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GENETIC BIAS COULD NOT BE IGNORED IN CLINICAL TRIALS
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- Author:
- No author available
- Journal Title:
- ACTA PHARMACEUTICA SINICA
- Issue:
- 8
- DOI:
- 10.3321/j.issn:0513-4870.1999.08.004
- Key Word:
- 细胞色素P450 2D6;新药临床试验;遗传偏差
Abstract： 目的:研究临床药理实验室数据库中的受试者是否有遗传偏差.方法:对数据库中的受试者和随机组织的受试者进行了CYP2D6基因分型对照研究.结果:CYP2D6慢代谢者在136位随机受试者中有9人(6.6%),而在138位临床药理实验室数据库的受试者中只有1人(0.7%),两组经统计有显著性差异.推测慢代谢者因易于体会到药物毒副作用,而易于从数据库中退出,造成数据库中受试者的遗传偏差.结论:新药试验时的受试者应随机组织或对其进行基因分型分析,以确保无遗传偏差.
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