目的:分析孕早期和孕晚期不规则抗体检测结果,探讨其临床意义及安全对略。方法:选取2018年7月至2019年9月来本院就诊的14 770名孕妇,分别在孕早期（≤16周）和孕晚期（≥32周）对其进行不规则抗体筛查,对初筛阳性者进一步行抗体鉴定及效价检测。留取任意一次不规则抗体筛查结果为阳性的孕妇分娩后新生儿的脐带血或静脉血,进行胎儿及新生儿溶血病（hemolytic disease of fetus and newborn,HDFN）检测。结果:14 770名孕妇中有63例在孕早期检出不规则抗体,孕早期的不规则抗体阳性率为0.43%;至孕晚期共有97例孕妇检出不规则抗体,孕晚期的不规则抗体阳性率为0.66%,孕晚期新增检出不规则抗体34例,占检出总数的35.05%,孕晚期阳性率高于孕早期,差异有统计学意义（ χ²=7.264,P<0.05）。孕早期和孕晚期抗体分布中,抗M抗体占比最高,分别为33.33%和34.02%,抗E抗体占比分别为12.69%和16.49%,抗D抗体占比分别为7.94%和8.25%,孕早期与孕晚期抗体分布情况基本相同（ χ²=2.269,P>0.05）。63例孕早期检出不规则抗体的孕妇中,孕晚期滴度升高≥2个梯度者有11例,孕晚期效价≥64者有7例;孕晚期新增的34例不规则抗体阳性孕妇的抗体效价普遍偏低,效价≥64者仅有1例。97例不规则抗体阳性孕妇所分娩的新生儿中,有12例可证实为非ABO-HDFN,8例为孕早期阳性者所分娩,其中6例为RH血型系统所致（抗D5例,抗Ec1例）,症状较重,经输血或换血治疗后缓解,另2例为抗M 1例,抗S 1例;4例为孕晚期新增阳性者所分娩,症状较轻。结论:上海地区孕妇孕晚期不规则抗体阳性检出率明显高于孕早期,而孕早期抗体阳性者的抗体效价偏高,会导致严重的HDFN;孕晚期再次检测可提高抗体检出率,保障临床用血安全,保障母婴安全。

Objective: To analyze the results of irregular antibody detection in early and late pregnancy and to study its clinical significance and safety strategy. Methods: A total of 14 770 pregnant women visited Shanghai First Maternity and Infant Hospital from July 2018 to September 2019 were enrolled and detected for irregular antibodies in the first trimester (≤16 weeks) and late pregnancy (≥32 weeks). In pregnant women with positive irregular antibody, umbilical cord blood or venous blood of newborn infant were collected for the testing of hemolytic disease of fetus and newborn HDFN. Results: Of the 14 770 case of pregnant women, 63 cases had irregular antibodies detected in the early pregnancy, with a positive rate of 0.43%, while 97 cases had irregular antibodies detected in late pregnancy, with a positive rate of 0.66%( χ²=7.264, P< 0.05). The number of cases with irregular antibody detected increased by 34cases in late pregnancy, accounting for 35.05% of the total positive irregular antibody cases. Majority of irregular antibody detected were anti-M antibodies, accounting for 33.33% and 34.02% in early and late pregnancy, respectively. Anti-E antibodies accounted for 12.69% and 16.49%, respectively, while proportion of anti-D antibodies were 7.94% and 8.25%, respectively. The distribution of antibody types between early and late pregnancy was similar( χ²=2.269, P>0.05). Of the 63 cases with irregular antibodies detected in early pregnancy, the titration of antibody increased by 2 gradients in 11 cases at late pregnancy, and 7 of them reached ≥ 64. The 34 cases with irregular antibody newly detected in late pregnancy generally had lower titration of antibodies, with only 1 case with titration≥64. Amongthe fetus delivered by 97 pregnant women with irregular antibodies, 12 were confirmed having non-ABO-HDFN; 8 were delivered by pregnant women with irregular antibody detected at early pregnancy, and 6 of the 8 were of the RH system (anti-D5, anti-Ec1), with more severe symptoms requiring blood transfusion or exchange transfusion. The 4 fetuses with non-ABO-HDFN delivered by women with irregular antibody newly detected at late pregnancy had mild symptoms. Conclusions: The detection rate of irregular antibody in late stage of pregnancy in Shanghai is obviously higher than that in early stage of pregnancy. Higher titer of antibody in early stage of pregnancy may result in serious HDFN. Retesting of irregular antibody in late pregnancy has some significance for ensu-ring the safety of mother and child.