舒眠胶囊与艾司唑仑治疗失眠症的临床疗效比较

目的：对比观察舒眠胶囊与艾司唑仑治疗失眠症的临床疗效和不良反应。方法将96例失眠症患者随机分为舒眠胶囊组和艾司唑仑组,两组患者分别给予舒眠胶囊和艾司唑仑治疗失眠症,疗程均为4周。2组患者在治疗前和治疗结束后分别测定PSQI评分和血清5-羟色胺（5-HT）水平,以PSQI评分的减分率作为疗效判定指标,计算2组的治疗有效率。治疗过程中每周测定一次患者的呼吸频率、心率及血、尿常规等,随时记录患者出现的不良反应,比较两种药物的不良反应发生率。结果舒眠胶囊组和艾司唑仑组患者药物治疗有效率分别为89．36％和91．83％;两组患者PSQI评分分别由治疗前的（15．1±2．5）和（14．7±2．1）降低为（9．5±2．9）和（8．6±3．2）（ P＜0．01）;舒眠胶囊组患者血清5-HT含量由治疗前的（1499．88±113．44）nmol· L－1升高至治疗后的（1786．75±116．22）nmol· L－1（P＜0．01）,而艾司唑仑组该指标则未见明显改变;舒眠胶囊和艾司唑仑不良反应发生率分别为4．26％和12．24％,舒眠胶囊显著低于艾司唑仑（P＜0．05）。结论舒眠胶囊和艾司唑仑治疗失眠症的有效率和PSQI评分下降程度均差异无显著性,但舒眠胶囊的不良反应少而轻,安全性高,耐受性好,值得推广。     

失眠症应用舒眠胶囊与艾司唑仑治疗的疗效对比研究

目的对比舒眠胶囊与艾司唑仑治疗失眠症的临床疗效。方法选择2015年8月-2016年7月于本院接受治疗的110例失眠症患者作为临床研究对象,按照其就诊时间进行编号并分组,对照组采用艾司唑仑治疗,观察组采用舒眠胶囊治疗,各55例,治疗4周为1个疗程,结束后进行效果评定。结果观察组治疗有效率为90.91%,对照组治疗有效率为87.27%,组间差异无统计学意义(P>0.05)。对照组和观察组治疗后PSQI评分分别为(8.24±0.78)分和(7.63±0.89)分,均较治疗前明显减少(P<0.05),但2组间差异无统计学意义(P>0.05)。观察组血清5-HT水平(1807.37±123.66)mmol·L~(-1)与治疗前比较明显减少(P<0.05),且与对照组比较差异有统计学意义(P<0.05)。观察组患者不良反应发生率为5.45%,与对照组16.36%相比明显降低(P<0.05)。结论舒眠胶囊和艾司唑仑治疗失眠症均能有效提高患者睡眠质量,但舒眠胶囊治疗不良反应少,安全性更高。     

扎来普隆治疗失眠症的对照研究

目的观察扎来普隆治疗失眠症的疗效和不良反应。方法对60例失眠症患者,随机分为扎来普隆组和阿普唑仑组,疗程4周。采用睡眠状况问卷自评量表（SRSS）和副反应量表（TESS）于治疗前后评价临床疗效和不良反应。结果两组均有显著疗效且疗效相当（P〉0．05）。两组TESS评分比较差异有统计学意义（P〈0．01）,扎来普隆组不良反应少。结论扎来普隆治疗失眠症疗效显著,不良反应少,依从性好,是治疗失眠症的有效药物。     

扎来普隆治疗失眠症的临床评价

目的评价扎来普隆治疗失眠症的疗效及安全性。方法以“zaleplon”、“insomnia”、“polysomnography”为关键词,在“OVID”数据库中检索最新文献。结果扎来普隆能快速诱导睡眠,不良反应小。结论扎来普隆是治疗失眠症安全、有效的药物。     

扎来普隆治疗失眠症的临床评价

目的评价扎来普隆治疗失眠症的疗效及安全性。方法以“zaleplon”、“insomnia”、“polysomnography”为关键词,在“OVID”数据库中检索最新文献。结果扎来普隆能快速诱导睡眠,不良反应小。结论扎来普隆是治疗失眠症安全、有效的药物。     

扎来普隆胶囊治疗失眠症的临床研究

目的 :评价扎来普隆胶囊治疗失眠症的疗效及安全性。方法 :采用多中心随机双盲双模拟平行对照的方法 ,共观察 2 14例 ,治疗组 10 6例 ,对照组 10 8例 ,疗程 10天。治疗期间采用睡眠状况评定表对睡眠情况进行评定。结果 :两组治疗 10天后均可明显改善睡眠 ,与治疗前相比 ,有显著性差异 (P <0 0 0 1) ;治疗组有效率 75 4 7% ,对照组有效率 72 2 2 % ,临床疗效两组无显著性差异 (P >0 0 5 ) ;两组均明显缩短入睡时间 ,延长睡眠时间 ,减少夜间醒的次数 ,减轻梦的程度 ,减轻白天困倦 ,提高睡眠质量。以上各项指标与治疗前相比均有显著性差异 (P <0 0 0 1) ,但两组间比较无统计学意义 (P >0 0 5 )。两组不良反应发生率为治疗组17 5 9% ,对照组 19 2 7% ,两组间无显著差异 (P >0 0 5 )。扎来普隆胶囊不良反应主要为头晕、乏力、头痛。结论 :扎来普隆胶囊是治疗失眠症安全有效的短时效催眠药     

乌灵胶囊和艾司唑仑治疗失眠症对照研究

目的观察乌灵胶囊治疗失眠症的疗效及安全性。方法采用平行对照研究方法,治疗组32例予口服乌灵胶囊每次3粒,3次/d,连服30d;对照组30例予口服艾司唑仑片每次2粒,每晚睡前1次,连服30d。于治疗前及治疗第14、30天分别以匹兹堡睡眠质量指数(PSQI)、睡眠障碍量表(SDRS)评估疗效与安全性。结果治疗组、对照组总有效率分别为90.63%、73.33%,有显著性差异(P<0.05),且治疗组未见明显不良反应。结论乌灵胶囊治疗失眠症疗效显著、安全可靠,值得临床推广使用。     

扎来普隆治疗失眠症的临床疗效与安全性评价

［摘要］目的观察扎来普隆治疗失眠症的疗效和安全性。方法失眠症患者197例，随机分为治疗组98例，对照组99例。治疗组给予扎来普隆胶囊5～10 mg， qn,po;对照组给予佐匹克隆片7.5～15 mg， qn,po，两组疗程均为15 d，治疗前及治疗后4，8，15 d后采用睡眠障碍量表（SDRS）、临床总体印象量表（CGI）及不良反应量表（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＝，治疗组和对照组显效率分别为82.7%，81.8%。两组疗效及不良反应比较差异无显著性（P＞0.05）。结论扎来普隆是一种安全有效的催眠药。     

艾司唑仑联合补肾益脑丸治疗失眠症的疗效分析

目的 探讨艾司唑仑联合补肾益脑丸对失眠症的临床洽疗效果.方法 选择北京军区总医院第三门诊部就诊的失眠症患者65例(所有患者均符合中国精神疾病分类方案与诊断标准中失眠症的诊断标准,排除有躯体疾病或精神障碍症状导致的继发性失眠及外源性睡眠障碍者).完全随机分为观察组(33例)和对照组(32例).观察组应用艾司唑仑联合补肾益脑丸治疗;对照组服用艾司唑仑单药治疗.分别于治疗前及治疗3个疗程后,采用匹兹堡睡眠质量指数( PSQI)对观察组和对照组的睡眠质量进行评定.结果 65例患者中完成研究62例;发生脱失3例,其中观察组脱失1例、对照组脱失2例,治疗3个疗程后,观察组与对照组比较,PSQI评分总分下降幅度大于对照组,差异有统计学意义(P＜0.05).2组治疗后患者的入睡时间缩短,PSQI评分下降[对照组分别为(2.1±0.5)分比(0.6±0.4)分,观察组分别为(2.1±0.5)分比(0.63±0.41)分],睡眠时间均延长,PSQI评分下降[对照组分别为(1.9±0.3)分比(1.0±0.6)分,观察组分别为(1.9±0.5)分比(0.9±0.6)分],睡眠质量、睡眠效率提高,差异有统计学意义(均P＜0.01).与对照组治疗后比较,观察组患者日间功能障碍减少,差异有统计学意义(P＜0.05).结论 艾司唑仑联合补肾益脑丸治疗失眠症有较好的治疗效果,并能减少艾司唑仑的不良反应.     

Hypnotic efficacy of estazolam compared with flurazepam in outpatients with insomnia

Estazolam is a new benzodiazepine hypnotic agent with an intermediate half-life of 12 to 15 hours. The authors designed an investigation to compare its hypnotic efficacy to that of flurazepam, generally considered the reference standard. The hypnotic efficacy of estazolam at two doses (1 mg and 2 mg) was compared with that of flurazepam (30 mg) in a double-blind, placebo-controlled, multicenter, 7-night study that involved 223 outpatients with insomnia. On subjective assessments of the patients, no differences were noted between estazolam 2 mg and flurazepam 30 mg on any of six sleep parameters. Patients who were receiving estazolam 1 mg rated their sleep significantly better than did patients who were receiving placebo on all parameters except sleep latency. Global evaluation of the physicians indicated significant improvement in quality of sleep, sleep depth, sleep duration, and nocturnal awakenings in all three active treatment groups; estazolam 2 mg and flurazepam also decreased sleep latency significantly. The percentage of patients who reported any adverse experience was 68% for flurazepam, 58% for estazolam 2 mg, and 54% for estazolam 1 mg; the incidence of adverse events in the placebo group was 43%. In conclusion, estazolam 2 mg was found to be as effective a hypnotic as flurazepam 30 mg. Estazolam 1 mg is also effective in the treatment of outpatients with insomnia, but to a lesser degree.     

Zaleplon improves sleep without producing rebound effects in outpatients with insomnia. Zaleplon Clinical Study Group

The efficacy and safety of three doses of zaleplon, a novel non-benzodiazepine hypnotic, were compared with those of placebo in outpatients with insomnia in this 4-week study, using zolpidem 10 mg as active comparator. Postsleep questionnaires were used to determine treatment effects on the patient's perception of sleep, as well as any development of pharmacological tolerance during therapy or rebound insomnia or withdrawal symptoms upon discontinuation of therapy. During week 1, sleep latency was significantly shorter with zaleplon 5, 10, and 20 mg compared to placebo. The significant decrease in sleep latency persisted through week 4 with zaleplon 20 mg, and was again evident with zaleplon 10 mg at week 3. Zaleplon 20 mg also had significant effects on sleep duration, number of awakenings, and sleep quality compared to placebo. No pharmacological tolerance developed during treatment with zaleplon and there were no indications of rebound insomnia or withdrawal symptoms after treatment discontinuation. Zolpidem 10 mg had significant effects on sleep latency, sleep duration, and sleep quality compared to placebo. However, a significantly greater incidence of withdrawal symptoms and a suggestion of sleep difficulty after treatment discontinuation (rebound insomnia) for all sleep measures was seen with zolpidem compared to placebo. There was no significant difference in the frequency of adverse events with active treatment compared to placebo. These results show that zaleplon provides effective treatment of insomnia with a favourable safety profile.     

扎来普隆胶囊治疗失眠症的多中心临床研究

目的　评价扎来普隆治疗失眠症的疗效和安全性。方法　符合CCMD - 3失眠症(非器质性失眠症)标准患者2 4 0例,采用随机双盲双模拟方法,均分为扎来普隆组(A组)和佐匹克隆组(B组) ,清洗3～7d后分别予扎来普隆10mg·d-1或佐匹克隆7 5mg·d-1,疗程14d。临床观察包括睡眠障碍量表(SDRS)、临床总体印象表(CGI)、治疗药物副作用量表(TESS)、不良事件记录表;实验室检查包括血常规、小便常规、肝肾功能、心电图。结果　两组基线与治疗各阶段SDRS量表总分的变化情况显示,A组有效率为86 .4 4 % ,B组为88.98% ;不良反应率分别为16 .6 7%、35 .0 0 %。结论　两组疗效相当,能有效地改善睡眠障碍,不良反应轻微,无须处理即自行消失。     

Zaleplon: a review of its use in the treatment of insomnia

Zaleplon is a pyrazolopyrimidine hypnotic agent which is indicated for the short term (2 to 4 weeks) management of insomnia. Zaleplon 5 and 10 mg at bedtime (usual recommended doses) significantly reduced sleep latency compared with placebo in clinical trials in nonelderly and elderly patients with insomnia. In general, sleep maintenance (sleep duration and number of awakenings) and sleep quality were not significantly different from placebo with zaleplon 5 and 10 mg/night. Zaleplon 20 mg/night significantly improved sleep latency and duration in nonelderly patients, but effects on number of awakenings were inconsistent and sleep quality generally did not improve. The relative hypnotic efficacy of zaleplon compared with that of triazolam and zolpidem is not yet clearly established. Tolerance to the hypnotic effects of zaleplon generally did not occur during 5 weeks' treatment, or during long term treatment (6 or 12 months) according to a small number of studies presented as abstracts. Zaleplon was well tolerated in clinical trials. The most common event was headache but the incidence was similar to that observed with placebo. Zaleplon 5 and 10 mg did not impair psychomotor function or memory even immediately after the dose in studies in volunteers or patients with insomnia. Zaleplon 20 mg, however, impaired psychomotor function and memory immediately after the dose but next-day effects were not observed. The psychomotor profile of zaleplon appears to be better than that of comparator agents. Rebound insomnia was not observed after sudden discontinuation of up to 12 months' treatment with zaleplon 5 and 10 mg/night and up to 4 weeks' treatment with zaleplon 20 mg/night. In addition, the potential for withdrawal syndrome with zaleplon appears to be low according to limited data. In conclusion, zaleplon 5, 10 and 20 mg administered at bedtime, or later if patients have difficulty sleeping, is an effective and well tolerated hypnotic agent. There was no evidence of next-day residual effects with the 5 and 10 mg dosages, and the incidence of withdrawal effects with zaleplon 5, 10 and 20 mg did not differ significantly to that observed with placebo. In addition, tolerance to the effects of zaleplon is unlikely to develop when administered for the recommended treatment period. The comparative efficacy and tolerability of zaleplon with other short acting nonbenzodiazepine hypnotics is difficult to establish. However, on the basis of current efficacy evidence and the lower incidence of residual effects with zaleplon 5 and 10 mg relative to comparator agents, this drug represents a useful option in the management of patients with insomnia who have difficulties initiating sleep.     

Estazolam and flurazepam: a multicenter, placebo-controlled comparative study in outpatients with insomnia

A multicenter, double-blind placebo-controlled clinical trial was designed to compare the safety and efficacy of estazolam compared with flurazepam as hypnotics. Outpatients complaining of insomnia were randomized to receive either estazolam 2 mg, flurazepam 30 mg or placebo for 7 consecutive nights. The analysis of efficacy was based on the patients' daily assessments of sleep and the investigators' global evaluations. Adverse events which were considered by the investigator to be attributable to, or of unknown relationship to the test medication were analyzed. The patient subjective questionnaire indicated that estazolam and flurazepam significantly improved all parameters (P less than .05) as compared to placebo. A marked or moderate improvement in sleep was reported by 81% (58/72), 78% (63/81) and 36% (27/76) of estazolam, flurazepam, and placebo recipients, respectively. There were no significant differences in hypnotic effect between estazolam and flurazepam. All efficacy parameters of the investigators' global evaluation improved significantly more (P less than .05) for patients receiving estazolam or flurazepam (except quality of sleep) than for those receiving placebo. The percentage of patients reporting any adverse experience was greatest for flurazepam (72%), followed by estazolam (59%), and placebo (43%). Somnolence and hypokinesia were the most commonly reported adverse events. An analysis of the global evaluation of side effects showed that flurazepam had a significantly worse side effect profile than estazolam (P less than .05) or placebo (P = .001). Estazolam and flurazepam effectively, and comparably, relieved insomnia when administered for 7 nights in adult patients complaining of insomnia. Estazolam demonstrated a more favorable side effect profile than flurazepam.     

Estazolam treatment of insomnia in generalized anxiety disorder: a placebo-controlled study

Estazolam, a triazolobenzodiazepine with an intermediate elimination half-life, has been shown previously to be an effective and safe hypnotic in insomniacs without concomitant psychiatric illness. Our study of the efficacy of estazolam in patients with insomnia associated with generalized anxiety disorder began when 108 patients meeting criteria for generalized anxiety disorder (mean total score of Hamilton Rating Scale for Anxiety [HAM-A] = 22.0 +/- 3.1 [SD]) and insomnia were given single-blind placebo for 7 nights. Nine patients whose anxiety and/or insomnia improved were dropped as placebo responders. The remaining 99 patients were randomly allocated (1:1) to double-blind treatment with either estazolam 2.0 mg or matching placebo for 7 nights. Hypnotic efficacy, as determined by patient-completed sleep questionnaires, was statistically significant for estazolam 2.0 mg versus placebo for all sleep indices (p less than 0.01). Patients treated with estazolam 2.0 mg showed significantly greater improvement in anxiety than those receiving placebo on the mean total score of HAM-A ([placebo, -3.4; estazolam, -7.1; p less than 0.001] and without the insomnia item [placebo, -2.7; estazolam, -5.5; p less than 0.001]). Anxiety scores on the State-Trait Anxiety Inventory showed greater improvement in the estazolam group, but without statistical significance (p = 0.237). Estazolam 2.0 mg is an effective hypnotic in patients with generalized anxiety disorder and appears to have a favorable anxiolytic action.     

Zaleplon - a review of a novel sedative hypnotic used in the treatment of insomnia

Zaleplon (N-[3-(3-cyanopyrazolo[1,5-a] pyrimidin-7-yl) phenyl]-N-ethyl acetamide) is a non-benzodiazepine recently introduced for clinical use. This agent is indicated for the short-term treatment of insomnia. Preclinical studies have shown that the benzodiazepines triazolam and Ro17-1812 can substitute for zaleplon in animals trained to distinguish zaleplon from saline. The benzodiazepine antagonist flumazenil can antagonise the discriminative stimulus effect of zaleplon. These findings suggest that zaleplon is recognised by animals as a benzodiazepine agent. Zaleplon is active after ip. and oral administration in a variety of motor performance tests, including locomotor activity, rotarod and the loaded grid. Zaleplon has been shown to be active in a number of different anticonvulsant models, including the pentylenetetrazole, isoniazid and electroshock models. The compound is also reported to be active against convulsions induced by bicuculline, picrotoxin and strychnine. Studies in anxiolytic models suggest that zaleplon may have weak anxiolytic activity. From preclinical studies, it appears zaleplon possesses a reduced risk of tolerance compared to triazolam, is less likely to potentiate the effects of ethanol and is unlikely to produce amnestic effects. In man, zaleplon is rapidly absorbed and undergoes extensive presystemic metabolism. The compound has a plasma half-life of approximately one hour and is metabolised primarily via the aldehyde oxidase system to form 5-oxo-zaleplon. This metabolite, along with other minor metabolites formed in vivo, do not appear to contribute to the activity of zaleplon. Metabolites of zaleplon are excreted primarily via the urine. Phase I studies suggest that single daytime doses of zaleplon up to 15 mg are well-tolerated. Short-term impairment of performance occurs when zaleplon is administered during the day at doses epsilon 20 mg. However, given the short half-life of the compound, significant impairment of daytime performance is unlikely if zaleplon is administered at bedtime or shortly after retiring for the evening. Results from Phase II/III studies suggest that zaleplon (5 - 20 mg) produces a dose-dependent reduction in sleep latency in patients suffering from primary insomnia. The clinical efficacy of zaleplon persists for at least four weeks at doses of 10 mg and 20 mg. Studies in patients with a history of drug abuse suggest that the abuse potential of zaleplon (at doses above the therapeutic dose range) is similar to that seen with the benzodiazepine triazolam.     

Zaleplon - a review of a novel sedative hypnotic used in the treatment of insomnia

Zaleplon (N-[3-(3-cyanopyrazolo[1,5-a] pyrimidin-7-yl) phenyl] -N-ethyl acetamide) is a non-benzodiazepine recently introduced for clinical use. This agent is indicated for the short-term treatment of insomnia. Preclinical studies have shown that the benzodiazepines triazolam and Ro17-1812 can substitute for zaleplon in animals trained to distinguish zaleplon from saline. The benzodiazepine antagonist flumazenil can antagonise the discriminative stimulus effect of zaleplon. These findings suggest that zaleplon is recognised by animals as a benzodiazepine agent. Zaleplon is active after ip. and oral administration in a variety of motor performance tests, including locomotor activity, rotarod and the loaded grid. Zaleplon has been shown to be active in a number of different anticonvulsant models, including the pentylenetetrazole, isoniazid and electroshock models. The compound is also reported to be active against convulsions induced by bicuculline, picrotoxin and strychnine. Studies in anxiolytic models suggest that zaleplon may have weak anxiolytic activity. From preclinical studies, it appears zaleplon possesses a reduced risk of tolerance compared to triazolam, is less likely to potentiate the effects of ethanol and is unlikely to produce amnestic effects. In man, zaleplon is rapidly absorbed and undergoes extensive presystemic metabolism. The compound has a plasma half-life of approximately one hour and is metabolised primarily via the aldehyde oxidase system to form 5-oxo-zaleplon. This metabolite, along with other minor metabolites formed in vivo, do not appear to contribute to the activity of zaleplon. Metabolites of zaleplon are excreted primarily via the urine. Phase I studies suggest that single daytime doses of zaleplon up to 15 mg are well-tolerated. Short-term impairment of performance occurs when zaleplon is administered during the day at doses greater than or equal to 20 mg. However, given the short half-life of the compound, significant impairment of daytime performance is unlikely if zaleplon is administered at bedtime or shortly after retiring for the evening. Results from Phase II/III studies suggest that zaleplon (5 - 20 mg) produces a dose-dependent reduction in sleep latency in patients suffering from primary insomnia. The clinical efficacy of zaleplon persists for at least four weeks at doses of 10 mg and 20 mg. Studies in patients with a history of drug abuse suggest that the abuse potential of zaleplon (at doses above the therapeutic dose range) is similar to that seen with the benzodiazepine triazolam.     

高效液相色谱法测定艾司唑仑片中艾司唑仑含量

目的探讨用高效液相色谱法测定艾司唑仑片含量的方法和条件。方法色谱柱为Kcromaisil ODS-1-C18柱(200 mm×4.6 mm,5μm);流动相为甲醇-水(60∶40),流速为1.0 mL/min;检测波长为223 nm;柱温为30℃。结果艾司唑仑进样量在0.103～2.06μg范围内线性关系良好(r=1.000 0),艾司唑仑平均回收率为99.73%,RSD=0.77%。结论该方法灵敏、专一、准确,适用于艾司唑仑片的含量测定。