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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(66%),而在138位临床药理实验室数据库的受试者中只有1人(07%),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。
Objective: To study if there is genetic deviation in subjects in clinical pharmacology laboratory database. METHODS: CYP2D6 genotyping controls were performed on subjects in the database and subjects in randomized groups. RESULTS: CYP2D6 slow metabolizers were 9 of 136 randomized participants (6.6%), compared with 1 (0.77%) of 138 subjects in the Clinical Pharmacology Laboratory database. Two groups The statistics showed significant differences. It is speculated that slow metabolism due to easy to understand the drug side effects, and easy to exit from the database, resulting in the genetic bias of the subjects in the database. CONCLUSIONS: Subjects in new drug trials should be randomized or genotyped to ensure no genetic bias.