对青年健康男性志愿受试者在新药I期临床试验中部分肝脏血液生化指标参考值范围的分析  

ANALYSIS ON NORMAL VALUES OF BIOCHEMICAL LABORATORY TESTS OF SOME LIVER FUNCTIONS OBTAINED FROM HEALTHY YOUNG MALE VOLUNTEERS PARTICIPATING IN I CLINICAL TRIALS OF NEW DRUGS

作　　者：李天云[1] 李家泰[1] 

机构地区：[1]北京医科大学第一医院

出　　处：《中国临床药理学杂志》1999年第4期285-287,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：本文对本研究所近五年来新药Ｉ期临床试验中入选的２１３名健康男性大学生（年龄２１～２５岁）的６项肝功指标（ＡＬＴ，ＡＳＴ，ＡＬＰ，ＴＰ，ＡＬｂ，Ｔｂｉｌ）测定结果与《全国临床检验操作规程（第二版）１９９７》［７］进行比较，并对二者存在的差别从实验对象进行了分析。本组受试者均为健康男性大学生，年龄差距小，均经严格体检证明健康，故ＡＬＴ（２～２６Ｕ·Ｌ－１）、ＡＳＴ（６～３４Ｕ·Ｌ－１）、与ＡＬＰ（３３～１１１Ｕ·Ｌ－１）等正常值均低于《全国临床检验操作规程（第二版）１９９７》［７］ＡＬＴ（５～４０Ｕ·Ｌ－１）、ＡＳＴ（８～４０Ｕ·Ｌ－１）、ＡＬＰ（４０～１５０Ｕ·Ｌ－１）等值。可供新药临床试验中对新药进行安全性评价时参考。Results of reference values of six items of liver function (ALT,AST, ALP, TP, ALb, Tbil)obtained from 213 healthy male students with the age of 21～25 years old who participated in phase I clinical trials of new drugs conducted by the Institute of Clinical Pharmacology, the first hospital of Beijing Medical University during past five years were compared with those indicated in “National Guideline for the Operation of Clinical Laboratory Tests, 2nd ed.1997",and objects were considered for analyzing the differences in reference values. All volunteers were healthy male students, the differences in age were small, they all passed careful physical examination and clinical laboratory tests proving they were healthy, therefore the reference values of ALT(2～26 U·L-1),AST(6～34 U·L-1),ALP(33～111 U·L-1) etc of them were lower than ALT(5～40U·L-1), AST(8～40 U·L-1), ALP (40～150 U·L-1) indicated in "National Guideline for the Operation of Clinical Laboratory Tests,2nd ed.1997." It is suggested that the results can offer reference in clinical trials of new drugs for safety evaluation.

关 键 词：健康男性 志愿受试者 新药 安全性 

分 类 号：R965.3[医药卫生—药理学]