Fan Gen-Hao, Xing Zuo-Ying, Liu Meng-Lin, Chen Zhao-Qi, Wang Yong-Xia
Henan University of Chinese Medicine Zhengzhou 450000,China.
Department of Traditional Chinese Medicine,Henan Provincial People's Hospital Zhengzhou 450000,China.
Zhongguo Zhong Yao Za Zhi. 2021 Mar;46(6):1523-1536. doi: 10.19540/j.cnki.cjcmm.20200712.501.
To systematically evaluate the efficacy and safety of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and its accompanying symptoms. PubMed, EMbase, Cochrane Library, VIP, CNKI, Wanfang, and China biomedical database(CBD) were searched to screen out from the establishment of the database to April 2020 about the clinical randomized controlled trials of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and accompanying symptoms. The articles were selected according to the inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis. TSA 0.9.5.10 Beta software was used for sequential analysis, and GRADE 3.6 was used for evidence quality evaluation. A total of 4 532 patients were included in 34 randomized controlled trials. Meta-analysis results showed that: Yangxue Qingnao Granules combined with conventional anti-hypertensive agents reduced systolic blood pressure(MD=-10.56, 95%CI[-13.63,-7.50], P<0.000 01) and diastolic blood pressure(MD=-8.21, 95%CI[-10.84,-5.59], P<0.000 01), improved total effective rate(RR=1.21, 95%CI[1.14, 1.29], P<0.000 01), improved patients dizziness(RR=1.29, 95%CI[1.21, 1.37], P<0.000 01), insomnia(RR=1.66, 95%CI[1.44, 1.91], P<0.000 01), headache(RR=1.32, 95%CI[1.21, 1.43], P<0.000 01), chest distress(RR=1.26, 95%CI[1.12, 1.42], P=0.000 1), memory loss(RR=1.24, 95%CI[1.10, 1.40], P=0.000 4), palpitation(RR=1.28, 95%CI[1.17, 1.41], P<0.000 01), and improved traditional Chinese medicine symptom scores(MD=-4.24, 95%CI[-5.25,-3.23], P<0.000 01) and headache symptom improvement scores(MD=-2.02, 95%CI[-2.51,-1.53], P<0.000 01) as compared with Western medicine group alone. Subgroup analysis results showed that Yang-xue Qingnao Granules combined with ACEI drug had more obvious effects in lowering systolic blood pressure and diastolic blood pressure. There was no statistically significant difference in the incidence of adverse reactions, and no abnormal liver and kidney function was observed in each study. Trial sequential analysis showed that the total effective rate was cumulative across the traditional and TSA thresholds, further confirming its clinical efficacy. The evidence level was mostly low or extremely low in GRADE evaluation. The clinical application of Yangxue Qingnao Granules combined with conventional Western medicine in the treatment of essential hypertension and its accompanying symptoms is clear and safe, so it is recommended for clinical application.
系统评价养血清脑颗粒联合传统西药治疗原发性高血压及其伴随症状的疗效和安全性。检索PubMed、EMbase、Cochrane图书馆、维普、中国知网、万方和中国生物医学数据库(CBD),筛选自建库至2020年4月关于养血清脑颗粒联合传统西药治疗原发性高血压及其伴随症状的临床随机对照试验。根据纳入和排除标准选取文献。采用RevMan 5.3软件进行Meta分析。采用TSA 0.9.5.10 Beta软件进行序贯分析,采用GRADE 3.6进行证据质量评价。34项随机对照试验共纳入4532例患者。Meta分析结果显示:养血清脑颗粒联合传统抗高血压药物可降低收缩压(MD=-10.56,95%CI[-13.63,-7.50],P<0.000 01)和舒张压(MD=-8.21,95%CI[-10.84,-5.59],P<0.000 01),提高总有效率(RR=1.21,95%CI[1.14,1.29],P<0.000 01),改善患者头晕(RR=1.29, 95%CI[1.21,1.37],P<0.000 01)、失眠(RR=1.66,95%CI[1.44,1.91],P<0.000 01)、头痛(RR=1.32,95%CI[1.21,1.43],P<0.000 01)、胸闷(RR=1.26,95%CI[1.12,1.42],P=0.000 1)、记忆力减退(RR=1.24,95%CI[1.10,1.40],P=0.000 4)、心悸(RR=1.28,95%CI[1.17,1.41],P<0.000 01),并改善中医症状评分(MD=-4.24,95%CI[-5.25,-3.23],P<0.000 01)和头痛症状改善评分(MD=-2.02,95%CI[-2.51,-1.53],P<0.000 ০1),与单纯西药组相比差异有统计学意义。亚组分析结果显示,养血清脑颗粒联合ACEI类药物在降低收缩压和舒张压方面效果更明显。不良反应发生率差异无统计学意义,各研究均未观察到肝肾功能异常。试验序贯分析显示,总有效率在传统阈值和TSA阈值上均有累积,进一步证实了其临床疗效。GRADE评价证据水平大多为低或极低。养血清脑颗粒联合传统西药治疗原发性高血压及其伴随症状临床应用明确、安全,建议临床应用。