唑吡坦联合帕罗西汀治疗抑郁失眠的临床研究

Clinical study on zolpidem combined with paroxetine in treatment of depression and insomnia

目的探讨酒石酸唑吡坦片联合盐酸帕罗西汀片治疗抑郁失眠的临床疗效和安全性。方法选取2012年12月—2014年12月上海中医药大学附属龙华医院就诊的抑郁症患者86例,随机分为对照组和治疗组,每组各43例。对照组患者饭后口服盐酸帕罗西汀片10 mg,1次/d。治疗组在对照组治疗的基础上睡前服用酒石酸唑吡坦片10 mg,1次/d。两组药物初始剂量均为10 mg,治疗1周后酌情增加至20 mg。两组均连续治疗4周。治疗后,评价两组的临床疗效,同时比较两组治疗前后PSQI、HAMD-17、HAMA评分,血生化指标水平以及不良反应发生情况。结果治疗后,对照组、治疗组的总有效率分别为76.74%、93.02%,两组总有效率比较差异具有统计学意义(P<0.05)。治疗1周后,两组HAMA评分均显著降低,同组治疗前后差异有统计学意义(P<0.05)。治疗2、4周后,两组PSQI、HAMD-17、HAMA评分均显著降低,同组治疗前后差异有统计学意义(P<0.05);且治疗组这些观察指标同期的降低程度明显优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组γ-氨基丁酸(GABA)、5-羟色胺(5-HT)水平均显著升高,同组治疗前后差异具有统计学意义(P<0.05);且治疗组这些观察指标的升高程度明显优于对照组,两组比较差异具有统计学意义(P<0.05)。出现的主要不良反应有头晕、恶心与食欲不振、口干、腹泻,两组不良反应发生率比较无统计学意义。结论酒石酸唑吡坦片联合盐酸帕罗西汀片治疗抑郁失眠具有良好的疗效,可以缓解失眠症状,增加GABA和5-HT水平,不增加不良反应,具有一定的临床推广应用价值。

Objective To explore the clinical efficacy and safety of Zolpidem Tartrate Tablets combined with Paroxetine Hydrochloride Tablets in treatment of depression and insomnia. Methods Patients（86 cases） with depression in Longhua Hospital Shanghai University of Traditional Chinese Medicine from December 2012 to December 2014 were randomly divided into control and treatment group, and each group had 43 cases. The patients in the control group were po administered with Paroxetine Hydrochloride Tablets 10 mg after dinner, once daily. The patients in the treatment group were po administered with Zolpidem Tartrate Tablets on the basis of the control group 10 mg before sleeping, once daily. The initial dose of patients in two groups was 10 mg, and was increased to 20 mg in 1 week after treatment. The patients in two groups were treated for 4 weeks. After treatment, the clinical efficacies were evaluated, and PSQI score, HAMD-17 score, HAMA score, the blood biochemical indexes, and adverse reactions in two groups were compared. Result After treatment, the clinical efficacies in the control and treatment groups were 76.74% and 93.02%, respectively, and there were differences between two groups（P〈0.05）. After treatment for one week, HAMA score of two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. After treatment for 2 and 4 weeks, PSQI, HAMD-17, and HAMA scores of two groups were obviously decreased, and the difference was statistically significant in the same group（P〈0.05）. And the scores in the treatment group were significantly lower than those of the control group in the same period, with significant difference between two groups（P〈0.05）. After treatment, the levels of GABA and 5-HT were significantly increased, and the difference was statistically significant in the same group（P〈0.05）. And the observational indexes in the treatment group were significantly higher than those in the control group, with significant difference between two groups（P〈0.05）. Major adverse reactions in two groups were dizziness, nausea, loss of appetite, dry mouth, and diarrhea, and there was no significant difference between two groups. Conclusion Zolpidem Tartrate Tablets combined with Paroxetine Hydrochloride Tablets has good clinical effect in treatment of depression and insomnia, can alleviate insomnia symptoms, increase the levels of GABA and 5-HT, and don＇t increase the adverse reaction, which has a certain clinical application value.