金匮肾气丸加减干预高血压病系统评价(1)
摘要：目的 系统评价金匮肾气丸加减干预高血压病的临床疗效与安全性。方法 计算机检索中国知识资源总库(CNKI)、中国学术期刊数据库(万方数据)、中文科技期刊数据库(重庆维普)、Cochrane Library、PubMed、Embase中金匮肾气丸加减干预高血压病临床随机对照试验文献。检索范围均从建库至2016年6月。按照Cochrane系统评价手册偏倚风险评估方法进行文献质量评价，采用RevMan5.3软件进行Meta分析。结果 共纳入9篇文献，共计受试者776例。Meta分析显示：与西药常规治疗比较，采用金匮肾气丸加减总有效率更优[OR=2.67，95%CI(1.73，4.11)，P<0.000 01]，其中联合用药优于单纯西药常规治疗[OR=3.27，95%CI(1.99，5.39)，P<0.000 01]，而单纯采用金匮肾气丸加减与单纯西药常规治疗疗效相当[OR=1.16，95%CI(0.43，3.09)，P=0.77]。结论 金匮肾气丸加减可改善高血压病患者的临床症状，联合用药可提高降压效果，安全性较好。但纳入研究文献质量偏低，尚需更多大样本、多中心、高质量的临床随机对照试验进一步验证。
关键词：金匮肾气丸；高血压；随机对照试验；系统评价；Meta分析
DOI：10.3969/j.issn.1005-5304.2018.07.021
中图分类号：R2-05；R259.441 文献标识码：A 文章编号：1005-5304(2018)07-0087-05
Abstract： Objective To evaluate the efficacy and safety of Jinkui Shenqi Pills on hypertension through Meta-analysis and systematic review. Methods Articles about intervention of modified Jinkui Shenqi Pills in hypertensive clinical randomized controlled trials were retrieved from CNKI， Wanfang database， VIP， Cochrane Library， PubMed， and Embase. They were all searched from inception to June 2016. Cochrane system evaluation manual bias risk assessment method was used to evaluate the quality of the articles， and RevMan5.3 software was used for Meta-analysis. Results Nine articles involving 776 cases were included in the study. Meta-analysis showed that the total effective rate of modified Jinkui Shenqi Pills was better than that of conventional Western medicine treatment [OR=2.67， 95%CI (1.73， 4.11)， P<0.000 01]， and combination therapy was superior to conventional Western medicine alone [OR=3.27， 95%CI (1.99， 5.39)， P<0.000 01]. However， the efficacy of modified Jinkui Shenqi Pills alone was equivalent to the conventional Western medicine alone [OR=1.16， 95%CI (0.43， 3.09)， P=0.77). Conclusion Modified Jinkui Shenqi Pills can improve the clinical symptoms of the patients with hypertension， and combination treatment can improve the antihypertensive effect. However， the quality of the included research literature is too low， yet more large-scale， multi-center， high-quality clinical randomized controlled trials are needed to further verify.
Keywords： Jinkui Shenqi Pills； hypertension； randomized controlled trials； systematic review； Meta-analysis
高血壓病具有明显的高患病率、高病死率、高致残率，低知晓率、低治疗率、低控制率即“三高三低”态势[1]，多表现为以动脉血压持续升高为特征的进行性“心血管综合征”，常伴其他靶器官损害或临床疾病，严重消耗医疗和社会资源，需要进行综合干预。
金匮肾气丸出自《金匮要略》，具育阴助阳之效，为临床干预高血压病阴阳两虚证的常用方[2]。药理研究表明，金匮肾气丸可调节下丘脑-垂体-性腺轴中钙调蛋白基因表达，改善肾阳虚大鼠激素水平，逆转肾阳虚状态[3]。本研究采用循证医学方法，对金匮肾气丸干预高血压病临床疗效与安全性进行评价，为中医药临床干预高血压病提供参考。, 百拇医药(崔晓荣 马学竹 李秋艳)
关键词：金匮肾气丸；高血压；随机对照试验；系统评价；Meta分析
DOI：10.3969/j.issn.1005-5304.2018.07.021
中图分类号：R2-05；R259.441 文献标识码：A 文章编号：1005-5304(2018)07-0087-05
Abstract： Objective To evaluate the efficacy and safety of Jinkui Shenqi Pills on hypertension through Meta-analysis and systematic review. Methods Articles about intervention of modified Jinkui Shenqi Pills in hypertensive clinical randomized controlled trials were retrieved from CNKI， Wanfang database， VIP， Cochrane Library， PubMed， and Embase. They were all searched from inception to June 2016. Cochrane system evaluation manual bias risk assessment method was used to evaluate the quality of the articles， and RevMan5.3 software was used for Meta-analysis. Results Nine articles involving 776 cases were included in the study. Meta-analysis showed that the total effective rate of modified Jinkui Shenqi Pills was better than that of conventional Western medicine treatment [OR=2.67， 95%CI (1.73， 4.11)， P<0.000 01]， and combination therapy was superior to conventional Western medicine alone [OR=3.27， 95%CI (1.99， 5.39)， P<0.000 01]. However， the efficacy of modified Jinkui Shenqi Pills alone was equivalent to the conventional Western medicine alone [OR=1.16， 95%CI (0.43， 3.09)， P=0.77). Conclusion Modified Jinkui Shenqi Pills can improve the clinical symptoms of the patients with hypertension， and combination treatment can improve the antihypertensive effect. However， the quality of the included research literature is too low， yet more large-scale， multi-center， high-quality clinical randomized controlled trials are needed to further verify.
Keywords： Jinkui Shenqi Pills； hypertension； randomized controlled trials； systematic review； Meta-analysis
高血壓病具有明显的高患病率、高病死率、高致残率，低知晓率、低治疗率、低控制率即“三高三低”态势[1]，多表现为以动脉血压持续升高为特征的进行性“心血管综合征”，常伴其他靶器官损害或临床疾病，严重消耗医疗和社会资源，需要进行综合干预。
金匮肾气丸出自《金匮要略》，具育阴助阳之效，为临床干预高血压病阴阳两虚证的常用方[2]。药理研究表明，金匮肾气丸可调节下丘脑-垂体-性腺轴中钙调蛋白基因表达，改善肾阳虚大鼠激素水平，逆转肾阳虚状态[3]。本研究采用循证医学方法，对金匮肾气丸干预高血压病临床疗效与安全性进行评价，为中医药临床干预高血压病提供参考。, 百拇医药(崔晓荣 马学竹 李秋艳)