安神胶囊治疗精神分裂症患者睡眠障碍临床研究

Clinical Study of AnShen Capsules in Treating Sleep Disorders of the Patients Suffering from Schizophrenia

目的:评价安神胶囊治疗精神分裂症患者睡眠障碍的临床疗效和安全性。方法:采用随机、对照的研究方法,将精神分裂症睡眠障碍患者222例分为对照组和治疗组各111例;治疗组口服安神胶囊,4粒/次,3次/d;对照组口服右佐匹克隆1.5~3 mg/d;2组均治疗6周;于治疗前及治疗后1、2、4、6周末评价睡眠评定量表(SDRS)及阳性与阴性症状量表(PANSS)疗效;并通过药物副作用量表(TESS)、临床总体印象量表(CGI)得分评价药物的安全性。结果:2组患者SDRS、PANSS总分和CGI在治疗第1周末开始下降,2组治疗后比较差异均有统计学意义(P<0.01);治疗结束时2组SDRS减分率治疗组为(75±23)%,对照组为(75±29)%,2组比较差异无统计学意义(P>0.05);PANSS有效率治疗组为78.3%,对照组为85.3%,2组比较差异无统计学意义(P>0.05);右佐匹克隆常见的副反应为轻度头昏、口苦、便秘等,治疗组视力模糊和严重度频度低于对照组(P<0.05)。结论:安神胶囊治疗精神分裂症患者睡眠障碍的临床疗效与右佐匹克隆相似,但不良反应发生率低。

Objective：To evaluate the clinical effect and safety of AnShen capsules in treating sleep disorders of patients with schizophrenia. Methods：With random and controlled study methods, 222 patients with sleep disor-ders were divided into the control group and the treatment group, 111 cases in each group. The treatment group was treated by orally taking AnShen Capsules, four capsules once, three times/d;and the control group was treated by o-rally taking eszopiclone, 1.5~3 mg/d, and both groups were treated for six weeks. The treating effects were evaluated by Sleep dysfunction rating scale （SDRS） and Positive and Negative Syndrome Scale （PANSS） before the interven-tion and the weekends of 1 st, 2 nd, 3 rd and 6th week after the intervention. And the drug safety was evaluated by scores of treatment emergent symptom scale （TESS） and clinical global impression scale （CGI）. Results：Total scores of SDRS and PANSS, and CGI of patients in two groups began to decrease in the weekend of the 1st week treat-ment, after the treatment, the differences between two groups were statistically significant （P〈0.01）. At the end of the treatment, SDRS deduction rate of the treatment group was （75±23）%, and that of the control group was （75±29）%, and the differences were not statistically significant （P〉0.05）. PANSS effective rate of the treatment group was 78.3%, and that of the control group was 85.3%, the differences were not statistically significant （P〉0.05）. Eszopi-clone had common side effects such as mild dizziness, bitterness in the mouth and constipation, and the side effects occurrence rate of AnShen capsules was significantly less than that of the eszopiclone group （P〈0.05）.Conclusion：Clinical effect of AnShen capsules in the treatment of sleep disorders of the patients with schizophrenia is close to that of eszopiclone, but the adverse event rate of the AnShen capsules is low.