益神宁心方对原发性失眠心脾两虚型患者唾液褪黑素、皮质醇水平的影响  

Effect of Yishen Ningxin Formula(益神宁心方)on Melatonin and Cortisol Levels in Saliva of Primary Insomnia Patients with Heart-spleen Deficiency Pattern

作　　者：史佳宁[1] 柴瑞佳 黄瑶[1] 蒋天君 诸燕英 张振贤[1] SHI Jianing;CHAI Ruijia;HUANG Yao;JIANG Tianjun;ZHU Yanying;ZHANG Zhenxian(Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai,200437)

机构地区：[1]上海中医药大学附属岳阳中西医结合医院,上海市200437

出　　处：《中医杂志》2021年第24期2157-2163,共7页Journal of Traditional Chinese Medicine

基　　金：上海市卫生和计划生育委员会上海市中医药发展办公室上海市进一步加快中医药事业发展三年行动计划建设项目[ZY(2018-2020)-FWTX-6011];上海市卫生健康委员会上海市中医药管理局上海市中医药事业发展三年行动计划(2018-2020年)医疗机构治未病服务能力提升项目[ZY(2018-2020)-ZWB-1001]。

摘　　要：目的评价益神宁心方治疗原发性失眠心脾两虚型患者的临床疗效并探讨可能作用机制。方法将130例原发性失眠心脾两虚型患者随机分为治疗组和对照组各65例。治疗组给予益神宁心方治疗,每晚餐后半小时以温水冲服。对照组予酒石酸唑吡坦片治疗,每晚1次,每次10 mg,睡前顿服。两组疗程均为4周。于治疗前及治疗2、4周后进行中医证候积分量表评分、匹兹堡睡眠质量指数(PSQI)评分,并判定治疗4周后临床疗效及中医证候疗效;分别在治疗前后3天内采集同一天中12:00、16:00、20:00、24:00的唾液样本,检测唾液褪黑素(MT)、皮质醇(CORT)浓度。结果治疗组脱落1例,完成观察64例,对照组脱落3例,完成观察62例。治疗组的失眠临床总有效率与中医证候总有效率分别为92.19%、85.94%,高于对照组的83.87%、64.52%(P<0.05)。治疗组治疗2周、4周后中医证候总积分及各单项评分均显著低于本组治疗前(P<0.05),且治疗2周、4周时心悸、健忘、神疲乏力、纳谷不香、面色少华、舌象、脉象评分及总积分均低于对照组同期(P<0.05)。治疗组治疗2周、4周后PSQI总积分及各成分评分均较治疗前显著降低(P<0.05),且睡眠效率、睡眠障碍、催眠药物、日间功能障碍评分低于同期对照组(P<0.05)。治疗组治疗4周后PSQI总积分低于同期对照组(P<0.05)。治疗组治疗后患者24:00时唾液中MT浓度较治疗前显著升高,且高于对照组治疗后同时间点(P<0.05)。两组患者治疗后12:00、16:00、20:00、24:00时唾液中CORT浓度均较治疗前下降(P<0.05)。结论益神宁心方能有效改善原发性失眠心脾两虚型患者的临床症状及中医证候,其作用机制可能与调节患者唾液褪黑素、皮质醇水平及昼夜节律有关。Objective To evaluate the clinical effect of Yishen Ningxin Formula(益神宁心方)in the treatment of primary insomnia due to heart and spleen deficiency,and to explore the possible mechanism.Methods Totally 130 primary insomnia patients with heart-spleen deficiency pattern were randomly divided into treatment group and control group with 65 patients in each group.The treatment group was given Yishen Ningxin Formula,taken with warm water half an hour after dinner,while the control group was treated with zolpidem tartrate tablets,once daily in the evening,10 mg each time before sleep;the treatment course of both groups lasted for four weeks.The traditional Chinese medicine(TCM)syndrome score and Pittsburgh Sleep Quality Index(PSQI)score were assessed before treatment and two as well as four weeks after treatment;the clinical effect and TCM syndrome efficacy were evaluated after 4 weeks of treatment.Saliva samples at 12:00,16:00,20:00,and 24:00 in the same day within 3 days before and after treatment were tested for the concentration of melatonin(MT)and cortisol(CORT).Results There were 64 complete cases and one drop-out in the treatment group,and 62 complete cases and three drop-outs in the control group.The total effective rate of insomnia and that of TCM syndromes in the treatment group were 92.19%and 85.94%,respectively,while those in the control group were 83.87%and 64.52%(P<0.05).After two weeks and four weeks of treatment,the score of overall TCM symptoms and of single symptom in the treatment group were decreased(P<0.05),and the scores of palpitations,poor memory,mental fatigue,poor appetite,pale complexion,tongue manifestation,pulse manifestation,and the overall score in the treatment group were lower than those in the control group(P<0.05).After two weeks and 4 weeks of treatment,the PSQI overall score and the domain scores in the treatment group significantly decreased(P<0.05),and the scores of sleep efficiency,sleep disturbances,use of sleeping medication,and daytime dysfunction in the treatment group

关 键 词：原发性失眠 益神宁心方 心脾两虚 匹兹堡睡眠质量指数 唾液 褪黑素 皮质醇 

分 类 号：R256.23[医药卫生—中医内科学]