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不同 Janus 激酶抑制剂联合甲氨蝶呤治疗类风湿关节炎的疗效和安全性:一项单中心随机试验。

Efficacy and safety of different Janus kinase inhibitors combined with methotrexate for the treatment of rheumatoid arthritis: a single-center randomized trial.

机构信息

Department of Rheumatology and Immunology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi Province, 530000, China.

Department of Rheumatology, Liu Zhou People's Hospital, Guangxi, China.

出版信息

Adv Rheumatol. 2023 Oct 16;63(1):50. doi: 10.1186/s42358-023-00331-1.

Abstract

OBJECTIVE

To compare the efficacy and safety between baricitinib (BARI) and tofacitinib (TOFA) for the treatment of the rheumatoid arthritis (RA) patients receiving methotrexate (MTX) in clinical practice.

METHODS

This retrospective study recruited 179 RA patients treated with BARI (2-4 mg/d) or TOFA (10 mg/d) at The First Affiliated Hospital of Guangxi Medical University from September 2019 to January 2022. The rate of low disease activity (LDA) was used as the primary end point. Secondary end points included the Disease Activity Scale-28 (DAS-28)-C-reactive protein (CRP); the rate of DAS28-CRP remission; visual analogue scale (VAS) for pain, swollen joint, and tender joint counts; and adverse events at the 6-month follow-up. Several factors affecting LDA achievement were also analyzed.

RESULTS

Seventy-four patients were treated with BARI and 105 were treated with TOFA, including 83.24% females, with a median (IQR) age of 56.0 (53.0-56.0) years old and disease duration of 12.0 (6.0-12.0) months. There was no difference of the rate of LDA between the BARI and TOFA treatment groups. All disease indices in the two groups were significantly improved, including a significantly lower VAS in the BARI group (P < 0.05), reflecting the drug efficacy after 1 and 6 months of treatment. The incidence of adverse reactions was similar in these two groups.

CONCLUSION

The treatment efficacy and safety of BARI and TOFA in the RA patients were similar, but BARI was more effective in pain relief than TOFA. An older baseline age was more likely to achieve LDA in the BARI group, while a low baseline erythrocyte sedimentation rate (ESR) was more likely to achieve LDA in the TOFA group.

摘要

目的

比较巴瑞替尼(BARI)和托法替布(TOFA)在治疗接受甲氨蝶呤(MTX)治疗的类风湿关节炎(RA)患者中的疗效和安全性。

方法

本回顾性研究纳入 2019 年 9 月至 2022 年 1 月在广西医科大学第一附属医院接受 BARI(2-4mg/d)或 TOFA(10mg/d)治疗的 179 例 RA 患者。低疾病活动度(LDA)率作为主要终点。次要终点包括疾病活动度 28 项评分-红细胞沉降率(DAS-28-ESR);DAS28-ESR 缓解率;视觉模拟量表(VAS)疼痛、肿胀关节和压痛关节计数;以及 6 个月随访时的不良事件。还分析了影响 LDA 达标率的多种因素。

结果

74 例患者接受 BARI 治疗,105 例患者接受 TOFA 治疗,其中 83.24%为女性,中位(IQR)年龄为 56.0(53.0-56.0)岁,病程为 12.0(6.0-12.0)个月。BARI 和 TOFA 治疗组的 LDA 率无差异。两组所有疾病指标均明显改善,BARI 组 VAS 明显降低(P<0.05),反映了治疗 1 个月和 6 个月后的药物疗效。两组不良反应发生率相似。

结论

BARI 和 TOFA 治疗 RA 患者的疗效和安全性相似,但 BARI 在缓解疼痛方面更有效。BARI 组中,基线年龄较大更有可能达到 LDA,而 TOFA 组中,基线红细胞沉降率(ESR)较低更有可能达到 LDA。

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