目的 系统评价复方丹参滴丸治疗原发性高血压的疗效及安全性。方法 电子检索CNKI、VIP、Wanfang、CBM、ChiCTR、PubMed、EmBase、Cochrane Library、Web of Science和Clinical Trials数据库中复方丹参滴丸治疗原发性高血压的中英文文献,时间从建库至2021年7月31日。由2名研究者独立筛选文献、提取数据和评价纳入研究偏倚风险后,对资料进行系统评价和Meta分析。结果 纳入22项研究,包含2759例研究对象。复方丹参滴丸联合化学降压药在收缩压[MD=−9.46,95% CI (−12.16,−6.75),P<0.000 01]、舒张压[MD=−5.85,95% CI (−7.58,−4.12),P<0.000 01]、降压有效率[RR=1.17,95% CI (1.12,1.22),P<0.000 01]、室间隔厚度(interventricular septal,IVS)[MD=−0.42,95% CI (−0.73,−0.11),P=0.008<0.05]、左心室舒张末内径(left ventricular end diastolic diameter,LVEDD)[MD=−1.49,95% CI (−2.11,−0.86),P<0.000 01]、心脑血管事件[RR=0.12,95% CI (0.05,0.29),P<0.000 01] 方面的疗效均明显优于单用化学降压药,在左心室后壁厚度(left ventricular posterior wall,LVPW)[MD=−0.20,95% CI (−0.47,0.07),P=0.15>0.05]、不良反应[RR=0.61,95% CI (0.33,1.15),P=0.13>0.05] 方面两组无显著差异。结论 目前临床证据表明复方丹参滴丸辅助治疗原发性高血压疗效确切且安全性较好。因纳入研究少,单用时的疗效及安全性尚不明确。由于纳入研究质量较低,尚需更多高质量临床研究予以验证。

Objective To systematically evaluate the efficacy and safety of Fufang Danshen Dripping Pills (复方丹参滴丸) in the treatment of essential hypertension (EH). Methods Chinese and English literatures on the treatment of EH by Fufang Danshen Dripping Pills in CNKI, VIP, Wanfang, CBM, ChiCTR, PubMed, Embase, Cochrane Library, Web of Science and Clinical Trials were searched electronically. The retrieval time was from database establishment to July 31, 2021. Two researchers independently screened the literature, extracted data and evaluated the risk of bias, and then conducted a systematic review and Meta-analysis. Results Twenty-two studies involving 2759 patients were included. Results showed that Fufang Danshen Dripping Pills combined with western antihypertensive drugs was significantly superior to western antihypertensive drugs alone in systolic blood pressure (SBP)[MD=−9.46, 95% CI(−12.16, −6.75), P < 0.000 01], diastolic blood pressure (DBP)[MD=−5.85, 95% CI(−7.58, −4.12), P < 0.000 01], antihypertensive efficiency[RR=1.17, 95% CI(1.12, 1.22), P < 0.000 01], interventricular septal (IVS)[MD=−0.42, 95% CI(−0.73, −0.11), P=0.008< 0.05], left ventricular end diastolic diameter (LVEDD)[MD=−1.49, 95% CI(−2.11, −0.86), P < 0.000 01] and cardio-cerebral vascular incidents[RR=0.12, 95% CI (0.05, 0.29), P < 0.000 01], but there was no significant difference in left ventricular posterior wall (LVPW)[MD=−0.20, 95% CI(−0.47, 0.07), P=0.15 > 0.05] and adverse reactions[RR=0.61, 95% CI (0.33, 1.15), P=0.13 > 0.05] between two groups. Conclusion Current evidence shows that Fufang Danshen Dripping Pills have a definite curative effect and good safety in the treatment of essential hypertension. Due to the small number of studies included, the efficacy and safety of single use are unclear. More high-quality studies will be needed in the future due to the low quality of included studies.

R285.64

高血压国家中医临床研究基地建设项目（国中医药发[2008]23号）；全国中医学术流派传承工作室第2轮建设项目（XSLP-2013-35）；山东省科技创新基地专项[鲁科字(2018)103号]