安徽中医学院学报2011,Vol.30Issue(6):28-32,5.DOI:10.3969.j.issn.1000-2219.2011.06.011
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
摘要
Abstract
Objective To evaluate the effects and safety of Tripterygium glucosides combined with methotrexate (MTX) in the treatment of theumatoid arthritis (RA). Methods A randomized, positively controlled, and openly designed clinical trial was employed. A total of 70 patients with active RA were enrolled. All patients were treated with MTX. Patients in the treatment group were treated with Tripterygium glucosieds, 20 mg per time, three times per day; while patients in the control group were treated with leflunomide, 20 mg per time, 1 time nightly. The course of treatment was 12 weeks. Three Variables Disease Activity Score 28 (DAS28-3) was selected as main evaluating index. Results After treatment,DAS28-3 in both groups were significantly decreased. Twenty-one patients (accounting for 61. 8%) in the treatment group, and 24 patients (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 1 patient in the treatment group, and in 4 patients in the control group.There were 16 premenopausal patients in treatment group, of which 3 patients appeared menstrual disorders 8 weeks after the treatment. Five patients had the same symptoms 12 weeks after the treatment, including 2 patients 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.关键词
雷公藤多苷/甲氨蝶呤/类风湿关节炎/随机对照试验Key words
Tripterygium glucosides / methotrexate/ theumatoid aarthritis/ randomised controlled trial分类
医药卫生引用本文复制引用
陈鹏,朱琳,邹荥,杜红莲,周云,顾向浩..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[J].安徽中医学院学报,2011,30(6):28-32,5.基金项目
江苏省徐州市科技局2007年课题(xm07c038) (xm07c038)