Brachott D, Lifschitz I, Mosley J W, Kendrick M A, Sgouris J T
J Lab Clin Med. 1975 Feb;85(2):281-6.
To determine the effect of fragmentation on potency of immune globulin preparations, two comparisons were carried out. In one study, the immune globulin was derived from American plasma; in the other, the source was Israeli plasma. In each of the two studies, three materials were given to household contacts of icteric hepatitis: (1) human albumin as a placebo; (2) immune globulin with the IgG intact; and (3) immune globulin of the same lot with the IgG deliberately fragmented by added fibrinolysin. Comparable reductions in secondary attack rates were achieved with fragmented and unfragmented materials from both lots. Fragmentation, therefore, had no deleterious effect. In addition, it was found that American globulin is comparable to Israeli globulin for protection against strains of Type A hepatitis prevalent in Israel. Administration in the second half (last 15 days) of the incubation period did not reduce the frequency of icteric disease.
为了确定片段化对免疫球蛋白制剂效力的影响，进行了两项比较。在一项研究中，免疫球蛋白源自美国血浆；在另一项研究中，来源是以色列血浆。在这两项研究中，分别给黄疸型肝炎患者的家庭接触者三种物质：（1）人白蛋白作为安慰剂；（2）完整IgG的免疫球蛋白；（3）同一批次的免疫球蛋白，其中IgG通过添加纤维蛋白溶酶故意片段化。来自两个批次的片段化和未片段化物质在二次发病率上有类似降低。因此，片段化没有有害影响。此外，还发现美国球蛋白在预防以色列流行的甲型肝炎毒株方面与以色列球蛋白相当。在潜伏期后半段（最后15天）给药并未降低黄疸疾病的发生率。
