银屑灵片及其优化方治疗寻常型银屑病的疗效及安全性的Meta分析

Meta-analysis of Efficacy and Safety of Yinxieling Tablet and Its Optimized Formula in the Treatment of Psoriasis Vulgaris

目的系统评价银屑灵片及其优化方(PSORI-CM01、PSORI-CM02)治疗寻常型银屑病的临床疗效及安全性。方法计算机检索PubMed、Embase、Cochrane Library、中国知网(CNKI)、维普中文期刊(VIP)、中国生物医学文献数据库(CBM)和万方数据知识服务平台(Wanfang)7个中、英文数据库中有关银屑灵片及其优化方治疗寻常型银屑病的随机对照试验(RCTs)及非随机干预性研究(NRSI),检索年限为数据库建库至2020年10月。2名研究员对检索出的文献进行筛选及提取有效数据,采用RevMan 5.3软件和R 3.3.3软件对纳入的研究进行Meta分析。结果共纳入8个临床研究,共计患者571例。Meta分析结果显示,与对照组相比,银屑灵片及其优化方可提高寻常型银屑病治疗的银屑病面积与严重程度指数(PASI)50应答率[RR=1.94,95%CI(1.19,3.16),P=0.008],且不良事件发生率低。银屑灵片及其优化方联合其他疗法(阿维A胶囊、β-七叶皂甙钠、耳穴、温泉及煤焦油、局部序贯治疗等)治疗寻常型银屑病的总有效率、PASI 50应答率及PASI 75应答率分别为88%[95%CI(0.78,0.95)]、75%[95%CI(0.42,0.97)]、10%[95%CI(0.01,0.26)];银屑灵片及其优化方单独治疗寻常型银屑病,PASI 50应答率和PASI 75应答率为36%[95%CI(0.14,0.61)]和13%[95%CI(0.03,0.27)]。结论银屑灵片及其优化方治疗寻常型银屑病可提高临床疗效,并具有良好的耐受性。但由于本系统评价纳入的研究样本量较小,因此对于银屑灵片及其优化方治疗寻常型银屑病的临床有效性及安全性结论仍需更多设计严谨、多中心、大样本的随机双盲试验加以验证。

Objective To evaluate the clinical efficacy and safety of Yinxieling tablet and its optimized formula(PSORI-CM01,PSORI-CM02)in the treatment of psoriasis vulgaris.Methods Seven English and Chinese databases,including PubMed,Embase,Cochrane Library,CNKI,VIP,CBM and Wanfang were searched for the randomized controlled trials(RCTs)and non-randomised studies of interventions(NRSI)of Yinxieling tablet and its optimized formula in the treatment of psoriasis vulgaris from their inception to October 2020.Two investigators screened the retrieved citations and extracted valid data independently.Meta-analysis was performed by Revman 5.3 software and R 3.3.3 software in the included studies.Results Eight clinical studies were included in this study,involving a total of 571 patients.The results of Meta-analysis showed that,compared with the control group,Yinxieling tablet and its optimized formula could increase the psoriasis area and severity index(PASI)50 response rate[RR=1.94,95%CI(1.19,3.16),P=0.008]and reduce the incidence of adverse events.When psoriasis vulgaris was treated with Yinxieling tablet or its optimized formula in combination with other therapies(Acitretin capsules,β-Aescin Sodium,auricular therapy,balneotherapy and coal tar,topical sequential therapy,et al),the total effective rate,PASI 50 response rate and PASI 75 response rate were 88%[95%CI(0.78,0.95)],75%[95%CI(0.42,0.97)]and 10%[95%CI(0.01,0.26)],respectively.And the PASI 50 response rate and PASI 75 response rate were 36%[95%CI(0.14,0.61)]and 13%[95%CI(0.03,0.27)]when Yinxieling tablet or its optimized formula was used alone.Conclusion Yinxieling tablet and its optimized formula can improve the clinical efficacy of psoriasis vulgaris,and are well-tolerated.However,due to the methodological flaws and small sample size of several included studies in this systematic review,a multicenter,randomized,double-blind,placebocontrolled,parallel-group clinical trial following rigorous method is urgently required to verify the efficacy and safety of Yinxieling tablet and its optimized formula in the treatment of psoriasis vulgaris.