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复方丹参滴丸联合常规降压药物治疗高血压左心室肥厚的临床疗效与安全性的Meta分析

[Meta-analysis of clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in treatment of hypertensive left ventricular hypertrophy].

作者信息

Chen Zhe, Peng Ying-Ying, Yang Feng-Wen, Hu Hai-Yin, Liu Chun-Xiang, Zhang Jun-Hua

机构信息

Tianjin University of Traditional Chinese Medicine Tianjin 301617, China Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.

Tianjin University of Traditional Chinese Medicine Tianjin 301617, China First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300381, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2021 May;46(10):2578-2587. doi: 10.19540/j.cnki.cjcmm.20210222.502.

Abstract

To systematically evaluate the clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy. China National Knowledge Infrastructure(CNKI), Wanfang, VIP, PubMed, EMbase, Cochrane Library, Ovid and Web of Science databases were searched by computer to retrieve the randomized controlled trials(RCTs) of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy from the establishment of databases to July 2020. After two researchers performed data retrieval, data extraction, and risk assessment of bias, they used RevMan 5.3 software for Meta-analysis. A total of 10 RCTs were included, with a total of 979 patients. Meta-analysis results showed that in terms of interventricular septal thickness(MD=-0.70, 95%CI[-1.15,-0.24], P=0.003), left ventricular posterior wall thickness(MD=-0.81, 95%CI[-1.41,-0.21], P=0.008), left ventricular mass index(MD=-8.75, 95%CI[-17.40,-0.10], P=0.05), systolic blood pressure(MD=-8.97, 95%CI[-13.46,-4.48], P<0.000 1), diastolic blood pressure(MD=-5.87, 95%CI[-8.39,-3.34], P<0.000 01) and left ventricular end-diastolic diameter(MD=-1.73, 95%CI[-2.38,-1.08], P<0.000 01), Compound Danshen Dripping Pills combined with conventional antihypertensive drugs was superior to conventional antihypertensive drugs. In terms of left ventricular ejection fraction(MD=0.41, 95%CI[-0.74, 1.55], P=0.49), there was no statistical difference in treatment between the two groups. Because of the small amount of literatures included in the safety aspect, it is impossible to give an accurate conclusion. The GRADE score showed that the level of evidence was low and extremely low. The results show that the Compound Danshen Dripping Pills combined with conventional antihypertensive drugs may effectively improve the clinical efficacy for hypertensive ventricular hypertrophy, and the safety needs to be further explored. Due to the low quality of the included literatures, more high-quality RCTs are needed for verification.

摘要

系统评价复方丹参滴丸联合传统降压药物治疗高血压性左心室肥厚的临床疗效及安全性。通过计算机检索中国知网(CNKI)、万方、维普、PubMed、EMbase、Cochrane图书馆、Ovid和Web of Science数据库,检索自建库至2020年7月复方丹参滴丸联合传统降压药物治疗高血压性左心室肥厚的随机对照试验(RCT)。两名研究人员进行数据检索、数据提取及偏倚风险评估后,采用RevMan 5.3软件进行Meta分析。共纳入10项RCT,共计979例患者。Meta分析结果显示,在室间隔厚度(MD=-0.70,95%CI[-1.15,-0.24],P=0.003)、左心室后壁厚度(MD=-0.81,95%CI[-1.41,-0.21],P=0.008)、左心室质量指数(MD=-8.75,95%CI[-17.40,-0.10],P=0.05)、收缩压(MD=-8.97,95%CI[-13.46,-4.48],P<0.000 1)、舒张压(MD=-5.87,95%CI[-8.39,-3.34],P<0.000 01)及左心室舒张末期内径(MD=-1.73,95%CI[-2.38,-1.08],P<0.000 01)方面,复方丹参滴丸联合传统降压药物优于传统降压药物。在左心室射血分数方面(MD=0.41,95%CI[-0.74,1.55],P=0.49),两组治疗差异无统计学意义。由于安全性方面纳入文献数量较少 , 无法给出准确结论。GRADE评分显示证据等级为低和极低。结果表明,复方丹参滴丸联合传统降压药物可能有效提高高血压性心室肥厚的临床疗效,安全性有待进一步探索。因纳入文献质量较低,尚需更多高质量RCT进行验证。

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