Chanchairujira Thawee, Chantaphakul Narumol, Thanwandee Thaweesak, Ong-Ajyooth Leena
Renal Division, Department of Medicine, Siriraj Hospital, Bangkok, Thailand.
J Med Assoc Thai. 2006 Aug;89 Suppl 2:S33-40.
Hepatitis B virus infection remains an important problem in hemodialysis patients. Only 50 to 60% of the patients develop seroconversion (anti-HBs Ab titer > 10 IU/L) after intramuscular hepatitis B vaccination. Small dose intradermal inoculation method of hepatitis B vaccine has been reported to be effective as well as economical, and could provide rapid seroconvesion of immunity. The aim of the present study was to compare the efficacy of intradermal hepatitis B vaccination with intramuscular vaccination in hemodialysis patients.
Fifty one hemodialysis patients were randomly assigned to two groups, 25 patients received a total 7 doses of 10 mmicrog of recombinant hepatitis B vaccine (Engerix B) intradermally every 2 weeks (ID group), whereas 26 patients received 40 microg intramuscularly at 0, 1, 2 and 6 months (IM group). Anti-HBs Ab titer was measured at 2, 3, 4 and 7 months after the first vaccination in both groups. Vaccination responses were classified into 3 subgroups according to anti-HBs Ab titer and these included excellent response (> 1,000 IU/L), good response (10-999 IU/L) and non-response (< 10 IU/L).
The seroconversion rates at 2, 3, 4, and 7 months in the ID group were 56%, 76%, 88%, and 92% compared with 31%, 42%, 65%, and 69% in the IM group, respectively. Only the seroconversion rates at 3 months were significantly higher in the ID group (76% versus 42%, p = 0.03). At 7 months after the first vaccination, good and excellent responders in the ID group were 72% (18/25) and 20% (5/25) compared with 34.5% (9/26) and 34.5% (9/26), respectively (p > 0.05). Only minor side effects were observed.
Seven doses of 10 mg intradermal vaccination induced a high seroconversion rate and were comparable with intramuscular regimen. Intradermal vaccination may be helpful for the rapid induction of protective level of antibodies and may be a cost-saving alternative to intramuscular vaccination in hemodilaysis patients.
乙肝病毒感染在血液透析患者中仍然是一个重要问题。肌肉注射乙肝疫苗后，只有50%至60%的患者出现血清学转换（抗-HBs抗体滴度>10 IU/L）。据报道，小剂量皮内接种乙肝疫苗的方法既有效又经济，并且可以快速实现免疫血清学转换。本研究的目的是比较皮内接种乙肝疫苗与肌肉注射疫苗在血液透析患者中的疗效。
51例血液透析患者被随机分为两组，25例患者每2周皮内接种共7剂10μg重组乙肝疫苗（安在时）（皮内注射组），而26例患者在0、1、2和6个月时肌肉注射40μg（肌肉注射组）。两组在首次接种后2、3、4和7个月测量抗-HBs抗体滴度。根据抗-HBs抗体滴度将疫苗接种反应分为3个亚组，包括良好反应（>1000 IU/L）、一般反应（10-999 IU/L）和无反应（<10 IU/L）。
皮内注射组在2、3、4和7个月时的血清学转换率分别为56%、76%、88%和92%，而肌肉注射组分别为31%、42%、65%和69%。只有皮内注射组3个月时的血清学转换率显著更高（76%对42%，p=0.03）。首次接种后7个月，皮内注射组的良好和良好以上反应者分别为72%（18/25）和20%（5/25），而肌肉注射组分别为34.5%（9/26）和34.5%（9/26）（p>0.05）。仅观察到轻微的副作用。
7剂10mg皮内接种可诱导较高的血清学转换率，与肌肉注射方案相当。皮内接种可能有助于快速诱导达到保护性抗体水平，并且可能是血液透析患者肌肉注射疫苗的一种节省成本的替代方法。
