目的 探索乌梢蛇祛风片治疗早期类风湿关节炎（Rheumatoid arthritis，RA）的疗效和安全性。方法 以本院早期RA患者（病程小于等于2年）为研究对象，采用开放、随机的研究方法，治疗组服用乌梢蛇祛风片+甲氨蝶呤10 mg qw；对照组单用甲氨蝶呤10 mg qw；疗程为24周，以美国风湿病协会（ACR）规定的RA疾病缓解度（缓解20%、50%、70%即为ACR20、ACR50、ACR70）和中医证候疗效作为评估标准。结果 治疗组完成76例，对照组完成74例。治疗组和对照组达到ACR20有效率分别为71%和52%，两组有统计学差异（P <0.05）；两组达到ACR50与ACR70无统计学差异（P > 0.05）。治疗24周后中医证候疗效，治疗组和对照组有效率分别80%和60%，有统计学差异（P < 0.01）。不同病程的RA（病程小于等于6个月和病程大于6个月）患者ACR20/50/70的有效率和中医证候疗效比较均无统计学差异（P > 0.05）。两组患者在试验过程中均未出现严重的不良反应。结论 乌梢蛇祛风片联合甲氨蝶呤治疗早期RA患者的ACR20疗效和中医证候疗效优于单用甲氨蝶呤，安全性良好。
Objective To explore the curative effects and safety of Zaocys dhumnades preparations in the treatment of early rheumatoid arthritis. Methods The patients with early rheumatoid arthritis (course less than or equal to 2 years) were treated with open and randomized research methods to observe the efficacy and safety of Zaocys dhumnades preparations. The observation group was treated with the Zaocys dhumnades pill + methotrexate 10 mg qw and the control group was treated by methotrexate 10 mg qw only. The course of treatment was 24 weeks. The degree of remission of RA disease (20%, 50%, 70% of remission is ACR20, ACR50, ACR70) and the curative effect of TCM syndromes are used as evaluation criteria. Results 76 cases were completed in the treatment group and 74 cases in the control group. The effective rate of ACR20 in the treatment group and control group was 71% and 52% , respectively, with statistical difference (P < 0.05). There was no statistically significant difference between ACR50 and ACR70 in the two groups (P > 0.05). After 24 weeks of treatment, the effective rate of the treatment group and control group was 80% and 60% respectively, with statistically significant differences (P < 0.01). There were no statistically significant differences in acr20/50/70 and TCM syndrome efficacy between RA patients with different disease courses (disease course less than or equal to 6 months and disease course more than 6 months) (P > 0.05). There were no serious adverse reactions in both groups. Conclusion the ACR20 efficacy and TCM syndrome efficacy of wuzhaopu qufeng tablet combined with methotrexate in the treatment of early RA patients were better than that of methotrexate alone, and was safe.