Pu Jincheng, Wang Xuan, Riaz Farooq, Zhang Tongyangzi, Gao Ronglin, Pan Shengnan, Wu Zhenzhen, Liang Yuanyuan, Zhuang Shuqi, Tang Jianping
Department of Rheumatology and Immunology, Tongji Hospital, Tongji University School of Medicine, Shanghai, China.
Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Xi'an Jiaotong University Health Science Center, Xi'an, China.
Front Pharmacol. 2021 Mar 19;12:621208. doi: 10.3389/fphar.2021.621208. eCollection 2021.
We aimed to assess the effectiveness and safety of iguratimod (IGU) in treating primary Sjögren's syndrome (pSS) by meta-analysis. Eight databases and two clinical trial websites were searched from conception to August 10, 2020, for relevant randomized controlled trials (RCTs) on outcomes of patients with pSS treated with IGU. Revman 5.4 was used for statistical analysis and creating plots. A total of 1,384 patients with pSS from 19 RCTs were included in this meta-analysis. Pooled results demonstrated that patients treated with IGU + hydroxychloroquine (HCQ) + glucocorticoid (GC) showed significant differences in erythrocyte sedimentation rate (ESR), rheumatoid factor (RF) level, platelet (PLT) count, immunoglobulin G (IgG) level, salivary flow rate, Schirmer's test result, EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), and efficacy rate ( ≤ 0.01) compared to patients treated with HCQ + GC. Compared to treatment with HCQ and GC, co-administration of IGU with GC showed significant differences in ESR and RF level ( ≤ 0.01); however, no significant differences were noted in IgG level. Conversely, the IgG level showed a significant improvement in the IGU + HCQ + GC group compared to the HCQ + GC group. The results of safety analysis revealed that seven trials showed no significant differences in adverse events (AEs) between the IGU + HCQ + GC and HCQ + GC groups ( = 0.15). Although no severe AEs were noted, gastrointestinal discomfort was the most common AE in the IGU group. No significant differences in AEs were observed between the IGU + GC and HCQ + GC groups. IGU improved the clinical symptoms of patients with pSS, including inflammatory indicators (ESR, IgG, and RF levels), PLT count, secretion function of the salivary and lacrimal glands (salivary flow rate and Schirmer's test result), and disease indexes (ESSDAI and ESSPRI), when co-administered with HCQ + GC therapy without increasing the risks of AEs. Therefore, IGU can be considered as an effective and safe drug for clinical therapy of pSS. Considering the limitations of the present trials, more long-term, multicenter, and high-quality RCTs are required to assess the effectiveness and safety of IGU for treating patients with pSS.
我们旨在通过荟萃分析评估艾拉莫德（IGU）治疗原发性干燥综合征（pSS）的有效性和安全性。从数据库建立至2020年8月10日，检索了八个数据库和两个临床试验网站，以查找关于IGU治疗pSS患者结局的相关随机对照试验（RCT）。使用Revman 5.4进行统计分析并绘制图表。本荟萃分析纳入了来自19项RCT的1384例pSS患者。汇总结果表明，与接受羟氯喹（HCQ）+糖皮质激素（GC）治疗的患者相比，接受IGU + HCQ + GC治疗的患者在红细胞沉降率（ESR）、类风湿因子（RF）水平、血小板（PLT）计数、免疫球蛋白G（IgG）水平、唾液流速、泪液分泌试验结果、欧洲抗风湿病联盟干燥综合征患者报告指数（ESSPRI）、欧洲抗风湿病联盟干燥综合征疾病活动指数（ESSDAI）和有效率方面存在显著差异（P≤0.01）。与HCQ + GC治疗相比，IGU与GC联合使用在ESR和RF水平上存在显著差异（P≤0.01）；然而，IgG水平无显著差异。相反，与HCQ + GC组相比，IGU + HCQ + GC组的IgG水平有显著改善。安全性分析结果显示，七项试验表明IGU + HCQ + GC组与HCQ + GC组在不良事件（AE）方面无显著差异（P = 0.15）。虽然未观察到严重不良事件，但胃肠道不适是IGU组最常见的AE。IGU + GC组与HCQ + GC组在AE方面未观察到显著差异。IGU与HCQ + GC联合治疗时，可改善pSS患者的临床症状，包括炎症指标（ESR、IgG和RF水平）、PLT计数、唾液腺和泪腺分泌功能（唾液流速和泪液分泌试验结果）以及疾病指数（ESSDAI和ESSPRI），且不增加AE风险。因此，IGU可被视为pSS临床治疗的有效且安全的药物。考虑到当前试验的局限性，需要更多长期、多中心和高质量的RCT来评估IGU治疗pSS患者的有效性和安全性。
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