Brodalumab治疗中、重度斑块状银屑病随机对照试验的Meta分析

Brodalumab for moderate-to-severe plaque psoriasis:a Meta-analysis

目的 :系统评价Brodalumab治疗中、重度斑块状银屑病的疗效和安全性。方法 :计算机检索2000—2017年中国期刊全文数据库(CNKI)、万方数据库、中国生物医学文献数据库、Pub Med、Medline及Embase,纳入Brodalumab治疗中、重度斑块状银屑病的随机对照试验(RCT)。由2名研究者单独使用Jadad评分量表对文献进行质量评价,采用Rev Man 5.3软件进行系统分析。结果:共纳入5篇RCT,包括4 076例中、重度斑块状银屑病患者。Meta分析示治疗12周时,Brodalumab组疗效和不良反应与安慰剂组比较,差异均有统计学意义(P<0.05)。Brodalumab组皮下注射140 mg或210 mg连续治疗12周后,银屑病患者银屑病皮损面积和严重程度指数(PASI)积分下降达75%(PASI 75)、PASI 90、PASI 100和疾病严重度静态测量级别达s PGA 0或1的例数均显著高于安慰剂组,差异有统计学意义(P<0.05)。Brodalumab组治疗后发生的主要不良反应为鼻咽炎。结论 :皮下注射Brodalumab 140 mg(2周1次)或210 mg(2周1次)连续12周治疗中、重度斑块状银屑病有效,但需注意不良反应的发生,仍需要更多RCT证实剂量与疗效及安全性的关系。

Objective： To assess the efficacy and safety of Brodalumab for moderate-to-severe plaque psoriasis. Methods： Randomized controlled tfials（RCTs） on Brodalumab for moderate-to-severe plaque psoriasis were searched in the websites of CNKI, Wanfang data, SinoMed, PubMed, Medline and Embase. Quality of each study was assessed independently by two reviewers using the Jadad scale. Statistical analysis was conducted using Review Manager 5.3 software. Results： Five RCTs, including 4 076 patients with moderate-to-severe plaque psoriasis, were analyzed. Ratios of efficacy of Brodalumab-treated to that of placebo-treated group, and ratios of adverse event rates in Brodalumab-treated to that in placebo-treated group were calculated. The Meta-analysis showed significant differences in the efficacy and adverse events between Brodalumab and placebo group after 12-week follow-up（P〈0.05）. Moreover, following subcutaneous injection of Brodalumab for 12 weeks, more patients with moderate-to-severe plaque psoriasis achieved PASI 75, PASI 90, PASI 100, sPGA 0 or 1 improvement in comparison with those treated with placebo（P〈0.05）. The most common adverse event was nasopharyngitis. Conclusions： Subcutaneous injections of Brodalumab 140 mg or 210mg every other week for 12 weeks are effective for moderate-to-severe plaque psoriasis. Cautions of adverse reactions should be taken, and more RCTs are required to determine the proper dose, efficacy and safety.