复方丹参滴丸对冠心病心绞痛辨证论治疗效影响的Meta分析

目的 系统评价复方丹参滴丸联合化学药常规治疗冠心病心绞痛的疗效及安全性。方法 检索中文数据库（知网、维普、中国生物医学文献、万方数据）及英文数据库（Pubmed、Cochrane Library）。检索关键词筛选符合条件的研究，根据Cochrane手册评价文献质量，应用Stata13.1和RevMan 5.3软件进行Meta分析、亚组分析，经上述方法系统性评价复方丹参滴丸治疗冠心病心绞痛在有无辨证用药2种情况下疗效区别。结果 纳入39项研究，共计3 941例患者，试验组1 991例，对照组1 950例，文献质量偏低。Meta分析结果显示，应用化学药常规治疗加用复方丹参滴丸组的临床疗效RR=1.24，95% CI（1.20，1.28），P<0.000 01]、心电图临床疗效RR=1.29，95% CI（1.21，1.37），P<0.000 01]、心绞痛发作频率WMD=-1.82，95% CI（-3.28，-0.36），P=0.01]、心绞痛发作持续时间WMD=-2.09，95% CI（-2.67，-1.50），P<0.000 01]、超敏C反应蛋白（hs-CRP）WMD=-2.63，95% CI（-4.39，-0.86），P=0.003]、内皮素（ET）WMD=-16.22，95% CI（-19.37，-13.06），P<0.000 01]、血小板聚集率WMD=-7.46，95% CI（-11.15，-3.78），P<0.000 1]、血小板颗粒膜蛋白（GMP-140）WMD=-5.64，95% CI（-6.88，-4.39），P<0.000 01]、纤维蛋白原WMD=-0.73，95% CI（-1.00，-0.46），P<0.000 01]与对照组相比有显著差异；在临床疗效方面，辨证用药组与无辨证用药组的合并效应无显著差异（P=0.55，I²=0）。共有15项研究阐述不良反应，试验组有43例出现不良反应，对照组有65例出现不良反应。漏斗图与Egger’s检验结果提示无明显发表偏倚。结论 冠心病心绞痛患者应用复方丹参滴丸安全有效，较单纯常规治疗可进一步提高临床疗效。结合辨证论治应用复方丹参滴丸疗效与不辨证用药疗效均显著，且无显著性差异。所得结论仍需建立在更多高质量、大样本量的文献基础上加以论证。

Meta analysis on efficacy of Compound Danshen Dropping Pills in treating angina based on syndrome differentiation

Objective To evaluate the efficacy and safety of the combination therapy of Compound Danshen Dropping Pills and conventional chemical drugs in the treatment of the angina by Meta-analysis. Methods Databases including CNKI, WanFang, CBM, VIP, PubMed, and Cochrane Library were searched to collect qualified researches, and the quality of articles was evaluated according to Cochrane Handbook. Meta-analysis including subgroup analysis was performed by using Stata 13.1 and RevMan 5.3 software. All these methods were used to systematically evaluate the safety and clinical efficacy of Compound Danshen Dropping Pills in the treatment of angina pectoris under two circumstances (with or without syndrome differentiation). Results A total of 39 studies involving 3 941 patients were studied, including 1 991 patients in the experimental group and 1 950 in the control group. The results of Meta analysis showed that:the clinical efficacyRR=1.24, 95%CI (1.20, 1.28), P<0.000 01], ECG efficacyRR=1.29, 95%CI (1.21, 1.37), P<0.000 01], angina attack frequencyWMD=-1.82, 95%CI (-3.28, -0.36), P=0.01], duration of angina attackWMD=-2.09, 95%CI (-2.67, -1.50), P<0.000 01], hs-CRPWMD=-2.63, 95%CI (-4.39, -0.86), P=0.003], ETWMD=-16.22, 95%CI (-19.37, -13.06), P<0.000 01], platelet aggregationWMD=-7.46, 95%CI (-11.15, -3.78), P<0.000 1], GMP-140WMD=-5.64, 95%CI (-6.88, -4.39), P<0.000 01] and fibrinogenWMD=-0.73, 95%CI (-1.00, -0.46), P<0.000 01] of routine western medicine treatment combine with Compound Danshen Dripping Pills group had significant difference compared with the control group; In terms of clinical efficacy, the combination effect of dialectical medication group and non dialectical medication group had no significant difference (P=0.55, I²=0). A total of 15 studies described adverse reactions, with 43 cases in the experimental group and 65 cases in the control group. There was no significant publication bias on funnel plot and Egger''s test. Conclusion It is safe and effective to use Compound Danshen Dropping Pills in patients with coronary heart disease and angina, which can further improve the clinical effect compared with the simple routine treatment. There is no significant difference between the therapeutic effect of Compound Danshen Dropping Pills and that of non-syndrome differentiation. However, these conclusions still need to be verified with more high-quality and large-sample literature.