Ustekinumab治疗斑块状银屑病疗效和安全性的Meta分析

目的评价Ustekinumab治疗斑块状银屑病的疗效和安全性。方法计算机检索中英文数据库，按照制定的标准纳入随机对照试验，手工查找检索到文献的参考文献。由2名研究者独立对各临床试验进行数据提取和质量评估。采用RevMan4．2．2软件进行Meta分析。结果纳入4项随机对照研究，共计2437例患者。Meta分析结果显示，Ustekinumab治疗斑块状银屑病12周获得的疗效（三项指标）优于安慰剂，但Ustekinumab90mg组和Ustekinumab45mg组的疗效无显著差异，相对危险度为0．94（95％可信区间0．82～1．07），P=0．34；治疗28周，在皮损消退方面的疗效Ustekinumab90mg组优于Ustekinumab45mg组，相对危险度为O．89（95％可信区间0．84～0．95），P=0．0006，在生活质量改善方面两组无显著差异，相对危险度为0．93（95％可信区间0．85～1．01），P=0．08。最常见的不良反应是上呼吸道感染、鼻咽炎、头痛，Ustekinumab与安慰剂、Ustekinumab两个剂量之间的发生率无显著差异。结论皮下注射Ustekinumab治疗中重度斑块状银屑病安全有效。

Efficacy and Safety of Ustekinumab for Plaque Psoriasis: A Meta-Analysis

Objective To assess the efficacy and safety of Ustekinumab for plaque psoriasis with meta-analysis. Method Both foreign and Chinese databases were searched to identity randomized controlled trials （RCTs） that reported the efficacy and safety of Ustekinumab for plaque psoriasis. We also searched the references of all primary studies. Two reviewers assessed the quality of each trial and extracted data independently. The Cochrane Collaboration＇s RevMan 4.2.2 software was used for statistical analysis. Results A total of 4 RCTs were included, including 2 437 patients. Meta-analysis results suggested that Ustekinumab was superior to placebo for moderate to severe plaque psoriasis at week 12,but there was no significant difference between the two groups of Ustekinumab at week 12 （RR= 0.94,95%CI 0.82-1.07, P=0.34）; at week 28, the Ustekinumab 90 mg group was superior to the Ustekinumab 45 mg group in the skin lesions subsidence （RR=0.89, 95%CI 0.84-0.95, P=0.000 6）, but there was no significant difference in the improvement of the life quality（RR=0.93, 95%CI 0.85N1.01, P=0.08）. The most common adverse events were upper respiratory tract infection, nasopharyngitis, headache, there were no significant differences between Ustekinumab and placebo, the two groups of Ustekinumab had no significant differences too. Conclusion The present study shows Ustekinumab to be safe and effective for patients with moderate-severe plaque psoriasis.