中华精神科杂志
中華精神科雜誌
중화정신과잡지
CHINESE JOURNA OF PSYCHIATRY
2010年
2期
106-110
,共5页
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
王雪芹%于訢%高旭光%馬辛%崔麗英%陸崢%潘小平%陳誌青%王少石%硃榮申%翁亞琴%趙學英%陳玉芳
왕설근%우흔%고욱광%마신%최려영%륙쟁%반소평%진지청%왕소석%주영신%옹아금%조학영%진옥방
入睡和睡眠障碍%治疗结果%催眠药和镇静药%老年人%唑吡坦
入睡和睡眠障礙%治療結果%催眠藥和鎮靜藥%老年人%唑吡坦
입수화수면장애%치료결과%최면약화진정약%노년인%서필탄
Sleep initiation and maintenance disorders%Treatment outcome%Hypnotics and sedatives%Aged%Zolpidem
目的 评价唑吡坦5 mg每日1次治疗老年原发性失眠的疗效和安全性.方法 采用开放性、前瞻性、固定剂量、多中心、自身对照的研究方法.115例符合美国精神障碍诊断和统计手册第4版原发性失眠诊断标准的老年门诊患者每日1次服用固定剂量唑吡坦5 mg,疗程3周.以治疗第1周末匹兹堡睡眠质量指数评分(PSQI)相对于基线的差值作为研究的主要疗效评价指标,次要疗效指标包括:治疗第3周末PSQI评分相对于基线的差值,治疗第1周末和第3周末主观睡眠有效参数评分(睡眠潜伏期、总的睡眠时间、睡眠质量)相对于基线的差值,治疗第3周末17项汉密尔顿抑郁量表(HAMD-17)评分和汉密尔顿焦虑量表(HAMA)评分相对于基线的差值.结果 治疗第1周末,PSQI量表总分较基线下降2.8分,差异有统计学意义(P＜0.01);治疗第3周末,PSQI评分较基线下降3.2分,差异有统计学意义(P＜0.01);治疗第1周末和第3周末主观睡眠有效参数均有明显改善:睡眠潜伏期缩短(P＜0.01),睡眠时间延长(P＜0.01),日间功能提高(P＜0.01);治疗第3周末,患者的HAMD-17和HAMA评分较基线均有降低(P＜0.01);不良事件的发生率为19.1%,主要为头晕、头痛、困倦、恶心、乏力等,程度为轻、中度.结论 每日1次服用固定剂量唑吡坦5 mg治疗老年原发性失眠安全有效.
目的 評價唑吡坦5 mg每日1次治療老年原髮性失眠的療效和安全性.方法 採用開放性、前瞻性、固定劑量、多中心、自身對照的研究方法.115例符閤美國精神障礙診斷和統計手冊第4版原髮性失眠診斷標準的老年門診患者每日1次服用固定劑量唑吡坦5 mg,療程3週.以治療第1週末匹玆堡睡眠質量指數評分(PSQI)相對于基線的差值作為研究的主要療效評價指標,次要療效指標包括:治療第3週末PSQI評分相對于基線的差值,治療第1週末和第3週末主觀睡眠有效參數評分(睡眠潛伏期、總的睡眠時間、睡眠質量)相對于基線的差值,治療第3週末17項漢密爾頓抑鬱量錶(HAMD-17)評分和漢密爾頓焦慮量錶(HAMA)評分相對于基線的差值.結果 治療第1週末,PSQI量錶總分較基線下降2.8分,差異有統計學意義(P＜0.01);治療第3週末,PSQI評分較基線下降3.2分,差異有統計學意義(P＜0.01);治療第1週末和第3週末主觀睡眠有效參數均有明顯改善:睡眠潛伏期縮短(P＜0.01),睡眠時間延長(P＜0.01),日間功能提高(P＜0.01);治療第3週末,患者的HAMD-17和HAMA評分較基線均有降低(P＜0.01);不良事件的髮生率為19.1%,主要為頭暈、頭痛、睏倦、噁心、乏力等,程度為輕、中度.結論 每日1次服用固定劑量唑吡坦5 mg治療老年原髮性失眠安全有效.
목적 평개서필탄5 mg매일1차치료노년원발성실면적료효화안전성.방법 채용개방성、전첨성、고정제량、다중심、자신대조적연구방법.115례부합미국정신장애진단화통계수책제4판원발성실면진단표준적노년문진환자매일1차복용고정제량서필탄5 mg,료정3주.이치료제1주말필자보수면질량지수평분(PSQI)상대우기선적차치작위연구적주요료효평개지표,차요료효지표포괄:치료제3주말PSQI평분상대우기선적차치,치료제1주말화제3주말주관수면유효삼수평분(수면잠복기、총적수면시간、수면질량)상대우기선적차치,치료제3주말17항한밀이돈억욱량표(HAMD-17)평분화한밀이돈초필량표(HAMA)평분상대우기선적차치.결과 치료제1주말,PSQI량표총분교기선하강2.8분,차이유통계학의의(P＜0.01);치료제3주말,PSQI평분교기선하강3.2분,차이유통계학의의(P＜0.01);치료제1주말화제3주말주관수면유효삼수균유명현개선:수면잠복기축단(P＜0.01),수면시간연장(P＜0.01),일간공능제고(P＜0.01);치료제3주말,환자적HAMD-17화HAMA평분교기선균유강저(P＜0.01);불량사건적발생솔위19.1%,주요위두훈、두통、곤권、악심、핍력등,정도위경、중도.결론 매일1차복용고정제량서필탄5 mg치료노년원발성실면안전유효.
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.
