Rand K H, Gibbs K, Derendorf H, Graham-Pole J
Department of Pathology, University of Florida, Gainesville 32610.
J Clin Pharmacol. 1991 Dec;31(12):1151-4. doi: 10.1002/j.1552-4604.1991.tb03688.x.
The pharmacokinetics of an intravenous immunoglobulin (IVIG), Gammagard (Baxter Healthcare Corp., Glendale, CA), were measured in 31 cytomegalovirus (CMV) antibody negative bone marrow transplant (BMT) patients as part of a multicenter efficacy trial of 2 weekly dose regimens. Since all patients lacked antibody to CMV and received only screened CMV negative blood products, the half-life of the exogenous CMV antibody could be measured with an ELISA assay. The CMV antibody titer was related to the immunoglobulin concentration using a standard curve. Compared with the 22-day half-life in normal subjects, the half-life in BMT patients was approximately 6 days for either the 250 mg/kg or 500 mg/kg dose regimen. The half-life did not change over the subsequent 3 weekly doses. Peak concentrations were 3.5 +/- 1.4 and 2.6 +/- 0.7 mg/mL of IVIG in week 1 as well as 5.5 +/- 2.6 and 3.4 +/- 1.2 mg/mL in week 3 after the 250 mg/kg and 500 mg/kg, respectively. Total body clearance of IVIG was 0.61 and 0.46 mL/kg/hr for the 500 mg/kg and 250 mg/kg, respectively.
作为一项关于每两周一次给药方案的多中心疗效试验的一部分，对31名巨细胞病毒（CMV）抗体阴性的骨髓移植（BMT）患者测定了静脉注射免疫球蛋白（IVIG）Gammagard（百特医疗保健公司，加利福尼亚州格伦代尔）的药代动力学。由于所有患者均缺乏CMV抗体且仅接受经过筛查的CMV阴性血液制品，因此可通过酶联免疫吸附测定（ELISA）法测定外源性CMV抗体的半衰期。使用标准曲线将CMV抗体滴度与免疫球蛋白浓度相关联。与正常受试者22天的半衰期相比，对于250mg/kg或500mg/kg剂量方案，BMT患者的半衰期约为6天。在随后的3次每周给药过程中，半衰期没有变化。在第1周，250mg/kg和500mg/kg剂量的IVIG峰值浓度分别为3.5±1.4和2.6±0.7mg/mL，在第3周分别为5.5±2.6和3.4±1.2mg/mL。500mg/kg和250mg/kg剂量的IVIG全身清除率分别为0.61和0.46mL/kg/hr。
