古塞奇尤单抗治疗中重度斑块状银屑病有效性和安全性的系统评价-中国药房

古塞奇尤单抗治疗中重度斑块状银屑病有效性和安全性的系统评价

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篇名：	古塞奇尤单抗治疗中重度斑块状银屑病有效性和安全性的系统评价
TITLE：	Efficacy and Safety of Guselkumab in the Treatment of Moderate-to-severe Plaque Psoriasis ：A Systematic Re- view
摘要：	目的：系统评价古塞奇尤单抗治疗中重度斑块状银屑病的有效性和安全性，为临床提供循证参考。方法：计算机检索PubMed、Embase、Cochrane图书馆、中国知网、维普网、万方数据等数据库，检索时限均为建库起至2019年10月，纳入古塞奇尤单抗对比安慰剂或阳性对照药治疗中重度斑块状银屑病的随机对照试验（RCT），筛选文献并提取资料后，采用Cochrane系统评价员手册5.1.0推荐的偏倚风险评估工具进行质量评价，使用Stata16.0软件进行Meta分析。结果：共纳入8项RCT，合计3488例患者。结果显示，古塞奇尤单抗组患者的银屑病皮损面积和严重程度指数（PASI）评分较基线下降≥90％的患者比例均显著高于安慰剂组[RR＝26.72，95％CI（15.98，44.70），P＜0.001]、阿达木单抗组[RR＝1.45，95％CI（1.32，1.59），P＜0.001]和司库奇尤单抗组（P＜0.0001），该组研究者全面评估（IGA）评分为0或1分（清除/几乎清除）的患者比例亦均显著高于安慰剂组[RR＝11.15，95％CI（8.22，15.14），P＜0.001]和阿达木单抗组[RR＝1.27，95％CI（1.19，1.35），P＜0.001]。此外，在IGA评分为0分（清除）的患者比例、PASI评分较基线下降≥75％的患者比例、皮肤病生活质量指数评分为0或1分的患者比例等方面，古塞奇尤单抗组均显著优于安慰剂和阿达木单抗组；在PASI评分较基线下降100％的患者比例方面，古塞奇尤单抗组也显著优于安慰剂组（P＜0.05），但与阿达木单抗组比较差异无统计学意义（P＞0.05）；而古塞奇尤单抗IGA评分为0分（清除）的患者比例等次要结局指标与司库奇尤单抗组比较差异均无统计学意义（P＞0.05）。在总不良反应发生率、因不良反应退出率等安全性指标方面，古塞奇尤单抗组与安慰剂或阿达木单抗组比较差异均无统计学意义（P＞0.05）。结论：古塞奇尤单抗在改善中重度斑块状银屑病患者症状方面的效果优于安慰剂、阿达木单抗和司库奇尤，且安全性良好。
ABSTRACT：	OBJECTIVE：To systematically evaluate the efficacy and safety of guselkumab in the treatment of moderate-to- severe plaque psoriasis ，and to provide evidence-based reference for the clinical treatment. METHODS ：Retrieved from PubMed ， Embase，Cochrane Library ，CNKI，VIP，Wanfang database during inception to Oct. 2019，randomized controlled trials （RCTs） about guselkumab versus placebo/positive control in the treatment of moderate-to-severe plaque psoriasis were collected. After literature screening and data extraction ，quality evaluation was performed by using the bias risk evaluation tool recommended by the Cochrane System evaluator manual 5.1.0. Meta-analysis was performed by using Stata 16.0 software. RESULTS ：Eight RCTs with a total of 3 488 patients were included. The results of Meta-analysis indicated that the proportion of patients who achieved 90％ reduction or more from baseline of psoriasis area and severity index （PASI）in guselkumab group was significantly higher than that placebo group [RR ＝26.72，95％CI（15.98，44.70），P＜0.001]，adaliumumab group [RR ＝1.45，95％CI（1.32，1.59）， P＜0.001] and secukinumab group （P＜0.000 1）. The proportion of patients with Investigator ’s Global Assessment （IGA）score of 0 or 1 in guselkumab group was significantly better than placebo group [RR ＝11.15，95％ CI（8.22，15.14），P＜0.001] and adaliumumab group [RR ＝1.27，95％CI（1.19，1.35），P＜0.001]. The proportion of patients with IGA score of 0，the proportion of patients who achieved 75％ reduction or more from baseline of PASI ，dermatology life qu ality index score of 0 or 1 in guselkumab group were signifi cantly superior than placebo group and adaliumumab gr oup，the proportion of patients who achieved 100％ reduction from baseline of PASI in guselkumab group Lewx- was significantly superior than placebo group （P＜0.05）， inn@outlook.com there was no significant difference compared with adaliumumab group （P＞0.05）. There was no statistical significance in the proportion of patients with IGA score of and other secondary outcome indicators between guselkumab and secukinumab group （P＞0.05）. In the safety indicators as total incidence rate of ADR ，rate of withdrawl due to ADR ，etc. ，there was no statistical significance between guselkumab and placebo/ adalimumab groups （P＞0.05）. CONCLUSIONS ：Guselkumab is superior to placebo ，adaliumumab and secukinumab in improving the symptoms of moderate-to-severe plaque psoriasis with good safety .
期刊：	2020年第31卷第10期
作者：	刘鑫，钟小燕，徐昌静，赵丹洁，范清泽，余彬，黄毅岚
AUTHORS：	LIU Xin，ZHONG Xiaoyan ，XU Changjing ，ZHAO Danjie ，FAN Qingze ，YU Bin，HUANG Yilan
关键字：	古塞奇尤单抗；中重度斑块状银屑病；有效性；安全性；系统评价；Meta分析
KEYWORDS：	Guselkumab；Moderate-to-severe plaque psoriasis ；Efficacy；Safety；Systematic review ；Meta-analysis
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