雪山金罗汉止痛涂膜剂治疗骨性关节炎66例临床观察

目的评估雪山金罗汉止痛涂膜剂治疗骨性关节炎(瘀血阻络证)的有效性及安全性。方法选择2011年2月—2012年1月唐山市中医医院等3家临床试验机构的骨性关节炎(瘀血阻络证)患者96例,最终入组88例,按3∶1分为试验组66例和对照组22例。试验组予雪山金罗汉止痛涂膜剂,对照组予骨质宁搽剂,2组疗程均为2周。通过对2组治疗前后的疗效性指标及安全性指标的检测,综合评估中医证候疗效和安全性。结果无论是中医证候疗效指标还是疾病的总有效率,2组均疗效相当,组间差异无统计学意义。2组均未见不良事件及不良反应,组间差异无统计学意义。结论雪山金罗汉止痛涂膜剂治疗骨性关节炎(瘀血阻络证)安全有效,且疗效与骨质宁搽剂相当。

Clinical observation of Xueshan Jinluohan Plastic for relieving pain in the treatment of 66 patients with osteoarthritis

Objective To evaluate the effectiveness and safety of Xueshan Jinluohan Plastic for relieving pain in the treatment of osteoarthritis(syndrome of stagnant blood blocking collaterals).Methods Ninety-six patients with osteoarthritis from 3 clinical testing institutes were selected,and finally 88 patients were enrolled in the group.With the proportion of 3 to 1,the patients were divided into trial group(n=66) and control group(n=22).The trial group was administered Xueshan Jinluohan Plastic for relieving pain,and the control group Guzhining Liniment.The courses of treatment of both groups were 2 weeks.The therapeutic effects and safety of TCM syndromes were comprehensively analyzed by detecting the indexes of therapeutic effects and safety of both groups before and after treatment.Results The indexes of therapeutic effects of TCM syndromes and the total effectiveness rate of disease in 2 groups were similar,and the difference between two groups showed no statistical significance.There were no adverse events and reactions in both groups and no statistical significance was shown between two groups.Conclusion Xueshan Jinluohan Plastic for relieving pain in the treatment of osteoarthritis is safe and effective,whose therapeutic effects is similar to that of Guzhining Liniment.