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加速乙型肝炎病毒疫苗接种方案在血液透析患者中的应用效果如何?一项随机对照试验。

The accelerated hepatitis B virus vaccination schedule among hemodialysis patients, does it work? A randomized controlled trial.

机构信息

Internal Medicine Department, Faculty of Medicine, Benha University, Benha, Egypt.

出版信息

J Nephrol. 2017 Dec;30(6):803-809. doi: 10.1007/s40620-017-0443-5. Epub 2017 Oct 3.

Abstract

BACKGROUND

Hemodialysis patients possess particular attributes which increase the susceptibility to hepatitis B virus (HBV) infections. HBV vaccination significantly decreased the number of new HBV-infected patients. However, the conventional vaccination schedule requires a 6-months duration. This study aimed to examine the efficacy the accelerated vaccination schedule among hemodialysis patients.

METHODS

In this study, 202 consecutive hemodialysis patients at New Jeddah hospital were enrolled. The inclusion criteria were: (1) age was above 18 years, (2) all patients had undetectable HBV surface antigen and antibody. Exclusion criteria included: (1) patient had a positive serum HBV surface antigen and antibody using enzyme-linked immunosorbent assay; (2) patient received a previous course of HBV vaccine, (3) patient who was pregnant. Patients were sequentially randomized to receive either Hepatitis B recombinant DNA vaccine (conventional schedule) or to receive combined hepatitis A and B vaccine injection (accelerated schedule). Testing for HBV surface antibodies was done one and three months after completion of the dosage schedule. The primary outcome was the proportion of seroprotection (defined by serum HBV surface antibodies ≥ 10 mIU/ml). Adverse reactions were evaluated regarding both fever and post-injection pain scale.

RESULTS

Patients' age ranged from 18 to 71 years.After 1 and 3 months of completion of the vaccination schedule, there was no statistical difference in the proportion of seroprotected patients among both groups.

CONCLUSION

Accelerated vaccination schedule using combined hepatitis A and B vaccine may be beneficial for HBV seroprotection among hemodialysis patients.

摘要

背景

血液透析患者具有增加乙型肝炎病毒 (HBV) 感染易感性的特殊属性。HBV 疫苗接种显著减少了新的 HBV 感染患者的数量。然而,常规的疫苗接种计划需要 6 个月的时间。本研究旨在检验加速疫苗接种计划在血液透析患者中的疗效。

方法

本研究纳入了新吉达医院的 202 例连续血液透析患者。纳入标准为:(1)年龄大于 18 岁;(2)所有患者均未检测到 HBV 表面抗原和抗体。排除标准包括:(1)患者使用酶联免疫吸附试验检测到血清 HBV 表面抗原和抗体阳性;(2)患者接受过 HBV 疫苗的先前疗程;(3)患者怀孕。患者被顺序随机分配接受乙型肝炎重组 DNA 疫苗(常规方案)或甲型肝炎和乙型肝炎联合疫苗注射(加速方案)。在完成剂量方案后 1 个月和 3 个月时检测 HBV 表面抗体。主要结局是血清保护率(定义为血清 HBV 表面抗体≥10mIU/ml)的比例。评估了发热和注射后疼痛量表的不良反应。

结果

患者年龄在 18 至 71 岁之间。在完成疫苗接种计划后的 1 个月和 3 个月,两组中血清保护患者的比例无统计学差异。

结论

使用甲型肝炎和乙型肝炎联合疫苗的加速疫苗接种计划可能有益于血液透析患者的 HBV 血清保护。

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