银屑胶囊联合阿维A胶囊治疗寻常型银屑病有效性与安全性的Meta分析

目的:系统评价银屑胶囊联合阿维A胶囊治疗寻常型银屑病的疗效和安全性,为临床用药提供循证参考。方法:计算机检索PubMed、Embase、Cochrane图书馆、中国生物医学文献数据库、中国知网、维普、万方数据库等,收集银屑胶囊联合阿维A胶囊(试验组)对比阿维A胶囊(对照组)治疗寻常型银屑病的随机对照试验(RCT)。筛选文献、提取数据并采用Cochrane系统评价员手册5.1.0提供的偏倚风险评估工具对纳入研究的质量进行评价,然后采用Rev Man 5.3软件进行Meta分析,采用TSA 0.9软件进行试验序贯分析。结果:共纳入7项RCT,共计660例患者。Meta分析结果显示,试验组患者总有效率[RR=1.15,95%CI(1.04,1.28),P=0.007]、IL-4水平[SMD=0.85,95%CI(0.02,1.68),P=0.04]、IL-10水平[SMD=0.56,95%CI(0.28,0.83),P<0.000 1]均显著高于对照组;银屑病面积与严重性指数评分[MD=-2.34,95%CI(-2.77,-1.91),P<0.000 01]、眼干发生率[RR=0.32,95%CI(0.23,0.45),P<0.001]、皮肤干燥发生率[RR=0.47,95%CI(0.32,0.71),P<0.001]、毛囊炎发生率[RR=0.42,95%CI(0.30,0.59),P<0.001]、转氨酶升高发生率[RR=0.18,95%CI(0.05,0.61),P=0.005]、高脂血症发生率[RR=0.48,95%CI(0.35,0.65),P<0.001]均显著低于对照组;两组患者鼻出血发生率比较差异无统计学意义[RR=0.46,95%CI(0.16,0.37),P=0.16]。序贯分析结果显示,银屑胶囊联合阿维A胶囊治疗寻常型银屑病提高总有效率的证据确切。结论:银屑胶囊联合阿维A胶囊治疗寻常型银屑病的疗效和安全性均较好。

Meta-analysis of Efficacy and Safety of Yinxie Capsules Combined with Acitretin Capsules in the Treatment of Psoriasis Vulgaris

OBJECTIVE:To evaluate the efficacy and safety of Yinxie capsules combined with Acitretin capsules in the treatment of psoriasis vulgaris in order to provide reference for clinical drug use.METHODS:Retrieved from PubMed,Embase,Cochrane Library,CBM,CNKI,VIP,Wanfang database,randomized controlled trials(RCTs)about Yinxie capsules combined with Acitretin capsules(trial group)vs.Acitretin capsules(control group)in the treatment of psoriasis vulgaris were collected.After literature screening,data extraction and quality evaluation with Cochrane 5.1.0 bias risk evaluation tool,Meta-analysis was performed by using Rev Man 5.3 software,and trial sequence analysis(TSA)was conducted with TSA 0.9 software.RESULTS:A total of 7 RCTs with 660 patients were included.Results of Meta-analysis showed that the total response rate[RR=1.15,95%CI(1.04,1.28),P=0.007],the levels of IL-4[SMD=0.85,95%CI(0.02,1.68),P=0.04]and IL-10[SMD=0.56,95%CI(0.28,0.83),P<0.000 1]in trial group were significantly higher than control group.The psoriasis area and severity index score[MD=-2.34,95%CI(-2.77,-1.91),P<0.000 01],incidence of dry eye[RR=0.32,95%CI(0.23,0.45),P<0.001],dry skin[RR=0.47,95%CI(0.32,0.71),P<0.001],folliculitis[RR=0.42,95%CI(0.30,0.59),P<0.001],the elevation of ALT[RR=0.18,95%CI(0.05,0.61),P=0.005]and hyperlipidemia[RR=0.48,95%CI(0.35,0.65),P<0.001]in trial group were significantly lower than control group.There was no statistical significance in nose bleeding between 2 groups[RR=0.46,95%CI(0.16,0.37),P=0.16].TSA showed that the evidence of enhancing total response rate by Yinxie capsules combined with Acitretin capsules in the treatment of psoriasis vulgaris was reliable.CONCLUSIONS:Yinxie capsules combined with Acitretin capsules show good efficacy and safety for psoriasis vulgaris.