艾司西酞普兰联合唑吡坦治疗原发性失眠的临床疗效和安全性评价

Effect and safety of escitalopram combined with zolpidem in treatment of primary insomnia patients

目的比较艾司西酞普兰联合唑吡坦与单用唑吡坦治疗原发性失眠的疗效及安全性。方法将72例失眠受试者按排列表法随机分为试验组（n=36）和对照组（n=36）。试验组用艾司西酞普兰10~20 mg·d-1联合唑吡坦5~10mg·d-1,治疗8周;对照组单用唑吡坦5~10 mg·d-1,治疗8周。在治疗前、治疗后第1,4,8周末分别完成匹兹堡睡眠质量指数量表（PSQI）、病人健康问卷（PHQ-9）、不良反应症状量表（TESS）,比较两者的疗效及安全性。结果 2组在治疗后各周末和治疗前相比,PSQI、PHQ-9总分均有下降,差异有统计学意义（P〈0.05）。在治疗后第8周末,试验组PSQI、PHQ-9总分低于对照组,差异有统计学意义（P〈0.05）。2组药品不良反应的发生率相比差异无统计学意义（P〉0.05）。结论艾司西酞普兰联合唑吡坦治疗原发性失眠患者安全性高,疗效更优。

Objective To compare the efficacy and safety of escitalo- pram combined with zolpidem and zolpidem alone on primary insomnia. Methods A total of 72 primary insomnia patients were recruited from outpatients in the Seventh Hospital of Hangzhou and were randomly divided into test group （ n = 36） and control group （ n = 36）. Patients in the test group were treated with escitalopram 10 -20 mg · d-1 combined zolpidem 5 - 10 mg · d-1 for 8 weeks, while patients in control group were treated with zolpidem 5 - 10 mg· d-1 only. The efficacy and ad- verse events were assessed with the pittsburgh sleep quality index （ PSQI）, patient health questionnaire （ PHQ - 9 ） and treatment emergent symptom scale （TESS）before and after 1,4 and 8 weeks treatment. Results The score of PSQI and PHQ -9 in two groups were decreased significantly at week 1, 4, 8 after treatment （ P 〈 0. 05 ）. The scores of PSQI and PHQ- 9 was lower in test group than that in control group at the end of 8 weeks after treatment （ P 〈 0. 05 ）. There were similar rates of adverse reactions between two groups （P 〉 0.05 ）. Conclusion Escitalopram combined with zolpidem is significantly effective and safe for primary insomnia patients.