唑吡坦治疗老年原发性失眠的开放性前瞻性多中心自身对照研究 |
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引用本文: | 王雪芹,于欣,高旭光,马辛,崔丽英,陆峥,潘小平,陈志青,王少石,朱荣申,翁亚琴,赵学英,陈玉芳. 唑吡坦治疗老年原发性失眠的开放性前瞻性多中心自身对照研究[J]. 中华精神科杂志, 2010, 43(1): 106-110. DOI: 10.3760/cma.j.issn.1006-7884.2010.02.014 |
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作者姓名: | 王雪芹 于欣 高旭光 马辛 崔丽英 陆峥 潘小平 陈志青 王少石 朱荣申 翁亚琴 赵学英 陈玉芳 |
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作者单位: | 北京大学精神卫生研究所药物临床试验机构,100191;北京大学人民医院神经内科;北京安定医院精神科;北京协和医院神经内科;上海市精神卫生中心精神科;广州市第一人民医院神经内科;上海市第一人民医院心理科;上海市第一人民医院分院神经内科;上海市第十人民医院神经内科; |
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摘 要: | Objective To evaluate the clinical efficacy and safety of zolpidem in treatment of primary insomnia in elderly patients.Methods An open, perspective, fixed-dose, multicentre and selfcontrolled clinical trial was conducted.Total of 115 elderly patients who met with the Diagnostic and Statistical Manual of Mental Disorders, 4th edition criteria for primary insomnia were administered 3 week nightly treatment with zolpidem 5 mg.The primary efficacy measurement was the change of Pittsburg Sleep Quality Index(PSQI) score after 1 week treatment in comparison with the baseline.The secondary efficacy measurement included the changes from baseline in total score of the PSQI, Hamilton Depression Scale (HAMD-17) and Hamilton Anxiety Scale (HAMA) and self-reported sleeping parameters ( latency of falling asleep, total sleeping time and sleeping quality) after 3 week treatment.Results The mean reduction score 17 items of PSQI were 2.8 after 1 week treatment and 3.2 at the end of 3 week ( P < 0.01 ).The selfreported sleeping parameters were much improved from the baseline (P <0.01 ).The total scores of HAMD and HAMA were reduced significantly ( P < 0.01 ) after 3 week treatment.The overall incidence of adverse events was 19.1%, with the frequent adverse events of dizziness, headache, sleepiness, nausea and fatigue, and the severity was mild or moderate.Conclusion It is effective and safe of zolpidem 5 mg nightly in treatment of elderly insomnia patients.
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关 键 词: | 入睡和睡眠障碍 治疗结果 催眠药和镇静药 老年人 唑吡坦 |
Efficacy and safety of zolpidem in treatment of primary insomnia in Chinese elderly: an open, selfcontrolled, multicenter study |
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Keywords: | Sleep initiation and maintenance disordersTreatment outcomeHypnotics and sedativesAgedZolpidem |
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