{"title":"晚期慢性肾病患者与维持性血液透析患者乙肝疫苗接种后血清转换率的比较","authors":"Tomoyuki Fujikura, Shinsuke Isobe, Shigeru Oikawa, Sayaka Ishigaki, Naoko Katahashi, Takamasa Iwakura, Naro Ohashi, Akihiko Kato, Hideo Yasuda","doi":"10.1007/s10157-025-02648-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients receiving dialysis are at an increased risk of hepatitis B virus (HBV) infection due to a compromised immune system. While HBV vaccination is recommended, the response rate to the standard vaccination regimen (3 doses of 10 µg HBV vaccine) among patients with chronic kidney disease (CKD) or receiving hemodialysis in Japan is unclear. This study evaluated the seroconversion rate, optimal timing, and CKD stage in patients receiving HBV vaccination.</p><p><strong>Methods: </strong>In this prospective, observational study conducted from May 2021 to July 2024, patients with advanced CKD not on dialysis and those receiving maintenance hemodialysis at two centers in Japan received 3 doses of 10 µg HBV vaccine at 0, 1, and 6 months. The primary outcome was the seroconversion rate, defined as anti-HBs antibody levels of ≥10 IU/mL, measured 1-3 months after the third dose.</p><p><strong>Results: </strong>Overall, 113 participants (63 with non-dialysis CKD and 50 with hemodialysis CKD) were included. The seroconversion rates were 64.3% in non-dialysis patients and 54.2% in patients on hemodialysis, with no significant difference (OR = 0.62, 95% CI 0.28-1.38). Multivariate analysis adjusting for covariates showed no significant difference (OR = 0.74, 95% CI 0.29-1.91), and sensitivity analysis confirmed this finding.</p><p><strong>Conclusions: </strong>The seroconversion rate of the standard HBV vaccination (3×10 µg) was not significantly different from those in non-dialysis patients with CKD. More effective vaccination strategies such as higher doses, third-generation vaccines, or vaccination at an earlier CKD stage are required to improve HBV protection in this population.</p>","PeriodicalId":10349,"journal":{"name":"Clinical and Experimental Nephrology","volume":" ","pages":""},"PeriodicalIF":2.2000,"publicationDate":"2025-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparison of seroconversion rates after hepatitis B vaccination in patients with advanced chronic kidney disease and those receiving maintenance hemodialysis.\",\"authors\":\"Tomoyuki Fujikura, Shinsuke Isobe, Shigeru Oikawa, Sayaka Ishigaki, Naoko Katahashi, Takamasa Iwakura, Naro Ohashi, Akihiko Kato, Hideo Yasuda\",\"doi\":\"10.1007/s10157-025-02648-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients receiving dialysis are at an increased risk of hepatitis B virus (HBV) infection due to a compromised immune system. While HBV vaccination is recommended, the response rate to the standard vaccination regimen (3 doses of 10 µg HBV vaccine) among patients with chronic kidney disease (CKD) or receiving hemodialysis in Japan is unclear. This study evaluated the seroconversion rate, optimal timing, and CKD stage in patients receiving HBV vaccination.</p><p><strong>Methods: </strong>In this prospective, observational study conducted from May 2021 to July 2024, patients with advanced CKD not on dialysis and those receiving maintenance hemodialysis at two centers in Japan received 3 doses of 10 µg HBV vaccine at 0, 1, and 6 months. The primary outcome was the seroconversion rate, defined as anti-HBs antibody levels of ≥10 IU/mL, measured 1-3 months after the third dose.</p><p><strong>Results: </strong>Overall, 113 participants (63 with non-dialysis CKD and 50 with hemodialysis CKD) were included. The seroconversion rates were 64.3% in non-dialysis patients and 54.2% in patients on hemodialysis, with no significant difference (OR = 0.62, 95% CI 0.28-1.38). Multivariate analysis adjusting for covariates showed no significant difference (OR = 0.74, 95% CI 0.29-1.91), and sensitivity analysis confirmed this finding.</p><p><strong>Conclusions: </strong>The seroconversion rate of the standard HBV vaccination (3×10 µg) was not significantly different from those in non-dialysis patients with CKD. More effective vaccination strategies such as higher doses, third-generation vaccines, or vaccination at an earlier CKD stage are required to improve HBV protection in this population.</p>\",\"PeriodicalId\":10349,\"journal\":{\"name\":\"Clinical and Experimental Nephrology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-03-04\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical and Experimental Nephrology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10157-025-02648-1\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"UROLOGY & NEPHROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical and Experimental Nephrology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10157-025-02648-1","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：由于免疫系统受损，接受透析的患者感染乙型肝炎病毒（HBV）的风险增加。虽然推荐接种HBV疫苗，但在日本慢性肾脏疾病（CKD）或接受血液透析的患者中，标准疫苗接种方案（3剂10µg HBV疫苗）的应答率尚不清楚。本研究评估了接受HBV疫苗接种的患者血清转换率、最佳时机和CKD分期。方法：在这项于2021年5月至2024年7月进行的前瞻性观察性研究中，在日本的两个中心，未进行透析的晚期CKD患者和接受维护性血液透析的患者在0、1和6个月时接受了3剂10µg HBV疫苗。主要终点是血清转化率，定义为在第三次给药后1-3个月测量的抗hbs抗体水平≥10 IU/mL。结果：总共纳入113名参与者（63名非透析CKD患者和50名血液透析CKD患者）。非透析患者血清转换率为64.3%，血液透析患者为54.2%，差异无统计学意义（OR = 0.62, 95% CI 0.28-1.38）。调整协变量的多因素分析显示无显著差异（OR = 0.74, 95% CI 0.29-1.91），敏感性分析证实了这一发现。结论：标准HBV疫苗的血清转换率（3×10µg）与非透析的CKD患者无显著差异。需要更有效的疫苗接种策略，如更高剂量，第三代疫苗，或在早期CKD阶段接种疫苗，以提高这一人群的HBV保护。
Comparison of seroconversion rates after hepatitis B vaccination in patients with advanced chronic kidney disease and those receiving maintenance hemodialysis.
Background: Patients receiving dialysis are at an increased risk of hepatitis B virus (HBV) infection due to a compromised immune system. While HBV vaccination is recommended, the response rate to the standard vaccination regimen (3 doses of 10 µg HBV vaccine) among patients with chronic kidney disease (CKD) or receiving hemodialysis in Japan is unclear. This study evaluated the seroconversion rate, optimal timing, and CKD stage in patients receiving HBV vaccination.
Methods: In this prospective, observational study conducted from May 2021 to July 2024, patients with advanced CKD not on dialysis and those receiving maintenance hemodialysis at two centers in Japan received 3 doses of 10 µg HBV vaccine at 0, 1, and 6 months. The primary outcome was the seroconversion rate, defined as anti-HBs antibody levels of ≥10 IU/mL, measured 1-3 months after the third dose.
Results: Overall, 113 participants (63 with non-dialysis CKD and 50 with hemodialysis CKD) were included. The seroconversion rates were 64.3% in non-dialysis patients and 54.2% in patients on hemodialysis, with no significant difference (OR = 0.62, 95% CI 0.28-1.38). Multivariate analysis adjusting for covariates showed no significant difference (OR = 0.74, 95% CI 0.29-1.91), and sensitivity analysis confirmed this finding.
Conclusions: The seroconversion rate of the standard HBV vaccination (3×10 µg) was not significantly different from those in non-dialysis patients with CKD. More effective vaccination strategies such as higher doses, third-generation vaccines, or vaccination at an earlier CKD stage are required to improve HBV protection in this population.
期刊介绍：
Clinical and Experimental Nephrology is a peer-reviewed monthly journal, officially published by the Japanese Society of Nephrology (JSN) to provide an international forum for the discussion of research and issues relating to the study of nephrology. Out of respect for the founders of the JSN, the title of this journal uses the term “nephrology,” a word created and brought into use with the establishment of the JSN (Japanese Journal of Nephrology, Vol. 2, No. 1, 1960). The journal publishes articles on all aspects of nephrology, including basic, experimental, and clinical research, so as to share the latest research findings and ideas not only with members of the JSN, but with all researchers who wish to contribute to a better understanding of recent advances in nephrology. The journal is unique in that it introduces to an international readership original reports from Japan and also the clinical standards discussed and agreed by JSN.
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