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

目的分析Ⅰ期临床药物试验中健康志愿者的一般状况。方法选择2009年1月到2010年8月在本院药物临床试验机构参加Ⅰ期临床药物试验筛选的177名健康志愿者,对一般资料及实验室、体格检查、心电图检查进行汇总分析。结果参加筛选的健康志愿者男女性别比值为2.53(170∶70),红细胞计数及血红蛋白异常的比例男性均比女性高(P<0.05),且低年龄组(<28岁)血红蛋白异常的比例更高(P<0.05);男性的中性粒细胞计数异常的比例为6.5%(女性:15.7%),与女性比较差别有统计学意义(χ2=3.90,P<0.05);男性的血糖异常比例为34.6%(女性:20.0%),与女性比较差别有统计学意义(χ2=4.39,P=0.036<0.05)。结论筛选Ⅰ期临床药物试验的健康志愿者时,男性及低年龄(<28岁)志愿者,应注意检查红细胞计数及血红蛋白、血糖;而女性志愿者注意监测中性粒细胞计数。

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 clinical 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）（P0.05）.The rate of neutrophilic granulocyte count abnormality male group person had a lower than females（6.5% vs 15.7%,χ2=3.90,P0.05）.The abnormality rate of blood glucose in male was 34.6%,higher than that in female group 20.0%（χ2=4.39,P=0.0360.05）.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.