Kim Grace Juyun, Lee Soo Youn, Park Ji Hye, Ryu Brian Y, Kim Ju Han
Seoul National University Biomedical Informatics (SNUBI), 28 Yongon-dong, Chongno-gu, Seoul, 110799, South Korea.
Interdisciplinary Program in Bioinformatics, Seoul National University College of Natural Sciences, 28 Yongon-dong, Chongno-gu, Seoul, 110799, South Korea.
Drug Saf. 2017 Jan;40(1):65-80. doi: 10.1007/s40264-016-0454-5.
Preemptive and multi-variant genotyping is suggested to improve the safety of patient drug therapy. The number of South Koreans who would benefit from this approach is unknown.
We aimed to quantify the number of patients who may experience serious adverse drug events (ADEs) due to high-risk pharmacogenetic variants and who may benefit from preemptive genotyping.
The health claims dataset of the Korean Health Insurance Review and Assessment service for 3 % of the South Korean population for year 2011 was used to calculate the number of patients exposed to 84 drugs covered by National Health Insurance with pharmacogenomic biomarkers. The product of ADE risk-conferring genotype prevalence, ADE prevalence rates, and genotype effect sizes in South Koreans or East Asians derived from published literature and the 1000 Genomes Project, and the drug exposure data were solved to estimate the number of South Koreans in whom preemptive genotyping may prevent serious ADEs.
Among 1,341,077 patients in the dataset with prescriptions, 47.4 % were prescribed a drug whose response was affected by genetic variants and 31.9 % were prescribed at least one drug with serious ADEs modulated by these variants. Without genetic testing, the number of South Korean patients predicted to experience serious ADEs due to their higher ADE risk genotypes was estimated at 729. Extrapolating this to the total South Korean population indicated that approximately 24,300 patients in 2011 might have benefitted from preemptive genotyping.
This study quantified the number of South Korean patients predicted to have serious ADEs and demonstrated the need for preemptive genotyping to assist safer drug therapy in South Korea.
建议采用前瞻性和多变量基因分型来提高患者药物治疗的安全性。受益于这种方法的韩国人数尚不清楚。
我们旨在量化因高风险药物遗传变异可能发生严重药物不良事件（ADE）以及可能从前瞻性基因分型中受益的患者数量。
利用韩国健康保险审查与评估服务机构2011年针对3%韩国人口的健康保险理赔数据集，计算接触到84种有药物基因组生物标志物的国家医疗保险覆盖药物的患者数量。根据已发表文献和千人基因组计划得出的韩国人或东亚人中赋予ADE风险的基因型患病率、ADE患病率以及基因型效应大小，并结合药物暴露数据，估算出前瞻性基因分型可预防严重ADE的韩国患者数量。
在数据集中有处方的1341077名患者中，47.4%的患者所开药物的反应受基因变异影响，31.9%的患者至少开具了一种受这些变异调节的有严重ADE的药物。若不进行基因检测，预计因ADE风险较高的基因型而发生严重ADE的韩国患者数量为729例。将此推算至韩国总人口，表明2011年约有24300名患者可能从前瞻性基因分型中受益。
本研究量化了预计会发生严重ADE的韩国患者数量，并证明在韩国需要进行前瞻性基因分型以辅助更安全的药物治疗。
