和胃安神针刺治疗原发性失眠患者的安全性和有效性研究  

Safety and Effectiveness of Hewei Anshen Acupuncture in Treatment Primary Insomnia

作　　者：朱敬云[1] 王琳琳[1] 任志欣[1] 王桂玲[2] 郭静[2] 吴艳荣[1] ZHU Jingyun;WANG Linlin;REN Zhixin;WANG Guiling;GUO Jing;WU Yanrong(The Second Affiliated Hospital to Zhengzhou University,Zhengzhou Henan China 450014;Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing China 100010)

机构地区：[1]郑州大学第二附属医院,河南郑州450014 [2]首都医科大学附属北京中医医院,北京100010

出　　处：《中医学报》2025年第4期884-889,共6页Acta Chinese Medicine

基　　金：国家自然科学基金面上项目(81774391);北京自然科学基金面上项目(7212170)。

摘　　要：目的:评估和胃安神针刺治疗原发性失眠的安全性和有效性。方法:采用随机对照试验设计,纳入60例符合国际疾病分类原发性失眠诊断标准的患者。随机分为试验组和对照组,每组30例。试验组接受和胃安神针刺治疗,对照组接受非效穴浅刺。治疗周期为4周,每周3次,共12次,随访至12周。观察指标包括匹兹堡睡眠质量指数(Pittsburgh sleep quality index,PSQI)、过度觉醒量表(hyperarousal scale,HAS)、阿森斯失眠量表(Athens insomnia scale,AIS)、汉密尔顿焦虑量表(Hamilton anxiety rating scale,HAMA)、汉密尔顿抑郁量表(Hamilton depression rating scale,HAMD)和中医证候积分。同时,测量血清中皮质醇(cortisol,CORT)、5-羟色胺(5-hydroxytryptamine,5-HT)和γ-氨基丁酸(γ-aminobutyric acid,GABA)的水平。结果:治疗4周和随访12周时,试验组所有观察指标均较对照组显著改善(P<0.001)。重复测量方差分析显示,时间主效应、组别主效应以及时间与组别的交互作用比较,差异均有统计学意义(P<0.001)。相关性分析揭示,和胃安神针刺疗法与随访12周时PSQI总分、HAS评分、AIS评分、HAMA评分、HAMD评分、中医证候积分以及血清CORT水平均为显著负相关,而与血清5-HT和GABA水平呈显著正相关(P<0.001)。此外,两组不良反应比较,差异无统计学意义(P>0.05)。结论:和胃安神针刺疗法可显著改善原发性失眠患者的睡眠质量及相关的生理和心理指标,且治疗安全性高。Objective:To evaluate the safety and effectiveness of Hewei Anshen acupuncture in treatment of primary insomnia.Methods:A randomized controlled trial design was used.Sixty patients who met the diagnostic criteria of primary insomnia of the International Classification of Diseases were included.The patients were randomly divided into test group and control group,with 30 cases in each group.The experimental group received Hewei Anshen acupuncture,and the control group received non-effective acupoint shallow acupuncture treatment.The treatment cycle was 4 weeks,3 times per week,a total of 12 treatments,and the follow-up period was up to 12 weeks.Observational indexes included Pittsburgh Sleep quality index(PSQI),Hyperarousal scale(HAS),Ascens insomnia scale(AIS),and Hamilton anxiety rating scale(HAMA),Hamilton depression rating scale(HAMD),and Chinese medicine syndrome points.At the same time,serum levels of cortisol(CORT),5-hydroxytryptamine(5-HT)and gamma-aminobutyric acid(GABA)were measured.Results:At 4 weeks of treatment and 12 weeks of follow-up,the experimental group showed significant improvement over the control group in all observed indices(P<0.001).Repeated-measures ANOVA showed that the time main effect,the group main effect,and the interaction between time and group reached statistical significance(P<0.001).Correlation analysis revealed that Hewei Anshen acupuncture therapy showed a significant negative correlation with total PSQI score,HAS score,AIS score,HAMA score,HAMD score,Chinese medicine syndrome points,and serum CORT level at 12 weeks of follow-up,and a significant positive correlation with serum 5-HT and GABA levels(P<0.001).In addition,there was no statistically significant difference in adverse reactions between the two groups(P>0.05).Conclusion:Hewei Anshen acupuncture treatment can significantly improve the sleep quality and related physiological and psychological indexes of primary insomnia patients,and the treatment is quite safe.

关 键 词：原发性失眠 和胃安神针刺 安全性 有效性 神经递质 

分 类 号：R256.23[医药卫生—中医内科学]