Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China.
Nephrol Dial Transplant. 2010 Jul;25(7):2303-9. doi: 10.1093/ndt/gfq094. Epub 2010 Feb 24.
The response to recombinant hepatitis B vaccine remains suboptimal among the dialysis population.
In this multi-centre randomized controlled trial, we studied the factors that modify the response to intramuscular Engerix-B vaccination in patients on peritoneal dialysis. The primary aim was to study if a three-dose schedule of extra-high dose (80 microg) of Engerix-B would offer better primary seroconversion and more persistent serological protection than the conventional 40-microg dose.
Forty-two peritoneal dialysis patients were randomized to receive the conventional 40-microg Engerix-B dose and 45 patients to 80-microg dose. Seroconversion [hepatitis B surface antibody (anti-HBs) level > or =10 IU/l 3 months after completion of the third dose] occurred in 78.6% of patients after 40-microg Engerix-B dosage treatment versus 62.2% for those receiving 80-microg Engerix-B treatment (P = 0.11). After 12 months, the persistence of protective anti-HBs also did not differ between 40- (45.2%) and 80-microg (51.1%) treatment groups (P = 0.67). In contrast, patients with seroconversion 3 months after the third dose of Engerix-B had a higher normalized protein nitrogen appearance (nPNA) than patients without seroconversion (1.16 +/- 0.25 versus 0.96 +/- 0.23 g/kg/day, P = 0.001). Conclusions. We found no evidence of a worthwhile clinical benefit from increasing the three-dose intramuscular Engerix-B vaccine from 40- to 80-microg dose. An unplanned analysis suggested a role of improved protein intake to improve the immune response to hepatitis B vaccine in peritoneal dialysis patients.
在透析人群中，重组乙型肝炎疫苗的反应仍然不理想。
在这项多中心随机对照试验中，我们研究了影响腹膜透析患者肌肉内接种乙型肝炎疫苗反应的因素。主要目的是研究三剂高剂量（80μg）乙型肝炎疫苗能否比常规 40μg 剂量提供更好的初次血清转换和更持久的血清学保护。
42 名腹膜透析患者被随机分配接受常规 40μg 乙型肝炎疫苗和 45 名患者接受 80μg 剂量。40μg 乙型肝炎疫苗剂量治疗组有 78.6%的患者在第三剂后 3 个月发生血清转换（乙型肝炎表面抗体（抗-HBs）水平>或=10IU/l），而接受 80μg 乙型肝炎疫苗治疗的患者有 62.2%发生血清转换（P=0.11）。12 个月后，保护性抗-HBs 的持续时间在 40-μg（45.2%）和 80-μg（51.1%）治疗组之间也没有差异（P=0.67）。相比之下，第三剂乙型肝炎疫苗后发生血清转换的患者的标准化蛋白氮出现率（nPNA）高于未发生血清转换的患者（1.16 +/- 0.25 与 0.96 +/- 0.23 g/kg/天，P=0.001）。结论：我们没有发现增加三剂肌肉内乙型肝炎疫苗剂量从 40μg 增加到 80μg 有任何临床获益的证据。一项计划外分析表明，改善蛋白质摄入可能有助于提高腹膜透析患者对乙型肝炎疫苗的免疫反应。
