反药“乌头半夏散”外治膝骨性关节病的临床疗效及安全性观察

Clinical Study on Efficacy and Safety of Knee Osteoarthritis with Incompatible Medications(Wutoubanxiasan)

目的:观察四川省名中医常振湘老师经验方反药"乌头半夏散"外治膝骨性关节病临床疗效及安全性。方法:将126例患者随机分为治疗组和对照组,治疗组使用"乌头半夏散"外敷膝骨关节,对照组使用相同处方缺半夏的"缺半夏散"外敷膝骨关节,用膝骨性关节病病情程度指数(Lequesne MG)分值、膝部疼痛视觉模拟评分法(VAS)分值作为疗效判定指标,以三大常规、肝肾功、心电图及皮肤受损指标观察其安全性。结果:治疗组显效率为55.56%,总有效率为92.06%;对照组显效率22.22%,总有效率49.21%。治疗组优于对照组(P<0.01)。治疗组和对照组均对皮肤有刺激,分别占总数的7.94%、3.17%。结论:反药"乌头半夏散"临床疗效优于非反药的"缺半夏散"。

Objective： To observe therapeutic effect and clinical safety of the treatment on knee osteoarthritis with Wutoubanxiasan, a experienced prescription from Prof. Chang Zhenxiang who was a famous Siehuan TCM doctor. Methods： 126 cases were divided into treatment group and control group in the proportion of 1：1 randomly. The treatment group was received external therapy of knee with Wutoubanxiasan and the control group was received the similar prescription without Pinellia Ternate. Therapeutic effect evaluation was based on the Lequesne＇ s indexes and the visual analog scale （VAS） and safety assessment on three routine tests, hepatic function, renal function, ECG and skin lesion indexes, Results：Remarked effect rate and total effect rate were 55.56% and 92.06% in the treatment group respectively and 22. 22% and 49.21% in the control group. There were significant differences（P 〈0. 01 ）. Skin irritation respons was seen in the both group, with the rate of 7.94% in the treatment group and 3. 17% in the control group. Conclusion ： Wutoubanxiasan has better clinical effect and higher rate of skin irritation respons than similar prescription without Pinellia Ternate.