甲氨喋呤联合雷公藤多甙片治疗类风湿性关节炎疗效及安全性观察

Study on efficacy and safety of combined methotrexate with Tripterygium wilfordii polyglycoside tablets in treatment of patients with rheumatoid arthritis

目的评价甲氨喋呤(MTX)联合雷公藤多甙片治疗类风湿性关节炎的疗效及安全性。方法将42例类风湿性关节炎患者随机分为两组:甲氨喋吟治疗组20例,接受甲氨喋吟10 mg/周;甲氨喋吟联合雷公藤多甙片治疗组22例,接受甲氨喋吟10 mg/周、雷公藤多甙片60 mg/d。观察治疗3个月两组患者病情改善情况及药物不良反应。结果按美国风湿病协会(ACR)类风湿性关节炎改善标准,39例完成3个月的治疗,MTX组19例完成患者中症状改善(达ACR20或以上)15例,总有效率78.9%。联合组20例患者病情改善16例,总有效率为80.0%,两组比较差异有显著性(P<0.05)。并且两组晨僵、关节肿痛数、关节压痛数、患者对疾病活动性的总体评价、医生对疾病活动性的总体评、红细胞沉降率、C反应蛋白等临床指标差异均有统计学意义。两组的不良反应比较,差异无统计学意义(P>0.05)。结论甲氨喋吟联合雷公藤多甙片治疗类风湿性关节炎的疗效优于单用甲氨喋吟治疗,且安全性好。

Objective To evaluate the efficacy and safety of combined methotrexate （MTX） with Tripterygium wilfordii polyglycoside tablets in treatment of patients with rheumatoid arthritis （RA）. Methods Firstly, 42 RA patients were divided into two groups ： MTX thepapy group and combination therapy group. Twenty patients in MTX therapy group were administrated with 10 mg methotrexate, once per week;22 patients in combination therapy group were taken with 10 mg methotrexate per week and 60 mg Tripterygium wilfordii polyglycoside per day. The im- provement in symptoms of patients and drug adverse reactions were observed after treatment for 3 months. Results According to the criteria of ACR, the rates of improvement in ACR20, ACR50 and ACRT0 in patients of combination therapy group were 76%, 54% and 33% respectively; while in MTX therapy group, rates of improvement in ACR20, ACRS0 and ACR were 4-8%, 30% and 24% respectively, and the difference was statistically significant between these two groups（ P 〈 0.05 ）. There was no statistically significant difference noted in adverse drug reactions between these two groups （ P 〉 0.05 ）. Conclusion The combination therapy is more effective and safer than MTX therapy in treatment of patients with rheumatoid arthritis.