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在接受维持性透析的患者中,乙肝疫苗(安在时®)与乙肝疫苗-CpG(海乐宝®)疫苗血清保护作用的真实世界比较。

A real world comparison of HepB (Engerix-B®) and HepB-CpG (Heplisav-B®) vaccine seroprotection in patients receiving maintenance dialysis.

机构信息

Dialysis Clinic Inc, Nashville, TN, USA.

Tufts Medical Center, Boston, MA, USA.

出版信息

Nephrol Dial Transplant. 2023 Feb 13;38(2):447-454. doi: 10.1093/ndt/gfac039.

DOI:10.1093/ndt/gfac039
PMID:35150277
Abstract

BACKGROUND

Vaccination against hepatitis B virus (HBV) is recommended for dialysis patients. Two reports comparing seroprotection (SP) rates following HepB and HepB-CpG in vaccine-naïve patients with chronic kidney disease enrolled few dialysis patients (n = 122 combined). SP rates in a subset of dialysis patients were not reported or not powered to detect statistically significant differences. SP rates in those requiring additional vaccine series or booster doses are not known.

METHODS

A retrospective cohort analysis including dialysis patients completing HepB or HepB-CpG vaccination between January 2019 and December 2020. Vaccine-naïve patients received a series of HepB or HepB-CpG (Series 1). A repeat series was given to nonresponders (Series 2). A booster regimen consists of one dose of either vaccine. Primary outcome was achieving SP (anti-HBs >10 mIU/mL) at least 60 days after the last HBV vaccine dose for Series 1 and Series 2, and achieving SP at least 3 weeks post-booster.

RESULTS

For Series 1 (n = 3509), SP after HepB vaccination was significantly higher (62.9% versus 50.1% for HepB-CpG; P < 0.0001). Series 2 (n = 1040) and booster (n = 2028) SP rates were similar between vaccines. Patients that received up to four HepB-CpG doses had higher SP rates compared with four doses of HepB (82.0% versus 62.9%, respectively; P < 0.0001).

CONCLUSIONS

SP rates in hepatitis B vaccine-naïve dialysis patients administered a recommended four doses of HepB were higher than those recommended two doses of HepB-CpG. SP rates were higher and achieved sooner if HepB-CpG was utilized initially and, if needed, for Series 2. Optimal HepB-CpG dosing deserves further study.

摘要

背景

乙型肝炎病毒 (HBV) 疫苗接种被推荐用于透析患者。有两份报告比较了在接受慢性肾脏病治疗的初免患者中,乙型肝炎疫苗 (HepB) 和 HepB-CpG 的血清保护 (SP) 率,其中纳入的透析患者人数较少 (共 122 例)。也未报告或未进行统计学上的显著差异检测来报告透析患者亚组的 SP 率。尚不清楚需要额外疫苗系列或加强剂量的患者的 SP 率。

方法

这是一项回顾性队列分析,纳入了 2019 年 1 月至 2020 年 12 月期间完成 HepB 或 HepB-CpG 疫苗接种的透析患者。初免患者接受 HepB 或 HepB-CpG 系列 1 疫苗接种。对无应答者给予重复系列疫苗接种 (系列 2)。加强方案由一剂两种疫苗中的任意一种组成。主要结局是在接受系列 1 和系列 2 的最后一剂 HBV 疫苗后至少 60 天和在接受加强剂后至少 3 周时达到 SP(抗-HBs >10 mIU/mL)。

结果

对于系列 1(n = 3509),HepB 疫苗接种后的 SP 率显著更高(HepB-CpG 为 50.1%;P < 0.0001)。在系列 2(n = 1040)和加强剂(n = 2028)中,两种疫苗的 SP 率相似。与接受 4 剂 HepB 相比,接受最多 4 剂 HepB-CpG 的患者 SP 率更高(分别为 82.0%和 62.9%;P < 0.0001)。

结论

在接受推荐剂量的 4 剂 HepB 的初免透析患者中,HBV 疫苗接种的 SP 率高于推荐剂量的 2 剂 HepB-CpG。如果最初使用 HepB-CpG 并在需要时进行系列 2 接种,SP 率更高,且更早达到。HepB-CpG 的最佳剂量值得进一步研究。

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