中国临床药理学杂志2011，Vol.27Issue(6)：464-466,3.
Ⅰ期临床药物试验中健康志愿者一般状况分析
Analysis about the general healthy situation of normal healthy volunteers in phase Ⅰ new drug clinical trail
郭月梅 1王宏山 1易嘉龙 1李玲芝 1宓为峰1
作者信息
- 1. 北京大学,精神卫生研究所,北京,100191
- 折叠
摘要
Abstract
Objective To analyse the healthy situation of the normal healthy volunteers in phase Ⅰ new drug clinical trail. Methods One hundred and seventy- seven healthy volunteers who came to the Sixth Hospital of Peking University for screening of phase Ⅰ new drug chnical trail were elected, from January/2009 to August/2010. Results The ratio of male and female was 2. 53 (170: 70). The rate of abnormality red blood cell count and hemoglobin of male healthy volunteers was higher than females, and the rate of hemoglobin abnormality of lower age ( ＜ 28 years) group had a higher than the elder group ( ＞ 28 years) ( P ＜0. 05 ). The rate of neutrophilic granulocyte count abnormality male group person had a lower than females (6. 5％ vs 15.7％, x2 = 3.90, P ＜0. 05 ). The abnormality rate of blood glucose in male was 34. 6％, higher than that in female group 20. 0％ (x2 = 4. 39, P = 0. 036 ＜ 0. 05 ).Conclusion During the screening of normal healthy volunteers in phase Ⅰ new drug clinical trail, it is necessary to monitor the red blood cell count, hemoglobin, blood glucose in male or younger ( ＜ 28 years)groups, and monitor neutrophilic granulocyte count in female group.关键词
Ⅰ期临床药物试验/健康志愿者Key words
phase Ⅰ clinical trials/ health volunteer分类
医药卫生引用本文复制引用
郭月梅,王宏山,易嘉龙,李玲芝,宓为峰..Ⅰ期临床药物试验中健康志愿者一般状况分析[J].中国临床药理学杂志,2011,27(6):464-466,3.
