临床药理学试验中40岁及以下健康志愿者的血常规参考区间的建立  

Establishment of Reference Interval of Blood Routine Test for Healthy Adults Aged 40 and Below in Clinical Pharmacology Test by Direct Method

作　　者：陈焕文[1] 钟平 张彧梅[1] 刘剑锋[2] CHEN Huan-wen;ZHONG Ping;ZANG Yu-mei;LIU Jian-feng(Xinglin Laboratory,The First Affiliated Hospital of Xiamen University,Xiam en 361000,China;BE and Phase I Clinical Trial Center,The First Affiliated Hospital of Xiamen University,Xiamen 361000,China)

机构地区：[1]厦门大学附属第一医院杏林分院检验科,福建厦门361000 [2]厦门大学附属第一医院BE/Ⅰ期临床试验研究中心,福建厦门361000

出　　处：《海峡药学》2021年第7期111-113,共3页Strait Pharmaceutical Journal

摘　　要：目的采用直接法建立临床药理学试验中40岁及以下健康志愿者的血常规参考区间。方法2018年9月20日至2019年6月25日,以我院临床试验中心参加临床药理学试验的741名健康志愿者为参考人群,建立白细胞(WBC),嗜中性粒细胞绝对计数(NE#),嗜酸性粒细胞绝对计数(EO#),红细胞(RBC),血红蛋白(HGB),血小板计数(PLT)6个参数的血常规参考区间并与实验室提供的参考区间进行比较。结果本文报道了本地区临床药理学试验中40岁及以下健康成人志愿者的6项血常规参数的参考区间;男、女红细胞和血红蛋白的参考区间差异有统计学意义。且本研究建立的参考区间与实验室提供的参考区间存在明显的差异。结论在临床药理学研究中应建立与本地区健康志愿者人群相匹配的血常规参考区间,可以大大降低假阳性的比例,进一步提高参考区间的参考价值。OBJECTIVE The reference intervals of blood routine test was established for healthy adults aged<40 in clinical pharmacology test using direct method.METHODS From September 20,2018 to June 25,2019,741 healthy adults who participated in clinical pharmacology test of Clinical Trial Center in our hospital were recruited to establish reference intervals of 6 parameters including white blood cells(WBC),absolute neutrophil count(NE#),absolute eosinophil count(EO#),erythrocyte(RBC),hemoglobin(HGB),and platelet count(PLT).Then newly established reference intervals were compared with existing reference intervals of laboratory.RESULTS This study reported 6 reference intervals of blood routine for healthy adults aged<40 in clinical trials;The reference intervals of red blood cells between men and women and hemoglobin were statistically significant different.A significant difference between the newly established reference intervals and the existing reference interval of our laboratory was observed.CONCLUSION In clinical pharmacology trials,it is necessary to establish specific reference intervals of blood routine for local healthy volunteers,which can greatly reduce the proportion of false positiv and further improve the validity of reference interval.

关 键 词：直接法 临床试验 血常规 参考区间 

分 类 号：R969.4[医药卫生—药理学]