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

目的 观察托法替布片联合羟氯喹片治疗难治性类风湿关节炎患者的临床疗效及安全性。方法 将难治性类风湿关节炎患者随机分为对照组和试验组。对照组给予柳氮磺吡啶肠溶片每次1.0 g,每天3次,口服+甲氨蝶呤片每次10 mg,每周1次,口服+羟氯喹片每次0.2 g,每天2次,口服;试验组在对照组治疗的基础上,联合口服枸橼酸托法替布片每次5 mg,每天2次。2组患者均治疗6个月。比较2组患者的临床疗效、疾病活动度、关节疼痛程度、类风湿因子(RF),以及药物不良反应的发生情况。结果 试验组入组80例,脱落4例,最终有76例纳入统计分析;对照组入组80例,脱落8例,最终有72例纳入统计分析。治疗后,试验组和对照组的总有效率分别为54.05%(40例/76例)和16.22%(12例/72例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的疾病活动评分28关节指数评分分别为(2.69±0.73)和(3.32±0.84)分,视觉模拟量表评分分别为(2.72±0.71)和(3.31±0.68)分,RF分别为(184.61±32.14)和(201.32±30.73)U·mL^(-1),在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有胃肠道反应、轻度肝损伤、血压升高,对照组的药物不良反应主要有胃肠道反应、轻度肝损伤。试验组和对照组的总药物不良反应发生率分别为19.74%和29.17%,在统计学上差异无统计学意义(P>0.05)。结论 托法替布片联合羟氯喹片治疗难治性类风湿关节炎患者的临床疗效确切,其能显著降低患者的病情活动度,缓解关节疼痛,且不增加药物反应的发生率。

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( allP< 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.