黄连温胆汤联合艾司唑仑片治疗卒中后睡眠障碍痰热内扰证临床研究

Clinical study of Huanglian-Wendan Decoction combined with Estazolam tablets in the treatment of post-stroke sleep disorders with syndrome of internal disturbance of phlegm-heat

目的评价黄连温胆汤联合艾司唑仑片治疗卒中后睡眠障碍(post-stroke sleep disorders,PSSD)痰热内扰证的临床疗效。方法将深圳市罗湖区人民医院2016年9月-2018年6月符合入选标准的96例PSSD痰热内扰证患者采用随机数字表法分为对照组47例和研究组49例。在常规治疗基础上对照组口服艾司唑仑片,研究组在对照组基础上服用黄连温胆汤。2组均治疗2周。分别于治疗前后进行中医证候评分,分别采用汉密尔顿焦虑量表(Hamilton Anxiety Scale,HAMA)、汉密尔顿抑郁量表(Hamilton Depression Scale,HAMD)评估患者的焦虑及抑郁状态,采用匹兹堡睡眠质量指数量表(Pittsburgh Sleep Quality Index,PSQI)评估睡眠质量;采用ELISA法检测血清脑源性神经营养因子(brain-derived neurotrophic factor,BDNF),采用高效液相-电化学检测器检测血清5-羟色胺,记录不良反应,评价临床疗效。结果研究组总有效率为91.8%(45/49)、对照组为76.6%(36/47),2组比较差异有统计学意义(χ^2=4.227,P=0.040)。治疗后,研究组HAMA、HAMD、PSQI评分低于对照组(t值分别为4.081、4.869、3.900,P值均<0.001);血清BDNF[(42.36±6.78)ng/ml比(33.98±6.41)ng/ml,t=6.217]、5-羟色胺[(127.21±12.39)ng/ml比(101.46±11.70)ng/ml,t=10.460]水平均高于对照组(P<0.01)。治疗期间,对照组不良反应发生率为14.9%(7/47)、研究组为8.2%(4/49),2组比较差异无统计学意义(χ^2=1.071,P=0.301)。结论黄连温胆汤联合艾司唑仑片可有效改善PSSD痰热内扰证患者的临床症状,缓解焦虑、抑郁状态,升高血清BDNF、5-羟色胺水平,提高睡眠质量及临床疗效。

Objective To evaluate the clinical effect of Huanglian-Wendan Decoction combined with Estazolam tablets in the treatment of post-stroke sleep disorders(PSSD)with syndrome of internal disturbance of phlegm-heat.Methods A total of 96 patients with PSSD who met the inclusion criteria in the People’s Hospital of Shenzhen Luohu District from September 2016 to June 2018 were randomly divided into the control group(47 cases)and the study group(49 cases)by random number table method.The control group took Estazolam tablets based on routine treatment,and the intervention group took Huanglian-Wendan Decoction based on the control group.Both groups were treated for 2 weeks.The TCM syndromes were recorded and scored before and after the treatment.The anxiety symptoms were assessed by Hamilton Anxiety Scale(HAMA)and the depression symptoms were assessed by Hamilton Depression Scale(HAMD)respectively.Sleep quality was assessed by Pittsburgh Sleep Quality Index(PSQI).The level of brain-derived neurotrophic factor(BDNF)was detected by ELISA,the level of 5-hydroxytryp-tamine(5-HT)was detected by high performance liquid-phase electrochemical detector.The adverse reactions were recorded and clinical efficacy was evaluated.Results The total clinical effective rate of the intervention group was 91.8%(45/49),and 76.6%(36/47)in the control group.There was significant difference between the two groups(χ^2=4.227,P=0.040).After the treatment,the scores of HAMA,HAMD and PSQI in the intervention group were significantly lower than that of the control group(t value were 4.081,4.869 and 3.900,respectively,all Ps<0.001).The levels of serum BDNF(42.36±6.78 ng/ml vs.33.98±6.41 ng/ml,t=6.217),5-HT(127.21±12.39 ng/ml vs.101.46±11.70 ng/ml,t=10.460)were significantly higher than that of the control group(P<0.01).During the treatment,the incidence of adverse reactions was 14.9%(7/47)in the control group and 8.2%(4/49)in the intervention group,and there was no significant difference between the two groups(χ^2=1.071,P=0.301).Conclusions Huanglian-Wendan Decoction combined with Estazolam tablets can improve the clinical symptoms,relieve anxiety and depression of PSSD patients with syndrome of internal disturbance of phlegm-heat,and improve sleep quality and clinical efficacy.