布罗达单抗治疗斑块状银屑病疗效与安全性的Meta分析

Efficacy and safety of brodalumab for patients with plaque psoriasis: a meta-analysis

目的评价布罗达单抗治疗斑块状银屑病的疗效与安全性。方法电子检索Pub Med、Cochrane Library、EMbase、EBSCO、Web of Science、中国知网、中国生物医学文献数据库、维普数据库以及万方数据库中关于布罗达单抗治疗斑块状银屑病的随机对照试验(RCTs),检索时限为2010年1月至2017年11月。对纳入的研究进行偏倚风险评估,采用Cochrane协作网推荐的Rev Man5.3软件对各效应指标进行Meta分析。结果共纳入5项RCTs,合计4 602例斑块状银屑病患者。Meta分析结果显示,布罗达单抗140 mg和210 mg组银屑病皮损面积和严重性指数积分下降≥75%的患者人数(PASI75)、PASI90以及PASI100指标均优于安慰剂组,差异有显著意义(P<0.000 01);布罗达单抗140 mg组PASI指标与优特克单抗组相当[RR=1.06,95%CI(0.97,1.16),P=0.22],布罗达单抗210 mg组PASI指标优于优特克单抗组[RR=1.43,95%CI(1.35,1.50),P<0.000 01]。安全性方面,布罗达单抗组总不良事件发生率较安慰剂组高[RR=1.14,95%CI(1.06,1.22),P=0.000 4],严重不良事件发生率和因不良事件退出率均无显著差异(P>0.05)。结论布罗达单抗治疗斑块状银屑病疗效显著,安全性亦较好。

AIM To evaluate the efficacy and safety of brodalumab for patients with plaque psoriasis.METHODS The randomized controlled trials（RCTs） of brodalumab for patients with plaque psoriasis published between January, 2010 and November, 2017 were searched from Pub Med, Cochrane Library, EMbase,EBSCO, CBM, CNKI, VIP database, and Wangfang database. The quality of the retrieved trials was evaluated and the results of studies were analyzed using Rev Man 5.3 software. RESULTS Five RCTs involving 4 602 patients were included. There were significant differences in psoriasis area and severity index 75（ PASI75）,PASI90, and PASI100 between the brodalumab（140 mg and 210 mg） groups and the placebo group（ P 〈0.000 01）. The terms of PASI in the brodalumab 140 mg group was comparable to that in the ustekinumab group（RR = 1.06, 95%CI（0.97, 1.16）, P = 0.22）. The terms of PASI in the brodalumab 210 mg group was better than that in the ustekinumab group（ RR = 1.43, 95% CI（ 1.35, 1.50）, P 〈0.000 01）. In terms of safety,the incidence of total adverse events in the brodalumab group was higher than that in the placebo group（RR =1.14, 95%CI（1.06, 1.22）, P = 0.000 4）. There was no significant difference in the severe adverse event rates and withdrawal rates（P〉0.05）. CONCLUSION Brodalumab is safe and effective for plaque psoriasis.