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米氮平和舍曲林用于痴呆的成本效益分析(Br J Psychiatry. 2013 Feb;202:121-8)
2013-02-01
编辑:环球医学 吴星
关键词: 米氮平,舍曲林,痴呆,抑郁症,成本效益
题目:米氮平和舍曲林用于痴呆的成本效益分析:随机对照试验(Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial)
背景:抑郁症是痴呆的一个常见和花费巨大的合并症。有关抗抑郁药对痴呆患者抑郁症,及其护理结局作用的成本效益数据较少。
目的:舍曲林和米氮平与安慰剂相比,用于痴呆患者抑郁症治疗的成本效益评估。
方法:一项实用的、多中心、随机安慰剂对照试验,并行成本效益分析(试验登记: ISRCTN88882979和EudraCT 2006-000105-38)。主要结局是在2个时间段:0~13周和0~39周总Cornell痴呆患者抑郁症级别(CSDD)评分。成本效益分析主要比较了接受舍曲林和米氮平或安慰剂患者治疗成本和主要结局指标有效性的差异。次要评估为使用从Euro-Qual(EQ-5D)和同一时期的社会加权计算得出的校正质量生命年(QALYs),进行成本效益分析。
结果:共纳入339例受试者,其中326例患者有成本数据(111例接受安慰剂、107接受舍曲林、108接受米氮平)。与安慰剂相比,主要结局抑郁的减轻上米氮平和舍曲林与安慰剂相比不具有成本效益。但是,在研究次要结局时,接受米氮平的患者组需要无偿护理的时间几乎是安慰剂组(6.74 vs 12.27小时/周)或舍曲林组的一半(6.74 vs 12.32小时/周)。米氮平组39周以上非正式护理成本分别比安慰剂组和舍曲林组低£1510和£1522。
结论:在减轻痴呆患者的抑郁上,米氮平和舍曲林的抑郁症治疗不具有成本效益。但是,如果成本包括无偿护理和生命质量,米氮平似乎具有成本效益。米氮平组的无偿护理(家庭)成本比舍曲林组或安慰剂组低。这可能与米氮平改善睡眠和减少焦虑有关。鉴于家庭护理作为首选以及家庭护理员对痴呆患者的潜在作用,还需进一步研究米氮平对痴呆患者及护理员潜在的行为和心理学症状改善作用。
(选题审校: 李灿 北京大学第三医院药剂科)
本文由翟所迪教授及其团队选题并审校,环球医学编辑完成。
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Br J Psychiatry. 2013 Feb;202:121-8. doi: 10.1192/bjp.bp.112.115212. Epub 2012 Dec 20.
Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial.
Romeo R, Knapp M, Hellier J, Dewey M, Ballard C, Baldwin R, Bentham P, Burns A, Fox C, Holmes C, Katona C, Lawton C, Lindesay J, Livingston G, McCrae N, Moniz-Cook E, Murray J, Nurock S, O'Brien J, Poppe M, Thomas A, Walwyn R, Wilson K, Banerjee S.
SourceBrighton & Sussex Medical School, University of Sussex, Brighton, East Sussex, UK. s.banerjee@bsms.ac.uk
Abstract
BACKGROUND: Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes.
AIMS: To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia.
METHOD: A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0-13 weeks and 0-39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods.
RESULTS: There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively.
CONCLUSIONS: In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.
PMID: 23258767 [PubMed - in process]
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ISRCTN/ISRCTN88882979
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