经皮颅-耳电刺激治疗轻中度抑郁症的随机单盲对照研究  

A Randomized,Single-blind,Controlled Trial on Transcutaneous Electrical Cranial-auricular Stimulation for Mild-to-moderate Depression

作　　者：谢乾梅 郑瑀[1] 施蕾[1] 冯子芹 许凤全[1] XIE Qianmei;ZHENG Yu;SHI Lei;FENG Ziqin;XU Fengquan(Guang′anmen Hospital of China Academy of Chinese Medical Sciences,Beijing 100053,China;Graduate School of China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]中国中医科学院研究生院,北京100700

出　　处：《世界中医药》2022年第6期847-852,共6页World Chinese Medicine

基　　金：国家重点研发计划项目(2018YFC1705801)。

摘　　要：目的:观察经皮颅-耳电刺激治疗轻中度抑郁症的临床疗效。方法:选取2019年12月至2020年12月中国中医科学院广安门医院收治的轻中度抑郁症患者140例作为研究对象,随机分为观察组(n=69)和对照组(n=71)。观察组采用华佗牌SDZ-IIB型电子针疗仪电刺激耳甲迷走神经和颅部印堂-百会穴,对照组予以口服草酸艾司西酞普兰片,2组均治疗8周。分别于治疗0、2、4、8周时观察2组患者蒙哥马利抑郁量表(MADRS)、汉密尔顿抑郁量表(HAMD-17项)、汉密尔顿焦虑量表(HAMA)评分,并在0、4、8周时评估2组患者匹兹堡睡眠质量指数(PSQI)评分,比较2组临床疗效。结果:1)在治疗8周后,2组的MADRS、HAMD-17、HAMA、PSQI量表评分均下降,与治疗前比较,差异均有统计学意义(均P<0.01);2)观察组和对照组同步治疗8周后,MADRS和HAMD-17评分均改善,观察组优于对照组,2组比较,差异均有统计学意义(均P<0.05);3)2组总有效率、临床治愈率比较,差异无统计学意义(P>0.05),在改善轻中度抑郁症患者抑郁情绪方面2组疗效相当;4)观察组未观察到不良反应,对照组在治疗2周后的不良反应发生率为28.17%。结论:经皮颅-耳电刺激治疗可以改善轻中度抑郁症患者的抑郁情绪,且不良反应少,无药物依赖性,可作为轻中度抑郁症患者抗抑郁治疗的有效选择。Objective:To observe the clinical effect of transcutaneous electrical cranial-auricular stimulation on mild-to-moderate depression.Methods:A total of 140 patients with mild-to-moderate depression treated in the Guang′anmen Hospital of China Academy of Chinese Medical Sciences from December 2019 to December 2020 were enrolled and randomly divided into an observation group(n=69)and a control group(n=71).The patients in the observation group were treated by electrical stimulation at auricular vagus nerve and Yintang(EX-HN 3)-Baihui(GV 20)by Hwato SDZ-IIB Electronic Acupuncture Stimulator Machine,and those in the control group were administered with Escitalopram Oxalate Tablets for eight weeks.The scores of Montgomery-Asberg Depression Rating Scale(MADRS),Hamilton Depression Rating Scale(HAMD-17),and Hamilton Anxiety Rating Scale(HAMA)were observed at the 0,2nd,4th,and 8th weeks of treatment in both groups.The scores of Pittsburgh Sleep Quality Index(PSQI)in both groups were evaluated at the 0,4th,and 8th weeks of treatment.The clinical efficacies of the two groups were compared after treatment.Results:1)The scores of MADRS,HAMD-17,HAMA,and PSQI decreased in both groups after eight weeks of treatment as compared with those before treatment(P<0.01).2)After eight weeks of treatment,the observation group was superior to the control group in improving MADRS and HAMD-17 scores(P<0.05).3)There were no significant differences in the total effective rate and clinical cure rate between the two groups(P>0.05).The observation group was equivalent to the control group in improving the depression of patients with mild-to-moderate depression.4)The observation group showed no adverse events,which was superior to the control group.Conclusion:Transcutaneous electrical cranial-auricular stimulation can improve the depressed mood of patients with mild-to-moderate depression without adverse events,drug dependence,and other side effects.Therefore,it can serve as an effective approach against depression in patients with mild-to-moderate

关 键 词：轻中度抑郁症 经皮颅-耳电刺激 草酸艾司西酞普兰 临床疗效 随机对照 单盲 

分 类 号：R245.31+9[医药卫生—针灸推拿学] R277.7[医药卫生—中医临床基础]