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精神分裂症患者在使用抗精神病药物治疗时进行细胞色素 P450 多态性检测的临床效果和成本效益:系统评价和经济评估。

The clinical effectiveness and cost-effectiveness of testing for cytochrome P450 polymorphisms in patients with schizophrenia treated with antipsychotics: a systematic review and economic evaluation.

机构信息

Liverpool Reviews and Implementation Group, University of Liverpool, UK.

出版信息

Health Technol Assess. 2010 Jan;14(3):1-157, iii. doi: 10.3310/hta14030.

DOI:10.3310/hta14030
PMID:20031087
Abstract

OBJECTIVE

To determine whether testing for cytochrome P450 (CYP) polymorphisms in adults entering antipsychotic treatment for schizophrenia leads to improvement in outcomes, is useful in medical, personal or public health decision-making, and is a cost-effective use of health-care resources.

DATA SOURCES

The following electronic databases were searched for relevant published literature: Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness, EMBASE, Health Technology Assessment database, ISI Web of Knowledge, MEDLINE, PsycINFO, NHS Economic Evaluation Database, Health Economic Evaluation Database, Cost-effectiveness Analysis (CEA) Registry and the Centre for Health Economics website. In addition, publicly available information on various genotyping tests was sought from the internet and advisory panel members.

REVIEW METHODS

A systematic review of analytical validity, clinical validity and clinical utility of CYP testing was undertaken. Data were extracted into structured tables and narratively discussed, and meta-analysis was undertaken when possible. A review of economic evaluations of CYP testing in psychiatry and a review of economic models related to schizophrenia were also carried out.

RESULTS

For analytical validity, 46 studies of a range of different genotyping tests for 11 different CYP polymorphisms (most commonly CYP2D6) were included. Sensitivity and specificity were high (99-100%). For clinical validity, 51 studies were found. In patients tested for CYP2D6, an association between genotype and tardive dyskinesia (including Abnormal Involuntary Movement Scale scores) was found. The only other significant finding linked the CYP2D6 genotype to parkinsonism. One small unpublished study met the inclusion criteria for clinical utility. One economic evaluation assessing the costs and benefits of CYP testing for prescribing antidepressants and 28 economic models of schizophrenia were identified; none was suitable for developing a model to examine the cost-effectiveness of CYP testing.

CONCLUSIONS

Tests for determining genotypes appear to be accurate although not all aspects of analytical validity were reported. Given the absence of convincing evidence from clinical validity studies, the lack of clinical utility and economic studies, and the unsuitability of published schizophrenia models, no model was developed; instead key features and data requirements for economic modelling are presented. Recommendations for future research cover both aspects of research quality and data that will be required to inform the development of future economic models.

摘要

目的

确定在接受精神分裂症抗精神病治疗的成年人中检测细胞色素 P450(CYP)多态性是否会改善结果,是否有助于医疗、个人或公共卫生决策,以及是否能有效利用医疗资源。

资料来源

检索了以下电子数据库以寻找相关的已发表文献:Cochrane 对照试验注册库、Cochrane 系统评价数据库、疗效评价文摘数据库、EMBASE、卫生技术评估数据库、ISI Web of Knowledge、MEDLINE、PsycINFO、NHS 经济评价数据库、健康经济评价数据库、成本效益分析(CEA)登记处和卫生经济学中心网站。此外,还从互联网和顾问小组成员处寻找了各种基因分型检测的公开信息。

方法

对 CYP 检测的分析有效性、临床有效性和临床实用性进行了系统评价。将数据提取到结构化表格中并进行叙述性讨论,并在可能的情况下进行了荟萃分析。还对精神科 CYP 检测的经济评估和与精神分裂症相关的经济模型进行了综述。

结果

在分析有效性方面,纳入了 46 项针对 11 种不同 CYP 多态性(最常见的是 CYP2D6)的不同基因分型检测的研究。敏感性和特异性均很高(99-100%)。在临床有效性方面,共发现 51 项研究。在接受 CYP2D6 检测的患者中,发现基因型与迟发性运动障碍(包括异常不自主运动量表评分)之间存在关联。唯一另一项有意义的发现是 CYP2D6 基因型与帕金森病有关。一项符合纳入标准的小型未发表研究评估了 CYP 检测在开处方抗抑郁药方面的成本和效益,还确定了 28 个精神分裂症经济模型;但没有一个适合开发模型来检验 CYP 检测的成本效益。

结论

用于确定基因型的检测似乎是准确的,尽管并非所有分析有效性方面都有报告。鉴于临床有效性研究没有令人信服的证据,缺乏临床实用性和经济研究,以及已发表的精神分裂症模型不适用,因此没有开发模型;而是提出了经济建模的关键特征和数据要求。未来研究的建议涵盖了研究质量和数据两个方面,这些数据将为未来经济模型的开发提供信息。

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