调肝益气定悸方治疗阵发性心房颤动合并阻塞性睡眠呼吸暂停低通气综合征的单病例随机对照临床研究  

A Single-case Randomized Controlled Clinical Study of Tiaogan Yiqi Dingji Formula in the Treatment of Paroxysmal Atrial Fibrillation with Obstructive Sleep Apnea Hypopnea Syndrome

作　　者：毛婷 张京春[1,2] 张珊 艾玉珍 潘秋 刘蓓 MAO Ting;ZHANG Jingchun;ZHANG Shan;AI Yuzhen;PAN Qiu;LIU Bei(Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Cardiovascular Diseases Center,China Academy of Chinese Medical Sciences,Beijing 100091,China;Beijing Changping Hospital of Integrated Chinese and Western Medicine,Beijing 100096,China)

机构地区：[1]中国中医科学院西苑医院,北京100091 [2]中国中医科学院心血管病中心,北京100091 [3]北京市昌平区中西医结合医院,北京100096

出　　处：《中西医结合心脑血管病杂志》2021年第17期2871-2878,共8页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：国家自然科学基金面上项目(No.81573817)。

摘　　要：目的观察调肝益气定悸方治疗阵发性心房颤动合并阻塞性睡眠呼吸暂停低通气综合征(OSAHS)的临床疗效。方法16例受试者来源于2019年4月—2019年9月中国中医科学院西苑医院心血管科门诊。采用单病例随机对照设计,以自身病例作为对照,单个病例研究周期分为3轮,每轮分为治疗期与对照期,分别采用调肝益气定悸方与安慰剂治疗,每期各4周。疗效指标为心房颤动发作频率及持续时间、心率变异性、临床症状疗效、中医证候疗效、生活质量评分。结果共纳入16例受试者,最终13例完成临床试验。与对照期相比,病例4、病例10、病例11的治疗期心房颤动发作频率及持续时间缩短,差异均有统计学意义(P<0.05)。与治疗前相比,11例受试者治疗期的心率变异性时域指标全部窦性心搏RR间期的标准差(SDNN)、相邻RR间期差值的均方根(rMSSD)、RR间期平均值标准差(SDANN)、三角指数均升高,差异均有统计学意义(P<0.05)。治疗期的临床症状疗效优于对照期,差异有统计学意义(P<0.05);病例1、病例2、病例6、病例7、病例9、病例10、病例12治疗期的中医证候疗效优于对照期,差异均有统计学意义(P<0.05);病例1、病例2、病例3、病例5、病例9、病例10、病例11、病例12治疗期的生活质量评分高于对照期,差异均有统计学意义(P<0.05)。结论调肝益气定悸方能够预防心房颤动复发、减少心房颤动发作频率及缩短心房颤动持续时间,改善心率变异性时域指标,改善临床症状,中医证候疗效明显,同时提高生活质量。Objective To evaluate the efficacy of Tiaogan Yiqi Dingji formula in the treatment of paroxysmal atrial fibrillation combined with obstructive sleep apnea hypopnea syndrome(OSAHS).Methods Sixteen subjects were enrolled in the Cardiovascular Clinic of Xiyuan Hospital,China Academy of Chinese Medical Sciences from April 2019 to September 2019.A single-case randomized control design was adopted,with itself as a control.Each case study was divided into 3 rounds,each of which was divided into the treatment period and the control period,being treated with Tiaogan Yiqi Dingji formula and placebo respectively.Each period contains 4 weeks.The curative effect indicators were the frequency of atrial fibrillation,the duration of atrial fibrillation,heart rate variability,clinical symptom curative effect,traditional Chinese medicine(TCM)syndrome curative effect,and life quality score.Results A total of 16 subjects were included,and finally 13 subjects completed clinical trials.Compared with the control period,the frequency and duration of atrial fibrillation during the treatment period of case 4,10,11 were significantly shortened,and the difference was statistically significant(P<0.05).Compared with data before treatment,the time-domain indicators of heart rate variability SDNN,SDANN,rMSSD,and triangular index of 11 subjects increased during the treatment period,and the difference was statistically significant(P<0.05).Compared with the control period,the clinical symptoms in the treatment period improved significantly,and the difference was statistically significant(P<0.05).Compared with the control period,the TCM syndromes of case 1,2,6,7,9,10,and 12 improved significantly in the treatment period(P<0.05).Compared with the control period,the quality of life scores of case 1,2,3,5,9,10,11,and 12 improved significantly during the treatment period,and the difference was statistically significant(P<0.05).Conclusion Tiaogan Yiqi Dingji formula can prevent the recurrence of atrial fibrillation,reduce the frequency of atrial fibrill

关 键 词：阵发性心房颤动 阻塞性睡眠呼吸暂停低通气综合征 调肝益气定悸方 心率变异性 中医证候 生活质量 单病例随机对照 

分 类 号：R54[医药卫生—心血管疾病]