右佐匹克隆治疗失眠症的疗效

目的:观察右佐匹克隆治疗失眠症的临床疗效与不良反应。方法:140例失眠症患者随机分为治疗组(70)例和对照组(70)例。治疗组患者每晚睡前服用右佐匹克隆3~6 mg;对照组患者每晚睡前服用劳拉西泮1~2 mg。连续服用4周。在服药前、服药后1周末、第2周末、第4周末应用阿森斯失眠量表(ASDR)评定患者睡眠障碍的改善情况。应用副反应量表(TESS)评定药物的不良反应。结果:ASDR评分在治疗结束时,两组较基线均显著降低(P<0.01);研究组和对照组的有效率分别为81.4%和78.6%,两组比较无显著性差异(P>0.05)。但研究组患者的起效时间较对照组快,总的睡眠质量更好。研究组不良反应发生率低于对照组(P<0.01)。结论:右佐匹克隆治疗失眠症患者疗效好,且不良反应少,是一种治疗失眠症安全而有效的新药。     

右佐匹克隆治疗失眠症疗效分析与评价

目的 探讨右佐匹克隆片治疗失眠症的临床疗效.方法 收录本院门诊"失眠症"患者109例,随机分成治疗组与对照组;治疗组予以右佐匹克隆片3mg口服每晚一次,对照组予以劳拉西泮2mg口服每晚一次,采用睡眠障碍评定量表(SDRS)评定疗效.结果 两组治疗结束时,评分较基线均有显著下降,两组显效率差异无统计学意义(P＞0.05).结论 右佐匹克隆片能够显著改善失眠症患者的睡眠,临床效果明显,而不产生肌肉松弛、认知与精神运动损害、耐药性及药物依赖等,是疗效肯定而安全性较高的药物.     

右佐匹克隆治疗失眠症疗效分析与评价

目的探讨右佐匹克隆片治疗失眠症的临床疗效。方法收录本院门诊"失眠症"患者109例,随机分成治疗组与对照组;治疗组予以右佐匹克隆片3mg口服每晚一次,对照组予以劳拉西泮2mg口服每晚一次,采用睡眠障碍评定量表(SDRS)评定疗效。结果两组治疗结束时,评分较基线均有显著下降,两组显效率差异无统计学意义(P>0.05)。结论右佐匹克隆片能够显著改善失眠症患者的睡眠,临床效果明显,而不产生肌肉松弛、认知与精神运动损害、耐药性及药物依赖等,是疗效肯定而安全性较高的药物。     

右佐匹克隆治疗失眠症92例

目的 评价右佐匹克隆和佐匹克隆治疗失眠症的疗效和安全性.方法 将183例失眠症患者随机分成2组,治疗组92例,对照组91例.治疗组给予右佐匹克隆片3 mg·d-1,睡前服;对照组给予佐匹克隆胶囊7.5～15.0 mg·d-1,睡前服;两组疗程均为15 d,治疗前及治疗第8,15天后采用睡眠障碍量表(SDRS)、临床总体印象量表(CGI)和不良反应量表(TESS)评定临床疗效和不良反应.结果 两组治疗结束时SDRS评分较基线均有显著下降(P＜0.01),治疗组显效率83.7%,对照组显效率81.3%,两组疗效及不良反应比较差异无显著性(P＞0.05).结论 失眠症患者服用右佐匹克隆后睡眠状况明显改善,且不良反应少,患者易于接受.     

右佐匹克隆与地西泮治疗失眠症的临床对比分析

目的对比分析右佐匹克隆与地西泮治疗失眠症的临床效果。方法随机选择60例失眠症患者进行分组治疗,分为右佐匹克隆组与地西泮组,每组均为30例,连续治疗14天后对其疗效进行比较评价。结果治疗后的右佐匹克隆组匹兹堡睡眠质量指数(PSQI)分值明显低于地西泮组(P<0.05),且右佐匹克隆组的临床疗效明显优于地西泮组(P<0.05)。结论失眠症患者应用右佐匹克隆治疗可获得更好的效果,较地西泮治疗更胜一筹,临床应用价值高。     

右佐匹克隆与佐匹克隆辅助治疗抑郁症睡眠障碍对照研究

目的探讨右佐匹克隆辅助治疗抑郁发作睡眠障碍的疗效及安全性。方法选取符合ICD-10抑郁发作诊断标准的门诊抑郁发作伴失眠患者,按随机分为右佐匹克隆组和佐匹克隆组,两组均观察两周。两组患者均在治疗前、治疗后第二周末采用PSQI、HAMD、TESS评定。以PSQI的减分率判定疗效。结果右佐匹克隆组和佐匹克隆组治疗后PSQI评分经I检验差异无统计学意义（P〉0．05）;但两组各因子分比较,治疗后日间功能障碍因子右佐匹克隆组显著低于佐匹克隆组（P〈O．05）;两组不良反应发生率差异无统计学意义（P〉0．05）。结‘论右佐匹克隆辅助治疗抑郁发作睡眠障碍疗效显著,对日间功能的影响显著低于佐匹克隆,安全性好,耐受性高。     

右佐匹克隆与唑吡坦治疗失眠症的疗效观察

目的:观察右佐匹克隆治疗失眠症的疗效。方法:将70例失眠症患者随机分为治疗组与对照组各35例,分别于睡前服用右佐匹克隆3mg与唑吡坦10mg,疗程均为2周。采用睡眠障碍量表(SDRS)、临床疗效总评量表(CGI)评估疗效。结果:2组治疗后SDRS总分均较治疗前下降,组间比较均无显著性差异(P>0.05);CGI总体疗效改善,2组不同时期疗效比较无显著性差异(P>0.05);2组不良反应均为口苦、头晕、口干,组间不良反应发生率比较差异无统计学意义(P>0.05);治疗组较对照组主观满意度高,2组比较有统计学意义(P<0.05)。结论:右佐匹克隆与唑吡坦治疗失眠症的疗效与安全性相当,但前者主观满意度较高。     

国产艾司佐匹克隆治疗失眠症的对照研究

目的:评价国产艾司佐匹克隆治疗失眠症的有效性和安全性。方法:采用多中心随机双盲双模拟、阳性药物平行对照的研究方法。入选228例,其中试验组113例,对照组115例。分别口服艾司佐匹克隆3～6 mg·d-1和佐匹克隆7．5～15 mg·d-1,疗程均为14 d。结果:睡眠障碍量表(SDRS)评分在治疗结束时两组较基线均显著降低(P<0．05);试验组和对照组的有效率分别为60．2％和62．6％,两组比较无显著性差异(P>0．05)。不良反应发生率分别为32．7％和33．9％,较常见的不良反应为口苦及头晕。结论:艾司佐匹克隆能改善睡眠,不良反应较少,是一种治疗睡眠障碍安全而有效的新药。     

右旋佐匹克隆与佐匹克隆治疗失眠症的系统评价

目的 系统评价右旋佐匹克隆与佐匹克隆治疗失眠症患者的疗效及安全性。方法 检索国内外科技期刊数据库,纳入右旋佐匹克隆、佐匹克隆治疗失眠症的随机对照试验,并进行Meta分析。结果 共纳入7项研究1021例患者,治疗2周后,2组睡眠障碍量表(SDRS)减分值比较差异无统计学意义[P=0.57,MD=0.77,95%CI(-1.88~3.41)];2组显效率差异无统计学意义[P=0.76,OR=0.96,95%CI(0.73~1.26)];2组头痛头晕、口干、口苦、恶心呕吐、嗜睡、上腹不适等不良反应发生率差异无统计学意义(P > 0.05)。结论 右旋佐匹克隆与佐匹克隆治疗失眠症疗效及安全性相似。     

A polysomnography study of eszopiclone in elderly patients with insomnia

ABSTRACT

Objective: To evaluate the safety and efficacy of eszopiclone 2?mg in elderly patients (aged 64-86 years) with chronic insomnia.

Methods: This was a randomized, double-blind, placebo-controlled 2‐week study. Patients meeting DSM-IV criteria for primary insomnia and screening polysomnography criteria (wakefulness after sleep onset [WASO] ≥ 20?min and latency to persistent sleep ≥ 20?min) were randomized to 2 weeks of nightly treatment with eszopiclone 2?mg (n = 136) or placebo (n = 128). Efficacy was assessed using polysomnography (Nights 1, 2, 13, and 14) and patient reports (Nights 1–14); safety was assessed using adverse events, clinical labs, physical examination, and vital signs. The mean of all efficacy results during the double-blind period was used for the efficacy analysis.

Results: Results indicated that eszopiclone was associated with significantly shorter sleep onset, less WASO, higher sleep efficiency, more total sleep time, and greater patient-reported quality and depth of sleep scores than placebo (?p < 0.05 for all) with a trend in patient-reported morning sleepiness (?p = 0.07). Other measures of daytime functioning (ability to function, daytime alertness, and sense of well-being) were not significantly different between the two treatment groups. Among patients who napped, eszopiclone patients reported fewer naps (?p = 0.03) and less cumulative naptime (median: 98?min placebo, 70?min eszopiclone, p = 0.07). Unpleasant taste, dry mouth, somnolence, and dizziness were higher in the eszopiclone group (12.5%, 8.8%, 6.6%, and 6.6%, respectively) than in the placebo group (0%, 1.6%, 5.5%, and 1.6%, respectively).

Conclusion: In this study, eszopiclone was well tolerated and produced significant improvements in both polysomnographic and patient-reported measures of sleep maintenance, sleep induction, and sleep duration in elderly patients with chronic primary insomnia.     

Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia

SUMMARY

Objective: Eszopiclone is a new, single-isomer, non-benzodiazepine, cyclopyrrolone agent under investigation for the treatment of insomnia. The present study was a randomized, double-blind, multicenter, placebo-controlled trial conducted to assess the efficacy and safety of eszopiclone in adults with chronic primary insomnia.

Research design and methods: Patients (n = 308) were randomized to receive placebo or eszopiclone (2?mg or 3?mg) for 44 consecutive nights, followed by 2 nights of single-blind placebo. Efficacy was evaluated with polysomnography (Nights 1, 15 and 29) and patient-reports (Nights 1, 15, 29 and 43/44). Next-day residual effects were evaluated using the Digit-Symbol Substitution Test (DSST).

Results: Eszopiclone 3?mg had significantly less time to sleep onset (?p ≤ 0.0001), more total sleep time and sleep efficiency (?p ≤ 0.0001), better sleep maintenance (p ≤ 0.01), and enhanced quality and depth of sleep (?p < 0.05) across the double-blind period compared with placebo. Eszopiclone 2?mg had significantly less time to sleep onset (?p ≤ 0.001), more total sleep time (?p ≤ 0.01) and sleep efficiency (?p ≤ 0.001), and enhanced quality and depth of sleep (?p < 0.05) compared with placebo, but did not significantly improve sleep maintenance. There was no evidence of tolerance or rebound insomnia after therapy discontinuation. Median DSST scores showed no decrement in psychomotor performance relative to baseline and did not differ from placebo in either eszopiclone group. Treatment was well tolerated; the most common adverse event related to eszopiclone was unpleasant taste.

Conclusions: Patients treated with nightly eszopiclone 3?mg had better polysomnographic (through Night 29) and patient-reported measures (through Night 44) of sleep over the 6-week trial. There was no evidence of tolerance or rebound insomnia and no detrimental effects on next-day psychomotor performance using the DSST.     

右佐匹克隆治疗慢性原发性失眠临床疗效观察

目的 观察右佐匹克隆治疗慢性原发性失眠临床疗效.方法 将120例慢性原发性失眠患者随机分为两组,治疗组60例用右佐匹克隆片3 mg,每晚1次,睡前服用;对照组60例用艾司唑仑片2 mg,每晚1次,睡前服用.疗程均为30d.采用匹兹堡睡眠质量指数(PSQI)对两组患者治疗前后的睡眠质量进行评估.结果 两组治疗前后睡眠质量均有改善.治疗组与对照组治疗后相比,治疗组改善更明显(P＜0.05).结论 右佐匹克隆能改善慢性原发性失眠患者的睡眠质量.     

中药新乐康与阿普唑仑治疗失眠对照研究

目的探讨中药新乐康治疗失眠的临床疗效及安全性。方法将53例失眠症患者随机分为中药组31例,对照组22例;中药组给予新乐康治疗,对照组给予阿普唑仑治疗,观察4周。于治疗前及治疗第2周、4周末采用睡眠状态问卷量表评定临床疗效,临床总体量表中对不良反应评分法评定。结果治疗4周末,中药组显效率54.9%,对照组为59.1%（P〉0.05）;SQ评分两组治疗2周末起均较治疗前有极显著性下降（P〈0.01）,并随治疗时间的延续逐渐下降;同期两组间评分差异均无统计学意义（P〉0.05）。中药组的不良反应明显低于阿普唑仑组。结论新乐康治疗失眠疗效与阿普唑仑相当,不良反应明显少于阿普唑仑,安全性、依从性好。     

右佐匹克隆治疗慢性失眠患者的临床疗效及安全性

目的研究右佐匹克隆治疗慢性失眠患者的临床疗效及安全性。方法选取原发性慢性失眠患者80例,随机分为治疗组和对照组各40例。治疗组给予右佐匹克隆3 mg,睡前口服,对照组给予同等样式的安慰剂,治疗时间为8周。比较两组治疗前和治疗第2、 4、 8周末匹兹堡睡眠质量指数(PSQI)、汉密尔顿抑郁量表(HAMD)评分。观察和比较两组不良反应发生情况。结果对照组治疗后PSQI和HAMD评分有下降趋势,但与治疗前比较无显著差异(P> 0.05),治疗组在治疗第4、 8周末PSQI、HAMD评分明显降低(P <0.05, P <0.01),且与对照组有显著差异(P <0.05, P <0.01)。两组不良反应发生率无显著差异(P> 0.05)。结论右佐匹克隆治疗慢性失眠患者疗效显著,可改善患者的焦虑、抑郁情绪,且安全性较高。     

舒眠胶囊联合右佐匹克隆治疗失眠症的临床研究

目的探讨舒眠胶囊联合右佐匹克隆片治疗失眠症的临床疗效。方法选择2016年1月—2017年2月陕西省人民医院收治的失眠症患者112例作为研究对象,将所有患者随机分为对照组和治疗组,每组各56例。对照组口服右佐匹克隆片,3 mg/次,1次/d。治疗组在对照组基础上于晚饭后临睡前口服舒眠胶囊,1.2 g/次,2次/d。两组患者均治疗4周。观察两组的临床疗效,比较两组的匹兹堡睡眠质量指数(PSQI)评分、促甲状腺激素(TSH)、三碘甲状腺氨酸(T3)和甲状腺素(T4)水平。结果治疗后,对照组和治疗组的总有效率分别为82.14%、94.64%,两组比较差异有统计学意义(P0.05)。治疗后,两组睡眠时间、主观质量、入睡时间、睡眠障碍、睡眠效率、日间功能、药物应用和PSQI评分均明显降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组TSH、T3和T4水平均明显降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。结论舒眠胶囊联合右佐匹克隆片治疗失眠症具有较好的临床疗效,能改善临床症状,调节甲状腺激素水平,安全性较好,具有一定的临床推广应用价值。     

甜梦口服液联合右佐匹克隆治疗脑梗死后失眠症的疗效观察

目的探讨甜梦口服液联合右佐匹克隆治疗脑梗死后失眠症临床疗效。方法选取2014年7月—2015年7月在铁岭市中心医院神经内科接受治疗的脑梗死后失眠症患者96例,随机分为对照组和治疗组,每组各48例。对照组患者睡前口服右佐匹克隆片,初始剂量1.5 mg/次,3 d后3 mg/次。治疗组在对照组基础上口服甜梦口服液,20 m L/次,3次/d。两组患者均治疗1个月。观察两组的临床疗效,比较两组改良爱丁堡–斯堪的那维亚卒中量表(MESSS)评分、匹兹堡睡眠质量量表(PSQI)评分和综合医院焦虑抑郁量表(HAD)评分情况。结果治疗后,对照组和治疗组的总有效率分别为83.33%、95.83%,两组比较差异有统计学意义(P0.05)。治疗后,两组MESSS评分、PSQI评分和HAD评分均明显降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标的下降程度明显优于对照组,两组比较差异具有统计学意义(P0.05)。结论甜梦口服液联合右佐匹克隆治疗脑梗死后失眠症具有较好的临床疗效,有利于患者神经功能恢复,提高患者睡眠质量,具有一定的临床推广应用价值。     

右佐匹克隆合并艾司西肽普兰治疗广泛性焦虑伴失眠的对照研究简

目的：比较广泛性焦虑伴失眠患者在抗焦虑治疗（艾司西酞普兰）初期合用或不用右佐匹克隆对患者失眠、焦虑症状的疗效与安全性。方法：将100例符合“中国精神障碍分类与诊断标准（第三版）”（CCMD-3）广泛性焦虑伴有失眠的患者随机分为试验组（52例）和对照组（48例）。试验组给予艾司西酞普兰合并右佐匹克隆治疗,对照组单用艾司西酞普兰治疗,观察期为8周。用汉密尔顿焦虑量表（HAMA）评定患者焦虑症状及疗效,用睡眠障碍量表（SDRS）评定失眠症状和疗效,同时用不良反应量表（TESS）和实验室检查评估治疗安全性。结果：试验组在治疗第1周末HAMA评分明显下降（P〈0．01）,对照组在第2周末HAMA评分明显下降（P〈0．01）,试验组在治疗后第1、2、4、6周末HAMA总分均低于对照组（P〈0．05）,第8周末差异无统计学意义（P〉0．05）。2组在治疗后第1、2、4周末SDRS总分均低于治疗前（P〈0．01）。试验组在第1、2、4周末SDRS总分均低于对照组（P〈0．01）。试验组较对照组更易发生头痛、口苦、口干、恶心及困倦感（P〈0．05）。结论：艾司西酞普兰合并右佐匹克隆治疗广泛性焦虑伴失眠,有助于快速改善患者的失眠和焦虑症状,但副反应相对明显。     

Efficacy and safety of eszopiclone across 6-weeks of treatment for primary insomnia

OBJECTIVE: Eszopiclone is a new, single-isomer, non-benzodiazepine, cyclopyrrolone agent under investigation for the treatment of insomnia. The present study was a randomized, double-blind, multicenter, placebo-controlled trial conducted to assess the efficacy and safety of eszopiclone in adults with chronic primary insomnia. RESEARCH DESIGN AND METHODS: Patients (n = 308) were randomized to receive placebo or eszopiclone (2 mg or 3 mg) for 44 consecutive nights, followed by 2 nights of single-blind placebo. Efficacy was evaluated with polysomnography (Nights 1, 15 and 29) and patient-reports (Nights 1, 15, 29 and 43/44). Next-day residual effects were evaluated using the Digit-Symbol Substitution Test (DSST). RESULTS: Eszopiclone 3 mg had significantly less time to sleep onset (p < or = 0.0001), more total sleep time and sleep efficiency (p < or = 0.0001), better sleep maintenance (p < or = 0.01), and enhanced quality and depth of sleep (p < 0.05) across the double-blind period compared with placebo. Eszopiclone 2 mg had significantly less time to sleep onset (p < or = 0.001), more total sleep time (p < or = 0.01) and sleep efficiency (p < or = 0.001), and enhanced quality and depth of sleep (p < 0.05) compared with placebo, but did not significantly improve sleep maintenance. There was no evidence of tolerance or rebound insomnia after therapy discontinuation. Median DSST scores showed no decrement in psychomotor performance relative to baseline and did not differ from placebo in either eszopiclone group. Treatment was well tolerated; the most common adverse event related to eszopiclone was unpleasant taste. CONCLUSIONS: Patients treated with nightly eszopiclone 3 mg had better polysomnographic (through Night 29) and patient-reported measures (through Night 44) of sleep over the 6-week trial. There was no evidence of tolerance or rebound insomnia and no detrimental effects on next-day psychomotor performance using the DSST.