Slepushkin A N, Gorbunov M A, Stepanchuk V A, Ikoev V N, Opanasiuk L G
Zh Mikrobiol Epidemiol Immunobiol. 1987 Apr(4):52-5.
The present work deals with the controlled trial aimed at the study of the effectiveness of specific immunoglobulin against hepatitis A, developed in the USSR. This immunoglobulin is prepared from carefully selected blood sera from persons who have had hepatitis A. In accordance with the program approved by the USSR Ministry of Health, two trials were organized among the most susceptible groups of the population: organized groups of preschool children and young adults. During 6 months of the subsequent surveillance carried out in both age groups, the highest morbidity rate in hepatitis A was registered among the nonimmunized subjects. Morbidity rate among the subjects immunized with common commercial immunoglobulin was 3-7 times higher than among those immunized with the specific preparation, but a small size of the groups and a low morbidity level prevented the statistically significant confirmation of this higher effectiveness. Specific immunoglobulin produced a statistically significant (t = 2.72 and 2.4) decrease in morbidity rate among the immunized subjects in both age groups in comparison with morbidity rate among the nonimmunized ones.
本研究涉及一项对照试验，旨在研究苏联研制的抗甲型肝炎特异性免疫球蛋白的有效性。这种免疫球蛋白是从精心挑选的曾患甲型肝炎的人的血清中制备的。根据苏联卫生部批准的方案，在最易感人群中组织了两项试验：学龄前儿童和青年成人的组织群体。在对两个年龄组进行的为期6个月的后续监测期间，甲型肝炎发病率最高的是未接种疫苗的人群。接种普通商业免疫球蛋白的人群的发病率比接种特异性制剂的人群高3至7倍，但由于群体规模小和发病率低，无法从统计学上显著证实这种更高的有效性。与未接种疫苗的人群相比，特异性免疫球蛋白使两个年龄组接种疫苗的人群的发病率在统计学上显著降低（t = 2.72和2.4）。
