交泰丸加减联合乌灵胶囊治疗失眠伴焦虑状态的临床研究

Effect of Jiaotai Pills Combined with Wuling Capsule on Insomnia Accompanied by Anxiety

目的观察交泰丸加减联合乌灵胶囊治疗失眠伴焦虑状态的临床疗效。方法选择失眠伴焦虑状态病人62例,随机分为对照组与治疗组各31例。治疗组给予交泰丸加减联合乌灵胶囊口服,对照组给予艾司唑仑片口服,观察28 d。比较两组治疗前、治疗第14天及治疗第28天匹兹堡睡眠质量指数问卷(PSQI)、焦虑自评量表(SAS)评分及中医证候积分。结果两组临床疗效比较,差异无统计学意义(P>0.05)。两组治疗第14天、第28天PSQI评分、SAS评分、中医证候积分与治疗前比较,差异均有统计学意义(P<0.05);治疗第14天两组PSQI评分、中医证候积分比较差异无统计学意义(P>0.05);SAS评分比较差异有统计学意义(P<0.05),且治疗组优于对照组(P<0.05)。治疗第28天两组PSQI评分、SAS评分、中医证候积分比较差异均有统计学意义(P<0.05),且治疗组优于对照组(P<0.05)。结论交泰丸加减联合乌灵胶囊治疗失眠伴焦虑状态病人对PSQI评分、SAS评分、中医证候积分改善程度均优于艾司唑仑。

Objective To observe the clinical efficacy of Jiaotai pills and Wuling capsule in treating insomnia accompanied by anxiety.Methods A total of 62 patients with insomnia accompanied by anxiety were randomized divided into treatment group and control group,with 31 cases in each group.The patients in treatment group were intervened by Jiaotai pills and Wuling capsule,while the patients in control group were intervened by oral administration of Estazolam,both groups were observed for 28 days.The Pittsburgh Sleep Quality Index(PSQI),Self-rating Anxiety Scale(SAS)scores and TCM syndrome integral were compared before treatment,and after 14 days and 28 days treatment.Results There was no significant difference in clinical efficacy between two groups(P>0.05).The PSQI,SAS scores and TCM syndrome integral were significantly decreased in two groups after treatment(P<0.05);There was no significant difference in PSQI scores between two groups after treatment for 14 days(P>0.05);the SAS and TCM syndrome scores were significantly decreased in two groups after treatment for 14 days(P<0.05);and the treatment group were superior to those in control group(P<0.05).The PSQI,SAS,and TCM symptom scores in treatment group were superior to those in control group after treatment for 28 days(P<0.05).Conclusion The effect of Jiaotai pills and Wuling capsule on PSQI,SAS,and TCM symptom scores in treatment of insomnia accompanied by anxiety was better than Estazolam.