Scheiermann N, Kuwert E K
Dev Biol Stand. 1983;54:347-55.
Hepatitis B immunoglobulins of 4 different manufacturers were administered intramuscularly into 37 healthy adults. Each person received an amount of 0.1 ml per kg bodyweight. Blood samples were taken on days 3, 7, 14, 21, 28, 63, 98 and 126 after passive immunization. The anti-HBs serum levels were determined using the International Reference Preparation of anti-HBs as standard reagent. The highest serum levels were seen on day 3 (38.9% of the test persons), day 7 (41.7%), day 14 (11.1%), and day 21 (8.3%) after application of the immunoglobulins with mean values between 138 and 355 mU anti-HBs/ml. The half-life of the preparations in man showed mean values between 17.5 and 25 days. The shortest half-life was 5.9 and the longest 35 days. Four months after passive immunization the anti-HBs levels had decreased to a percentage of 1.2 to 2.5 of the maximum serum concentration (1.7 to 8.9 mU anti-HBs/ml). The passive immunization via the intramuscular route does not accomplish an instantaneously available, maximum anti-HBs titer. There seems to be a great range of variation in uptake and elimination of the immunoglobulins in man. Still, since preparations for intravenous application are not at hand, hepatitis B immunoglobulins for intramuscular use must play a major role in post-exposure prophylaxis of hepatitis B virus infection.
将4个不同厂家生产的乙型肝炎免疫球蛋白经肌肉注射给37名健康成年人。每人按每千克体重0.1毫升的剂量给药。在被动免疫后的第3、7、14、21、28、63、98和126天采集血样。以抗-HBs国际参考制品作为标准试剂测定抗-HBs血清水平。免疫球蛋白应用后，在第3天（38.9%的受测者）、第7天（41.7%）、第14天（11.1%）和第21天（8.3%）观察到最高血清水平，抗-HBs平均值在138至355 mU/ml之间。这些制剂在人体中的半衰期平均值在17.5至25天之间。最短半衰期为5.9天，最长为35天。被动免疫四个月后，抗-HBs水平已降至最大血清浓度的1.2%至2.5%（1.7至8.9 mU抗-HBs/ml）。通过肌肉注射途径进行的被动免疫不能立即达到最大抗-HBs效价。人体对免疫球蛋白的摄取和消除似乎存在很大差异。尽管如此，由于没有静脉用制剂，肌肉注射用乙型肝炎免疫球蛋白在乙型肝炎病毒感染的暴露后预防中仍必须发挥主要作用。
