中药解郁丸及地西泮治疗失眠对照探究.docVIP

中药解郁丸及地西泮治疗失眠对照探究 　 作者：白红娟 郑燕华 张俐丽 【摘要】 　　目的 探讨中药解郁丸治疗失眠的临床疗效及安全性。 方法 将53例失眠症患者随机分为中药组31例，对照组22例；中药组给予解郁丸治疗，对照组给予地西泮治疗，观察4 w。于治疗前及治疗第2 w、4 w末采用睡眠状态问卷量表评定临床疗效，临床总体量表中对副反应评分法评定不良反应。 结果 治疗4 w末，中药组显效率54.9%，对照组为59.1%（P＞0.05）；SQ评分两组治疗2 w末起均较治疗前有极显著性下降（P均＜0.01），并随治疗时间的延续逐渐下降；同期两组间评分差异均无显著性（P均＞0.05）。中药组的不良反应明显低于地西泮组。 结论解郁丸治疗失眠疗效与地西泮相当，不良反应明显少于地西泮，安全性、依从性好。 【关键词】 失眠；解郁丸；地西泮 　　【Abstract】 Objective To explore the efficacy and safety of resolving depression pill in the treatment of insomnia. Merthods 53 insomniacs were randomly divided into the traditional Chinese medicine(TCM，n=31，orally took resolving depression pill) and control group(n=22，did diazepam) for 4 weeks. The clinical efficacy were assessed with the Sleeping Questionnaire（SQ）and adverse effects with the Clinical Global Impression（CGI）before treatment and at the end of the 2nd and 4th week treatment. Results At the and of the 4th week，excellence rates were respectively 54.1% of the TCM group and 59.1% of the control(Pgt;0.05)；compared with pretreatment，since the end of the 2nd week SQ scores of both the 2 groups lowered very significantly(both Plt;0.01) and gradually did along with treatment lasting；there were no significant differences in synchronization comparisons between the 2 groups(Pgt;0.05). Adverse effects were obviously lower in the TCM than in the control. Conclusion Resolving depression pill is equivalent to diazepam and has fewer adverse effects，higher safety and better compliance in the treatment of insomnia. 　　【Keywords】 Insomnia；resolving depression pill；diazepam 　　失眠是对睡眠的质和量持续相当长时间的不满意状况［1］，是一种影响机体生理和心理健康的重要因素。虽然有许多起效快，作用强的睡眠诱导剂或镇静催眠药可治疗失眠，但存在一定的副作用，潜在的成瘾性等不足之处。中药解郁丸具有抗焦虑抑郁和镇静催眠作用，为探讨其治疗失眠患者的临床疗效及安全性，我们与经典的镇静催眠药物地西泮治疗进行了对照研究，现将结果报道如下。 　　1 对象与方法 　　1.1 对象 病例来源于我院门诊或住院治疗的患者。入组标准：（1）符合《中国精神障碍分类与诊断标准》第3版（CCMD3）失眠症诊断标准［2］，以失眠为主的神经症、抑郁症、失眠症等患者；（2）年龄18 a～65 a；（3）未服用任何药物，体格检查、实验室及心电图检查均无异常；（4）排除严重脑、心、肝、肾等严重躯体疾病，妊娠或哺乳期妇女，重型精神病，酒精及药物依赖者。共入组53例，随机分为两组。中药组（解郁丸治疗）31例，男12例，女19例；年龄18 a～61 a，平均（44.8±14.1） a；平均病程（