半夏白术天麻汤联合温胆汤治疗高血压合并高脂血症临床疗效的Meta分析和试验序贯分析

Clinical Effects of Banxia Baizhu Tianma Decoction Combined with Wendan Decoction in the Treatment of Hypertension with Hyperlipidemia:A Meta Analysis and Trial Sequential Analysis

[目的]系统评价半夏白术天麻汤联合温胆汤治疗高血压病合并高脂血症(hypertension-hyperlipidemia,HTN-HLP)的临床有效性及安全性。[方法]检索中国知网(China National Knowledge Infrastructure,CNKI)、万方(Wanfang Database)、维普资讯(VIP Information)、中国生物医学文献数据库(China Biology Medicine Disc,CBM)、Web of Science、PubMed、The Cochrane Library、Embase等数据库,检索时限为建库至2022年7月。根据纳入和排除标准,筛选符合标准的随机对照试验(randomized controlled trials,RCT)。使用Cochrane手册进行风险偏倚评估和质量评价,采用Revman 5.4软件进行Meta分析,以TSA 0.9Beta软件进行序贯分析。[结果]共纳入9篇研究,涉及820例患者。Meta分析结果显示,相比于对照组,治疗组在提高临床总有效率[相对危险度(relative risk,RR)=1.19,95%置信区间(confidence interval,CI)(1.09,1.30),P=0.0002],降低收缩压[均方差(mean deviation,MD)=-14.18,95%CI(-18.68,-9.68),P<0.00001]和舒张压[MD=-6.11,95%CI(-7.05,-5.18),P<0.00001]水平,降低低密度脂蛋白胆固醇[MD=-0.64,95%CI(-0.72,-0.57),P<0.00001]、总胆固醇[MD=-1.28,95%CI(-1.35,-1.21),P<0.00001]和甘油三酯水平[MD=-0.63,95%CI(-0.71,-0.55),P<0.00001],升高高密度脂蛋白胆固醇水平[MD=0.17,95%CI(0.12,0.22),P<0.00001],以及改善血浆黏稠度[MD=-0.84,95%CI(-1.26,-0.43),P<0.00001]和红细胞压积[MD=-4.24,95%CI(-5.24,-3.23),P<0.00001]等方面均优于对照组;治疗组不良反应发生率与对照组比较,差异无统计学意义[RR=0.50,95%CI(0.25,1.00),P=0.05]。序贯分析提示,治疗组的临床总有效率高于对照组具有假阳性可能,需要纳入更多试验验证,但肯定了治疗组降低收缩压的疗效优于对照组。[结论]HTN-HLP的治疗中加用半夏白术天麻汤联合温胆汤,能够提高临床疗效,且不增加常规药物的不良反应。

[Objective]To evaluate the efficacy and safety of Banxia Baizhu Tianma Decoction combined with Wendan Decoction in the cure of hypertension with hyperlipidemia(HTN-HLP).[Methods]The China National Knowledge Infrastructure(CNKI),Wanfang Database,VIP Information,China Biology Medicine Disc(CBM),Web of Science,PubMed,The Cochrane Library and Embase databases were searched from the establishment time to July 2022.According to the inclusion and exclusion criteria,the randomized controlled trials(RCT)that met the criteria were screened.The Cochrane handbook was used for the risk assessment,and the Revman 5.4 software was used for Metaanalysis,the TSA 0.9Beta software was used for sequential analysis.[Results]A total 9 literatures were included,involving 820 patients.The Meta-analysis results showed that the treatment group had done much better than controlled group at increasing the effective rate[relative risk(RR)=1.19,95%confidence interval(CI)(1.09,1.30),P=0.0002],decreasing systolic pressure[mean deviation(MD)=-14.18,95%CI(-18.68,-9.68),P<0.00001]and diastolic pressure[MD=-6.11,95%CI(-7.05,-5.18),P<0.00001],decreasing low density lipoprotein cholesterol[MD=-0.64,95%CI(-0.72,-0.57),P<0.00001],total cholesterol[MD=-1.28,95%CI(-1.35,-1.21),P<0.00001]and triglyceride[MD=-0.63,95%CI(-0.71,-0.55),P<0.00001],increasing high density lipoprotein cholesterol[MD=0.17,95%CI(0.12,0.22),P<0.00001],decreasing plasma viscosity[MD=-0.84,95%CI(-1.26,-0.43),P<0.00001]and packed cell volume[MD=-4.24,95%CI(-5.24,-3.23),P<0.00001].The adverse reaction rate between treatment group and controlled group had no significant difference[RR=0.50,95%CI(0.25,1.00),P=0.05].The sequential analysis showed that the effective rate of the treatment group was higher than that of the controlied group with the possibility of false positive and more trials needed to be included for validation,but it confirmed the treatment group was more effective in reducing systolic pressure than the controlied group.[Conclusion]In the treatment of HTN-HLP,adding Banxia Baizhu Tianma Decoction combined with Wendan Decoction can improve the clinical effect and doesn’t increase the adverse reaction.