Palmović D, Crnjaković-Palmović J
University Hospital of Infectious Disease, Dr. Fran Mihaljevic, Zagreb, Croatia.
Infection. 1993 Jan-Feb;21(1):42-5. doi: 10.1007/BF01739311.
The efficacy of hepatitis B (HB) vaccine alone or combined with hepatitis B immunoglobulin (HBIg) in preventing hepatitis B virus (HBV) infection was studied in a controlled trial. Recombinant HB vaccine (Engerix-B, 20 micrograms) was given to 40 susceptible health-care workers within three days of exposure (Group B). In another group of 37 medical professionals a single dose of HBIg (0.06 mg/kg) was administered intramuscularly within three days of exposure, followed immediately by the first dose of vaccine (20 micrograms dose) (Group A). In both groups the next doses of recombinant vaccine were administered one, two and six months later. One month after the fourth dose of vaccine the percentage of incidence of antibody to hepatitis B virus surface antigen (anti-HBs) was 94.6% in group A and 95% in group B with geometric mean titer of antibodies of 340 and 380 mIU/ml, respectively. A control group consisted of 34 persons who did not receive any specific immunoprophylaxis (Group C). All subjects were followed for at least ten months. The protective value of immunization, both active alone and combined passive and active, was clearly effective since none of the recipients developed acute symptomatic HBV infection compared with two (6%) of 34 not immunized persons (Fisher's exact test p = 0.01). Thus, in the absence of evidence of lesser efficacy for the use of HB vaccine alone after exposure to HBsAg-positive blood, this schedule would seem to be the treatment of choice in adult persons.
在一项对照试验中研究了单独使用乙肝（HB）疫苗或联合乙肝免疫球蛋白（HBIg）预防乙肝病毒（HBV）感染的效果。在暴露后三天内，给40名易感医护人员接种重组HB疫苗（安在时，20微克）（B组）。在另一组37名医学专业人员中，在暴露后三天内肌肉注射一剂HBIg（0.06mg/kg），随后立即接种第一剂疫苗（20微克剂量）（A组）。两组均在1个月、2个月和6个月后接种后续的重组疫苗剂量。在接种第四剂疫苗1个月后，A组乙肝病毒表面抗原抗体（抗-HBs）的发生率为94.6%，B组为95%，抗体几何平均滴度分别为340和380mIU/ml。一个对照组由34名未接受任何特异性免疫预防的人员组成（C组）。所有受试者至少随访10个月。单独主动免疫以及被动和主动联合免疫的保护作用均明显有效，因为与34名未免疫者中的2人（6%）相比，所有接种者均未发生急性症状性HBV感染（Fisher精确检验p=0.01）。因此，在没有证据表明暴露于HBsAg阳性血液后单独使用HB疫苗疗效较差的情况下，该方案似乎是成人的首选治疗方法。
