目的:观察独活寄生汤加减联合针灸治疗类风湿性关节炎的临床疗效。方法:将80例类风湿性关节炎患者随机分为治疗组和对照组各40例。治疗组采用独活寄生汤加减联合针灸治疗,对照组采用美洛昔康片口服治疗,20 d为1疗程,连续2个疗程;观察两组临床症状、体征改善情况及血沉、C反应蛋白、血流变学改变情况,并进行对比分析。结果:治疗组痊愈18例(45.0%),显效16例(40.0%),有效4例(10.0%),无效2例(5.0%);对照组痊愈9例(22.5%),显效14例(35.0%),有效12例(30.0%),无效5例(12.5%),两组临床疗效比较,治疗组优于对照组,差异有统计学意义(P<0.05);两组治疗前各项指标比较,差异无统计学意义(P>0.05),两组组内治疗前后比较,差异均有统计学意义(P<0.05);两组治疗后各项指标比较,治疗组疗效优于对照组,差异有统计学意义(P<0.05)。结论:独活寄生汤加减联合针灸治疗类风湿性关节炎临床疗效良好。

Objective To evaluate the efficacy and safety of leflunomide in comparison with methotrexate (MTX) on patients with rheumatoid arthritis (RA) in China.Methods Five hundred and sixty-six patients with active rheumatoid arthritis were randomly assigned to receive leflunomide at 20 mg once daily or MTX at 15 mg once weekly in a controlled trial. Five hundred and four patients completed the 12-week treatment and some patients continued the treatment for 24 weeks.Results Both leflunomide and MTX could improve the symptoms, signs, and joint function, but there were no changes in X-ray observations of patients with rheumatoid arthritis. In the leflunomide group, the overall rates of effectiveness at 12 weeks and 24 weeks were 86.94% and 92.31% respectively; the rates of remarkable improvement were 64.95% and 79.81% respectively. In the MTX group, the overall rates of effectiveness at 12 weeks and 24 weeks were 84.04% and 83.15% respectively; the rates of remarkable improvement were 56.81% and 75.28% respectively. According to intent-to-treat analysis, the ACR 20% response rates at 12 weeks and 24 weeks in the leflunomide group were 62.54% and 67.18% respectively, compared with 60.08% and 61.32% respectively in MTX group. No statistical differences were shown in the efficacy between the two groups (P>0.05). The adverse events in the leflunomide group were gastrointestinal symptoms, skin rash, alopecia, nervous system symptoms, decreased leukocyte count, and elevation of alanine aminotransferase (ALT). Most of these side effects were mild and transient. The incidence of adverse events in the leflunomide group was 16.84%, significantly lower than that in MTX group (28.17%, P=0.002).Conclusions Leflunomide is effective in the treatment of RA with less adverse events than MTX. Its efficacy is similar to MTX, but the incidence of adverse events and the rate of withdrawal due to adverse events were lower in the leflunomide group than in MTX group.