乙肝疫苗接种后新生儿乙型肝炎表面抗原一过性阳性的研究

Research on vaccine-induced transient hepatitis B surface antigen positivity in newborn infants

目的回顾性分析并探讨接种乙型肝炎（简称乙肝）疫苗与新生儿乙型肝炎表面抗原（HBsAg）一过性阳性的关系。方法对进行HBsAg检测的178例新生儿资料进行回顾性分析，对疫苗接种后的HBsAg阳性发生率、“乙肝二对半”模式、HBsAg浓度及与接种时间的关系等进行了统计分析，通过胆红素干扰试验排除新生儿黄疸对HBsAg检测的影响，根据新生儿血容量进行乙肝疫苗体外稀释，检测其HBsAg浓度。结果178例新生儿共检测184次，检出HBsAg阳性16例，其中11例为乙肝疫苗引起的HBsAg阳性，3例为母婴垂直传播引起的HBsAg阳性，2例不确定。新生儿乙肝疫苗接种后HBsAg阳性主要发生于接种疫苗后0～7d，与疫苗接种后8～14d及15～31d比较，HBsAg的阳性率差异有统计学意义（P值分别为0．046、0．032）。疫苗接种后的HBsAg浓度为0．12（0．07～0．25）IU／mL，属低值水平。接种疫苗后0～2d，HBsAg浓度最高，之后逐渐下降。乙肝疫苗接种后11例以HBsAg单项阳性为主，其中3例同时伴乙型肝炎表面抗体（HBsAb）阳性，不同于乙肝病毒感染后常见血清模式。将乙肝疫苗1：600稀释后检测HBsAg为0．13IU／mL，与乙肝疫苗引起的HBsAg阳性浓度[0．12（0．07～0．25）IU／mL]近似。干扰试验显示383．9μmol／L总胆红素、29．9μmol／L直接胆红素不影响HBsAg检测。结论接种乙肝疫苗2周内的新生儿发生HBsAg一过性阳性的可能性较大，建议HBsAg检测在乙肝疫苗接种2周后再进行。

Objective To retrospectively analyze and study the relationship of vaccination against hepatitis B virus with transient hepatitis B surface antigen（HBsAg） positivity in newborn infants. Methods The data of 178 newborn infants were collected and analyzed retrospectively, who were determined for HBsAg. The positive rate of HBsAg, hepatitis B 5 items, HBsAg concentration and vaccination time after vaccine inducing were determined, and the relationships were analyzed statistically. Interference testing was performed to investigate the influence of serum jaundice in HBsAg assay. The hepatitis B virus vaccine was diluted in vitro according to neonatal blood volume, and HBsAg concentration was detected. Results A total of 178 newborn infants were determined for 184 times totally, and 16 newborn infants had positive HBsAg. Of these 16 newborn infants, 11 cases could be attributed to vaccination, 3 cases were due to mother-to-child transmission, and 2 cases were with unknown cause. The HBsAg positivity for newborn infants receiving vaccine 0-Td were statistically significant in comparison with those of 8-14 d and 15-31 d （P = 0. 046 and 0. 032）. After the vaccine was injected, the concentration of HBsAg was 0.12 （0.07-0.25） IU/mL, which was at low level. The concentration of HBsAg reached the highest level after 0-2d of injection, and then it decreased gradually. There were totally 11 samples which were HBsAg single positive, and 3 samples of them were both HBsAg and anti- hepatitis B surface antigen antibody （HBsAb） positive, which was obviously different from the common serum pattern of hepatitis B virus infection. HBsAg concentration was 0.13 IU/mL at 1： 600 dilution of vaccine, being similar with that of vaccine-induced HBsAg positive [ 0. 12 （0.07-0.25） IU/mL ]. Jaundice interference testing showed that 383.9 μmol/L total bilirubin and 29.9μmol/L direct bilirubin distraetors did not affect HBsAg results. Conclusions Transient HBsAg positivity can occur in newborn infants within 2 weeks post-vaccination. Newborn infants may not be screened for HBsAg within 2 weeks following vaccination against hepatitis B virus.