Clinical observation of tofacitinib combined with hydroxychloroquine in the treatment of refractory rheumatoid arthritis

WANG Mingjie; XU Fengjin; ZHANG Yan; XUE Yan

doi:10.6039/j.issn.1001-0408.2024.06.16

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Clinical observation of tofacitinib combined with hydroxychloroquine in the treatment of refractory rheumatoid arthritis

更新时间：2024-04-09

- Clinical observation of tofacitinib combined with hydroxychloroquine in the treatment of refractory rheumatoid arthritis
- ZHONGGUO YAOFANG Vol. 35, Issue 6, Pages: 729-733(2024)
- 作者机构：
  
  1.衡水市人民医院风湿免疫科，河北衡水　053000
  2.河北医科大学临床学院，石家庄　050017
  3.衡水市人民医院全科医学科，河北衡水　053000
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2024.06.16
  CLC： R979.5;R453
- Published：30 March 2024，
  
  Received：23 September 2023，
  
  Revised：28 February 2024，
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王明杰,徐风金,张艳等.托法替布联合羟氯喹治疗难治性类风湿关节炎的临床观察 ^Δ[J].中国药房,2024,35(06):729-733.

WANG Mingjie,XU Fengjin,ZHANG Yan,et al.Clinical observation of tofacitinib combined with hydroxychloroquine in the treatment of refractory rheumatoid arthritis[J].ZHONGGUO YAOFANG,2024,35(06):729-733.
王明杰,徐风金,张艳等.托法替布联合羟氯喹治疗难治性类风湿关节炎的临床观察 ^Δ[J].中国药房,2024,35(06):729-733. DOI： 10.6039/j.issn.1001-0408.2024.06.16.

WANG Mingjie,XU Fengjin,ZHANG Yan,et al.Clinical observation of tofacitinib combined with hydroxychloroquine in the treatment of refractory rheumatoid arthritis[J].ZHONGGUO YAOFANG,2024,35(06):729-733. DOI： 10.6039/j.issn.1001-0408.2024.06.16.

摘要

目的

观察托法替布联合羟氯喹治疗难治性类风湿关节炎（RA）的临床疗效和安全性。

方法

选取2021年1月1日至2022年1月1日衡水市人民医院风湿免疫科收治的难治性RA患者120例，按照简单随机分配方法分为A组、B组和C组，每组40例。A组患者给予枸橼酸托法替布片+硫酸羟氯喹片，B组患者给予枸橼酸托法替布片+甲氨蝶呤片，C组患者给予枸橼酸托法替布片+来氟米特片，3组患者均连续用药6个月。观察3组患者的疗效，治疗前后的疾病活动度评分28（DAS28）、Sharp评分和生化指标[红细胞沉降率（ESR）、C-反应蛋白（CRP）]、免疫指标[类风湿因子（RF）、抗环瓜氨酸多肽（CCP）抗体]、血清细胞因子指标[白细胞介素6（IL-6）、肿瘤坏死因子α（TNF-α）]水平，记录治疗期间的不良反应发生情况。

结果

治疗后，A组ACR50、ACR70患者比例均显著高于B、C组（

＜0.05），3组患者的DAS28评分、Sharp评分以及生化、免疫、血清细胞因子指标均显著低于同组治疗前（

＜0.05），且随治疗时间延长逐渐降低；A组患者治疗6个月时的DAS28评分、Sharp评分、RF、抗CCP抗体、IL-6、TNF-α水平均显著低于B、C组（

＜0.05）。3组患者的腹泻、恶心呕吐、白细胞减少、皮疹、肝肾功能异常及头晕发生率比较，差异均无统计学意义（

＞0.05）。

结论

托法替布联合羟氯喹治疗难治性RA的疗效和安全性均较好。

Abstract

OBJECTIVE

To observe the clinical efficacy and safety of tofacitinib combined with hydroxychloroquine in the treatment of refractory rheumatoid arthritis （RA）.

METHODS

From January 1， 2021 to January 1， 2022， 120 patients with refractory RA were selected as the study objects. According to the principle of random allocation， the patients were divided into group A， group B and group C， with 40 patients in each group. Group A was given Tofacitinib citrate tablet + Hydroxychloroquine sulfate tablet； group B was given Tofacitinib citrate tablet + Methotrexate tablet； group C was given Tofacitinib citrate tablet + Leflunomide tablet. Three groups were given relevant medicine for 6 months. Therapeutic efficacy and disease activity score 28 （DAS 28） of 3 groups as well as Sharp score， the levels of biochemical indicators [erythrocyte sedimentation rate （ESR）， C-reactive protein （CRP）]， immune indexes [rheumatoid factor （RF）， anti-cyclic peptide containing citrulline （anti-CCP） antibody]， serum cytokine indicators [interleukin-6 （IL-6） and tumor necrosis factor-α （TNF-α）] before and after treatment were observed； the occurrence of adverse drug reactions during treatment was recorded.

RESULTS

After treatment， the proportions of ACR50 and ACR70 patients in group A were significantly higher than groups B and C （

＜0.05）； DAS28 score， Sharp score， biochemical indicators， immune indexes and serum cytokine indicators of 3 groups were significantly lower than before treatment （

＜0.05）， and gradually decreased with prolonged treatment time； after 6 months of treatment， DAS28 score， Sharp score， RF， anti-CCP antibody， the levels of IL-6 and TNF-α in group A were significantly lower than group B and C （

＜0.05）. There was no significant difference in the incidence of diarrhea， nausea and vomiting， leukopenia， rash， abnormal liver and kidney function， or dizziness among 3 groups （

＞0.05）.

CONCLUSIONS

Tofacitinib combined with hydroxychloroquine shows good efficacy and safety for refractory RA.

关键词

难治性类风湿关节炎托法替布羟氯喹疗效安全性

Keywords

tofacitinibhydroxychloroquineefficacysafety

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