小续命汤联合针刺治疗周围性面神经麻痹急性期风寒袭络证的随机对照研究

Randomized Controlled Study of Xiaoxuming Tang with Acupuncture on Acute Peripheral Facial Paralysis with Syndrome of Wind Cold Attacking Collaterals

目的探讨小续命汤联合针刺治疗急性期周围性面神经麻痹风寒袭络证的临床疗效及对免疫炎症反应的调节作用。方法采用随机数字表法将144例急性期周围性面神经麻痹(风寒袭络证)患者随机分为对照组和观察组,每组各72例。对照组给予小续命汤安慰剂颗粒联合针刺治疗;观察组采用小续命汤加减联合针刺治疗,疗程4周。治疗前、治疗后2周和4周进行House-Brackmann(H-B)面神经功能分级量表和面神经功能分级评定;治疗前后进行面部残疾指数(FDI)量表[躯体功能评分(FDIP)和社会生活功能评分(FDIS)]、临床面部评价量表(FaCE)和风寒袭络证积分评价;检测患者治疗前后外周血CD3^(+)、CD4^(+)、CD8^(+)细胞亚群水平、肿瘤坏死因子α(TNF-α)、白细胞介素1β(IL-1β)、IL-6水平,并计算CD4^(+)细胞中辅助性T淋巴细胞17(Th17)和调节性T细胞(Treg)的比例。结果观察组的临床疗效优于对照组(Z=2.014,P<0.05);观察组FDIP和FDIS评分高于对照组,风寒袭络证积分低于对照组(P<0.01);观察组在治疗后2周和4周H-B面神经功能分级量表评分和面神经功能评分均高于对照组(P<0.01);观察组FaCE量表6个维度评分高于对照组(P<0.01);观察组CD3^(+)、CD4^(+)、Treg水平和CD4^(+)/CD8^(+)高于对照组(P<0.05),CD8^(+)、Th17水平及Th17/Treg低于对照组(P<0.05);观察组TNF-α、IL-1β和IL-6水平低于对照组(P<0.01)。结论小续命汤加减联合针刺治疗急性期周围性面神经麻痹(风寒袭络证)患者有较好的临床疗效,并能调节患者免疫功能和炎性反应,安全性较好。

Objective To discuss the clinical effect of Xiaoxuming Tang with acupuncture on acute peripheral facial paralysis with syndrome of wind cold attacking collaterals,and to study the regulatory effect of Xiaoxuming Tang with acupuncture on immune inflammatory response.Methods According to a random number table,144 patients with acute peripheral facial paralysis(wind-cold attack syndrome)were randomly divided into control group and observation group,with 72 cases in each group.The control group was treated with Xiaoxuming Tang placebo granules combined with acupuncture.The observation group was treated with Xiaoxuming Tang combined with acupuncture.The treatment continued for 4 weeks.Before treatment,at the second and fourth week after treatment,scores of House-Brackmann(H-B)facial nerve function rating scale and facial nerve function were graded.Before and after treatment,scores of facial disability index(FDI),such as physical function score(FDIP)and social life function score(FDIS),facial clinimetric evaluation scale(FaCE)and syndrome of wind cold attacking collaterals were graded.And levels of CD3^(+),CD4^(+),CD8^(+),and tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1β),IL-6 in peripheral serum were detected.The proportion of T lymphocyte 17(Th17)and regulatory T cells(Treg)in CD4^(+)cell was calculated.And security was evaluated.Results The rank sum test showed that clinical effect in observation group was better than that in control group(Z=2.014,P<0.05).At the second and fourth week,scores of H-B facial nerve function rating scale,facial nerve function,FDIP,FDIS,six dimensions in FaCE scale were higher than the data in control group(P<0.01).And score of syndrome of wind cold attacking collaterals was lower than the data in control group(P<0.01).Levels of CD3^(+),CD4^(+),Treg and CD4^(+)/CD8^(+)were higher than the levels in control group(P<0.05),and levels of CD8^(+),Th17,Th17/Treg,TNF-α,IL-1βand IL-6 were lower than those in control group(P<0.05,P<0.01,respectively).Conclusion Addition and subtraction therapy of Xiaoxuming Tang with acupuncture used to treat acute peripheral facial paralysis with syndrome of wind cold attacking collaterals has good clinical efficacy and safety.It can regulate the immune function and inflammatory reaction.