Recommendations from the EGAPP Working Group: testing for cytochrome P450 polymorphisms in adults with nonpsychotic depression treated with selective serotonin reuptake inhibitors
Recommendations from the EGAPP Working Group: testing for cytochrome P450 polymorphisms in adults with nonpsychotic depression treated with selective serotonin reuptake inhibitors
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DOI：
10.1097/gim.0b013e31815bf9a3
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发表时间：
2007-12-01
影响因子：
8.8
通讯作者：
Teutsch, Steven
中科院分区：
文献类型：
--
作者：
Berg, Alfred O.;Piper, Margaret;Teutsch, Steven
本声明总结了基因组应用实践和预防评估（EGAPP）工作组关于开始接受选择性5-羟色胺再摄取抑制剂（SSRI）治疗的成人患者的CYP 450基因检测的建议，以及支持性科学证据。EGAPP是由美国疾病控制和预防中心国家公共卫生基因组学办公室开发的一个项目，旨在支持一个严格的循证过程，以评估基因检测和其他基因组应用，这些应用正在从美国的研究过渡到临床和公共卫生实践。EGAPP工作组的一个关键目标是制定关于临床基因组应用的结论和建议，并与支持性科学证据建立明确的联系。工作组成员是遗传学、实验室医学和临床流行病学方面的非联邦专家，他们召集起来建立方法和流程;确定审查主题的优先次序;参加委托证据审查的技术专家小组;发表建议;建议摘要EGAPP工作组发现，没有足够的证据支持关于支持或反对使用EGAPP的建议。CYP 450测试在成人开始SSRI治疗非精神病性抑郁症。在缺乏支持性证据的情况下，并考虑到其他背景问题，EGAPP不鼓励使用CYP 450测试开始SSRI治疗的患者，直到进一步的临床试验完成。理由：FGAPP工作组发现没有证据表明CYP 450测试与SSRIs治疗的成人临床结果。虽然一些对健康患者单次服用SSRI的研究报告了基因型CYP 450药物代谢状态与循环SSRI水平之间的相关性，但对正在接受SSRI治疗的患者的研究并不支持这种相关性。此外，CYP 450基因型与患者关注的结果并不一致，包括对SSRI治疗的临床反应或治疗导致的不良事件。没有证据表明CYP 450检测结果影响SSRI选择或剂量并改善患者结局，或在医疗，个人或公共卫生决策中有用。在缺乏支持临床效用的证据的情况下，尚不清楚CYP 450检测的潜在获益是否超过潜在危害。潜在的危害可能包括增加成本而不影响临床决策或改善患者结局，SSRI药物治疗效果较差，或在管理CYP 450酶代谢的其他药物时不适当使用基因型信息。
This statement summarizes the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group recommendations regarding CYP450 genetic testing in adult patients beginning treatment with selective serotonin reuptake inhibitors (SSRIs), and the supporting scientific evidence. EGAPP is a project developed by the National Office of Public Health Genomics at the Centers for Disease Control and Prevention to support a rigorous, evidence-based process for evaluating genetic tests and other genomic applications that are in transition from research to clinical and public health practice in the United States. A key goal of the EGAPP Working Group is to develop conclusions and recommendations regarding clinical genomic applications and to establish clear linkage to the supporting scientific evidence. The Working Group members are nonfederal experts in genetics, laboratory medicine, and clinical epidemiology convened to establish methods and processes; set priorities for review topics; participate in technical expert panels for commissioned evidence reviews; publish recommendations; and provide guidance and feedback on other project activities.Summary of RecommendationThe EGAPP Working Group found insufficient evidence to support a recommendation for or against use of CYP450 testing in adults beginning SSRI treatment for non-psychotic depression. In the absence of supporting evidence, and with consideration of other contextual issues, EGAPP discourages use of CYP450 testing for patients beginning SSRI treatment until further clinical trials are completed.Rationale: The FGAPP Working Group found no evidence linking testing for CYP450 to clinical outcomes in adults treated with SSRIs. While some studies of a single SSRI dose in healthy patients report an association between genotypic CYP450 drug metabolizer status and circulating SSRI levels, this association was not supported by studies of patients receiving ongoing SSRI treatment. Further, CYP450 genotypes are not consistently associated with the patient outcomes of interest, including clinical response to SSRI treatment or adverse events as a result of treatment. No evidence was available showing that the results of CYP450 testing influenced SSRI choice or dose and improved patient outcomes, or was useful in medical, personal, or public health decision-making. In the absence of evidence supporting clinical utility, it is not known if potential benefits from CYP450 testing will outweigh potential harms. Potential harms may include increased cost without impact on clinical decision making or improvement in patient outcomes, less effective treatment with SSRI drugs, or inappropriate use of genotype information in the management of other drugs metabolized by CYP450 enzymes.