一个12基因的药物遗传小组来预防药物不良反应:一个开放的,多中心的,受控的,集群随机的交叉实施研究
Jesse J Swen1, Cathelijne H van der Wouden1, Lisanne En Manson1
1Department of Clinical Pharmacy and Toxicology, Leiden University Medical Centre, Leiden, Netherlands.
Lancet (London, England)
|February 4, 2023
概括
在一项大型欧洲研究中,使用12基因组的预防性药物遗传测试显著降低了药物不良反应. 这种以基因型为导向的方法在各种医疗环境中证明了可行性,提高了药物治疗的安全性.
科学领域:
- 药物基因组学
- 临床药理学
- 遗传学
背景情况:
- 对于单基因药物对来说,已知药物遗传学测试的好处.
- 预防性基因组组的临床实用性需要严格的评估.
研究的目的:
- 评估12基因药物遗传组的临床实用性,用于预防性基因定型.
- 评估基因型导向治疗对药物不良反应的影响.
主要方法:
- 在欧洲7个国家的18个医院,9个卫生中心,28个药房进行了开放式,多中心,受控,随机分组的交叉实施研究.
- 在接受首次指标药物处方的患者中,对50种生殖系变异进行12基因药物基因组定型.
- 基因型导向治疗 (遵循荷兰药物遗传学工作组对可操作变异的建议) 与标准治疗的比较.
- 主要结局:在12周内出现临床相关的不良反应.
主要成果:
- 在基因型指导组,3342人,在标准治疗组,3602人.
- 在可操作结果的患者中,药物不良反应发生率为21. 0% (研究) 和27. 7% (对照) (OR 0. 70; p=0. 0075).
- 在所有患者中,发病率为21. 5% (研究) 和28. 6% (对照组) (OR 0. 70; p < 0. 0001).
结论:
- 使用12基因药物遗传组的基因型导向治疗显著降低了药物不良反应.
- 这一战略在欧洲的各种医疗保健系统中是可行的.
- 大规模实施可以提高药物治疗的安全性.
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