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在23名健康成人志愿者中,对一种新的S/D处理制备的正常人肌注免疫球蛋白(S/D-HNIG)和商品的正常人肌注免疫球蛋白(HNIG)的药物动力学和耐受量,采用双盲法平行分组进行了比较研究。对受试者随机地肌注750mg HNIG或S/D-HNIG,注射后进行血清甲型肝炎病毒抗体水平测定。对其中的13名受试者分批给予第二次S/D-HNIG 750mg注射。结果表明两种制品的甲型肝炎病毒抗体的药物动力学相似。平均(±SD)血清半寿期HNIG是27.1±5.9天,两组S/D-HNIG的半寿期分别为25.0±6.2天和20.5±4.0天。平均增加的甲型肝炎病毒抗体是在曲线范围内(Auc:0-63天):HNIG为2149±612iu天/L,两组S/D-HNIG分别为2342±624iu天/L和3305
In 23 healthy adult volunteers, pharmacokinetics of a new S / D-treated normal human immunoglobulin (S / D-HNIG) and commercial human immunoglobulin (HNIG) Study and tolerance, using a double-blind parallel group conducted a comparative study. Subjects were randomized to intramuscular injection of 750 mg HNIG or S / D-HNIG and serum hepatitis A virus antibody levels were determined after injection. Thirteen of these subjects were given a second 750 mg injection of S / D-HNIG in batches. The results show that the two products have similar pharmacokinetics of the Hepatitis A virus antibodies. Mean (± SD) serum half-life HNIG was 27.1 ± 5.9 days with a half-life of 25.0 ± 6.2 days and 20.5 ± 4.0 days for both S / D-HNIG groups. The average increase in Hepatitis A virus antibodies was within the curve range (Auc: 0-63 days): HNIG was 2149 ± 612iu days / L, and S / D-HNIGs were 2342 ± 624iu days / L and 3305, respectively