益气温阳法治疗面瘫的临床研究

目的:评价益气温阳法治疗面瘫的疗效和安全性。方法:将180例面瘫患者随机分为益气温阳药敷治疗组60例、针刺对照组60例和针刺加药敷组60例,疗程均为40天。结果:对总体疗效而言,意向性分析(intention-to-treat,ITT)结果显示3个组总有效率分别为86.67%、90.00%和95.00%,方案数据分析(per-protocol population,PP)结果显示3个组总有效率分别为89.29%、90.91%和96.55%,总体疗效差异具有临床和统计学意义(P<0.05)。但益气温阳药敷治疗组与针刺对照组疗效比较差异无统计学意义(P>0.05),两个组的疗效具有临床上的非劣性(P<0.05)。ITT分析与PP分析结果一致。临床观察中未发现益气温阳药敷治疗组明显毒副作用和不良反应。结论:益气温阳法治疗面瘫安全有效,值得推广应用。

Clinical Study on Yiqiwenyang Therapy for Treatment of Facial Paralysis

Objective:To assess the efficacy and safety of Yiqiwenyang therapy in the treatment of facial paralysis.Methods: One hundred and eighty cases of facial paralysis were randomly divided into a Yiqiwenyang therapy sticking group(n=60),a routine acupuncture group(n=60) and a routine acupuncture combination Yiqiwenyang therapy sticking group(n=60).The therapeutic course for three groups was forty days.Results:All the results were analyzed on the basis of intention-to-treat and per-protocol population.In the Yiqiwenyang therapy sticking group,the effective rates were 86.67% and 89.29% respectively.In the routine acupuncture group,the effective rates were 90.00% and 90.91% respectively.In the routine acupuncture combination Yiqiwenyang therapy sticking group,the effective rates were 95.00% and 96.55% respectively.There was significant difference between in the three groups, P<0.05.But the effective rates of Yiqiwenyang therapy sticking group and routine acupuncture group,there was no significant difference between in the two groups.The efficacy of between two groups was noninferiority,P<0.05.ITT and PP analysis revealed similar results.No adverse effect was found in the clinical observation.Conclusions: Efficacy and safety of Yiqiwenyang therapy in the treatment of facial paralysis.