艾拉莫德治疗炎性关节炎和退行性关节炎的疗效与安全性的系统评价和荟萃分析。

A systematic review and meta-analysis of the efficacy and safety of iguratimod in the treatment of inflammatory arthritis and degenerative arthritis.

作者信息

Long Zhiyong, Zeng Liuting, Yang Kailin, Chen Junpeng, Luo Yanfang, Dai Charles C, He Qi, Deng Ying, Ge Anqi, Zhu Xiaofei, Hao Wensa, Sun Lingyun

机构信息

Department of Physical Medicine and Rehabilitation, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Guangzhou, China.

Department of Rheumatology and Immunology, Nanjing Drum Tower Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Graduate School of Peking Union Medical College, Nanjing, China.

出版信息

Front Pharmacol. 2024 Oct 10;15:1440584. doi: 10.3389/fphar.2024.1440584. eCollection 2024.

OBJECTIVE

To assess the efficacy and safety of iguratimod (IGU) in the treatment of inflammatory arthritis and degenerative arthritis.

METHODS

Initially, randomized controlled trials (RCTs) on using IGU in treating inflammatory arthritis and degenerative arthritis were systematically gathered from various databases up to February 2024. Subsequently, two researchers independently screened the literature, extracted data, assessed the risk of bias in included studies, and conducted a meta-analysis using RevMan 5.4 software.

RESULTS

Fifty-four RCTs involving three inflammatory arthritis were included, including ankylosing spondylitis (AS), osteoarthritis (OA), and rheumatoid arthritis (RA). For AS, the meta-analysis results showed that IGU may decrease BASDAI (SMD -1.68 [-2.32, -1.03], < 0.00001) and BASFI (WMD -1.29 [-1.47, -1.11], < 0.00001); IGU may also decrease inflammatory factor [ESR: (WMD -10.33 [-14.96, -5.70], < 0.0001); CRP: (WMD -10.11 [-14.55, -5.66], < 0.00001); TNF-α: (WMD -6.22 [-7.97, -4.47], < 0.00001)]. For OA, the meta-analysis results showed that IGU may decrease VAS (WMD -2.20 [-2.38, -2.01], < 0.00001) and WOMAC (WMD -7.27 [-12.31, -2.24], = 0.005); IGU may also decrease IL-6 (WMD -8.72 [-10.00, -7.45], < 0.00001). For RA, the meta-analysis results showed that IGU may improve RA remission rate [ACR20: (RR 1.18 [1.02, 1.35], = 0.02); ACR50: (RR 1.32 [1.05, 1.64], = 0.02); ACR70: (RR 1.44 [1.02, 2.04], = 0.04)] and decrease DAS28 (WMD -0.92 [-1.20, -0.63], < 0.00001); IGU may also decrease inflammatory factors [CRP: (SMD -1.36 [-1.75, -0.96], < 0.00001); ESR: (WMD -9.09 [-11.80, -6.38], < 0.00001); RF: (SMD -1.21 [-1.69, -0.73], < 0.00001)]. Regarding safety, adding IGU will not increase the incidence of adverse events.

CONCLUSION

IGU might emerge as a promising and secure therapeutic modality for addressing AS, OA, and RA.

SYSTEMATIC REVIEW REGISTRATION

Identifier PROSPERO: CRD42021289249.

目的

评估艾拉莫德（IGU）治疗炎性关节炎和退行性关节炎的疗效及安全性。

方法

首先，截至2024年2月，从多个数据库系统收集关于使用IGU治疗炎性关节炎和退行性关节炎的随机对照试验（RCT）。随后，两名研究人员独立筛选文献、提取数据、评估纳入研究的偏倚风险，并使用RevMan 5.4软件进行荟萃分析。

结果

纳入了涉及三种炎性关节炎的54项RCT，包括强直性脊柱炎（AS）、骨关节炎（OA）和类风湿关节炎（RA）。对于AS，荟萃分析结果显示IGU可能降低巴斯强直性脊柱炎疾病活动指数（BASDAI）（标准化均数差 -1.68 [-2.32, -1.03]，<0.00001）和巴斯强直性脊柱炎功能指数（BASFI）（加权均数差 -1.29 [-1.47, -1.11]，<0.00001）；IGU还可能降低炎性因子[红细胞沉降率（ESR）：（加权均数差 -10.33 [-14.96, -5.70]，<0.0001）；C反应蛋白（CRP）：（加权均数差 -10.11 [-14.55, -5.66]，<0.00001）；肿瘤坏死因子-α（TNF-α）：（加权均数差 -6.22 [-7.97, -4.47]，<0.00001）]。对于OA，荟萃分析结果显示IGU可能降低视觉模拟评分（VAS）（加权均数差 -2.20 [-2.38, -2.01]，<0.00001）和西安大略和麦克马斯特大学骨关节炎指数（WOMAC）（加权均数差 -7.27 [-12.31, -2.24]，=0.005）；IGU还可能降低白细胞介素-6（IL-6）（加权均数差 -8.72 [-10.00, -7.45]，<0.00001）。对于RA，荟萃分析结果显示IGU可能提高RA缓解率[美国风湿病学会20%改善标准（ACR20）：（相对危险度 1.18 [1.02, 1.35]，=0.02）；ACR50：（相对危险度 1.32 [1.05, 1.64]，=0.02）；ACR70：（相对危险度 1.44 [1.02, 2.04]，=0.04）]并降低28个关节疾病活动评分（DAS28）（加权均数差 -0.92 [-1.20, -0.63]，<0.00001）；IGU还可能降低炎性因子[CRP：（标准化均数差 -1.36 [-1.75, -0.96]，<0.00001）；ESR：（加权均数差 -9.09 [-11.80, -6.38]，<0.00001）；类风湿因子（RF）：（标准化均数差 -1.21 [-1.69, -0.73]，<0.00001）]。关于安全性，加用IGU不会增加不良事件的发生率。