坤泰胶囊治疗甲亢引起失眠临床观察

Clinical Effect Observation of Kuntai Capsule on Treatment of Insomnia Caused by Hyperthyroidism

目的:观察坤泰胶囊对甲亢引起的失眠的临床疗效。方法:选择2015年1月—2015年12月于我院进行甲亢引发失眠治疗的患者共计76例,随机分为观察组和对照组,各38例,在治疗甲亢的基础上对照组使用舒乐安定片2 mg,睡前服用,观察组患者给予坤泰胶囊4粒/次,3次/d,两组患者均21 d为1个疗程。观察1个疗程后两组患者PSQI评价、临床疗效、中医证候评分、不良反应以及甲状腺功能情况。结果:两组患者治疗前PSQI评分无明显差异,治疗后评分均明显降低,但与对照组比较仍无组间差异(P>0.05)。观察组患者的痊愈率与总有效率明显高于对照组,且具有统计学差异(P<0.05)。两组患者中医症候评分治疗前无明显差异(P>0.05),治疗后均明显减少,但观察组减少的更为明显,与对照组相比具有组间差异(P<0.05)。与治疗前相比,两组患者FT3、FT4均明显降低,而TSH明显升高,且具有统计学差异(P<0.05)。但两组间各项数据差异不大(P>0.05)。观察组共发生2例不良反应,不良反应发生率为5.26%;对照组共发生9例不良反应,不良反应发生率为23.68%。观察组不良反应发生率明显低于对照组,且具有统计学差异(P<0.05)。结论:坤泰胶囊对于甲亢引起的失眠具有良好的治疗作用,能够明显改善患者的睡眠质量,减轻临床症状,且安全性高。

Objective：To observe the clinical effect of Kuntai Capsule on treatment of insomnia caused by hyperthyroidism. Methods：76 cases with insomnia caused by hyperthyroidism,which admitted in our hospital during January 2015- December 2015,were selected as the research object and divided into the observation group experimental group and the control group randomly,each group of 38 cases. On the basis of the treatment of hyperthyroidism,the control group was given estazolam tablets 2 mg. At bedtime,the observation group given Kuntai Capsule 4 grains/time,3 times/d,two groups of patients were 21 days for a course of treatment. PSQI evaluation,clinical efficacy,TCM syndrome score,adverse reaction and thyroid function were observed in two groups after 1 courses of treatment. Results：There was no significant difference in PSQI scores between the two groups before treatment. After treatment,the scores were significantly lower,but there was no difference between the two groups（P〈0.05）. The cure rate and total effective rate of the observation group were significantly higher than that of the control group,and there was statistical difference（P〈0.05）. There was no significant difference between the two groups before treatment（P〈0.05）. After treatment,the patients in the groups were significantly decreased,but the observation group decreased more significantly compared with the control group（P〈0.05）. Compared with before treatment,the two groups of patients with FT4,FT3 were significantly lower,and TSH was significantly higher,and with statistical difference（P〈0.05）. But the data between the two groups were not different（P〈0.05）. The incidence of adverse reactions was 5.26% in the observation group,9 cases in the control group and 2 cases in the control group,the adverse reaction rate was 23.68%. The incidence of adverse reactions in the observation group was significantly lower than that of the control group,and with statistical difference（P〈0.05）. Conclusion：Kuntai Capsule for hyperthyroidism caused by insomnia has a good therapeutic effect,can significantly improve the sleep quality of patients,reduce clinical symptoms,and high safety.