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阿普司特治疗银屑病关节炎长期临床疗效评估(PALACE)的荟萃分析。

A meta-analysis of apremilast on psoriatic arthritis long-term assessment of clinical efficacy (PALACE).

作者信息

Qu Xiaoyu, Zhang Sixi, Tao Lina, Song Yanqing

机构信息

a Department of Pharmacy , The First Hospital of Jilin University , Changchun , PR China.

出版信息

Expert Rev Clin Pharmacol. 2016 Jun;9(6):799-805. doi: 10.1586/17512433.2016.1159130. Epub 2016 Apr 8.

DOI:10.1586/17512433.2016.1159130
PMID:26918950
Abstract

The aim of this article was to assess the efficacy and safety of apremilast in treatment of psoriatic arthritis (PsA) with meta-analysis method. We included four randomized clinical trials identified from MEDLINE, EMBASE, Cochrane Library, "ISRCTN Register" and "ClinicalTrials.gov" which compared apremilast with placebo. The meta-analysis was performed by the software of Review Manager, version 5.2. Apremilast was associated with significantly higher proportion of patients who achieved ACR20 at week 16 (in apremilast 20 mg subgroup, odds ratio [OR]= 2.04, 95% confidence interval [Cl] 1.58-2.63, P<0.00001; in apremilast 30 mg subgroup, OR=2.53, 95%Cl 1.96-3.25, P<0.00001) and significantly higher scores of Health Assessment Questionnaire-Disability Index (in apremilast 20 mg subgroup, WMD=-0.11, 95%Cl -0.16-0.06, P<0.0001; in apremilast 30 mg subgroup, WMD=-0.16, 95%Cl -0.21-0.11, P<0.00001). Apremilast was as safe as placebo in terms of serious adverse events (AEs). The AEs occurred in participants with apremilast were mild and well tolerated during treatment. Apremilast can be used in treatment of PsA with lower costs, oral availability and well tolerated. But the long-term benefit and safety of apremilast should be further investigated.

摘要

本文旨在采用荟萃分析方法评估阿普米司特治疗银屑病关节炎(PsA)的疗效和安全性。我们纳入了从MEDLINE、EMBASE、Cochrane图书馆、“国际标准随机对照试验编号注册库”和“临床试验.gov”中识别出的四项随机临床试验,这些试验比较了阿普米司特与安慰剂。荟萃分析由Review Manager 5.2版软件进行。阿普米司特与在第16周达到美国风湿病学会20%改善标准(ACR20)的患者比例显著更高相关(在阿普米司特20mg亚组中,比值比[OR]=2.04,95%置信区间[Cl]1.58 - 2.63,P<0.00001;在阿普米司特30mg亚组中,OR = 2.53,95%Cl 1.96 - 3.25,P<0.00001),且健康评估问卷残疾指数得分显著更高(在阿普米司特20mg亚组中,加权均数差[WMD]= -0.11,95%Cl -0.16~ -0.06,P<0.0001;在阿普米司特30mg亚组中,WMD = -0.16,95%Cl -0.21~ -0.11,P<0.00001)。在严重不良事件(AE)方面,阿普米司特与安慰剂一样安全。接受阿普米司特治疗的参与者发生的不良事件在治疗期间轻微且耐受性良好。阿普米司特可用于治疗PsA,成本较低、口服可用性好且耐受性良好。但阿普米司特的长期益处和安全性仍需进一步研究。

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