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Health Technol Assess:精神分裂症用氯氮平控制不佳时添加阿米舒必利有无效果?

2022-05-06 贾朝娟 环球医学

难治性精神分裂症对氯氮平不完全响应时添加第2种抗精神病药物的做法尚无证据支持。


难治性精神分裂症对氯氮平不完全响应时添加第2种抗精神病药物的做法尚无证据支持。2017年9月,发表在《Health Technol Assess》的一项研究显示,接受阿米舒必利的患者在12周随访时具有较高的成为响应者的机会。

背景:当难治性精神分裂症对氯氮平不完全响应时,临床医生常常添加第2种抗精神病药物,尽管这种做法缺乏强有力的证据。

目的:本研究的主要目的是证实阿米舒必利用于氯氮平治疗抵抗的精神分裂症增强效果的临床有效性和成本效果。

设计:本研究是一项多中心、双盲、个体化随机、安慰剂-对照试验,随访12周。

环境:本研究在NHS成人精神病的多学科小组进行。

受试者:符合条件的受试者是年龄为18~65岁的治疗抵抗性精神分裂症患者,对氯氮平单药治疗无响性,持续症状严重程度在标准水平和社会功能受损。

干预:干预包括氯氮平联合阿米舒必利或安慰剂12周。在前4周,受试者接受400 mg阿米舒必利或2种匹配的安慰剂胶囊,在之后的8周内,根据临床选择增加阿米舒必利剂量至800 mg或4个匹配的安慰剂胶囊。

主要结局测试指标:主要结局测试指标是“响应者”百分比,采用阳性和阴性症状量表总评分减少20%为标准响应阈值。

结果:68名受试者被随机分配。同分配至安慰剂组的受试者相比,接受阿米舒必利的患者在12周随访结束时具有较高的成为响应者的机会(比值比 1.17,95%置信区间 0.40~3.42)和较多的阴性症状改善,尽管在6周随访时两种结果均未出现且均无统计学意义。阿米舒必利组出现更多副作用,包括心脏副作用。经济学分析显示,增加阿米舒必利可能具有短期成本-效果优势[净节约成本范围是£329至£2011;生命质量调整年(QALYs)未显示差异],且可能具有长期成本-效果优势。

局限性:试验招募人数不足,因此,检测活性药物与安慰剂组之间显着差异的统计分析能力会受限。经济学分析显示,由于较短的持续时间和相对较小的受试者人数导致较高的不确定性。

结论:阿米舒必利用于增强氯氮平治疗精神分裂症相比氯氮平单药治疗,其风险获益未显示完全响应,提示未来需要大型研究进行进一步调查。确定的阿米舒必利-氯氮平联合副作用负担的大小和程度可能部分反应了本研究中副作用的综合评估。未来试验中这种治疗策略的设计应该考虑在随访4至6周内临床响应可能并不明显,虽然目前在急性精神病发作的抗精神病治疗研究中通常被认为是足够的。经济学研究显示需要更大、更长期的研究去阐明有关阿米舒必利的节约成本程度和对QALYs影响的不确定性。从阿米舒必利-氯氮平联合中识别出副作用的程度和特点意味着在临床和研究环境中氯氮平联合二线抗精神病药需要监测安全性和耐受性的特点和频率。

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    2018-09-02 shizhenshan
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    2018-02-23 rgjl
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    2017-12-19 shock_melon
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    2017-09-21 dongjia2015
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    2017-09-20 138****9420

    学习了.希望通过大的标本量.提高准确性.

    0

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