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血液透析患者的乙肝疫苗接种:一项随机临床试验。

Hepatitis B vaccination in haemodialysis patients: a randomized clinical trial.

作者信息

Bock Marilene, Barros Elvino, Veronese Francisco J V

机构信息

Graduate Program in Medical Sciences-Nephrology, Nephrology Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.

出版信息

Nephrology (Carlton). 2009 Apr;14(3):267-72. doi: 10.1111/j.1440-1797.2008.01040.x. Epub 2009 Jan 13.

DOI:10.1111/j.1440-1797.2008.01040.x
PMID:19207871
Abstract

AIM

A short vaccination protocol against hepatitis B was compared to the standard approach in patients under haemodialysis who were primarily non-responsive to the vaccine.

METHODS

This randomized, controlled open trial included 51 chronic haemodialysis subjects previously vaccinated against hepatitis B and with anti-HBs levels of less than 10 IU/mol/L. Twenty-six patients received 20 microg i.m. once a week for 8 weeks (short protocol) and 25 subjects three doses of 40 microg i.m. at months 0, 1 and 6 (standard protocol). Clinical and laboratory data were compared between responders and non-responders. A logistic regression model included selected parameters to assess risk factors for non-seroconversion.

RESULTS

Seroconversion rates to vaccine at 2 months were 80% and 78% in the short and standard protocol groups, respectively (P = 0.99). Median of anti-HBs levels were similar up to 6 months of follow up, but patients in the standard protocol showed a trend to higher anti-HBs in month 3 and a more steady decline in antibody titres. Non-responders were older, had longer duration of dialysis and a higher prevalence of a prior renal transplant and hepatitis C. In multivariate analysis, only advanced age and hepatitis C remained independently associated with non-responsiveness to vaccination.

CONCLUSION

In haemodialysis patients, a short vaccination protocol against hepatitis B did not provide any benefit compared to the standard approach with respect to peak anti-HBs titres or a higher rate of seroprotection at the end of follow up. Other strategies to increase seroconversion rates should be explored, especially in the elderly and in patients with hepatitis C.

摘要

目的

将一种针对乙型肝炎的短程疫苗接种方案与标准方案在主要对疫苗无反应的血液透析患者中进行比较。

方法

这项随机、对照开放试验纳入了51名既往接种过乙型肝炎疫苗且抗-HBs水平低于10 IU/mol/L的慢性血液透析受试者。26名患者每周一次肌肉注射20微克,共8周(短程方案),25名受试者在第0、1和6个月分三次肌肉注射40微克(标准方案)。比较了应答者和无应答者的临床和实验室数据。一个逻辑回归模型纳入了选定参数以评估未发生血清转化的危险因素。

结果

短程方案组和标准方案组在2个月时的疫苗血清转化率分别为80%和78%(P = 0.99)。在长达6个月的随访中,抗-HBs水平的中位数相似,但标准方案组的患者在第3个月抗-HBs有升高趋势,且抗体滴度下降更平稳。无应答者年龄更大,透析时间更长,既往肾移植和丙型肝炎的患病率更高。在多变量分析中,只有高龄和丙型肝炎仍与疫苗接种无反应独立相关。

结论

在血液透析患者中,针对乙型肝炎的短程疫苗接种方案与标准方案相比,在抗-HBs峰值滴度或随访结束时更高的血清保护率方面没有任何益处。应探索其他提高血清转化率的策略,尤其是在老年人和丙型肝炎患者中。

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