清心安神颗粒治疗失眠之痰热扰心证的临床观察

Clinic Observation of Treating Insomnia Caused by Phlegm-heat Disturbing Heart Based on the Theory of Spirit

目的基于"心神学说"观察清心安神颗粒治疗失眠之痰热扰心证的临床疗效及安全性。方法将符合标准的患者随机分为治疗组和对照组,各30例,治疗组服用清心安神颗粒,每日1剂,分早晚2次服用;对照组服用艾司唑仑每晚1次,每次1粒。连续治疗,2组治疗疗程均为14d。于服药前、服药2周后、停药后1个月、2个月、3个月分别进行匹兹堡睡眠质量指数量表(PSQI)、中医证候量表评估。结果治疗组和对照组服药2周后均能降低匹兹堡睡眠质量指数量表、中医证候量表评分,2组间比较评分差异无统计学意义(P>0.05);但在随访期间,随停药时间延长,治疗组PSQI及中医证候量表分值回升缓慢,而对照组出现明显反复;停药后3月随访2组PSQI、中医证候量表评分存在显著性差异,有统计学意义(P<0.05)。用药过程中,治疗组不良反应发生率较低,安全性良好。结论清心安神颗粒治疗失眠之痰热扰心证临床疗效确切,远期疗效显著,为从"心神学说"论治失眠提供了临床依据。

OBJECTIVE To observe the clinic efficiency and safety of Qingxin Anshen Gradual treating insomnia caused by phlegm-heat disturbing heart based on ＂the theory of spirit＂. METHODS Patients welI up to the standard were put into two groups ： treatment group and control group with 30 cases in each group. The treatment group was given Qingxin Anshen Gradual, one dose a day, morning and evening hours service. The control group was given Estazolam Tablets, once every night, one at a time. The treatment lasted for 14 days, and Pittsburgh Sleep Quality Index （PSQI） and the symptom and sign checklist in traditional Chinese medicine were tracked at different time, namely before the treatment, 2 weeks, 1 month, 2 month and 3 month after the treatment. RESULTS The evaluations showed that there was no significant difference between the two groups after 2 weeks （P〈0.05）; however, after ceasing the medication, the treatment group＇s evaluation turned back slowly, and the control group recurrence obviously. 3 month later, the evaluations showed significant differences between the two groups （P〈0.05）, and the treatment group had a lower adverse reaction rate and higher safety. CONCLUSION Qingxin Anshen Gradual has a long-duration effectiveness on treating insomnia caused by phlegm-heat and provides a clinic evidence of treating insomnia through ＂the theory of spirit＂.