清热解毒活血法外治类风湿关节炎的临床研究

目的：评价清热解毒活血法外治类风湿关节炎（RA）活动期关节炎症的临床疗效和安全性。方法：纳入120例辨证为热毒蕴结、气滞血瘀型RA活动期的患者。随机分为治疗组60例，对照组60例，治疗组采用具有清热解毒活血作用的消炎止痛膏，对照组采用安慰剂，1贴/d，选择1个受累关节外用。每个疗程7 d，共治疗2个疗程，观察关节肿痛总积分(包括疼痛、肿胀、关节发热、压痛等)；疼痛视觉模拟评分法(Visual Analogue Scale/Score，简称VAS评分）及血沉（ESR）变化。结果：治疗组总效率（60.4%）明显优于对照组（20.0%）。完成治疗后治疗组的关节症状总积分、VAS评分均明显改善(P<0.01)，且显著优于对照组(P<0.01)。治疗组ESR较治疗前明显下降(P<0.01)，但与对照组比较无统计学意义(P>0.05)。2组不良事件无统计学意义。结论：清热解毒活血外治法能明显改善类风湿关节炎活动期关节红肿热痛症状，起效较快，安全性好，值得进一步深入研究并在临床推广应用。

Study on External Therapy of Rheumatoid Arthritis by Heat Detoxification and Blood Acceleration

To observe the clinical efficacy and safety of the external therapy by heat detoxification and blood acceleration in treating active RA.Methods:In this double-blinded parallel controlled clinical trail,120 patients with active RA were randomly divided into two groups,with 60 cases in each.The intervention of the treatment group was sticking Xiaoyanzhitong Paste on one suffered joint one piece a day.The Patients in control group received Placebo.Clinical and laboratory parameters were observed and tested in two groups before and after the two-week treatment course.Results:The total efficiency rate of the treatment group (60.4%) was significantly better than that of the control group (20.0%) (P<0.01).Comparison of the total score of joint symptoms and VAS between two groups showed the same result (P<0.01).ESR in the treatment group decreased obviously,but no significant difference was detected between the two groups.The incidence of adverse events was similar between the two groups (P>0.05).Conclusion:The study proves that compared with placebo,Xiaoyanzhitong Paste is a better anti-inflammatory analgesic for patients with active RA.Main symptoms are significantly improved,while no obvious adverse events are seen in the study.External therapy by heat detoxification and blood acceleration may be a safe and effective treatment for active RA.