甲磺酸瑞波西汀治疗抑郁症的临床试验

目的:评价国产甲磺酸瑞波西汀片治疗抑郁症的疗效与安全性。方法:采用随机、双盲、双模拟、氟西汀平行对照研究。48例抑郁症患者随机分为瑞波西汀组24例与氟西汀组24例,分别口服甲磺酸瑞波西汀片8 mg·d-1或氟西汀20 mg·d-1,疗程42 d。观察汉密尔顿抑郁量表与临床总体印象量表总分变化及药物不良反应。结果:两组汉密尔顿抑郁量表评分在治疗结束时较基线均显著减少(P<0．01);瑞波西汀组与氟西汀组有效率分别为70．8％与65．2％,差异无统计学意义(P>0．05)。瑞波西汀组常见的不良反应为口干、失眠、头昏和食欲减退,发生率与氟西汀差异无统计学意义(P>0．05)。结论:甲磺酸瑞波西汀治疗抑郁症的疗效及安全性与氟西汀相似。     

瑞波西汀治疗抑郁症的Ⅱ期临床观察

目的评价瑞波西汀片治疗抑郁症的临床疗效和安全性。方法对符合《CCMD-3》抑郁症诊断标准的46例抑郁症患者进行瑞波西汀片和氟西汀的随机双盲对照研究,其中瑞波西汀片组22例(8mg/d),氟西汀组24例(20mg/d),共治疗6周。采用汉密尔顿抑郁量表(HAMD),汉密尔顿焦虑量表(HAMA),临床总体评定量表(CGI)评定临床疗效,不良事件量表评定安全性。结果经6周治疗后,瑞波西汀片组治疗总有效率为69.57%,氟西汀组为76.00%,两组相比较,差异无显著性(P>0.05)。两组的HAMD,HAMA评分治疗前后相比较差异有高度显著性(P<0.01)。不良反应分析,两组药物不良反应的发生率无显著性差异(P>0.05),常见的不良反应有口干、出汗、恶心、便秘等。结论瑞波西汀片治疗抑郁症疗效好,安全性较高,适合临床应用。     

瑞波西汀治疗老年抑郁症的临床观察

目的：评价瑞波西汀治疗首发老年抑郁症的疗效和安全性。方法：采用随机、单盲、平行对照方法。受试者分别口服瑞波西汀胶囊8 mg.d^-1或帕罗西汀片20 mg.d^-1。采用HAMD、HAMA（汉密尔顿抑郁、焦虑量表）总分减分率以及CG1分作为主要疗效指标;实验室检查、生命体征等观察药物安全性。结果：共收集符合入组标准的患者80例,瑞波西汀组（试验组）与帕罗西汀组（对照组）各40例。治疗42 d后,瑞波西汀组HAMD、HAMA总分明显下降,与治疗基线相比均有显著性差异（P〈0.01）,但两组间相比差异无统计学意义（P〉0.05）;瑞波西汀组有效率（HAMD减分率≥50%）为82.5%,帕罗西汀组为77.5%,两组间相比差异无统计学意义（P〉0.05）;瑞波西汀组临床治愈率（HAMD、HAMA总分≤8）为62.5%,帕罗西汀组为55.0%,两组间差异无统计学意义（P〉0.05）;在CGI评分上,两组间差异亦无统计学意义。安全性分析显示：两组不良反应的症状和发生率相比差异均无统计学意义。结论：瑞波西汀治疗首发老年抑郁症安全有效,不良反应较少。     

瑞波西汀与氟西汀治疗抑郁症的系统评价

目的:比较瑞波西汀与氟西汀治疗抑郁症的疗效及不良反应的差异。方法:检索国内关于瑞波西汀与氟西汀对照研究治疗抑郁症的文献,应用系统评价方法对查阅到的9篇进行评估。结果:瑞波西汀与氟西汀的疗效差异无显著性[P>0.05,OR=1.01,95%CI(0.77~1.32)],2组药物不良反应的发生率差异无显著性(P>0.05)。结论:瑞波西汀与氟西汀的疗效治疗抑郁症的疗效和不良反应相似,是一种安全有效的抗抑郁药。     

甲磺酸瑞波西汀治疗抑郁症的随机双盲对照临床试验

目的评价新药甲磺酸瑞波西汀治疗抑郁症的有效性和安全性。方法 采用随机双盲双模拟、阳性药平行对照的研究。受试者分别口服瑞波西汀胶囊8mg／d或氟西汀片20mg／d。疗程6周。结果 共收集符合入组务件的病人48例,两组各24例。主要疗效指标汉密尔顿抑郁量表(HAMD)评分在治疗结束时较基线显著减少(p<0.01)。瑞波西汀组的有效率88％,氟西汀组的有效率100％,两组相比差异无显著意义。两组常见不良反应有口干、恶心、便秘、头昏、鼻塞、心电图异常等。两组间无显著性差异。 结论 试验药瑞波西汀与对照药氟西汀具有类似的疗效与不良反应,为治疗抑郁症的安全而有效的新药。     

甲磺酸瑞波西汀治疗抑郁症的疗效与安全性

目的:评价瑞波西汀治疗抑郁症的有效性和安全性。方法:73例抑郁症患者随机分成2组,治疗组为36例,给予甲磺酸瑞波西汀胶囊8~12mg.d-1;对照组37例,给予氟西汀胶囊20~40mg.d-1,2组疗程均为6周,治疗前及治疗后1、2、4、6周末采用HAMD、HAMA及TESS量表评定临床疗效和不良反应。结果:2组治疗结束时HAMD与HAMA评分均有显著下降(P<0.01),治疗组显效率为69.4%,对照组显效率为67.6%,2组疗效及不良反应比较无显著性差异(P>0.05)。结论:瑞波西汀与氟西汀治疗抑郁症的疗效和不良反应相似,是一种安全、有效的抗抑郁药。     

瑞波西汀片治疗抑郁症的多中心随机双盲临床研究

目的评价甲磺酸瑞波西汀(抗抑郁药)治疗抑郁症的有效性和安全性以及对伴焦虑症状抑郁症的疗效。方法采取多中心、随机、双盲双模拟、阳性药平行对照、剂量固定的研究方法,对212例抑郁症患者分别进行甲磺酸瑞波西汀(试验组105例)和盐酸氟西汀(对照组107例)治疗,观察疗程均为6周;以汉密尔顿抑郁量表(HAMD)作为主要疗效评价指标,以HAMA评分的变化评价治疗抑郁症伴焦虑症状的疗效;采用不良事件记录、实验室检查、生命体征等评价药物安全性。结果治疗6周末,2组HAMD总分减分值(15.91 vs 15.93)、HAMD总分减分率和治疗有效率差异均无统计学意义(P>0.05);2组HAMA总减分值差异无统计学意义(P>0.05)。2组药物不良反应发生率(20.56%vs 28.57%)差异无统计学意义(P>0.05)。结论甲磺酸瑞波西汀与盐酸氟西汀相似,是一种安全有效的新型抗抑郁药。     

西酞普兰与盐酸氟西汀治疗抑郁症的疗效对照研究

目的：比较西酞普兰与盐酸氟西汀治疗抑郁症的疗效和安全性。方法：将51例抑郁症患者分为西酞普兰组和盐酸氟西汀两组，其中西酞普兰组26例，盐酸氟西汀患者25例，分别接受每R20-60mg西酞普兰或盐酸氟西汀治疗，疗程共8周，在治疗前、治疗后1、2、4、8周分别进行汉米尔顿抑郁量表（HAMD）评定疗效和副反应量表（TESS）评定药物不良反应。结果：对抑郁症的治疗，西酞普兰的总有效率为88．5％，盐酸氟西汀的总有效率为84．0％，两组比较差异无统计学意义（P＞0．05）。但是西酞普兰组的总体不良反应的发生率明显少于盐酸氟西汀组，差异有统计学意义（P〈0．01）。结论：西酞普兰是安全、有效的抗抑郁药。     

西酞普兰与氟西汀治疗抑郁症的对照研究

目的：探讨西酞普兰与氟西汀治疗抑郁症的疗效及安全性。方法：将60例符合CCMD-3诊断标准的抑郁发作患者随机分为西酞普兰组和氟西汀组,疗程8周,用汉密尔顿抑郁量表（HAMD）和副反应量表（TESS）评定疗效和不良反应。结果：两组总体疗效相当,副反应相近。结论：西酞普兰和氟西汀均是既安全又有效的抗抑郁药。     

艾司西酞普兰与氟西汀治疗抑郁症疗效观察

目的：探讨艾司西酞普兰与氟西汀治疗抑郁症的疗效和安全性。方法：将110例抑郁症患者随机分为艾司西酞普兰组与氟西汀组,治疗6周,用汉密尔顿抑郁量表（HAMD）和治疗中出现的症状量表（TESS）评定疗效和不良反应。结果：艾司西酞普兰组与氟西汀组总体疗效相当,艾司西酞普兰起效快,不良反应较轻。结论：艾司西酞普兰治疗抑郁症既有效又安全。     

Reboxetine: a double-blind comparison with fluoxetine in major depressive disorder

The aim of this study was to compare the efficacy and tolerability of reboxetine, a uniquely selective noradrenaline reuptake inhibitor, with the selective serotonin reuptake inhibitor, fluoxetine. A double-blind, randomized, parallel-group, multicentre design was employed. One hundred and sixty-eight patients with acute major depressive episodes were randomized to receive oral reboxetine (8-10 mg/day) or oral fluoxetine (20-40 mg/day). The treatment period was 8 weeks. Reboxetine and fluoxetine were similarly effective as assessed by the mean reduction in total Hamilton Depression Rating Scale score, the percentage of responders and patients in remission, Clinical Global Impression severity of illness and global improvement scores and Montgomery-Asberg Depression Rating Scale. A sub-analysis of patients with severe depression indicated that reboxetine had superior efficacy compared with fluoxetine. Both treatments resulted in some improvement in Social Adaptation Self-evaluation Scale total scores and this was more evident for those patients treated with reboxetine who achieved remission. Both treatments were well tolerated. The results indicate that reboxetine is an effective and well tolerated antidepressant, being more effective than fluoxetine in patients with severe depression, and more effective in terms of social functioning in those patients who achieved remission.     

瑞波西汀与氟西汀治疗抑郁症随机双盲多中心临床研究

目的:评价瑞波西汀治疗抑郁症的疗效和安全性。方法:采用随机、双盲双模拟、氟西汀平行对照、剂量固定的多中心研究。受试者分别口服瑞波西汀胶囊8mg·d-1或氟西汀片20mg·d-1。采用汉密尔顿抑郁量表(HAMD)总分减分值作为主要疗效指标,以临床总体印象量表(CGI)和汉密尔顿焦虑量表(HAMA)评分作为次要疗效指标;采用药物不良反应量表(TESS)、实验室检查、生命体征等观察药物安全性。结果:共收集符合意向治疗抑郁症病人(ITT)222例,瑞波西汀组(试验组)109例,氟西汀组(对照组)113例。符合研究方案病人(PP)213例,瑞波西汀组104例,氟西汀组109例。治疗6wk后,瑞波西汀组HAMD总分减分值为(16±s7)分,氟西汀组为(16±7)分,与治疗基线相比差异均有非常显著意义(P<0.01),但2组相比差异无显著意义(P>0.05);瑞波西汀组有效率(HAMD减分率≥50%)为81.7%,氟西汀组为77.9%,2组相比差异无显著意义(P>0.05);瑞波西汀组临床治愈率(HAMD总分≤8)为62.4%,氟西汀组为58.4%,2组差异无显著意义(P>0.05);在CGI,HAMA评分上,2组差异亦无显著意义。安全性分析显示,2组不良反应的症状和发生率相比差异均无显著意义。结论:瑞波西汀治疗抑郁症安全有效。     

Reboxetine,a new noradrenaline selective antidepressant,is at least as effective as fluoxetine in the treatment of depression

The clinical profile of reboxetine, a selective noradrenaline reuptake inhibitor, was compared with that of the selective serotonin reuptake inhibitor fluoxetine and placebo in a double-blind, multicenter, parallel-group clinical trial of patients with major depression. Among the 381 patients treated with reboxetine 8 to 10 mg/day, fluoxetine 20 to 40 mg/day, or placebo for up to 8 weeks, a statistically significant greater reduction in the mean Hamilton Rating Scale for Depression (21-item HAM-D) total score (the primary efficacy variable) was seen for both active treatment groups compared with placebo (p < 0.024). A significantly greater proportion of patients treated with either reboxetine or fluoxetine also achieved a response (>or=50% reduction in HAM-D) or remission (HAM-D 相似文献   

瑞波西汀治疗老年期抑郁障碍的双盲对照研究

目的:了解瑞波西汀治疗老年期抑郁障碍的疗效及不良反应。方法:60例老年期抑郁障碍患者分成两组,瑞波西汀组30例,给予瑞波西汀4～8 mg·d-1;氟西汀组30例,给予氟西汀20～40 mg·d-1;观察4周,评定疗效。结果:瑞波西汀组总有效率80．00％,氟西汀组总有效率70．00％,和疗前比较两组统计学处理均有显著性差异(P< 0．01),药物不良反应基本相当。结论:瑞波西汀是一种有效、安全的抗抑郁药物,有改善睡眠的作用,不良反应轻。     

Comparison of efficacy and tolerability of reboxetine and venlafaxine XR in major depression and major depression with anxiety features: an open label study

OBJECTIVE: The aim of this study was to compare the efficacy and tolerability of reboxetine in the treatment of major depressive disorder (MDD) and MDD with anxiety features to venlafaxine XR. METHOD: Patients with MDD, aging 18 between 65 years, were randomly allocated to two groups receiving either open-label venlafaxine XR capsules (n = 50) or reboxetine tablets (n = 43). Subjects were administered Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Scale (HAM-A) at baseline and 2, 4, 7, 10 weeks after the baseline visit. RESULTS: Response rates to antidepressant treatment were significantly higher in the venlafaxine XR group at 10th week. When patients having anxious depression were analysed separately; response rate for anxiety of reboxetine group was significantly higher at 7th week only. Mean number of side effects were significantly higher in reboxetine group. Only one subject in each group was dropped out due to side effect. CONCLUSION: We may suggest that reboxetine is as effective and tolerable as venlafaxine XR in the treatment of MDD and MDD with anxiety features, and it may be considered a treatment option to venlafaxine XR.     

Switching to reboxetine: an efficacy and safety study in patients with major depressive disorder unresponsive to fluoxetine

The aim of the present study was to evaluate the efficacy and safety of an immediate switch to reboxetine, a selective noradrenaline reuptake inhibitor (selective NRI), in patients with depression unresponsive to the selective serotonin reuptake inhibitor (SSRI) fluoxetine.The study included 128 adult outpatients with DSM-IV major depressive disorder (MDD) who had not responded to at least 6 to 12 weeks of fluoxetine treatment, with at least 3 weeks of treatment on a minimum dose of 40 mg/d. Patients were switched, without a washout period, to reboxetine 4 mg twice daily, with the possibility of increasing the dose to 10 mg/d (given in divided doses) after 4 weeks of treatment. Efficacy was assessed using the 17-item Hamilton Rating Scale for Depression (HAM-D-17) and the Clinical Global Impression Improvement (CGI-I) and Severity (CGI-S) scales. Safety was evaluated by recording spontaneously reported adverse events.A statistically significant (P < 0.001) improvement in the mean total HAM-D-17 score was seen from baseline by week 1 of treatment with reboxetine, and the improvement continue to week 8. CGI-I and CGI-S scores were similarly improved. The switch to reboxetine was well tolerated; the most common treatment-emergent adverse events were insomnia, headache, dry mouth, diaphoresis, and constipation, all of which were mild to moderate in severity and decreased in frequency as the study progressed.Immediate switching to reboxetine appears to be a safe and effective treatment for patients with depression who have failed to respond to an adequate dose of fluoxetine.     

Effects of reboxetine on Hamilton Depression Rating Scale factors from randomized, placebo-controlled trials in major depression

Reboxetine is the first selective norepinephrine reuptake inhibitor (NRI) approved for the treatment of major depressive disorder (MDD). Although reboxetine has demonstrated efficacy for the treatment of depression, its effects on specific depressive symptoms have not been reported. We evaluated the effects of reboxetine on four Hamilton Depression Rating Scale (HAM-D) factors: psychomotor retardation, anxiety, cognitive disturbance and insomnia. Data were obtained from four short-term (4-8-week), randomized, placebo-controlled trials of reboxetine for the treatment of MDD. For each study, mean changes in HAM-D symptom factor scores from randomization to the study endpoint were compared between reboxetine and placebo. In addition, data from all four studies were pooled to determine the proportions of patients who either improved or worsened with treatment were compared between placebo (n = 353) and reboxetine (n = 350) treatment groups. Compared to placebo, reboxetine significantly improved psychomotor retardation in all four trials. Cognitive disturbance and anxiety were improved in three of four trials, and insomnia was improved in one trial with a positive trend in the second trial. Reboxetine, a selective NRI, improves symptoms of psychomotor retardation, anxiety and cognitive disturbance during treatment of MDD.     

圣约翰草提取物与氟西汀对照治疗脑卒中后抑郁65例

目的:评价圣约翰草提取物治疗脑卒中后抑郁(PSD)的疗效及安全性.方法:65例PSD患者随机分为治疗组32例及对照组33例,分别服用圣约翰草提取物450mg·d-1,po,tid和氟西汀20mg·d-1,po,qd,疗程均为6周.疗效评价采用汉密尔顿抑郁量表(HAMD)、抑郁自评量表(SDS)和评价日常生活能力量表(ADL).安全性评价采用不良反应量表(TESS)、实验室检查及体检.结果:治疗组治疗PSD有效率为84.4%,对照组为81.8%,两组之间差异无显著性(P>0.05).而且圣约翰草提取物可促进卒中后神经康复,两组常见不良反应较轻,不良反应发生率差异无显著性(P>0.05).结论:圣约翰草提取物治疗脑卒中后抑郁有较好的疗效,可促进卒中后神经康复,不良反应轻,安全性高.