雷公藤多苷联合甲氨蝶呤治疗类风湿关节炎的随机对照试验

Tripterygium Glucosides Combined with Methotrexate in Treatment of Rheumatoid Arthritis:A Randomised Controlled Trial

目的评价雷公藤多苷联合甲氨蝶呤(methotrexate,MTX)治疗类风湿关节炎(rheumatoid arthri-tis,RA)的有效性及安全性。方法采用随机、阳性药物对照、开放性设计,纳入活动性RA患者70例。两组均给予MTX,治疗组给予雷公藤多苷20mg,每日3次;对照组给予来氟米特20mg,每晚1次。共治疗12周。以3变量疾病活动指数28(three variables disease activity score 28-3,DAS28-3)为主要评估指标。结果两组治疗后,DAS28-3评分均较治疗前明显下降;治疗组中等反应者21例(61.8%),对照组中等反应者24例(70.6%),两组中等反应率比较,差异无统计学意义。治疗组有1例、对照组有4例用药4周后出现丙氨酸转氨酶或天门冬氨酸转氨酶升高2～3倍正常上限。治疗组绝经期前女性共16例,使用8周后,有3例出现月经紊乱;12周后,有5例出现月经紊乱,其中2例闭经。结论短期内雷公藤多苷可替代来氟米特与MTX联合治疗RA,治疗12周后,多数患者可取得中等反应,不良反应轻微,但应注意其对性腺的影响。

Objective To evaluate the effects and safety of Tripterygium glucosides combined with methotrexate（MTX）in the treatment of rheumatoid arthritis（RA）.Methods A randomized,positively controlled,and openly designed clinical trial was employed.A total of 70patients with active RA were enrolled.All patients were treated with MTX.Patients in the treatment group were treated with Tripterygium glucosieds,20mg per time,three times per day;while patients in the control group were treated with leflunomide,20mg per time,1time nightly.The course of treatment was 12weeks.Three Variables Disease Activity Score 28（DAS28-3）was selected as main evaluating index.Results After treatment,DAS28-3in both groups were significantly decreased.Twenty-one patients（accounting for 61.8%）in the treatment group,and 24patients（accounting for 70.6%）in the control group,had moderate responses,respectively.There was no significant difference in response rate between the two groups.Four weeks after the treatment,the levels of alanine transaminase,and aspartic transaminase were increased by 2-3 times upper limits of normal in 1patient in the treatment group,and in 4patients in the control group.There were 16premenopausal patients in treatment group,of which 3patients appeared menstrual disorders 8weeks after the treatment.Five patients had the same symptoms 12weeks after the treatment,including 2patients with amenorrhea.Conclusion In a short term,Tripterygium glucosides can replace leflunomide in treatment of RA if combined with MTX.Twelve weeks after treatment,most patients can obtain moderate responses with mild adverse effects,but its influence on gonad should be noticed.