上海地区女性卵泡期血清性激素指标长期生物学变异研究  

Long-term biological variation of serum sex hormones during female follicular phase in Shanghai

作　　者：王正权 吴正沐[1] 李文[1] WANG Zhengquan;WU Zhengmu;LI Wen(Assisted Reproduction Department,Shanghai Key Laboratory of Embryonic Diseases,International Peace Maternal and Child Health Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200030,China)

机构地区：[1]上海交通大学医学院附属国际和平妇幼保健院辅助生殖科上、海市胚胎源性疾病重点实验室,上海200030

出　　处：《检验医学》2024年第3期282-288,共7页Laboratory Medicine

摘　　要：目的了解上海地区女性卵泡期血清性激素指标长期生物学变异数据,以导出基于生物学变异的性能规范。方法招募上海交通大学医学院附属国际和平妇幼保健院64名志愿者(20~40岁非妊娠期女性),采集每位志愿者每月月经期第2或3天外周血样本,持续6个月,检测7项血清性激素指标[抗米勒管激素(AMH)、雌二醇(E2)、促卵泡激素(FSH)、黄体生成素(LH)、泌乳素(PRL)、孕酮(Prog)、睾酮(Testo)]水平。根据相关公式导出“最佳”“适当”“最低”3个水平的允许不精密度、允许偏移和允许总误差。结果与欧洲临床化学和检验医学联合会(EFLM)数据库数据相比,Prog、Testo项目个体内变异(CV_(I))和个体间变异(CV_(G)),FSH项目CV_(I)与已有数据差异无统计学意义(P>0.05);E2项目CV_(I)和CV_(G)均显著高于已有数据(P<0.01);PRL、LH项目CV_(I)和CV_(G),FSH项目CVG,AMH项目CV_(I)均显著低于已有数据(P<0.01);AMH项目CV_(G)尚无报道。结论确定了上海地区女性卵泡期7项血清性激素指标的长期生物学变异数据。可为临床开展相关指标性能验证提供基于上海地区人群生物学变异导出的性能规范。Objective To investigate the long-term biological variation of 7 serum sex hormones during female follicular phase in Shanghai,and to derive the performance specification based on biological variation.Methods A total of 64 volunteers(non-pregnant females aged 20-40 years old)were enrolled from the International Peace Maternal and Child Health Hospital affiliated to Shanghai Jiao Tong University School of Medicine.Peripheral blood samples were collected on the 2nd or 3rd day of menstruation of each volunteer every month for 6 months.The 7 serum sex hormones[anti-Müllerian hormone(AMH),estradiol(E2),follicle-stimulating hormone(FSH),luteinizing hormone(LH),prolactin(PRL),progesterone(Prog)and testosterone(Testo)]were determined.The allowable imprecision,allowable deviation and allowable total error of the 3 levels of"best","appropriate"and"lowest"were derived according to the relevant formulas.Results Compared with European Federation of Clinical Chemistry and Laboratory Medicine(EFLM)database,Prog,Testo intra-individual coefficient of variation(CV_(I))and inter-individual coefficient of variation(CV_(G)),FSH CV_(I) were compared with existing data,and there was no statistical significance(P>0.05).CV_(I) and CV_(G) of E2 were higher than the existing data(P<0.01),CV_(I) and CV_(G) of PRL and LH,CV_(G) of FSH and CV_(I) of AMH were lower than the existing data(P<0.01),and no CV_(G) of AMH had ever been reported.Conclusions Long-term biological variation data of 7 serum sex hormones of females in Shanghai has been determined.It can provide a performance specification based on the biological variation of the population in Shanghai.

关 键 词：性激素 卵泡期 生物学变异 性能规范 上海 

分 类 号：R446.1[医药卫生—诊断学]