Page 99 - 《中国药房》2024年6期

·药物与临床·

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

1 #
王明杰 1， 2＊ ，徐风金 ，张 艳 ，薛 燕（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
1
3
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）
中图分类号 R979.5；R453 文献标志码 A 文章编号 1001-0408（2024）06-0729-05
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（P＜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
（P＜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（P＜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（P＞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。
关键词 难治性类风湿关节炎；托法替布；羟氯喹；疗效；安全性

Clinical observation of tofacitinib combined with hydroxychloroquine in the treatment of refractory
rheumatoid arthritis
WANG Mingjie ，XU Fengjin ，ZHANG Yan ，XUE Yan（1. Dept. of Rheumatology and Immunology， Hengshui
3
1
1
1， 2
Municipal People’s Hospital， Hebei Hengshui 053000， China；2. College of Clinical Medicine， Hebei Medical
University， Shijiazhuang 050017， China；3. Dept. of General Medicine， Hengshui Municipal People’s Hospital，
Hebei Hengshui 053000， China）
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 （P＜0.05）； DAS28 score， Sharp score， biochemical
indicators， immune indexes and serum cytokine indicators of 3 groups were significantly lower than before treatment （P＜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 （P＜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 （P＞0.05）. CONCLUSIONS
Δ 基金项目 河北省科技计划项目（No.2022HBKJ00033）；衡水市
Tofacitinib combined with hydroxychloroquine shows good
科技计划项目（No.2020014069Z）
＊第一作者 主治医师。研究方向：难治性类风湿关节炎。E- efficacy and safety for refractory RA.
mail：wangmingjie202307@163.com KEYWORDS refractory rheumatoid arthritis； tofacitinib；
# 通信作者 主任医师，硕士。研究方向：中西医结合治疗类风湿 hydroxychloroquine； efficacy； safety
关节炎。E-mail：xufengjin2008@sina.com

中国药房 2024年第35卷第6期 China Pharmacy 2024 Vol. 35 No. 6 · 729 ·