天麻钩藤颗粒联合降压药治疗原发性高血压病的系统评价及试验序贯分析

Systematic evaluation and trial sequential analysis of Tianma Gouteng Granules combined with anti-hypertensive drugs in treatment of essential hypertension

系统评价天麻钩藤颗粒联合常规降压药治疗原发性高血压病的有效性及安全性。检索PubMed、EMbase、Cochrane Library、维普中文科技期刊数据库(VIP)、中国知网数据库(CNKI)、万方数据库(Wanfang)、中国生物医学文献服务系统(SinoMed)等自建库至2020年4月收录的关于天麻钩藤颗粒联合常规降压药治疗原发性高血压病的随机对照试验,根据纳排标准筛选文献,使用RevMan 5.3软件进行Meta分析。共纳入15项随机对照试验,1 508例患者。Meta分析结果显示,天麻钩藤颗粒联合常规西药在降低收缩压(MD=-10.24,95%CI[-13.54,-6.95],P<0.000 01)、舒张压(MD=-5.33,95%CI[-7.21,-3.45],P<0.000 01),改善患者临床疗效(RR=1.22,95%CI[1.15,1.28],P<0.000 01)和中医证候疗效(RR=1.26,95%CI[1.02,1.57],P=0.04),提高一氧化氮含量(MD=9.59,95%CI[7.23,11.96],P<0.000 01),降低内皮素-1(MD=-10.74,95%CI[-15.74,-5.75],P<0.000 1)、肿瘤坏死因子(MD=-0.28,95%CI[-0.36,-0.19],P<0.000 01)、白细胞介素-6(MD=-39.71,95%CI[-43.40,-36.03],P<0.000 01)等方面的作用优于对照组,在不良反应发生方面试验组与对照组差异无统计学意义,均未发生肝肾功能异常,亚组分析结果显示在降低收缩压和舒张压发面,使用天麻钩藤颗粒联合血管紧张素Ⅱ受体拮抗剂(ARB)类药物的作用更明显。试验序贯分析显示临床疗效累计纳入的研究穿过了传统界值和TSA界值,进一步肯定了其临床疗效。临床应用天麻钩藤颗粒联合常规西药治疗原发性高血压病及伴随症状的疗效明确,并且具有一定的安全性,推荐临床应用。

To systematically evaluate the efficacy and safety of Tianma Gouteng Granules combined with conventional anti-hypertensive drugs in the treatment of essential hypertension. The clinical randomized controlled trials(RCTs) on the treatment of essential hypertension with Tianma Gouteng Granules combined with conventional anti-hypertensive drugs were searched in PubMed, EMbase, Cochrane Library, VIP, CNKI, Wanfang, SinoMed since the establishment of the databases to April 2020 based on inclusion and exclusion criteria, and Meta-analysis was conducted by using RevMan 5.3 software. A total of 15 RCTs were included, involving a total of 1 508 patients. Meta-analysis results showed that Tianma Gouteng Granules combined with conventional Western medicine were supe-rior to the control group in reducing systolic blood pressure(MD=-10.24, 95%CI[-13.54,-6.95], P<0.000 01), diastolic blood pressure(MD=-5.33, 95%CI[-7.21,-3.45], P<0.000 01), improving the clinical efficacy of patients(RR=1.22, 95%CI[1.15, 1.28], P<0.000 01) and curative effect of traditional Chinese medicine syndrome(RR=1.26, 95%CI[1.02, 1.57], P=0.04), increasing nitric oxide content(MD=9.59, 95%CI[7.23, 11.96], P<0.000 01), reducing endothelin-1(MD=-10.74, 95%CI[-15.74,-5.75], P<0.000 1), tumor necrosis factor(MD=-0.28, 95%CI[-0.36,-0.19], P<0.000 01), and interleukin-6(MD=-39.71, 95%CI[-43.40,-36.03], P<0.000 01). There was no statistically significant difference between the test group and the control group in the incidence of adverse reactions. No liver and kidney dysfunction occurred. The results of the subgroup analysis showed that the effect of Tianma Gouteng Granules combined with ARB drugs was more obvious in reducing the systolic and diastolic pressure. Trial sequential analysis showed that the studies accumulatively included for clinical efficacy crossed the traditional threshold and the TSA threshold, further affirming its clinical efficacy. The clinical application of Tianma Gouteng Granules combined with conventional Western medicine in the treatment of primary hypertension and accompanying symptoms has clear efficacy and certain safety, so it is recommended for clinical application.