化学发光免疫分析法检测正常孕妇抗磷脂抗体水平及在不同孕期的比较  

Detection of antiphospholipid antibody levels in normal pregnant women by chemiluminescence immunoassay and comparison between different trimesters

作　　者：周慧如 周玉侠 周凤荣 范刚 沈峰[1] 何倩 焦瑾 吴卫卫 王谢桐 Zhou Huiru;Zhou Yuxia;Zhou Fengrong;Fan Gang;Shen Feng;He Qian;Jiao Jin;Wu Weiwei;Wang Xietong(Department of Clinical Laboratory,Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University,Jinan 250014,China;Department of Maternal and Child Health Care,Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University,Jinan 250014,China;Department of Clinical Laboratory,Shandong Provincial Hospital Affiliated to Shandong First Medical University,Jinan 250021,China;Department of Obstetrics(Key Laboratory of Birth Regulation and Control Technology of National Health Commission of China),Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University,Jinan 250014,China)

机构地区：[1]青岛大学附属山东省妇幼保健院检验科,济南250014 [2]青岛大学附属山东省妇幼保健院社会保健科,济南250014 [3]山东第一医科大学附属省立医院检验科,济南250021 [4]青岛大学附属山东省妇幼保健院产科(国家卫生健康委员会生育调控技术重点实验室),济南250014

出　　处：《中华围产医学杂志》2022年第11期823-828,共6页Chinese Journal of Perinatal Medicine

基　　金：山东省医药卫生科技发展计划(202011001495)。

摘　　要：目的采用化学发光免疫分析法检测健康未孕及妊娠期女性抗心磷脂抗体(anticardiolipin antibody,aCL)和抗β2-糖蛋白Ⅰ抗体(anti-β2-glycoproteinⅠantibody,aβ2GPⅠ)-IgA/IgG/IgM的水平,并探讨不同孕期的变化。方法前瞻性纳入2020年4月至2021年8月于青岛大学附属山东省妇幼保健院进行孕前优生健康检查的无不良妊娠史的健康孕龄妇女(非孕组)和产前检查的妊娠经过正常的孕妇(妊娠期组)。采用BIO-FLASH化学发光免疫分析仪检测aCL和aβ2GPⅠ-IgA/IgG/IgM水平,计算P_(95)和P_(99)。采用Mann-WhitneyU检验比较未孕组和妊娠期组aCL和aβ2GPⅠ-IgA/IgG/IgM的水平,采用Kruskal-WallisH检验比较早、中、晚不同孕期各抗体的变化,并采用Spearman相关分析孕期与aCL、aβ2GPⅠ-IgA/IgG/IgM的相关性。结果符合纳入标准454例,因各种原因排除19例后,余435例纳入分析。未孕组110例,妊娠期组325例,其中早孕期(≤13周+6)110例,中孕期(孕14^(+0)~27周^(+6))110例,晚孕期(≥28周)105例。未孕组aCL-IgA/IgG/IgM和aβ2GPⅠ-IgA/IgG/IgM的P_(99)分别为7.31、14.70、7.92、3.58、13.60和4.95 CU,妊娠期组aCL-IgA/IgG/IgM和aβ2GPⅠ-IgA/IgG/IgMP_(99)分别为5.90、12.78、5.70、1.60、10.65和3.90 CU,均低于试剂制造商所给出的20 CU的界值。妊娠期组aCL-IgA/IgG/IgM和aβ2GPⅠ-IgG/IgM水平均明显低于未孕组[aCL-IgA:1.90 CU(1.40~2.70 CU)与2.90 CU(2.20~3.83 CU),Z=-7.14;aCL-IgG:3.00 CU(2.20~4.50 CU)与6.10 CU(4.20~7.83 CU),Z=-10.26;aCL-IgM:1.40 CU(1.10~2.30 CU)与2.65 CU(2.08~3.73 CU),Z=-8.87;aβ2GPⅠ-IgG:3.50 CU(2.60~4.90 CU)与4.75 CU(3.60~5.93 CU),Z=-5.45;aβ2GPⅠ-IgM:0.70 CU(0.50~1.20 CU)与1.00 CU(0.60~1.53 CU),Z=-3.73;P值均<0.001]。晚孕期aCL-IgA水平高于早孕期和中孕期;与早孕期相比,中孕期aCL-IgG/IgM水平降低,中、晚孕期aβ2GPⅠ-IgG水平降低(P值均<0.05)。Spearman相关分析显示,aCL-IgG/IgM、aβ2GPⅠ-IgA/IgM与孕期(早、中、晚孕期)无明显相关性(P值均>0.05)。aCL-IgAObjective Chemiluminescence immunoassay was used to detect the levels of anticardiolipin antibody(aCL)-IgA/IgG/IgM and anti-β2-glycoproteinⅠantibody(aβ2GPⅠ)-IgA/IgG/IgM in healthy non-pregnant and pregnant women to explore the changes of antiphospholipid antibody in different pregnancy periods.Methods This prospective study was conducted in Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University,involving normal pregnant women who underwent prenatal examination and healthy non-pregnant women with no history of adverse pregnancy who underwent progestational eugenic health examination from April 2020 to August 2021.The levels of aCL-IgA/IgG/IgM and aβ2GPⅠ-IgA/IgG/IgM were detected using BIO-FLASH chemiluminescence immunoassay analyzer and P_(95) as well as P_(99) were calculated,respectively.The difference in the six data between non-pregnant and pregnant women was compared using Mann-Whitney U test.Kruskal-Wallis H test was used to compare the change of each antibody in different pregnancy periods and Spearman correlation was used to analyze the correlation between different trimester and the levels of aCL-IgA/IgG/IgM and aβ2GPⅠ-IgA/IgG/IgM.Results A total of 454 cases met the inclusion criteria,and 435 cases were included in the analysis after excluding 19 cases,among them 110 were non-pregnant women and 325 were pregnant women,including 110 cases in the first trimester(≤13+6 weeks),110 cases in the second trimester(14^(+0)~27^(+6) weeks),and 105 cases in the third trimester(≥28 weeks).P_(99) value of aCL-IgA/IgG/IgM and aβ2GPⅠ-IgA/IgG/IgM in the non-pregnant women were 7.31,14.70,7.92,3.58,13.60,and 4.95 CU,which in the pregnant women were 5.90,12.78,5.70,1.60,10.65,and 3.90 CU,and were all lower than the cut-off value of 20 CU that given by the analyzer manufacturer.The levels of aCL-IgA/IgG/IgM,and aβ2GPⅠ-IgG/IgM in the pregnant women were significantly decreased comparing with the non-pregnant women[aCL-IgA:1.90 CU(1.40-2.70 CU)vs 2.90 CU(2.20-3.83 CU

关 键 词：抗磷脂综合征 抗体 抗心脂 抗体 抗磷脂 妊娠 发光测定法 

分 类 号：R446.6[医药卫生—诊断学] R714[医药卫生—临床医学]