曲唑酮与佐匹克隆治疗慢性睡眠障碍患者的临床疗效和安全性研究

Effect and safety of trazodone and zopiclone in treatment of chronic sleep disorder

目的:比较曲唑酮与佐匹克隆治疗慢性睡眠障碍患者的临床疗效及安全性。方法:将152例睡眠障碍受试者按排列表法随机分为研究组(n=76)和对照组(n=76)。研究组用曲唑酮50mg/d,治疗8周;对照组用佐匹克隆7.5 mg/d,治疗8周。在治疗前、治疗后第2周、4周、6周、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)、广泛性焦虑障碍量表(GAD-7)、不良反应症状量表(TESS),比较两者疗效及安全性。结果:两组在治疗后和治疗前相比,PSQI、PHQ-9、GAD-7总分均有下降,差异有统计学意义(P<0.05)。在治疗后第2、4、6、8周末,研究组总睡眠时间优于对照组,对照组入睡潜伏期优于研究组,差异有统计学意义(P<0.05)。药物不良反应的发生率,研究组19.73%,对照组11.84%,差异有统计学意义(P<0.05)。结论:曲唑酮治疗慢性睡眠障碍患者能有效地延长总睡眠时间,佐匹克隆能有效地缩短入睡潜伏期。据此,佐匹克隆安全性优于曲唑酮。

AIM： To compare the effect and safety of trazodone and zopiclone on insomnia disor- der. METHODS： A total of 152 insomnia disorder patients were recruited from outpatient in the Sev- enth Hospital of Hangzhou and were randomly divid- ed into test group （ n = 76） and control group （ n = 76）. Patients in the test group were treated with trazodone （50 mg/d for 8-week）, while patients in control group were treated with zopiclone （7.5 mg/d for 8-week）. The efficacy and adverse events were assessed with the Pittsburgh Sleep Quality Index （PSQI）, Patient Health Questionnaire （ PHQ-9 ）, Generalized Anxiety Disorder （ GAD-7 ） and Treat- ment Emergent Symptom Scale （TESS） before and after 2, 4, 6, 8 weeks treatment. RESULTS ： The score of PSQI, PHQ-9 and GAD-7 in two groupswere decreased significantly after treatment in two groups （P 〈 0.05 ）. The score of total sleep time was lower in test group than control group （P 〈 0.05 ）, and sleep onset latency was lower in control group than test group （P 〈 0.05 ）. The rates of side effects （19.73%） in test group was higher than in control group （ 11.84% ） （P 〈 0.05 ）. CONCLU- SION： Trazodone is significantly effective for pro- longing total sleep time, and zopiclone can shorten for sleep onset latency in insomnia disorder patients. Zopiclone was more safety than trazodone.