一项系统性综述和荟萃分析，共纳入 19 项随机对照试验，评估了伊古曲替姆联合其他疗法治疗干燥综合征的疗效。
A Systematic Review and Meta-Analysis of 19 Randomized Controlled Trials of Iguratimod Combined With Other Therapies for Sjogren's Syndrome.
机构信息
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases (NCRC-DID), Key Laboratory of Rheumatology and Clinical Immunology, Ministry of Education, Beijing, China.
People's Hospital of Ningxiang City, Ningxiang City, China.
出版信息
Front Immunol. 2022 Jul 28;13:924730. doi: 10.3389/fimmu.2022.924730. eCollection 2022.
OBJECTIVE
To explore the efficacy and safety of Iguratimod intervention in Primary Sjogren's syndrome (pSS).
METHODS
Many databases were searched to collect the RCTs. Three independent reviewers extracted data and assessed the quality of the studies based on the Cochrane Handbook. The statistical analysis was done by RevMan 5.3 and STATA. The quality of evidence was evaluated by GRADE tool.
RESULTS
Twenty-nine RCTs with 2258 participants were included in this review. The meta-analysis shows that: iguratimod experiment group can reduce the ESSPRI score (WMD -1.93 [-2.33, -1.52], P<0.00001), ESSDAI score (WMD -1.39 [-1.81, -0.98], P<0.00001), Schirmer's test (WMD 1.77 [0.85, 2.70], P=0.0002), RF (WMD -5.78 [-7.59, -3.97], P<0.00001), and decrease the ESR level (WMD -7.05 [-9.84, -4.26], P<0.00001). Meanwhile, the summary result showed the addiction of Iguratimod may not increase the adverse events. The adverse events were mainly gastrointestinal discomfort, abnormal liver function, and rash and itching. The quality of evidence of adverse events was moderate. Referring to minimal clinically important difference (MCID), the improvement of ESSPRI is clinically significant, and the improvement of ESSDAI for patients older than 60 years old may be clinically significant.
CONCLUSION
Based on current evidence, iguratimod can effectively reduce ESSPRI score, ESSDAI score, Schirmer's test score and decrease systemic inflammatory response (such as ESR level and RF level) without increasing the probability of adverse events. The recommended course of treatment is at least 12 weeks.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?, identifier CRD42020220770.
目的
探索来氟米特干预原发性干燥综合征（pSS）的疗效和安全性。
方法
检索多个数据库以收集 RCTs。三位独立的审稿人根据 Cochrane 手册提取数据并评估研究质量。统计分析采用 RevMan 5.3 和 STATA。使用 GRADE 工具评估证据质量。
结果
纳入了 29 项 RCT，共 2258 名参与者。Meta 分析显示：来氟米特实验组可降低 ESSPRI 评分（WMD-1.93[-2.33，-1.52]，P<0.00001）、ESSDAI 评分（WMD-1.39[-1.81，-0.98]，P<0.00001）、Schirmer 试验（WMD 1.77[0.85，2.70]，P=0.0002）、RF（WMD-5.78[-7.59，-3.97]，P<0.00001）和降低 ESR 水平（WMD-7.05[-9.84，-4.26]，P<0.00001）。同时，汇总结果显示来氟米特的不良反应发生率并未增加。不良反应主要为胃肠道不适、肝功能异常、皮疹和瘙痒。不良反应的证据质量为中度。参考最小临床重要差异（MCID），ESSPRI 的改善具有临床意义，而 60 岁以上患者 ESSDAI 的改善可能具有临床意义。
结论
基于现有证据，来氟米特可有效降低 ESSPRI 评分、ESSDAI 评分、Schirmer 试验评分和降低全身炎症反应（如 ESR 水平和 RF 水平），而不增加不良反应的发生概率。推荐的疗程至少为 12 周。
系统评价注册
https://www.crd.york.ac.uk/prospero/display_record.php？，标识符 CRD42020220770。
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