异有统计学意义[RR＝1.49，95%CI（1.13，1.96），P＜0.01]，表明治疗组可有效改善心电图疗效总有效率。③心绞痛发作次数：FD＋WM对WM，两组差异有统计学意义[MD＝1.07，95% CI（0.48，1.66），P＜0.01]。其他分析未见组间差异。④不良反应：4篇文献明确表示无不良反应发生，4篇文献报道了不良反应，多为头痛、恶心、面色潮红等，不影响治疗。治疗组出现不良反应9例，对照组9例。结论 FD用于治疗UAP具有一定的疗效，安全性相对可靠。但因纳入文献质量不高且存在偏倚，需进一步研究。

Objective To systematically evaluate the clinical efficacy and safety of Fufang-Danshen Injection （FD） in the treatment of unstable angina pectoris（UAP）. Methods Randomized controlled trials （RCTs） and quasi-RCTs regarding FD in the treatment of UAP were collected through comprehensive searches of China National Knowledge Infrastructure（CNKI）, Chinese Scientific Journals Database（VIP）, Wan fang Database, Chinese Biomedical Literature Database（CBM）, PubMed, Embase and Cochrane Library from January 1979 to December 2013. Two reviewers independently assessed the quality of the included studies by the Cochrane risk of bias, and extracted the information from the included studies. Meta-analysis was conducted with the software Review Manager 5.2. Results A total of 13 studies with 1156 participants were included. In the meta-analysis, ①the total effective rate of UAP：in term of FD＋conventional therapy with western medicine（WM）vsWM, the difference between two groups was statistically significant [RR=1.32, 95%CI（1.21, 1.43）, P〈0.01]; FD＋low molecular weight heparin＋WM vs WM, difference between two groups was also statistically significant [RR=1.29, 95% CI（1.17, 1.42）, P〈0.01], which indicated that the efficacy of experimental group was higher than the control group. Other interventions, such as FD＋WM vs low＆amp;nbsp;molecular weight heparin＋WM and FD vs WM, there was no significant difference between two groups. ②the total effective rate of ECG：in term of FD＋WM vs WM, the difference between two groups was statistically significant [RR=1.34, 95%CI （1.14, 1.57）, P〈0.01]; in term of FD vs WM, difference between two groups was statistically significant [RR=1.49, 95%CI（1.13, 1.96）, P〈0.01], which indicated that experimental group can effectively improve the total effective rate of ECG. ③ frequency of angina attacks：in term of FD＋WM vs WM, the difference between two groups was statistically significant [MD=1.07, 95%CI（0.48, 1.66）, P〈0.01]. No differences between groups existed in other analysis. ④ adverse drug reactions（ADRs）：4 articles cleared that there was no ADRs in the studies, 4 studies reported ADRs, which represented headache, nausea, flushing and so on. There were 9 cases in the experimental group, and 9 in control group. Conclusion Based on the meta-analysis, FD was effective and relatively safe for the treatment of UAP in clinical. However, since the articles enrolled in the study were not in high quality, more qualified studies should be conducted for the further assessment of efficacy and safety of FD for UAP.