Liu Meng-Lin, Fan Gen-Hao, Zhang Huai-Liang
Henan University of Traditional Chinese Medicine Zhengzhou 450000,China.
the First Affiliated Hospital of Henan University of Traditional Chinese Medicine Zhengzhou 450000,China.
Zhongguo Zhong Yao Za Zhi. 2021 Mar;46(6):1511-1522. doi: 10.19540/j.cnki.cjcmm.20200702.501.
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.
系统评价天麻钩藤颗粒联合传统降压药物治疗原发性高血压的疗效及安全性。根据纳入和排除标准，检索自数据库建立至2020年4月在PubMed、EMbase、Cochrane Library、维普、中国知网、万方、中国生物医学文献数据库中关于天麻钩藤颗粒联合传统降压药物治疗原发性高血压的临床随机对照试验（RCT），并采用RevMan 5.3软件进行Meta分析。共纳入15项RCT，涉及1508例患者。Meta分析结果显示，天麻钩藤颗粒联合西药在降低收缩压（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）、提高患者临床疗效（RR=1.22，95%CI[1.15，1.28]，P<0.000 01）及中医证候疗效（RR=1.26，95%CI[1.02，1.57]，P=0.04）、增加一氧化氮含量（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）和白细胞介素-6（MD=-39.71，95%CI[-43.40，-36.03]，P<0.000 01）方面优于对照组。试验组与对照组不良反应发生率比较，差异无统计学意义，未出现肝肾功能损害。亚组分析结果显示，天麻钩藤颗粒联合ARB类药物在降低收缩压和舒张压方面效果更明显。试验序贯分析显示，纳入临床疗效的研究累计越过传统界值和TSA界值，进一步肯定了其临床疗效。天麻钩藤颗粒联合西药治疗原发性高血压及伴随症状临床应用疗效明确，安全性尚可，建议临床应用。
