A comparative study of the efficacy of acute and continuation treatment with escitalopram versus duloxetine in patients with major depressive disorder

ABSTRACT

Objective: This study evaluated the efficacy and tolerability of escitalopram and duloxetine in the treatment of major depressive disorder (MDD).

Research design and methods: Patients were randomised to 24 weeks of double-blind treatment with fixed doses of escitalopram (20?mg) (n = 143) or duloxetine (60?mg) (n = 151). The primary analysis of efficacy was an analysis of covariance (ANCOVA) of change from baseline to endpoint (week 24) in MADRS total score (last observation carried forward).

Main outcome measures; Results: At week 8, the mean change from baseline in total MADRS score was –19.5 for patients treated with escitalopram (n = 141) and –17.4 for patients treated with duloxetine (n = 146), a difference of 2.1 points (?p < 0.05). At week 8, the proportion of responders (≥?50% decrease in MADRS) was 69% (escitalopram) and 58% (duloxetine) (?p < 0.05) and remission (MADRS ≤?12) rates were 56% (escitalopram) and 48% (duloxetine) (NS). For the primary endpoint, the mean change from baseline in total MADRS score at week 24 was –23.4 for patients treated with escitalopram and –21.7 for patients treated with duloxetine, a difference of 1.7 points (?p = 0.055, one-sided). The difference in mean change from baseline in MADRS total score favoured escitalopram at weeks 1, 2, 4, 8, 12 and 16 (?p < 0.05). The overall withdrawal rates were 22% (escitalopram) and 25% (duloxetine) (NS). The withdrawal rate due to adverse events was lower for escitalopram (9%) compared to duloxetine (17%) (?p < 0.05) and significantly more patients treated with duloxetine reported insomnia (12.6% vs. 4.9%) and constipation (8.6% vs. 2.8%).

Conclusion: Escitalopram was superior to duloxetine in acute treatment and at least as efficacious and better tolerated in long-term treatment of MDD.     

度洛西汀配合康复训练联合治疗卒中后抑郁的临床研究

目的：观察度洛西汀配合康复训练对卒中后抑郁和神经功能恢复的影响。方法将80例脑卒中抑郁患者随机分为治疗组和对照组,治疗组采用度洛西汀治疗和康复训练并辅以心理疏导;对照组只采用度洛西汀治疗,两组共治疗8周。采用汉密尔顿抑郁量表（HAMD）、改良爱丁堡斯堪的那维亚量表（MESSS）和Barthel指数分别对治疗组和对照组患者在治疗前和治疗8周后进行评定。结果治疗8周后两组HAMD评分、HESSS评分及改良Barthel指数评分比较差异有统计学意义（P〈0.01）。结论度洛西汀配合康复训练卒中后抑郁患者起效快,不良反应少,更有利于神经功能恢复。     

Stress urinary incontinence: new management options

ABSTRACT

Stress urinary incontinence is the most prevalent form of urinary incontinence. In spite of its significant negative impact on quality of life less than one-third of patients in the UK present with symptoms to their GP.

This review article includes papers that were retrieved through PubMed using search criteria ‘stress urinary incontinence’, ‘management’ and the specific therapy area, e.g. tension-free vaginal tape. The main guidance of the Department of Health (London, UK) and associated bodies was also used.     

艾司西酞普兰与度洛西汀治疗抑郁症的对照研究

目的探讨艾司西酞普兰与度洛西汀治疗抑郁症的疗效和安全性。方法共入组60例抑郁症患者,均为心理科门诊就诊的患者,符合《中国精神疾病分类与诊断标准（第三版）》（CCMD-3）中抑郁症或抑郁发作的诊断标准。随机分为两组,各30例,分别服用艾司西酞普兰和度洛西汀治疗,疗程8周;于治疗前及治疗1,4,8周末以汉密尔顿抑郁量表（HAMD）评定疗效,以治疗时出现的症状量表（TESS）评定药物副反应。结果在1,4,8周末,艾司西酞普兰组有效率分别为10.00%、83.33%、93.33%,度洛西汀组有效率分别为3.33%、63.33%、80.00%,两组各时点有效率差异无统计学意义（P〉0.05）,HAMD评分差异无统计学意义（P〉0.05）;艾司西酞普兰组治疗8周内副反应发生率为10%,度洛西汀组为16.7%,两者差异无统计学意义（P〉0.05）。结论艾司西酞普兰和度洛西汀治疗抑郁症8周内有效率较高,两者有效率接近,副反应类似。     

度洛西汀治疗广泛性焦虑障碍的疗效和安全性

目的调查度洛西汀治疗广泛性焦虑障碍（GAD）的疗效及安全性。方法将符合DSM—IV广泛性焦虑障碍诊断标准的住院患者随机分为度洛西汀组38例和文拉法辛组37例,进行为期8周的治疗观察;于基线时、治疗2,4,8周末评定汉密尔顿焦虑量表（HAMA）判断临床疗效;基线时及治疗8周末评定席汉残疾量表（SDS）评定社会功能恢复状况;药物不良反应量表（TESS）评价安全性。结果两组治疗2,4,8周末在有效率、HAMA评分方面与基线时比较差异有统计学意义（P〈0．01）,两组间比较差异无统计学意义（P〉0．05）;治疗8周末两组sDs评分均较基线时有明显改善,差异有统计学意义（P〈0．01）,两组间比较有统计学意义（P〈0．05）;两组均未见严重药物不良反应。结论度洛西汀治疗广泛性焦虑障碍起效快、疗效好、安全性高,同时对社会功能恢复起到积极作用。     

度洛西汀对小鼠急性毒性及遗传毒性的研究

目的:探讨度洛西汀对成年雄性小鼠的急性毒性及遗传毒性。方法:采用小鼠急性毒性试验观察致死率及半数致死量(LD₅₀)。采用小鼠骨髓微核试验、小鼠精子畸变试验及生殖与淋巴器官重量指数检测方法,将小鼠均分为6组,即阴性对照组、阳性对照组,度洛西汀1、2、3和4组(分别给予度洛西汀5、10、20和40 mg/kg),观察度洛西汀不同剂量对小鼠精子畸变率、骨髓微核率及生殖与淋巴器官重量指数的影响。结果:度洛西汀急性毒性试验结果表明,灌胃给予度洛西汀的LD₅₀为188.3 mg/kg。微核试验与精子畸变试验结果表明,度洛西汀灌胃剂量为5、10和20 mg/kg时(度洛西汀1、2和3组)均未诱发小鼠精子畸变率和骨髓微核率的改变,与阴性对照组相比,差异均无统计学意义(P>0.05);度洛西汀4组小鼠的精子畸变率、骨髓微核率均高于阴性对照组,差异有统计学意义(P<0.05)。度洛西汀1、2、3和4组小鼠的生殖与淋巴器官重量指数与阴性对照组相比,差异均无统计学意义(P>0.05)。结论:灌胃给予度洛西汀的LD₅₀为188.3 mg/kg,安全性高。度洛西汀以5、10和20 mg/kg的剂量灌胃对小鼠无生殖与遗传毒性,当灌胃剂量达到40 mg/kg时对雄性小鼠有轻微的潜在遗传毒性。     

度洛西汀与文拉法辛治疗抑郁症疗效和安全性的Meta分析

摘 要 目的： 评价度洛西汀和文拉法辛治疗抑郁症的疗效与安全性。方法: 计算机检索PubMed、CNKI、VIP、万方数据库等文献数据库,以及手工检索相关文献,采用RevMan5.3进行Meta分析。结果: 纳入研究12项,共872例患者,Meta分析显示：在痊愈率(RR=0.99, 95%CI：0.78~1.27)和有效率(RR=1.01, 95%CI：0.91~1.13）方面,度洛西汀组（治疗组）和文拉法辛组（对照组）的差异无统计学意义（P>0.05）;治疗组和对照组的不良反应分析（RR合并=1.05, 95%CI：0.86~1.28）显示,两组的差异无统计学意义（P>0.05）。但是通过亚组分析显示,消化系统(RR=1.43, 95%CI：1.11~1.84)和心血管系统(RR=0.41, 95%CI：0.21~0.79)方面的不良反应发生率的差异有统计学意义（P<0.05）,治疗组胃肠道反应比对照组多,心血管方面不良反应较对照组少。结论:度洛西汀和文拉法辛治疗抑郁症疗效相当,不良反应也无明显差异,但是在临床使用中对于有消化系统疾病或心血管系统疾病的患者,在药物选择时应有所区别,以减少不良反应风险,提高治疗效率。     

度洛西汀在术后镇痛中的应用

度洛西汀是一种5-羟色胺和去甲肾上腺素再摄取抑制药,近年有学者探索其用于术后镇痛。但由于度洛西汀的药理特性,可能引起术中高血压、出血增加、影响围术期药物代谢等,其用法相对保守。本文对现有研究中度洛西汀用于手术患者的作用机制、用药方案、不良反应等进行阐述,综合分析现有研究结果,以期为该药物的安全、高效应用提供参考。     

Predictors of duloxetine response in patients with oxaliplatin‐induced painful chemotherapy‐induced peripheral neuropathy (CIPN): a secondary analysis of randomised controlled trial – CALGB/alliance 170601

Duloxetine is an effective treatment for oxaliplatin‐induced painful chemotherapy‐induced peripheral neuropathy (CIPN). However, predictors of duloxetine response have not been adequately explored. The objective of this secondary and exploratory analysis was to identify predictors of duloxetine response in patients with painful oxaliplatin‐induced CIPN. Patients (N = 106) with oxaliplatin‐induced painful CIPN were randomised to receive duloxetine or placebo. Eligible patients had chronic CIPN pain and an average neuropathic pain score ≥4/10. Duloxetine/placebo dose was 30 mg/day for 7 days, then 60 mg/day for 4 weeks. The Brief Pain Inventory‐Short Form and the EORTC QLQ‐C30 were used to assess pain and quality of life, respectively. Univariate and multiple logistic regression analyses were performed to identify demographic, physiologic and psychological predictors of duloxetine response. Higher baseline emotional functioning predicted duloxetine response (≥30% reduction in pain; OR 4.036; 95% CI 0.999–16.308; p = 0.050). Based on the results from a multiple logistic regression using patient data from both the duloxetine and placebo treatment arms, duloxetine‐treated patients with high emotional functioning are more likely to experience pain reduction (p = 0.026). In patients with painful, oxaliplatin‐induced CIPN, emotional functioning may also predict duloxetine response. ClinicalTrials.gov, Identifier NCT00489411     

Assessment of Anxiety in Clinical Trials with Depressed Patients Using the Hamilton Depression Rating Scale

Background

The Hamilton Depression Rating Scale (HAMD₁₇) is an outcome measure widely used in major depressive disorder (MDD) clinical trials. The objective of this analysis was to assess the validity of the anxiety/somatisation factor of the HAMD₁₇ as a measure of anxiety in patients with MDD.

Methods

We pooled data from 1466 outpatients with MDD from four 8-week controlled studies of duloxetine. We performed a factor analysis of the HAMD₁₇ to investigate the anxiety/somatisation factor.

Results

The HAMD₁₇ factor analysis yielded 6 factors, but did not yield the pre-specified anxiety/somatisation factor. This latter factor showed weak correlation with the Hamilton Anxiety Scale total and subscale scores at baseline (0.46), but higher correlation coefficients over the trials up to 0.81. We identified another anxiety factor that included the hypochondriasis item in this sample.

Conclusion

Findings from this large sample suggest that the factor structure of the HAMD₁₇ is unstable in MDD and that the anxiety/somatisation subscale should not be routinely used for anxiety assessment in depressed patients.