扎来普隆治疗失眠症的疗效及安全性：随机双盲对照研究

目的：评价国产二类新药扎来普隆治疗失眠症的临床疗效及安全性。方法：采用随机、双盲双模拟、平行对照方法。受试者分别每晚口服扎来普隆或唑吡坦10～20mg，疗程14d。结果：扎来普隆组24例，唑毗坦组23例，两组治疗后的睡眠障碍评定量表评分(SDRS)均较治疗前显著降低，两组间SDRS总分(F=0.1416，P=0.8880)、SDRS下降率(F=1.3172，P=0.1944)差异均无显著性意义。治疗总有效率分别为扎来普隆组72％，唑吡坦组58％，两组差异无显著性意义(X^2=0.9150，P=0.3602)。两组的不良反应主要有头昏、恶心、头痛，发生率差异无显著性意义。结论：扎来普隆可明显改善失眠症状，其疗效及不良反应与唑吡坦相似，是一种安全、有效的治疗成人失眠的药物。     

国产扎来普隆治疗失眠症的多中心随机双盲对照研究

目的：评价国产扎来普隆胶囊治疗失眠症的有效性和安全性。方法：多中心、随机、双盲、双模拟、阳性药平行对照研究，209例失眠症患者随机分为扎来普隆组（105例）与唑吡坦组（104例）,分别口服扎来普隆胶囊10mg&#8226;d-1或唑吡坦片10mg&#8226;d-1，疗程14天。结果：睡眠障碍量表总评分在治疗结束时两组较基线均显著减少(p<0.01)；有效率扎来普隆组为62.7%与唑吡坦组为61.0%，差异无显著性 (p>0.05)。扎来普隆较常见的不良反应为：头晕、头昏、口苦，未出现严重的不良反应。结论：国产扎来普隆胶囊治疗失眠症安全、有效。     

扎莱普隆胶囊治疗失眠症的随机双盲对照试验

【目的】评价国产扎莱普隆胶囊治疗失眠症的有效性和安全性。【方法】采用随机、双盲、双模拟、阳性药平行对照研究。48例失眠症患者随机分为试验组（24例）与对照组（24例），分别口服扎莱普隆胶囊10mg／d或唑吡坦片10mg／d，疗程14d，观察两组疗效及不良反应。【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减少（P〈0．01）；试验组有效率为58．3％，对照组有效率为45．5％，两组比较差异无显著性（P〉0．05）。扎来普隆较常见的不良反应为头晕、口苦、口干，未出现严重的不良反应。【结论】扎莱普隆胶囊为安全而有效的催眠药物。     

养血清脑颗粒联合帕罗西汀治疗情绪障碍性失眠症疗效观察

【目的】探析养血清脑颗粒联合帕罗西汀治疗情绪障碍性失眠症患者的效果及其作用机制。【方法】选取2013年4月至2015年10月本院所收治的情绪障碍性失眠症患者80例作为研究对象,按照就诊先后顺序编号分为观察组与对照组,各40例。对照组应用盐酸帕罗西汀进行治疗,观察组在对照组基础上联合养血清脑颗粒,比较两组治疗总有效率、治疗前后匹兹堡睡眠质量指数（PSQI）、汉密尔顿焦虑量表评分（HAMA）及药物不良反应发生率。【结果】观察组治疗总有效率为92．5％（37／40）,高于对照组75．0％（30／40）,差异有统计学意义（ P＜0．05）。两组治疗前、治疗2周及4周后的 PSQI 评分与治疗前、治疗2周后的 HAMA 评分均无显著差异,观察组治疗8周后的 PSQI 评分及治疗4周及8周后的 HAMA 评分均低于对照组,差异有统计学意义（ P ＜0．05）。观察组与对照组不良反应发生率分别为12．5％、10．0％,差异无统计学意义（ P ＞0．05）。【结论】养血清脑颗粒联合帕罗西汀治疗情绪障碍性失眠症具有理想效果,与单纯西药治疗相比,患者睡眠质量与情绪障碍改善幅度均更大,且安全性高。     

五脏俞梅花针叩刺拔罐治疗失眠症的疗效分析

目的：评价五脏俞梅花针叩刺拔罐治疗失眠症临床疗效。方法：将60例失眠患者随机分为针刺治疗组和药物对照组进行疗效对比观察。结果：治疗组有效率为93.3%,对照组有效率为80%,两组疗效比较差异有统计学意义（P〈0.05）。结论：五脏俞梅花针叩刺拔罐治疗失眠症疗效确切。     

中医药治疗顽固性失眠62例疗效观察

我院1997- 0 1～2 0 0 4 - 0 1采用中药辩证治疗顽固性失眠6 2例,疗效满意,总结如下。1　对象和方法1.1　对象　本组男4 9例,女6 1例,年龄2 4～70岁,平均4 4 .6岁,病程最短1a,最长18a。入睡困难5 8例,晨醒过早或睡中易醒5 2例,夜间睡眠只有1～2 h85例,平均睡眠时间2 .6 h。所有病例均符合《CCMD- 2 - R》失眠症的诊断标准[1 ] 。随机分为治疗组和对照组,治疗组6 2例,男2 2例,女4 0例,年龄2 4～70岁,平均4 3.8岁,病程最短1a,最长15 a,入睡困难32例,晨醒过早或睡中易醒者30例,5 0例夜间睡眠1～2 h,平均睡眠时间2 .4 h。对照组:4 8例,男2 6例…     

梦香汤配合认知行为疗法治疗失眠症

失眠症,中医称为“不寐”或“不得卧”、“不得眠”、“目不瞑”等,是一种迁延难愈的疑难病症,此病的治疗古今中外方法甚多,但有关其远期疗效的报道较少,近年来采用中药梦香汤配合认知行为疗法治疗失眠症24例,疗效满意。     

右佐匹克隆治疗老年原发性失眠症的疗效及安全性分析

目的：评价右佐匹克隆治疗老年原发性失眠症的疗效和安全性。方法将130例老年原发性失眠症患者随机分为两组,治疗组65例每晚睡前口服右佐匹克隆1～3 mg;对照组65例每晚睡前口服艾司唑仑片1～2 mg,疗程均为4周。用匹兹堡睡眠质量指数量表（PSQI）评定两组患者治疗前后的睡眠质量,药物不良反应量表（TESS）评定不良反应。结果治疗组有效率为83．9％,对照组有效率为82％,两组疗效比较差异无统计学意义（P ＞0．05）;两组不良反应量表（TESS）比较差异有统计学意义（P ＜0．05）。结论右佐匹克隆治疗老年原发性失眠症疗效与艾司唑仑片相似,但不良反应低于艾司唑仑片。     

自制溴化钠苯甲酸钠咖啡因合剂治疗失眠症疗效分析

目的 探讨自制溴化钠苯甲酸钠咖啡因合剂对失眠症的疗效.方法 将96例患者随机分为两组,对照组给予刺五加6片/次,3次/d,口服;治疗组在此基础上加用自制溴化钠苯甲酸钠咖啡因合剂口服治疗,10 ml/次,3次/ d,在治疗第4周末评定疗效.结果 治疗组和对照组治疗4周末评定,总有效率分别为81.25%和52.18%(P<0.01),无明显不良反应.结论 自制溴化钠苯甲酸钠咖啡因合剂治疗失眠症是安全有效的.     

奥扎格雷钠改善急性纯运动型腔隙性脑梗死患者的运动功能随机、双盲、安慰剂对照

目的采用随机、双盲、安慰剂对照方法观察血栓素合成酶抑制剂奥扎格雷钠对急性运动型腔隙性脑梗死患者运动功能、血小板活性、血浆炎症因子及纤溶活性的影响.方法以2003-10/2004-10黑龙江省医院收治的急性运动型腔隙性脑梗死患者212例为观察对象,所有患者发病24 h内入院,无出血倾向,2周内未使用过抗凝或抗血小板聚集药物.212例患者按药物编号随机抽签分为奥扎格雷钠组115例,对照组97例.所有患者的基础治疗(银杏叶注射液20 mL加胞二磷胆碱0.5 g静脉滴注)相同,在此基础上,对照组应用安慰剂80 mg、奥扎格雷钠组加用奥扎格雷钠80 mg静脉滴注,2次/d,连用14 d.①治疗前后采用Fugl-Meyer运动功能评分法(共50项,上肢33项,下肢17项,每项2分,满分100分,＜50分为有严重运动障碍)评估运动功能.②观察不良事件和副反应.③采血测血小板聚集率、血栓素合成酶B2、血浆Ⅷ因子相关抗原、白细胞介素6、组织型纤溶酶原激活物及其抑制物活性测定.干预和评估均采用盲法.结果按实际处理分析,201例(奥扎格雷钠组109例,对照组92例)进入结果分析.①Fugl-Meyer运动功能评分结果奥扎格雷钠组治疗后患者上肢功能较治疗前和对照组明显提高(53.27±7.44,18.93±7.60,29.88±7.94,P＜0.01);奥扎格雷钠组治疗后患者下肢功能较治疗前和对照组治疗后明显提高(28.14±4.97,11.94±4.76,17.83±3.08,P＜0.01).②奥扎格雷钠组治疗后血小板聚集率、血栓素合成酶B2、血浆Ⅷ因子相关抗原、白细胞介素6和组织型纤溶酶原激活物抑制物活性明显低于治疗前和对照组治疗后(P＜0.01),组织型纤溶酶原激活物活性明显高于治疗前和对照组治疗后(P＜0.05).③两组在治疗过程中均无脑出血和消化道出血倾向,奥扎格雷钠组发生轻度副反应共6例.结论奥扎格雷钠能明显抑制急性运动型腔隙性脑梗死患者血小板聚集及血栓素合成酶释放、降低凝血活性,改善纤溶,抑制急性脑梗死病情进展,对发病24 h以内的急性纯运动性腔隙性脑梗死患者的上下肢运动功能恢复疗效显著、且安全可靠.     

Safety of zaleplon in the treatment of insomnia

OBJECTIVE: To evaluate the safety of zaleplon, a quick-acting, rapidly eliminated nonbenzodiazepine (non-BZD) hypnotic, as described in clinical investigations of adult and/or elderly subjects. DATA SOURCES: Published and presented studies evaluating zaleplon, a novel non-BZD, were identified via MEDLINE (1995-July 2001), Current Contents (ISI database), bibliographic reviews, and consultation with sleep specialists who also identified published abstracts containing data not yet published in peer-reviewed journals. DATA SYNTHESIS: Transient and chronic insomnia are common problems that should be clinically evaluated and appropriately treated. BZDs have been a primary pharmacotherapy for treating insomnia, despite their disadvantages. Newer hypnotics, characterized by increased receptor-binding specificity and favorable pharmacokinetics, provide potentially better alternatives to BZDs. Assessments included residual sedation, psychomotor impairment, or cognitive dysfunction during treatment, as well as the occurrence of rebound insomnia and withdrawal effects after discontinuation of therapy. CONCLUSIONS: Zolpidem, the first non-BZD hypnotic, appears to have short- and long-term safety profiles similar to those of the BZD triazolam. Zaleplon, a newer non-BZD sleep medication, has a quick onset of action and undergoes rapid elimination, which results in a better safety profile than previously available agents. Additionally, rebound insomnia and other withdrawal effects have not been demonstrated with zaleplon, and the drug is well tolerated in both young and elderly patients. These characteristics may be clinically advantageous for patients who should not receive BZDs.     

Effect of zolpidem on sleep in women with perimenopausal and postmenopausal insomnia: a 4-week, randomized, multicenter, double-blind, placebo-controlled study

BACKGROUND: Although most adults in the United States obtain less sleep than they need, women report more sleep deprivation throughout their lifetime than do men. The prevalence of self-reported sleep difficulty increases as women make the transition from the premenopausal to the postmenopausal period. OBJECTIVE: The purpose of this study was to assess the clinical efficacy and safety of zolpidem as a treatment for insomnia in perimenopausal and postmenopausal women. METHODS: Women who were perimenopausal or postmenopausal for >or=6 months, who had developed insomnia in conjunction with menopausal symptoms, and who had difficulty maintaining sleep or had nonrestorative sleep for >or=6 months were eligible for this 4-week, multicenter study. Sleep maintenance difficulty had to occur an average of >or=3 nights per week and had to be accompanied by >or=2 nocturnal hot flashes, hot flushes, or night sweats. Patients were randomized in a double-blind fashion to 1 of 2 treatment groups--zolpidem 10 mg or placebo. Capsules were provided in weekly blister cards, and patients were instructed to take 1 capsule each night at bedtime. Patients recorded estimates of their sleep quality and quantity and daytime functioning on daily morning and evening questionnaires, and made weekly global assessments of sleep. RESULTS: The study included 141 women (mean age +/- SD, 50.8 +/- 4.5 years; age range, 39-60 years). Increases in reported total sleep time were significantly greater in the zolpidem group than in the placebo group (P < 0.01) for each treatment week. Wake time after sleep onset and number of awakenings decreased significantly in the zolpidem group compared with the placebo group (P < 0.05). Each week, approximately twice as many patients in the zolpidem group as in the placebo group reported improved sleep (P < 0.001 for each week). The improvement in sleep-related difficulty with daytime functioning was significantly greater in the zolpidem group than in the placebo group (P < 0.05). The effects of zolpidem did not diminish with the duration of treatment. CONCLUSIONS: Zolpidem 10 mg/d was effective and well tolerated in the treatment of menopause-related insomnia in perimenopausal and postmenopausal women.     

Haloperidol in the acute treatment of migraine: a randomized, double-blind, placebo-controlled study

OBJECTIVE: To assess the efficacy and safety of i.v. haloperidol in treatment of acute migraine headache in a double-blind, randomized, placebo-controlled study design. BACKGROUND: Neuroleptics are mainly used as antiemetics in acute migraine. In a previous open trial haloperidol was effective in relieving migraine pain. DESIGN: Patients were randomized into 2 groups receiving intravenously either 5 mg haloperidol in 500 mL of normal saline or 500 mL of normal saline alone. Pain was assessed by visual analogue scale (VAS) before and 1 to 3 hours after the infusion. If the patient felt no relief in pain intensity 1 to 3 hours after the infusion and had received placebo, he/she then received haloperidol infusion as an open trial. The open trial also included 7 patients who refused from the placebo-controlled trial. About 1 month after the infusion the patients were contacted by telephone and interviewed about the side effects of the treatment. RESULTS: Forty patients were enrolled into the double-blind, placebo-controlled study. Before the infusion the VAS values were 7.7 in the haloperidol and 7.2 in the placebo group. After the infusion the VAS values were 2.2 in the haloperidol and 6.3 in the placebo group (P < .0001). Significant pain relief was achieved in 80% of the patients treated with haloperidol, whereas only 3 patients (15%) responded to placebo (P < .0001). Seventeen patients treated with placebo without response together with 7 patients who refused from the placebo-controlled study participated in the open trial. In this group VAS declined from 6.7 to 2.4 and 79% of these patients felt significant pain relief. The most common side effects caused by haloperidol were sedation and akathisia, the latter being more troublesome. These effects were very common in patients participating in the double-blind (80%) and open (88%) trials. Sixteen percent of the patients considered the side effects intolerable and would not like the migraine attacks to be treated with haloperidol in the future. Three patients (7%) returned to the emergency ward because of a relapse. CONCLUSIONS: This study shows that i.v. haloperidol is very effective in relieving migraine-associated pain. Because the majority of the patients had taken other medication without response, haloperidol appears to be an effective rescue medication even when other types of treatment have failed. Relapses are rare, but side effects are common, limiting the use of haloperidol in some patients.     

Clindamycin versus chloramphenicol in treatment of anaerobic infections: a prospective, randomized, double-blind study

Seventy patients with substantiated anaerobic infections were treated parenterally with clindamycin or chloramphenicol in a prospective, double-blind, randomized study. No significant differences in clinical response or toxicity were noted between the two groups of patients.     

Effect of analgesia administration timing on early post-operative period characteristics: a randomized, double-blind, controlled study

This study investigated the effect of time of analgesia administration in 64 patients undergoing total abdominal hysterectomy. Patients received standard general anaesthesia and were divided randomly into two equal groups. At the time of fascia closure, patients in the intra-operative (Iop) group received 0.5 mg/kg pethidine intravenously. On arrival in the post-anaesthesia care unit, the same dose of pethidine was given to patients in the post-operative (Pop) group. All patients then used a patient-controlled analgesia pump to administer pethidine analgesia as required. Times to extubation, response to verbal stimulation and orientation, post-operative pain scores and analgesic consumption were recorded. Times to extubation and response to verbal stimulation were significantly longer in the Iop group. Pain scores, analgesic consumption and additional analgesic requirements were significantly higher in the Pop group in the first 2 h post-operatively. In conclusion, intra-operative administration of pethidine provided better pain management than post-operative administration.     

Smoking reduction treatment with 4-mg nicotine gum: a double-blind, randomized, placebo-controlled study

BACKGROUND: Smoking reduction may provide a harm-reduction alternative treatment for smokers who are not ready to quit smoking. This study evaluated the efficacy of nicotine gum in helping smokers reduce or quit smoking. METHODS: This randomized, double-blind, placebo-controlled trial involved 364 smokers who were not ready to quit but were willing to reduce their smoking intensity. Participants received either 4-mg nicotine gum (n = 184) or placebo gum (n = 180) as desired for up to 12 months. The primary outcome was sustained smoking reduction, which was defined as a decrease in daily cigarette consumption of at least 50% compared with baseline. Secondary measures included point-prevalence abstinence, intention to quit, and cardiovascular risk markers. RESULTS: At 4 months, the sustained smoking reduction rate in the nicotine gum group was twice that of the placebo group (15.8% versus 6.7%, P = .008). Point-prevalence abstinence was 6.6% for the nicotine gum group and 2.2% for the placebo group (P = .07). At 13 months, there was a significant difference in the smoking reduction rate for the nicotine (8.2%) and placebo (2.8%) groups (P = .036). At month 13, the abstinence rates were 12% and 4.5% for the nicotine and placebo groups, respectively (P = .012). Concomitant use of nicotine gum and cigarette smoking was well tolerated. Carbon monoxide levels decreased significantly (P = .01). CONCLUSION: Nicotine gum may be an efficacious harm-reduction alternative for smokers who are not ready to quit and may promote smoking cessation, the ultimate goal in the treatment of tobacco dependence.     

Botulinum toxin type a prophylactic treatment of episodic migraine: a randomized, double-blind, placebo-controlled exploratory study

OBJECTIVE: This exploratory trial evaluated the safety and efficacy of multiple treatments of botulinum toxin type A (BoNTA; BOTOX, Allergan, Inc., Irvine, CA, USA) as prophylactic treatment of episodic migraine headaches. DESIGN AND METHODS: This was an 11-month randomized, double-blind, placebo-controlled, exploratory study. Patients were screened during a 30-day baseline period, and eligible patients with 4 or more migraine episodes and < or =15 headache days entered a single-blind 30-day placebo run-in period. Patients were classified as placebo nonresponders (PNR) if they had at least 4 moderate-to-severe migraine episodes and did not experience at least a 50% decrease from baseline in the frequency of migraine episodes following their placebo treatment. All other subjects were classified as placebo responders (PR). Patients were randomized within each stratum (PNR, PR) to 3 treatments with BoNTA (110 to 260 U of BoNTA per treatment cycle) or placebo at 90-day intervals using a modified follow-the-pain treatment paradigm. The primary efficacy outcome measure was the mean change from baseline in the frequency of migraine episodes for the 30 days prior to day 180 in the PNR group. Secondary efficacy measures included the proportion of patients with a decrease from baseline of 50% or more migraine episodes per 30-day period. Patients were allowed to take concomitant acute and prophylactic headache medications. Adverse events were reported. RESULTS: A total of 809 patients were screened and 369 patients (89.2% female; mean age, 45 years; range, 20 to 65 years) entered the placebo run-in period and were subsequently randomized to BoNTA or placebo. The mean total dose of BoNTA was 190.5 units (U) (range, 110 U to 260 U). The predetermined primary efficacy endpoint was not met. Substantial mean improvements of 2.4 and 2.2 fewer migraine episodes per month at day 180 in the PNR stratum treated with BoNTA and placebo, respectively, were observed (P > .999). From day 180 through the end of the study (day 270) at least 50% of all patients in each treatment group had a decrease from baseline of 50% or more migraine episodes per 30-day period. However, in the group of patients with > or =12 headache days at baseline (and < or =15 headache days), BoNTA patients experienced a mean change from baseline of -4.0 headache episodes at day 180 compared with -1.9 headache episodes in the placebo group (P= .048). The majority of treatment-related adverse events were transient and mild to moderate in severity. Only 7 patients (1.9%) discontinued the study due to adverse events (6 BoNTA, 1 placebo). CONCLUSION: There were no statistically significant between-group differences in the mean change from baseline in the frequency of migraine episodes per 30-day period. There were substantial, sustained improvements during the course of the study in all groups. Multiple treatments with BoNTA were shown to be safe and well tolerated over an active treatment period lasting 9 months.     

Impulse magnetic-field therapy for insomnia: A double-blind, placebo-controlled study

This 4-week double-blind, placebo-controlled study assessed the efficacy of impulse magnetic-field therapy for insomnia. One hundred one patients were randomly assigned to either active treatment (n = 50) or placebo (n = 51) and allocated to one of three diagnostic groups: (1) sleep latency; (2) interrupted sleep; or (3) nightmares. Efficacy endpoints were intensity of sleep latency, frequency of interruptions, sleepiness after rising, daytime sleepiness, difficulty with concentration, and daytime headaches. In the active-treatment group, the values of all criteria were significantly lower at study end (P < .00001). The placebo group also showed significant symptomatic improvement (P < .05), but the differences between groups were highly significant (P < .00001). Seventy percent (n = 34) of the patients given active treatment experienced substantial or even complete relief of their complaints; 24% (n = 12) reported clear improvement; 6% (n = 3) noted a slight improvement. Only one placebo patient (2%) had very clear relief; 49% (n = 23) reported slight or clear improvement; and 49% (n = 23) saw no change in their symptoms. No adverse effects of treatment were reported.