他克莫司软膏治疗银屑病疗效及安全性的系统评价

Efficacy and Safety of Tacrolimus Ointment in Treatment of Psoriasis: A Systematic Review

目的系统评价他克莫司软膏治疗银屑病的有效性和安全性。方法计算机检索Ovid Medline、EMBase、Cochrane Library、中国学术期刊全文数据库、中国生物医学文献数据库、中文科技期刊数据库和万方数据库,检索时限均从建库至2016年12月。由两位研究员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man5.3版软件进行Meta分析。结果最终纳入RCTs16个,患者共1126例。Meta分析结果显示:总有效率和医生总体评价他克莫司组优于对照组[RR=1.38,95%CI(1.27,1.50),P<0.000 01、RR=1.83,95%CI(1.32,2.53),P=0.0003],均差异有统计学意义。两组总体不良反应发生率差异无统计学意义[RR=2.05,95%CI(0.89,4.71),P=0.09],但在单药治疗与联合治疗亚组中,皮肤瘙痒[RR=3.19,95%CI(1.00,10.15),P=0.05、RR=5.80,95%CI(1.55,21.68),P=0.009]和皮肤灼热[RR=2.38,95%CI(1.23,4.60),P=0.01、RR=6.00,95%CI(1.38,26.09),P=0.02]的发生率治疗组高于对照组,均差异有统计学意义。漏斗图分析提示无明显发表偏倚。结论他克莫司软膏可提高银屑病治疗的有效率。受纳入研究质量的限制,该结论尚需高质量、大样本的RCT加以证实。

Objective To systematically review the efficacy and safety of tacrolimus ointment in the treatment of psoriasis. Methods The databases such as Ovid Medline, EMBase, Cochrane Library, CNKI, CBM, VIP and WanFang Data were searched.The retrieval time was from inception to December 2016.Two reviewers independently screened the literature, extracted the data and assessed the methodological quality of the included studies.Then the meta-analysis was performed using RevMan 5.3 software. Results A total of 16 RCTs involving 1126 patients were included.The results of meta-analysis showed that, tacrolimus group was superior to control group, there were significant differences in the total effective rate [RR=1.38, 95%CI（1.27, 1.50）, P〈0.000 01] and physician’s global assessment result [RR=1.83, 95%CI（1.32, 2.53）, P=0.000 3].There was no significant difference in the total incidence of adverse events [RR=2.05, 95%CI（0.89, 4.71）, P=0.09] between the two groups.But in the subgroups of monotherapy and combined therapy, the incidence rates of pruritus [RR=3.19, 95%CI（1.00, 10.15）, P=0.05, RR=5.80, 95%CI（1.55, 21.68）, P=0.009] and skin burning sensation [RR=2.38, 95%CI（1.23, 4.60）, P=0.01, RR=6.00, 95%CI（1.38, 26.09）, P=0.02] in treatment group were significantly higher than those in control group.There was no obvious publication bias shown by funnel plot analysis. Conclusion Tacrolimus ointment can increase the effective rate of psoriasis.For the limitation of quality of included studies, this conclusion still needs to be proved by conducting RCTs with high quality and large sample size.