艾瑞昔布治疗关节炎疗效及安全性的系统评价和meta分析

Efficacy and safety of imrecoxib in the treatment of arthritis:a systematic review and meta-analysis

目的系统评价艾瑞昔布治疗关节炎的疗效及安全性。方法检索中国期刊全文数据库、万方数据知识服务平台、维普数据库及Embase、PubMed、Cochrane Library、Clinical Trials.gov,收集艾瑞昔布治疗关节炎的RCTs。采用RevMan5.4软件进行meta分析。结果共纳入16项研究,涉及2154例患者和4种关节炎。meta分析结果显示,观察组治疗骨关节炎患者的视觉模拟评分法评分[MD=-1.41,95%CI(-1.73,-1.09),P<0.00001]和不良反应发生率[RR=0.66,95%CI(0.49,0.88),P=0.005]明显低于对照组,Lysholm膝关节评分[MD=9.68,95%CI(4.19,15.18),P=0.0006]高于对照组;两组总有效率、西安大略和麦克马斯特大学骨关节炎指数比较,差异均无统计学差异(P>0.05)。观察组治疗脊柱关节炎患者的总有效率(P<0.05)、巴斯强直性脊柱炎疾病活动指数[MD=0.28,95%CI(0.07,0.50),P=0.01]和红细胞沉降率[MD=2.10,95%CI(1.05,3.15),P<0.0001]明显高于对照组,观察组巴斯强直性脊柱炎功能指数、C反应蛋白和不良反应发生率与对照组比较,差异均无统计学差异(P>0.05);亚组分析显示,艾瑞昔布400 mg/d的临床疗效指标与对照组比较,差异均无统计学差异(P>0.05)。结论艾瑞昔布治疗可以改善关节炎患者的症状和炎症水平,且安全性较高。

Objective To systematically evaluate the efficacy and safety of imrecoxib in the treatment of arthritis.Methods CNKI,Wanfang databases,VIP,Embase,PubMed,Cochrane Library and Clinical Trials.gov were searched to col⁃lect the randomized controlled trials.RevMan5.4 was used for meta-analysis.Results A total of 16 studies were included,in⁃volving 2154 patients and 4 types of arthritis.The meta-analysis results showed that imrecoxib for osteoarthritis had lower visu⁃al analogue scale scores[MD=-1.41,95%CI(-1.73,-1.09),P<0.00001]and incidence of adverse reactions[RR=0.66,95%CI(0.49,0.88),P=0.005]than those of the controls,and Lysholm knee scores[MD=9.68,95%CI(4.19,15.18),P=0.0006]were higher.Total effective rate,Western Ontario and McMaster University osteoarthritis index were not statistically different from the control group.In the treatment spondyloarthritis,imrecoxib had a higher overall effective rate(P<0.05),Bath ankylosing spondylitis disease activity index[MD=0.28,95%CI(0.07,0.50),P=0.01],and erythrocyte sedimentation rate[MD=2.10,95%CI(1.05,3.15),P<0.0001]than those of the controls,and Bath ankylosing spondylitis functional index,C-reactive protein and incidence of adverse events were not statistically significant from the control group.Subgroup analysis showed that none of these indices were statistically different from the control group for 400 mg/d imrecoxib.Conclusion Imrecoxib improves symptoms and inflammation levels in patients with arthritis and has a high safety profile.