成年血液透析患者对重组乙型病毒性肝炎疫苗的应答与影响情况的初步研究

目的本研究探讨了国产重组乙型病毒性肝炎（乙型肝炎）疫苗在我国成年血液透析患者中应用的安全性、效果和影响疫苗应答的可能因素。方法29位年龄（53．1±13．3）。岁，己开始规律性透析一月以上终末期肾病（ESRD）患者，透析龄（32．9±25．5）月，病情稳定，乙型肝炎全套，丙型肝炎抗体均为阴性，肝功能正常，从未接种过乙型肝炎疫苗的患者。分别于0，1，6月接受皮下注射10μg乙型肝炎疫苗共三次，在接受最后一次注射后3月测定乙型肝炎表面抗体（HbsAb）的阳性率。血液透析室乙型肝炎全套和丙型肝炎抗体均阴性的工作人员10人接受皮下注射乙型肝炎疫苗作为正常对照组，注射剂量、方法、时间相同。结果：疫苗的耐受性好，血液透析组和对照组各有一人次出现轻度发热（〈38℃），没有发生其它的不良反应。所有患者均完成三次注射和复查，血液透析组HbsAb的阳性率为51．7％，对照组HbsAb的阳性率为70％，5年后HbsAb阳性组存活11人，9人HbsAb仍为阳性，2人HbsAb转阴（一人2年后转阴、另一人3年）。结论血液透析患者因细胞免疫功能受损HbsAb的阳性率较对照组低。本研究中HbsAb阳转的血液透析患者同未阳转的患者比较，在性别、年龄、原发病、体重及红细胞压积（Hct）、血钙、磷、全段甲状旁腺激素（iPTH）、透析充分性方面无差别，但两组在白蛋白、前白蛋白值上有显著性差异（P〈0．05），提示营养情况可能和透析患者对重组乙型肝炎疫苗的应答有关。

Immune response and the factors influencing the response after vaccination with recombinant hepatitis surface antigen in adult hemodialysis patients

Objective To evaluate the safety and efficacy of the recombinant HBV vaccine made in China in adult hemodialysis patients, and the factors influencing the response to the vaccination. Method We assigned 29 patients （aged 53.1 ± 13.3 years） who had received hemodialysis for more than one month, without previous HBV vaccination, but with negative serum HBV and HCV antibodies and normal liver function, to be vaccinated intradermally with 10μg HBV vaccine 3 times at 0, 1 st and 6th months. Anti-HBV antibodies were measured after the last vaccination for 3 months. The medical staffs working in the hemodialysis center with negative serum HBV and HBC antibodies were also vaccinated using the same vaccination schedule as the controls. Result The vaccine was well tolerated. Lower fever （〈 38~C） was found in one patient and one control, but without other untoward reactions. All patients completed the 3 vaccinations and serum anti-HBV antibody assays. Positive response to the vaccine was found in 51.7% patients and 70% controls. After 5 years, 11 patients with response to the vaccine were still alive, of whom 9 remained serum positive HBV antibodies, and 2 turned to be negative （one became negative after 2 years, and one after 3 years）. Conclusion Lower response to the vaccination exhibited in hemodialysis patients due to their impaired immunological function. In this study, no significant differences in age, sex, primary diseases, body weight, hematocrit, serum calcium and phosphorus, iPTH and dialysis efficacy, but significant differences in serum albumin and pre-albumin （P 〈 0.05） were found between patients responding to the vaccination and those without response to the vaccination, suggesting that nutrition status of hemodialysis patients may affect the response to the vaccination.