艾司西酞普兰治疗首发重症抑郁伴失眠患者的临床试验研究

Clinical Research of Escitalopram on Treatment of Severe Depressive Patients with Insomnia in the First

目的观察艾司西酞普兰对首发重症抑郁伴失眠患者睡眠因子的影响。方法中国地区4家中心开放研究,对伴失眠的首发重症抑郁患者进行询问病史、体格检查、实验室检查、匹兹堡睡眠质量指数量表（PSQI）和汉密尔顿抑郁量表（HAMD）等,符合入选标准并且没有排除因素者进入试验。受试者在开始治疗前1天进行失眠严重指数量表（ISI）、蒙哥马利抑郁量表（MADRS）、广泛性焦虑量表（GAD-7）和临床疗效总评量表（CGI）的评分,并开始记录睡眠日记。同时给予艾司西酞普兰早餐后口服治疗,初始剂量为5-10 mg/d。每天清晨与晚上记录睡眠日记,在下一次访视时返还给研究者。分别在开始治疗第7天、第14天和第30天进行随访,再次完成PSQI、ISI、MADRS、GAD-7和CGI的评分。同时包括不良事件的记录。每次随访后根据患者的疗效调整艾司西酞普兰的剂量,最高剂量为20 mg/d。对人口统计学特征、生命体征以及评分量表等应用SSPS 10.0软件进行ANOVA分析。结果入组患者160例,男性67例,平均年龄（42±12）岁;女性93例,平均年龄（41±12）岁。在4个访视点中体重、血压、心率每两个访视点之间均无统计学差异。在4个访视点中PSQI、ISI、MADRS、GAD-7和CGI的评分逐渐减少,并且每2个访视点之间均有统计学差异。开始药物治疗第7天即有明显的疗效,这种疗效从开始药物治疗的第30天仍然继续强化。艾司西酞普兰的剂量由初始剂量（9.7±1.5）mg,逐渐增加到（14.8±4.0）mg,在（14.8±4.0）mg水平发挥了比较理想的疗效。只有2例患者出现轻微头晕、心慌等不适。结论失眠是抑郁症患者最常见的症状,艾司西酞普兰在治疗伴失眠首发的重症抑郁症状的同时可以很好地改善患者的失眠,效果明显。本研究提示艾司西酞普兰治疗伴失眠首发的重症抑郁症患者的最佳有效剂量为15 mg/d。

Objective To observe the therapeutic effect of escitalopram on severe depressed patients accompany with insomnia. Methods We chose compatible patients through consulting medical history, physical examination, laboratory examination, Pittsburgh sleep quality index （PSQI） and Hamilton Depression Scale （HAMD） et al, and the patients were graded by index scale（ISI）, Montgomery Depression Scale（MADRS）, generalized anxiety scale（GAD-7） and the Clinical Global Impression Scale（CGI） the previous day, in addition began to record sleep diary. Meanwhile Patients were given oral escitalopram after breakfast, the initial dosage was 5-10 mg/d, recorded sleep diary in the morning and evening which gave researcher in the next visit. The clinical follow-up on the seventh day, fourteenth day and thirtieth day respectively, and graded by ISI, MADRS, PSQI GAD-7 and CGI again, including record adverse events also. The dosage of escitalopram was adjusted according to therapeutic effect, the highest dosage was 20mg/day. ANOVA analysis of demographic characteristics, vital signs and scale based on SSPS10.0. Results In 160 cases of patients, 67 males, mean age（42±12）years old, 93 females, mean age（41±12）years old. In the four visit, weight, pressure and heart rate hadno statistically difference. The scores of PSQ, ISI, MADRS, GAD-7 and CGI decreased, andeach of the two visits had significant difference. The therapeutic effect was obvious after the seventh day, which continued to strengthen on the thirtieth day. The dosage of escitalopram gradually increased from （9.7±1.5） mg to （14.8 ±4.0） mg, and in （14.8 ± 4.0） mg level, it played an ideal effect, only 2 patients had a little discomfort of dizziness and palpitation. Conclusion Insomnia is the most common symptom of depressed patients, escitalopram can improve the symptom of severe depressed patients, and their insomnia furthermore. This study suggests that the best effective dose of escitalopram in the treatment of severe depressive patients with insomnia is about 15mg/day.