甜梦胶囊联合黛力新对神经衰弱失眠的治疗研究

Clinical efficacy of deanxit combined with Tianmeng capsule in treating neurasthenia patients with insomnia

目的研究甜梦胶囊联合黛力新对神经衰弱失眠的治疗作用及安全性。方法将83例神经衰弱确诊患者随机分为两组,对照组40例口服黛力新,研究组43例加用甜梦胶囊治疗,随访30 d。使用匹兹堡睡眠质量量表(PSQI)、抑郁自评量表(SDS)、焦虑自评量表(SAS)评定治疗效果,用治疗副反应量表(TESS)评定药物不良反应,并将两组评分及不良反应进行比较。结果两组PSQI、SDS、SAS评分治疗后较治疗前明显改善,且研究组SDS、SAS、PSQI评分优于对照组(P<0.05),两组均无严重药物不良反应。结论甜梦胶囊联合黛力新治疗神经衰弱失眠有很好的疗效,临床应用较安全。

Objective To investigate the efficacy and safety of deanxit combined with Tianmeng capsule in treating neurasthenia patients with insomnia. Methods 83 patients with a clinical diagnosis of neurasthenia were consecutively allocated to receive deanxit plus Tianmeng capsule（ experimental group,n = 40）,or deanxit（ placebo group,n = 43） for 30 days. The treatment efficacy were assessed by Pittsburgh sleep quality index（ PSQI） 、Selfrating depression scale（ SDS） 、Self-rating anxiety scale（ SAS）,and the side effects were assessed by Treatment Emergent Symptom Scale（ TESS）. Results Both groups have signi ficant therapeutic effect. Significant differences between the two groups（ experimental group vs placebo） were also found in sleep quality scores（ data1 vs data2,P〈0. 05）,depression scores（ P〈0. 05）,and anxiety scores（ P〈0. 05）. The remission of symptoms in the combination group was significantly better than that in the monotherapy group,and no serious adverse events was observed in two groups. Conclusion The combination therapy has better efficacy than the monotherapy in improving the symptoms of neurasthenia with insomnia. In addition,this combination treatment is safe.