雪山金罗汉止痛涂膜剂治疗风湿性关节炎瘀血痹阻证66例临床观察

Clinical observation on Xueshan Jinluohan analgesic film in treating 66 patients with rheumatoid arthritis with syndrome of blood stasis and obstructive arthralgia

[目的]评价雪山金罗汉止痛涂膜剂治疗风湿性关节炎瘀血痹阻证的有效性及安全性。[方法]采用随机、单盲、阳性药平行对照、多中心临床试验方法,试验组应用雪山金罗汉止痛涂膜剂涂于患处,每日3次,对照组应用布洛芬搽剂涂于患处,每日3次,4周为1个疗程,疗程结束后检测用药前后的疗效性指标和安全性指标。[结果]治疗组无论是中医证候疗效指标还是疾病的总有效率均明显优于对照组,有统计学差异(P<0.05);2组受试者均未见不良事件和不良反应发生。[结论]雪山金罗汉止痛涂膜剂用于治疗风湿性关节炎瘀血痹阻证疗效肯定,安全性良好,且疗效优于对照药布洛芬搽剂。

[Objective] To investigate the efficacy and safety of Xueshan Jinluohan analgesic film in treating patients of rheumatoid arthritis with syndrome of blood stasis and obstructive arthralgia. [Methods] A trial of multi-center, randomized, single-blinded, positive drug controlled methods were used. The treatment group was treated by Xueshan Jinluohan analgesic film, external application thrice a day. The control group was treated by brufen liniment, external application thrice a day also. The treating course was four weeks between two groups. The efficacy and safety was evaluated after a course. [Results] There were significant differences between two groups on TCM syndromes and total effective rate. The total effective rate in treatment group was higher than that in control group （P〈0.05）. There was no adverse events between two groups, and there was no statistical difference between two groups. [Conclusion] Xueshan Jinluohan analgesic film has definite curative effect and is safe in treating functional dyspepsia. It has better efficacy than brufen liniment.