机构地区:[1]山东中医药大学 [2]山东中医药大学附属医院周围血管病科,山东济南250014
出 处:《海南医学院学报》2020年第16期1264-1272,共9页Journal of Hainan Medical University
基 金:山东省中医药科技发展计划项目(2019-0205,2013ZDZK-047);山东省自然基金面上项目(ZR2017MH038)。
摘 要:目的:系统评价四妙勇安汤治疗外周动脉闭塞性疾病(peripheral arterial occlusive disease,PAOD)的临床疗效及安全性。方法:共检索及筛选8个国内外数据库(均从建库至2020年3月)收录的四妙勇安汤治疗PAOD的临床随机对照试验(randomized controlled trial,RCT)文献。根据Cochrane Handbook 5.1.0评价标准对检索到的原始研究进行质量评估,通过RevMan5.3软件对最终纳入的研究进行Meta分析。结果:共检索到350篇文献,其中符合纳入标准的研究有14项,总样本量为1254例。Meta分析结果显示:与常规应用西药相比,在西药治疗基础上联合四妙勇安汤可明显提高PAOD患者的临床总有效率[RR=1.20,95%CI(1.14,1.27),P<0.00001],提高踝肱指数(ankle brachial index,ABI)[MD=0.79,95%CI(0.66,0.92),P<0.00001]和趾肱指数(toe brachial index,TBI)[RR=0.13,95%CI(0.10,0.16),P<0.00001],降低C反应蛋白水平[MD=-8.55,95%CI(-8.99,-8.11),P<0.00001]和低密度脂蛋白水平[MD=-0.41,95%CI(-0.62,-0.19),P=0.0002],并提高高密度脂蛋白水平[MD=0.32(0.22,0.43),P<0.00001],不良反应发生率对比无统计学意义[RR=0.50,95%CI(1.15,1.64),P=0.25]。结论:四妙勇安汤联合常规西药治疗PAOD的疗效优于单纯常规西药治疗,且安全性相当。但鉴于所分析文献质量存在一定局限性,本研究得出的阳性结果仍需研究方案可靠的大样本、多中心的临床试验进一步加以验证。Objective:To systematicallyevaluate the clinical efficacy and safety of SimiaoYong'andecoction in the treatment of peripheral occlusive disease(PAOD).Methods:Eight randomized controlled clinical trials(RCT)of SimiaoYong'andecoction in the treatment of PAOD were selected from domestic and foreign databases(all from database construction to March 2020).The quality of the retrieved original studies was evaluated according to the evaluation criteria of Cochrane Handbook 5.1.0,and meta-analysis on the included studies were carried out by RevMan5.3 software.Results:A total of 350 articles were found,among which 14 studies met the inclusion criteria and were retrieved,with a total sample size of 1254 cases.The results of meta-analysis showed thatcompared with conventional western medicine alone,combined use of western medicine with SimiaoYong'andecoction significantly improved the total clinical response rate of patientsRR=1.20,95%CI(1.14,1.27),P<0.00001,improved ankle brachial index(ABI)MD=0.79,95%CI(0.66,0.92),P<0.00001 and toe brachial index(TBI)RR=0.13,95%CI(0.10,0.16),P<0.0d ecreased c-reactive protein levelsMD=-8.55,95%CI(-8.99,-8.11),P<0.00001 and LDL levels MD=-0.41,95%CI(-0.62,-0.19),P=0.0002,and increased HDL levelsMD=0.32,95%CI(0.22,0.43),P<0.00001.But there was no statistically significant difference in the incidence of adverse reactionsRR=0.50,95%CI(1.15,1.64),P=0.25.Conclusion:SimiaoYong'andecoction combined with conventional western medicine is more effective than conventional western medicine alone in the treatment of PAOD.However,in view of the limitations of the quality of the analyzed literature,but the positive results obtained in this study still need to be further verified by a large sample and multi-center clinical trials with a reliable research program.
分 类 号:R259[医药卫生—中西医结合]
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