甜梦胶囊联合阿普唑仑治疗睡眠障碍对照研究

【关键词】 心身疾病；睡眠障碍；甜梦胶囊；阿普唑仑；联合用药

　　【摘要】 目的 探讨甜梦胶囊联合阿普唑仑治疗睡眠障碍的疗效及不良反应。 方法 将84例睡眠障碍患者按时间顺序分为两组，每组各42例。研究组采用阿普唑仑联合甜梦胶囊治疗，对照组单用阿普唑仑治疗，疗程均为4w。于治疗前和治疗第1、2、4w末及停药后第1、4、8w末采用匹兹堡睡眠质量指数量表评定临床疗效和自行设计的不良反应量表评定不良反应。其中研究组2例不合作、3例失访，资料完整者37例；对照组失访4例，资料完整者38例。两组共65例顺利完成治疗和随访。 结果 经过4w治疗，患者的睡眠质量均得以改善。研究组阿普唑仑的平均剂量低于对照组，且不良反应少而轻，停药后睡眠改善持续时间长。结论 甜梦胶囊联合阿普唑仑治疗失眠症疗效肯定，用药剂量低，且不良反应少而轻，停药后反跳现象不明显。

　　【关键词】 心身疾病；睡眠障碍；甜梦胶囊；阿普唑仑；联合用药

　　A controlled study of Tianmeng capsule combined with alprazolam in somnipathy　

　　【Abstract】 Objective To explore the therapeutic effectiveness and side effects of Tianmeng capsule combined with alprazolam in somnipathy. Methods 84 patients with somnipathy were divided into 2 groups( both n =42) according time order. Research group took Tianmeng capsule combined with alprazolam and control group did single alprazolam for 4 weeks. Clinical effectiveness and side effects were assessed with the Pittsburgh Sleep Quality Index(PSQI) and Selfmade Treatment Emergent Symptom Scale(SMTESS) before treatment and at the ends of 1st,2nd and 4th week during treatment and at the ends of 1st,4th and 8th week after treatment, respectively. 65 patients of both the 2 groups completed treatment and followup. Results After 4 week treatment, sleep quality of the patients improved. Compared with the control group,the mean dosage of alprazolam was smaller in the research group, side effects were fewer and milder and duration of sleep improvement longer after treatment. Conclusion Tianmeng capsule combined with alprazolam had precise curative effect in somnipathy, dose was smaller and side effects were fewer and milder, and rebound phenomenon was not marked after treatment.

　　【Keywords】 Psychosomatic diseases; somnipathy; Tianmeng capsule; alprazolam

　　睡眠与健康密切相关，睡眠障碍可直接影响心身健康。国内有关中药对睡眠障碍的治疗研究已有很多报道，但中成药的对照研究较少。作者近2年采用中成药甜梦胶囊与阿普唑仑联合治疗睡眠障碍与单用阿普唑仑治疗睡眠障碍进行了对照研究，现将结果报告如下。

　　1 资料与方法

　　1.1 对象 84例睡眠障碍患者均来源于2002年7月～2003年12月湖南省脑科医院及中南大学湘雅二医院门诊及住院部。入组标准：（1）符合《中国精神障碍分类与诊断标准》第3版（CCMD3）［1］失眠症诊断标准；（2）入组前1w未服用镇静、催眠药物，心电图、血常规及生化检查无异常；（3）排除各种精神障碍所致睡眠障碍及手术期疼痛、成瘾物质依赖所造成的睡眠障碍。按时间顺序将入组病例分为两组,每组各42例。其中研究组2例不合作,3例失访，资料完整者37例；对照组失访4例，资料完整者38例。研究组男17例，女20例；平均年龄30.3±11.2a，平均病程2.12±1.2a；婚姻状况：未婚5例，已婚30例，离异2例；主要临床表现：初始失眠7例，多梦易醒3例，早醒5例，混合失眠22例；睡眠时间：＞6h者6例，5～6h者6例，＜5h者25例；既往服药29例。对照组男18例，女20例；平均年龄32.4±10.9a，平均病程2.10±1.4a；婚姻状况：未婚4例，已婚31例，离异3例；主要临床表现：初始失眠8例，多梦易醒4例，早醒5例，混合失眠21例；睡眠时间：＞6h者6例，5～6h者7例，＜5h者25例；既往服药27例。两组年龄、性别、婚姻状况、临床症状、病程等均无显著性差异（P＞0.05）。