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[基于不同接种方案的慢性肾脏病患者乙肝疫苗接种的免疫原性及影响因素]

[Immunogenicity and influencing factors of hepatitis B vaccination based on different vaccination schedules among chronic kidney disease patients].

作者信息

Feng Y L, Han Y J, Yao T, Wang J M, Liu H T, Guo H P, Chai G W, Liu L M, Wang F Z, Wang S P

机构信息

Department of Epidemiology, School of Public Health, Shanxi Medical University, Taiyuan 030001, China.

Department of Nephrology, Linfen Central Hospital, Linfen 041000, China.

出版信息

Zhonghua Liu Xing Bing Xue Za Zhi. 2022 Feb 10;43(2):241-247. doi: 10.3760/cma.j.cn112338-20210807-00618.

Abstract

To explore the immunogenicity and influencing factors of hepatitis B vaccination based on different vaccination schedules among chronic kidney disease (CKD) patients. 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 tests, analysis of variance, unconditional logistic regression analysis. 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 (<0.05). The GMCs of anti-HBs showed similar results (2 091.11 mIU/ml and 2 441.50 mIU/ml 1 675.21 mIU/ml) (<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) (<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) (<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%: 1.02-9.96) and 5.32 (95%: 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%: 1.26-8.80) and 4.78 (95%: 1.47-15.57) times higher than those in the patients with such therapy, respectively. 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.

摘要

探讨基于不同接种程序的慢性肾脏病(CKD)患者乙肝疫苗接种的免疫原性及影响因素。对山西省4家医院参与随机对照试验、完成3剂20μg疫苗接种(0、1、6月)以及4剂20μg或60μg疫苗接种(0、1、2、6月)的CKD患者,于2019年5月至2020年7月进行调查。按照1∶1∶1的比例,将273例CKD患者随机分为3组。在全程接种疫苗后的第1个月和第6个月,采用化学发光微粒子免疫分析法对血清样本中的抗乙肝表面抗原抗体(抗-HBs)进行定量检测。通过检验、方差分析、非条件logistic回归分析对抗-HBs的阳性率、高水平阳性率、几何平均浓度(GMC)及影响因素进行分析。共有273例CKD患者参与。全程接种疫苗后第1个月,4剂20μg疫苗接种组(92.96%,66/71)和4剂60μg疫苗接种组(93.15%,68/73)CKD患者的阳性率高于3剂20μg疫苗接种组(81.69%,58/71)(P<0.05)。抗-HBs的GMC结果相似(分别为2091.11mIU/ml、2441.50mIU/ml和1675.21mIU/ml)(P<0.05)。全程接种疫苗后第6个月,4剂60μg疫苗接种组(94.83%,55/58)CKD患者的阳性率高于3剂20μg疫苗接种组(78.79% ,52/6)(P<0.05)。4剂60μg疫苗接种组患者抗-HBs的GMC(824.28mIU/ml)显著高于3剂20μg疫苗接种组(639.74mIU/ml)和4剂20μg疫苗接种组(755.53mIU/ml)(P<0.05)。在控制混杂因素后,全程接种疫苗后第1个月和第6个月,4剂60μg疫苗接种组CKD患者的阳性率分别是3剂20μg疫苗接种组患者的3.19倍(95%CI:1.02 - 9.96)和5.32倍(95%CI:1.27 - 22.19)。无免疫抑制或激素治疗的CKD患者的阳性率分别是有此类治疗患者的3.33倍(95%CI:1.26 - 8.80)和4.78倍(95%CI:1.47 - 15.57)。4剂20μg或60μg乙肝疫苗接种可提高CKD患者的免疫原性。4剂60μg疫苗接种可能对该人群抗-HBs的维持起积极作用。有免疫抑制或激素治疗的CKD患者免疫原性较差。

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