Thürmann P A, Sonnenburg-Chatzopoulos C, Lissner R
Department of Clinical Pharmacology, University Clinic Frankfurt, Germany.
Eur J Clin Pharmacol. 1995;49(3):237-42. doi: 10.1007/BF00192385.
In two independent trials 10 and 12 healthy volunteers received the novel intravenous immunoglobulin (IVIG) preparations BT 511 and BT 507, respectively. BT 511 contains 5 g human plasma proteins per 100 ml, more than 95% of which are immunoglobulins of the G class (IgG). BT 507 contains in addition 61 IU antibody against hepatitis B surface antigen (anti-HBs).ml-1. In trial I volunteers received 4.0 ml/kg (n = 4) and 8.0 ml.kg-1 (n = 6) BT 511 to study the tolerability and the magnitude of the increase in immunoglobulins in plasma as well as their decline over 1 month. After administration of the lower dose, plasma IgG increased from 10.7 to 14.7 g.l-1 directly after the infusion. Following the 8.0 ml.kg-1 dose a more pronounced increase from 12.4 to 21.2 g.l-1 was observed. No adverse events occurred. After 1 month IgG concentrations had almost reached baseline values at 12.2 g.l-1 in the 4.0 ml.kg-1 group, but were still significantly increased at 15.2 g.l-1 after the high dose. There was a linear correlation between the maximal IgG plasma concentration and the subsequent decline of IgG during the 29-day observation period. After administration of BT 507 maximal anti-HBs concentrations of 1778 mU.ml-1 occurred 1.4 h after termination of the infusion. The terminal elimination half-life was 22.4 days, and total clearance and volume of distribution were determined to be 0.122 ml.min-1 and 5.41, respectively. The pharmacokinetic parameters calculated for anti-HBs as an indicator of IgG were in accordance with the pharmacokinetic behaviour of native IgG.
在两项独立试验中，分别有10名和12名健康志愿者接受了新型静脉注射免疫球蛋白（IVIG）制剂BT 511和BT 507。BT 511每100 ml含有5 g人血浆蛋白，其中超过95%是G类免疫球蛋白（IgG）。BT 507还含有61 IU乙型肝炎表面抗原抗体（抗-HBs）·ml⁻¹。在试验I中，志愿者接受4.0 ml/kg（n = 4）和8.0 ml·kg⁻¹（n = 6）的BT 511，以研究耐受性、血浆中免疫球蛋白增加的幅度以及它们在1个月内的下降情况。给予较低剂量后，输注后血浆IgG直接从10.7 g·l⁻¹增加到14.7 g·l⁻¹。给予8.0 ml·kg⁻¹剂量后，观察到从12.4 g·l⁻¹到21.2 g·l⁻¹有更明显的增加。未发生不良事件。1个月后，4.0 ml·kg⁻¹组的IgG浓度在12.2 g·l⁻¹时几乎达到基线值，但高剂量后在15.2 g·l⁻¹时仍显著升高。在29天观察期内，最大IgG血浆浓度与随后IgG的下降之间存在线性相关性。给予BT 507后，输注结束后1.4小时出现最大抗-HBs浓度为1778 mU·ml⁻¹。终末消除半衰期为22.4天，总清除率和分布容积分别确定为0.122 ml·min⁻¹和5.41。以抗-HBs作为IgG指标计算的药代动力学参数与天然IgG的药代动力学行为一致。
