盐酸曲唑酮与阿普唑仑治疗成人广泛性焦虑效果比较的Meta分析

目的系统评价盐酸曲唑酮与阿普唑仑治疗成人广泛性焦虑的有效性及安全性。方法计算机检索PubMed（1980～2012．5）、CBM（1990～2012．5）、VIP（1989～2012．5）、CNKI（1990～2012．5）币口Wanfang Data（1990～2012．5）,收集盐酸曲唑酮与阿普唑仑治疗成人广泛性焦虑的随机对照试验,南两名评价者按照纳入与排除标准选择试验、提取资料和评价质量后,采用RevMan5．0软件进行Meta分析。结果纳入5个RCT,共403例广泛性焦虑症患者。Meta分析结果显示：①治疗4周后,盐酸曲唑酮组与阿普唑仑组的HAMA评分和治愈率的差异无统计学意义[RR=I．04,95％CI（0．95,1．13）,P=0．38;RR=I．05,95％CI（0．75,1．48）,P=0．76]。②盐酸曲唑酮组的嗜睡发生率低于阿普哗仑组[RR=0．42,95％CI（0．25,0．72）,P=0．001],但两组在头晕、乏力、食欲减退发生牢方面,差异无统计学意义[RR=0．52,95％CI（0．27,1．01）,P=0．05;RR=0．10,95％CI（0．01,1．41）,P=0．09;RR=2．82,95％CI（0．28,28．23）,P=0．38]。结论盐酸曲唑酮和阿普唑仑治疗广泛性焦虑的疗效无差异,但盐酸曲唑酮不良反应较少,而阿普唑仑更易引起嗜睡。由于纳入研究数量有限且方法学质量不高,本研究结果尚需更多高质量随机对照试验进一步证实。     

A comparative,randomised, double-blind study of trazodone prolonged-release and paroxetine in the treatment of patients with major depressive disorder

ABSTRACT

Objectives: To evaluate the efficacy and safety of trazodone prolonged release compared with paroxetine in the treatment of patients with major depression.

Research design and methods: A total of 108 patients aged 20–68 years were enrolled in this multicentre, double-blind, double-dummy, randomised, paroxetine-controlled study. Each patient received 3 days single-blind placebo treatment followed by 6 weeks double-blind treatment with either trazodone prolonged release 150–450?mg/day (n = 55) or paroxetine 20–40?mg/day (n = 53).

Outcome measures: Efficacy was evaluated by the rate of patients responding to each treatment and considered to be in remission, and by mean changes from baseline in the Hamilton Depression Rating scale scores (HAM-D), Montgomery Asberg Depression Rating Scale scores (MADRS), and Clinical Global Impression (CGI) – Severity and Global Improvement scores. Time to onset of efficacy and safety were assessed.

Results: Trazodone and paroxetine were equally effective at reducing symptoms of depression and promoting remission. Onset of efficacy was slightly faster for patients treated with paroxetine. Overall, there were no significant differences between the groups at endpoint in efficacy measures, and in percentage of responders (> 85%) or patients in remission (> 65%). Sleep disorders (HAM-D subset) were significantly less evident for patients in the trazodone group at the end of the study (?p < 0.05). Adverse drug reactions were reported by 35% of trazodone-treated patients (mainly of the nervous system) and 26% of paroxetine-treated patients (mainly gastrointestinal), although none was considered to be serious.

Conclusions: This study showed that after a 6-week period trazodone and paroxetine are not different in reducing the symptoms of depression and, in many patients, in producing the remission of the illness. The known divergence in tolerability profile of the two medications, related to their differing pharmacological properties, was also confirmed. Trazodone may be of advantage in depressed patients with sleep difficulties.     

Electrophysiological and haemodynamic changes with trazodone,amitriptyline and placebo in depressed out-patients

Summary

Fourteen out-patients with major depressive disorder completed a double-blind, randomized, parallel group study using trazodone (n=6), amitriptyline (n=5) and matching placebo (n=3). The average daily doses used were 223?mg and 95.3?mg for trazodone and amitriptyline, respectively, over the 28-day treatment period. Cardiovascular function was monitored with high speed ECG and by determining systolic time intervals. No significant effects of either drug on supine or standing blood pressure were demonstrated. Trazodone increased QT_con Day 1 only, and reduced heart rate and increased the PR interval on Day 15; these effects had disappeared by Day 29. Amitriptyline markedly increased heart rate, PR interval and QT_c, and reduced T wave amplitude on Days 15 and 29. Trazodone had no consistent effect on systolic time intervals except to increase the LVET index, whereas amitriptyline increased both PEP index and PEP/LVET ratio on Days 15 and 29. It is concluded that amitriptyline had a much more marked effect on cardiac function than did trazodone.     

左氧氟沙辛、坦索罗辛、曲唑酮联合治疗Ⅲ型前列腺炎118例分析

目的 探讨左氧氟沙星联合坦索罗辛及曲唑酮治疗慢性非细菌性（Ⅲ型）前列腺炎的疗效. 方法 对118例慢性非细菌性前列腺炎患者采用左氧氟沙星0.2 2次/d＋坦索罗辛0.2μg每晚一次＋曲唑酮50μg3次/d,口服治疗,疗程4～12周.应用美国国立卫生研究院（NIH）慢性前列腺炎症状评分（NIH-CPSI）标准对治疗前后总评分及所包括的患者疼痛评分、排尿症状评分、生活质量评分并进行统计学分析. 结果 多数患者症状有明显改善,全部患者治疗前后NIH-CPSI总评分分别为（26.81±3.69）分、（13.41±5.31）分比较,差异有统计学意义（P＜0.01）;疼痛不适前后评分分别为（12.81±2.52）分、（8.91±3.51）分比较,差异有统计学意义（P＜0.01）;排尿症状前后评分分别为（5.76±1.89）分、（2.79±1.38）分（P＜0.01）;生活质量前后评分分别为（9.12±3.21）分、（4.28±2.46）分（P＜0.01）. 结论 左氧氟沙星联合坦索罗辛及曲唑酮治疗慢性非细菌性（Ⅲ型）前列腺炎效果明显.     

曲唑酮联合低剂量西地那非治疗合并勃起功能障碍的早泄患者的临床观察

目的:评价曲唑酮联合低剂量西地那非治疗合并勃起功能障碍(ED)的早泄患者的临床效果.方法:80例诊断为合并ED的早泄患者分为实验组(曲唑酮联合低剂量西地那非)和对照组(单用曲唑酮),每组40例.实验组每天睡前服用曲唑酮50 mg,西地那非25mg,疗程2个月.对照组每天睡前服用曲唑酮50 mg,疗程2个月.以治疗前后IIEF一5评分和阴道内射精潜伏期(IELT)的变化来评价治疗效果,进行组内和组间比较,同时记录夫妻对性生活的满意情况.Tess副反应量表评定药物的不良反应.结果:实验组勃起功能改善35例,有效率为87.5%;早泄改善33例,有效率为82.5%;性生活满意率50%;对照组勃起功能改善20例,有效率为50%;早泄改善18例.有效率为45%;性生活满意率60%.在勃起功能、早泄改善和性生活满意度方面差异均有显著统计学意义(P<0.01),两组的不良反应轻,无停药者.结论:对合并ED的早泄患者采取曲唑酮联合低剂量西地那非治疗安全、有效、耐受性好.     

曲唑酮与阿普唑仑治疗焦虑症比较研究

目的 比较曲唑酮与阿普唑仑治疗焦虑症的疗效及不良反应。方法将61例焦虑症患者随机分为两组,其中曲唑酮组30例(男性12例,女性18例,年龄38.4±13.5a),予曲唑酮100mg-d-1·Bid·PO,4w为一个疗程。阿普唑仑组31例(男14例,女性17例,年龄41.7±13.2a),予阿普唑仑1.2mg·d-1·Bid·PO,4w为一个疗程。结果 曲唑酮组有效率为86.6％,阿普唑仑组有效率为87.10％,经卡方检验,两组无显著差异(P>0.05)。药物不良反应发生率阿普唑仑组高于曲唑酮组,但反应轻微不影响治疗。结论 曲唑酮与阿普唑仑比较,两药疗效相同,曲唑酮不良反应较阿普唑仑少。     

曲唑酮治疗广泛性焦虑障碍的随机对照双盲试验

目的评价曲唑酮与阳性对照药阿普唑仑比较,治疗广泛性焦虑障碍的疗效及其安全性.方法采用随机对照试验方法,将60例广泛性焦虑障碍患者分成曲唑酮组(50～150 mg/d,30例)和阿普唑仑组(1.2～4 mg/d,30例),在3 d清洗期后,进入疗程为4周的治疗,采用SPSS 10.0统计包和意向性治疗分析方法分析资料.结果曲唑酮组总有效率77%(23/30),阿普唑仑组总有效率70%(21/30),两组疗效差异无统计学意义(P＞0.05),其药物不良反应两组基本相当.两组均没有失访.结论曲唑酮是一种有效、安全的抗焦虑药物,有改善睡眠的作用,无潜在的依赖性,不良反应轻,主要表现为头晕、食欲下降等.     

曲唑酮合并氟西汀治疗男性抑郁症的疗效及安全性

目的观察曲唑酮合并氟西汀治疗抑郁症的疗效及安全性。方法将60例符合入组标准的男性抑郁症患者随机分为研究组（30例）和对照组（30例），研究组予以氟西汀合并曲唑酮治疗，对照组单用氟西汀治疗，疗程8周。于入组时及治疗后1、2、4、8周采用HAMD。，项评分、HAMA评分、阿森氏失眠量表（AIS）、亚利桑那性生活问卷（Arizona Sexual Experience Scale，ASEX）、国际勃起功能指数问卷（IIEF-5）进行疗效评定，并进行不良反应评估。结果治疗第八周末两组HAMD总分、体重因子分、认知障碍因子分、迟缓因子分、睡眠障碍因子分的差异具有统计学意义（P〈0．05或P〈0．01），研究组均低于对照组。研究组AIS（P〈0．05）、ASEX（P〈0．01）、IIEF-5（P〈0．01）评分优于对照组。治疗第八周末研究组临床痊愈26例（86．7％），对照组20例（66．7％），两组比较差异无统计学意义（X^2=3．354，P〉0．05）。性功能改善情况：研究组痊愈8例（26．67％），显效16例（53．33％），有效4例（13．33％），无效2例（6．67％）；对照组分别为2例（6．67％），13例（43．33％），6例（20％），9例（30％）。两组疗效差异具有统计学意义（X^2=8．765，P〈0．05）。两组不良反应无显著差异，均为轻度。结论曲唑酮合并氟西汀对男性抑郁症患者抑郁、睡眠及性功能障碍有较好的疗效，安全性高。     

帕罗西汀合并小剂量曲唑酮治疗伴勃起功能障碍抑郁症的对照研究

目的探讨帕罗西汀合并小剂量曲唑酮对伴有勃起功能障碍(ED)抑郁症患者的疗效及安全性。方法将101例伴有勃起功能障碍的抑郁症患者随机分为研究组(50例)和对照组(51例),研究组在常规给予帕罗西汀治疗的基础上,合并小剂量曲唑酮,对照组仅给予帕罗西汀,疗程6周;于治疗前及治疗后1、2、4、6周采用汉密顿抑郁量表(HAMD)、勃起功能国际指数评分问卷(IIEF-5)及副反应量表(TESS)评定疗效、勃起功能及副反应。结果对抑郁症状的治疗,2组疗效相当,研究组显效率为86.0%,对照组为78.4%;但1周末及2周末研究组HAMD评分显著低于对照组(P<0.05)。对勃起功能,2组的显效率分别为56.0%、21.6%,差异具有显著性(P<0.01);研究组的IIEF-5评分于4周末即显著高于对照组;ED改善与HAMD阻滞因子减分值呈正相关。2组间TESS评分无显著性差异。结论帕罗西汀合并小剂量曲唑酮治疗抑郁症起效快,且可显著改善患者的勃起功能,安全性高。     

曲唑酮与文拉法辛治疗抑郁症的对照研究

目的　评价曲唑酮治疗抑郁症的临床疗效和副反应。方法　对 72例抑郁症患者随机分为曲唑酮组 (36例 )与文拉法辛组 (36例 )进行对照性研究 ,疗程 8周 ,采用汉密顿抑郁量表 (HAMD) ,汉密顿焦虑量表(HAMA)、临床总体印象量表 (CGI)及副反应量表 (TESS)评定疗效及副反应。结果　曲唑酮与文拉法辛的临床疗效相似 ,两组的显效率和有效率分别为 6 1%、78%与 6 1%、81% ,差异无显著性 (P >0 0 5 ) ,副反应两组间差异也无显著性 (P >0 0 5 )。结论　曲唑酮与文拉法辛相比 ,在治疗抑郁症方面 ,有相似的疗效和安全性