Objective: To explore the immunogenicity and influencing factors of hepatitis B vaccination based on different vaccination schedules among chronic kidney disease (CKD) patients. Methods: CKD patients who participated in randomized controlled trials in four hospitals in Shanxi province and completed three doses of 20 µg vaccination (at months 0, 1 and 6) and four doses of 20 µg or 60 µg vaccination (at months 0, 1, 2, and 6) were surveyed from May 2019 to July 2020.According to the ratio of 1∶1∶1, 273 CKD patients were divided into 3 groups randomly. Quantification of the anti-hepatitis B surface antigen-antibody (anti-HBs) in serum samples was performed using chemiluminescent microparticle immunoassay at months 1 and 6 after the entire course of the vaccinations. The positive rate, high-level positive rate, geometric mean concentration (GMC) of anti-HBs, and the influencing factors were analyzed by χ2 tests, analysis of variance, unconditional logistic regression analysis. Results: A total of 273 CKD patitents were participants.The positive rates in the CKD patients with four doses of 20 µg vaccination (92.96%,66/71) or 60 µg vaccination (93.15%, 68/73) were higher than that in the CKD patients with three doses of 20 µg vaccination (81.69%, 58/71) at month one after the full course of the vaccinations (P<0.05). The GMCs of anti-HBs showed similar results (2 091.11 mIU/ml and 2 441.50 mIU/ml vs. 1 675.21 mIU/ml) (P<0.05). The positive rate was higher in the CKD patients with four doses of 60 µg vaccination (94.83%,55/58) than in those with three doses of 20 µg vaccination (78.79%,52/66) (P<0.05) at month six after the full course of the vaccinations. And the GMC of anti-HBs in the patients with four doses of 60 µg vaccination (824.28 mIU/ml) was significantly higher than those in the patients with 3 or 4 doses of 20 µg vaccination (639.74 mIU/ml and 755.53 mIU/ml) (P<0.05). After controlling the confounding factors, the positive rate in the CKD patients with four doses of 60 µg vaccination were 3.19 (95%CI: 1.02-9.96) and 5.32 (95%CI: 1.27-22.19) times higher than those in the patients with three doses of 20 µg vaccination at months 1 and 6 after the full course of the vaccinations, respectively. The positive rate in CKD patients without immune suppression or hormone therapy was 3.33 (95%CI: 1.26-8.80) and 4.78 (95%CI: 1.47-15.57) times higher than those in the patients with such therapy, respectively. Conclusions: Four doses of 20 µg or 60 µg hepatitis B vaccination could improve the immunogenicity in patients with CKD. And four doses of 60 µg vaccination might play a positive role in maintaining anti-HBs in this population. The immunogenicity in the CKD patients with immune suppression or hormone therapy was poor.
目的： 分析不同免疫方案对慢性肾脏病（CKD）患者接种乙型肝炎（乙肝）疫苗的免疫效果及影响因素。 方法： 研究对象为2019年5月至2020年7月在山西省4家医院参加随机对照试验的CKD患者273例。按1∶1∶1比例采用区组随机分为3组（每组91例），分别接受0-1-6月20 µg、0-1-2-6月20 µg、0-1-2-6月60 µg乙肝疫苗接种，在全程接种后1个月和6个月随访期采用化学发光微粒子免疫分析法进行乙型肝炎表面抗体（抗-HBs）的定量检测，采用χ2检验、方差分析、非条件logistic回归的统计学方法分析其阳性率、强阳性率和几何平均浓度（GMC）及影响因素。 结果： 273例CKD患者中，全程接种后1个月随访期，0-1-2-6月20 µg和0-1-2-6月60 µg组的抗-HBs阳性率［92.96%（66/71）和93.15%（68/73）］及抗-HBs GMC（2 091.11 mIU/ml和2 441.50 mIU/ml）明显高于0-1-6月20 µg组［81.69%（58/71）及1 675.21 mIU/ml］（均P<0.05）；全程接种后6个月随访期，0-1-2-6月60 µg组抗-HBs阳性率（94.83%，55/58）明显高于0-1-6月20 µg组（78.79%，52/66）（P<0.05），0-1-2-6月60 µg组抗-HBs GMC（824.28 mIU/ml）明显高于0-1-2-6月20 µg组（755.53 mIU/ml）和0-1-6月20 µg组（639.74 mIU/ml）（P<0.05）。控制潜在混杂因素后，全程接种后1个月和6个月随访期，按0-1-2-6月接种60 µg乙肝疫苗的抗-HBs阳性的概率分别是0-1-6月20 µg组的3.19（95%CI：1.02~9.96）和5.32（95%CI：1.27~22.19）倍，不服用激素/免疫抑制剂者的抗-HBs阳性的概率分别是服用者的3.33（95%CI：1.26~8.80）和4.78（95%CI：1.47~15.57）倍。 结论： 0-1-2-6月20 µg和0-1-2-6月60 µg免疫方案均可提高CKD患者乙肝疫苗免疫效果，且0-1-2-6月60 µg方案对该人群抗-HBs水平的维持有积极作用。服用激素/免疫抑制剂的CKD患者乙肝疫苗免疫效果不佳。.