中国临床药理学杂志2024，Vol.40Issue(5)：663-667,5.DOI:10.13699/j.cnki.1001-6821.2024.05.007
托法替布联合羟氯喹治疗难治性类风湿关节炎患者的临床研究
Clinical trial of tofacitinib combined with hydroxychloroquine in the treatment of patients with refractory rheumatoid arthritis
摘要
Abstract
Objective To observe the clinical efficacy and safety of tofacitinib tablets combined with hydroxychloroquine tablets in the treatment of patients with refractory rheumatoid arthritis.Methods Patients with refractory rheumatoid arthritis were randomly divided into control and treatment groups.The control group was given enteric-coated sulfasalazine tablets 1.0 g per time,three times a day,orally+methotrexate tablets 10 mg per time,once a week,orally+hydroxychloroquine sulfate tablets 0.2 g per time,twice a day,orally.The treatment group received citrate tofacitinib tablets 5 mg per time,twice a day,orally,on the basis of control group.Two groups were treated for 6 months.The clinical efficacy,disease activity,joint pain level,rheumatoid factor(RF),and adverse drug reactions were compared between the two groups.Results Treatment group was enrolled 80 cases,4 cases dropped out,and 76 cases were included in the statistical analysis.Control group was enrolled 80 cases,8 cases dropped out,and 72 cases were included in the statistical analysis.After treatment,the total effective rates of treatment and control groups were 54.05％(40 cases/76 cases)and 16.22％(12 cases/72 cases)with significant difference(P＜0.05).After treatment,the disease activity score in 28 joints scores of treatment and control groups were(2.69±0.73)and(3.32±0.84)points;the visual analog scale scores were(2.72±0.71)and(3.31±0.68)points;the RF levels were(184.61±32.14)and(201.32±30.73)U·mL-1;the differences were statistically significant(all P＜0.05).The adverse drug reactions in the treatment group were gastrointestinal reactions,mild liver damage and elevated blood pressure,while those in the control group were gastrointestinal reactions and mild liver damage.The incidences of total adverse drug reactions in the treatment and control groups were 19.74％and 29.17％without significant difference(P＞0.05).Conclusion Tofacitinib tablets combined with hydroxychloroquine tablets have a definitive clinical efficacy in the treatment of refractory rheumatoid arthritis patients,which can significantly reduce the disease activity and relieve joint pain,without increasing the incidence of adverse drug reactions.关键词
托法替布片/羟氯喹片/难治性类风湿关节炎/疾病活动度/临床疗效/安全性评价Key words
tofacitinib tablet/hydroxychloroquine tablet/refractory rheumatoid arthritis/disease activity/clinical efficacy/safety evaluation分类
药学引用本文复制引用
王明杰,徐风金,张艳,薛燕..托法替布联合羟氯喹治疗难治性类风湿关节炎患者的临床研究[J].中国临床药理学杂志,2024,40(5):663-667,5.基金项目
衡水市科技计划基金资助项目(2020014069Z) （2020014069Z）
