聪明的试验:药物遗传测试对实用临床试验中不良事件的影响
Michael T Eadon1, Marc B Rosenman2, Pengyue Zhang3
1Indiana University School of Medicine, Department of Medicine, Indianapolis, IN, USA.
The pharmacogenomics journal
|September 9, 2023
概括
在一项大型试验中,药物遗传测试并没有显著减少药物不良事件 (ADEs) 的总体. 然而,针对某些药物的向测试显示,严重的副作用和死亡率有所降低.
科学领域:
- 药物基因组学 药物基因组学
- 临床药理学 临床药理学
- 药品安全 药品安全
背景情况:
- 药物不良事件 (ADEs) 对死亡率,发病率和医疗保健成本作出了重大贡献.
- 药物遗传学测试有可能减轻ADEs并提高药物的疗效.
- 在INGENIOUS试验中,研究了药物遗传小组测试对ADE频率的影响.
研究的目的:
- 确定是否进行和报告药物遗传学小组测试会影响ADE的发生率.
- 评估药物遗传测试对整体ADEs,严重ADEs和死亡率的影响.
主要方法:
- 一个务实的,随机对照试验 (N=2612) 被改编为倾向匹配分析.
- 参与者获得了26种药物遗传学可控药物的处方.
- 干预涉及一个具有可行的建议的药物遗传学测试小组;主要结局是1年内的ADEs (修改后的CTCAE).
主要成果:
- 在测试和对照组之间没有观察到总体ADE (OR 0.96),严重ADE (OR 0.91) 或死亡率 (OR 0.60) 的显著差异.
- 16.1%的人经历了任何ADE,3.2%的人在1年内经历了严重的ADE.
- 亚组分析表明,与阿里皮普拉和SSRI/SNRIs相关的药物基因定型减少了严重的副作用和死亡 (OR 0.34).
结论:
- 在这项研究中,药物遗传学小组测试并没有降低整体ADEs.
- 聪明试验中的局限性可能影响了结果.
- 未来的研究应该探索预防性药物遗传检测策略.
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