辨证运用中药复方颗粒联合氟哌噻吨美利曲辛片治疗焦虑性失眠临床研究

Clinical Study on Chinese Medicine Compound Granules with Syndrome Differentiation Combined with Flupentixol and Melitracen Tablets for Anxiety Insomnia

目的:观察辨证运用中药复方颗粒联合氟哌噻吨美利曲辛片治疗焦虑性失眠的临床疗效。方法:将120例焦虑性失眠患者按随机数字表法分为对照组和观察组各60例。对照组给予氟哌噻吨美利曲辛片治疗,观察组在对照组基础上辨证运用中药复方颗粒剂治疗,2组均治疗4周。比较2组治疗前后失眠严重程度量表(SPIEGEL)评分、匹茨堡睡眠质量指数量表(PSQI)评分、汉密尔顿焦虑量表(HAMA)评分,统计2组临床疗效及治疗期间不良反应发生情况。结果:观察组临床疗效优于对照组,差异有统计学意义(Z=-2.285,P<0.05)。治疗前,2组SPIEGEL评分、PSQI各项指标评分、HAMA评分比较,差异均无统计学意义(P>0.05)。治疗后,2组SPIEGEL评分、PSQI各项指标评分、HAMA评分较治疗前降低(P<0.05),且观察组SPIEGEL评分、PSQI各项指标评分、HAMA评分均低于对照组(P<0.05)。2组不良反应发生率比较,差异无统计学意义(P>0.05)。结论:辨证运用中药复方颗粒联合氟哌噻吨美利曲辛片治疗焦虑性失眠能明显改善患者睡眠质量和焦虑状态,临床疗效较好。

Objective: To observe the clinical effect of Chinese medicine compound granules with syndrome differentiation combined with flupentixol and melitracen tablets for anxiety insomnia. Methods:A total of 120 cases of patients with anxiety insomnia were divided into the control group and the observation group according to the random number table method,with 60 cases in each group. The control group was treated with flupentixol and melitracen tablets, and the observation group was additionally treated with Chinese medicine compound granules with syndrome differentiation based on the treatment of the control group. Both groups were treated for four weeks. The scores of insomnia severity scale(SPIEGEL),Pittsburgh Sleep Quality Index(PSQI) and Hamilton Anxiety Scale(HAMA) were compared between the two groups before and after treatment, and the clinical effects and adverse reactions during treatment were counted. Results:The clinical effect in the observation group was better than that in the control group,the difference being significant(Z=-2.285, P<0.05). Before treatment, there was no significant difference being found in the comparison of scores of SPIEGEL,PSQI and HAMA between the two groups(P>0.05).After treatment,scores of SPIEGEL,PSQI and HAMA in the two groups were decreased when compared with those before treatment(P<0.05), and the above scores in the observation group were lower than those in the control group(P<0.05). There was no significant difference being found in the comparison of the incidence of adverse reactions between the two groups(P>0.05). Conclusion: Chinese medicine compound granules with syndrome differentiation combined with flupentixol and melitracen tablets for anxiety insomnia can significantly improve the sleep quality and anxiety state with good clinical effects.