针灸治疗贝尔麻痹临床多中心随机对照试验研究

Acupuncture and Moxibustion for Treatment of Bell's Palsy: A Multicenter Randomized Controlled Trial

目的:证实针灸治疗贝尔麻痹的临床疗效。方法:4个中心共480例患者纳入研究,439例完成整个研究过程。所有病例随机分为对照组(基础组)和治疗组(基础加针灸组、针灸组)。基础组治疗用强的松、维生素B_1、维生素B_(12)及地巴唑,针灸组治疗用毫针刺加灸,基础加针灸组则二者结合。共治疗4周。采用症状体征、House-Brackmann分级量表、面部残疾指数(FDI)评分量表进行疗效评价。结果:4个中心完成情况良好,4个中心疗效差异无显著性,研究方案执行较好。3个组分组均衡,基线状况良好,可比性强(P>0.05);3个组的疗效差异有显著性,其中治疗组疗效优于对照组、针灸组疗效最好(P<0.05,P<0.01)。轻度面瘫和急性期面瘫疗效优于重度面瘫和非急性期面瘫(P<0.01)。比较治疗前后House-Brackmann量表分级和治疗前后面部残疾指数躯体功能评分(FDIP),治疗组疗效优于对照组(P<0.01)。结论:针灸治疗贝尔麻痹临床疗效肯定,其效果优于基础对照组和基础加针灸组。

To verify therapeutic effect of acupuncture on Bell's palsy. Methods: Of 480 cases enrolled in the present study in 4 clinical centers. 439 cases completed the study and 41 cases missed. All the patients enrolled were randomly divided into a control group and two treatment groups. The control group were treated by basic treatment, i. e. Prednision. VitB_1. VitB_(12) and Dibazole, and the treatment groups were given acupuncture and moxibustion or the basic treatment plus acupuncture and moxibustion for 4 weeks. Symptoms and signs. House-Brackmann Scale and face deformity indexe (FDI) Scale were adopted to evaluate the therapeutic effects. Results: The general data were comparable among the three groups (P>0. 05). There were significant differences in the therapeutic effect among the three groups, the treatment groups being superior to the control group, and the therapeutic effect in the acupuncture group was the best (P<0. 05. P<0. 01). The therapeutic effect for mild facial palsy and facial palsy at acute stage were superior to those for severe facial palsy and facial palsy at non-acute stage (P<0. 01). According to evaluation of House-Brackmann Scale and facial deformity index somatoic function Scale, the therapeutic effects of the treatment groups were better than that of the control group. acupuncture group being the best. Conclusion: Acupuncture and moxibustion have a definite therapeutic effect on Bell's palsy. better than that of basic control treatment or basic treatment plus acupuncture and moxibustion.