中西药治疗类风湿关节炎随机对照的临床研究

A Randomized Controlled Clinical Trial of Chinese Medicine vs Western Medicine in the Treatment of Rheumatoid Arthritis

目的:比较中西药治疗类风湿关节炎(RA)的有效性和安全性。方法:105例RA患者随机分为2组,中药组53例,口服雷公藤和益肾蠲痹丸治疗;西药组52例,口服甲氨蝶呤和来氟米特治疗,疗程均24周。治疗前后观察2组患者临床症状(包括休息痛、晨僵、肿胀关节数及指数、关节压痛关节数及指数),分析患者的健康状况问卷(HAQ)评分,患者及医师对疾病总体状况的评分,临床疗效及不良反应等。结果:治疗12周时,2组临床症状、HAQ评分、患者及医师对疾病总体状况评分与治疗前比较均明显下降(P<0.01),2组间比较差异无统计学意义;临床疗效比较2组差异亦无统计学意义。第24周时,中药组各项观察指标均差于西药组(P<0.05,0.01);不良反应比较2组差异无统计学意义,但中药组排除月经不调的副反应,则不良反应的发生率明显低于西药组。结论:西药治疗RA远期疗效好于中药组,但2种治疗方法均有优劣,合理使用将会使治疗更优化。

Objective： To evaluate the efficacy and safety of Chinese medicine in the treatment of patients with rheumatoid arthritis （RA） compared to western medicine. Methods： A randomized controlled clinic trial of patients with RA was carried out. Patients were divided into Chinese medicine group given Tripterygium wilfordii （TW） and Yishen j uanbi pills （n = 53） and western medicine group given methotrexate and leflunomide （n= 52）, for 24 weeks. Assessments included pain VAS, morning stiffness, number of swollen joints and joints with pressing pain, health assessment questionnaire, and the global assessments about disease activity of patients and physicians. Efficacy was assessed using the American College of Rbeumatology criteria for 20% （ACR20） improvement, and clinical and laboratory adverse reactions of the drugs were observed in both groups. Results： ACR20 improvement in Chinese medicine group at the 12th and 24th week was 58.49% and 67.92% respectively. Between western medicine group and Chinese medicine group, there was no statistically significant difference at the 12th week （P〉0.05）, but at the 24th week, it was worse in Chinese medicine group than in western medicine group （P〈0.05, or P〉0.01）. However, there was no significant difference in the total incidence of adverse reactions between two groups（P〉0.05）. Conclusion： Global assessment of the efficacy and safety in both groups is evenly matched, although Chinese medicine and western medicine are of different advantage and disadvantage.