解郁清心配方颗粒联合远程交互式CBT-I治疗肝郁化火型慢性失眠的临床疗效

Curative Effect of Jieyu Qingxin Formula Granules Combined with Remote Interactive CBT-I in Treating Chronic Insomnia of Liver-depression and Fire-turning Type

目的:观察解郁清心配方颗粒联合远程交互式失眠认知行为治疗(CBT-I)治疗肝郁化火型慢性失眠的临床疗效。方法:该研究为前瞻性随机对照试验,选择2022年1月至2023年6月就诊于安徽省六安市中医院住院及门诊120例慢性失眠病人(肝郁化火型)为此次试验的对象,随机将其分成2组,各组60例。对照组采取远程交互式CBT-I方案;观察组在对照组基础上加用解郁清心配方颗粒治疗。干预治疗4周,观察6周。各组数据比较:临床疗效、治疗前后中医证候积分变化与失眠严重程度指数(ISI)评分变化、抑郁自评量表(SDS)与焦虑自评量表(SAS)的评分变化、睡眠总时间、觉醒时间、睡眠潜伏期、睡眠效率等体动记录仪(ActiGraph)睡眠参数值变化、血清神经烯醇化酶(NSE)、腺苷、多巴胺(DA)、5-羟色胺(5-HT)水平变化、不良反应。结果:观察组治疗总有效率(92.45%,49/53)高于对照组(76.92%,40/52),差异具有统计学意义(χ^(2)=4.7111,P<0.05)。与本组治疗前比较,治疗后两组患者中医证候积分、ISI评分、SAS评分与SDS评分均明显下降,睡眠总时间明显延长,觉醒时间、睡眠潜伏期明显缩短,睡眠效率提高,NSE、DA水平均明显下降,腺苷、5-HT水平明显升高(P<0.05)。与对照组患者治疗后比较,观察组患者中医证候积分、ISI评分、SAS评分与SDS评分明显降低,睡眠总时间延长,睡眠效率升高,觉醒时间、睡眠潜伏期缩短,DA、NSE水平降低,5-HT、腺苷水平明显升高(P<0.05)。治疗期间,观察组出现1例恶心,对照组未见不良反应,两组差异无统计学意义。结论:解郁清心配方颗粒联合远程交互式CBT-I通过降低NSE、DA,提高5-HT及腺苷水平等,改善患者焦虑(SAS评分)、抑郁(SDS评分)情绪,从而改善睡眠,可有效治疗肝郁化火型慢性失眠。

Objective:To observe the clinical effect of Jieyu Qingxin formula granules combined with remote interactive cognitive behavioral therapy for insomnia(CBT-I)on chronic insomnia of liver depression and fire-turning type.Method:This study was a prospective randomized controlled trial.120 patients with chronic insomnia of liver depression and fire-turning type in Lu'an traditional Chinese medicine Hospital from January 2022 to June 2023 were selected as objects.They were randomly divided into two groups,with 60 cases in each group.The control group received remote interactive CBT-I.The observation group was treated with Jieyu Qingxin formula granules on the basis of the control group.Intervention treatment lasted for four weeks,and observation lasted for six weeks.Comparison of data of each group:clinical efficacy,changes in traditional Chinese medicine(TCM)syndrome score before and after treatment,changes in insomnia severity index(ISI)score,self-rating depression scale(SDS)and self-rating anxiety scale(SAS)score changes,total sleep time,wake time,sleep latency,sleep efficiency,Actigraphy sleep parameter value changes,serum neuron specific enolase(NSE),adenosine,dopamine(DA),5-hydroxytryptamine(5-HT)level changes,and adverse reactions.Result:The total effective rate in the observation group(92.45%,49/53)was higher than that in the control group(76.92%,40/52),and the difference was statistically significant(χ^(2)=4.7111,P<0.05).After treatment,TCM syndrome score,ISI score,SAS score,and SDS score were decreased in all groups.The total sleep time was extended,and wake time and sleep latency were shortened.The sleep efficiency was increased,but the NSE and DA levels were decreased.Adenosine and 5-HT levels were increased in all groups(P<0.05).After treatment,compared with the control group,the observation group had lower TCM syndrome score,ISI score,SAS score,and SDS score,longer total sleep time,higher sleep efficiency,shorter wake time and sleep latency,lower NSE and DA levels,and higher adenosine and 5-HT level(P<0.05).There was one case of nausea in the observation group and no adverse reaction in the control group during treatment.There was no significant difference between the two groups.Conclusion:By reducing NSE and DA and increasing the levels of 5-HT and adenosine,the anxiety(SAS score)and depression(SDS score)of patients can be improved,so as to improve their sleep and effectively treat chronic insomnia of liver depression and fire-turning type.