乙肝免疫球蛋白的临床试验。为国家心肺研究所1972 - 1975年的研究制定政策和材料。

Clinical trials of hepatitis B immune globulin. Development of policies and materials for the 1972-1975 studies sponsored by the National Heart and Lung Institute.

作者信息

Surgenor D M, Chalmers T C, Conrad M E, Friedewald W T, Grady G F, Hamilton M, Mosley J W, Prince A M, Stengle J M

出版信息

N Engl J Med. 1975 Nov 20;293(21):1060-2. doi: 10.1056/NEJM197511202932102.

DOI:10.1056/NEJM197511202932102

Abstract

Plasma from persons with high titers of hepatitis B antibody (anti-HBs) was used to manufacture one lot of hepatitis B "immune" globulin sufficient for four interlocking clinical trials of prevention or modification of hepatitis B infections. The trials were carried out in renal dialysis units, in medical personnel with accidental exposures to hepatitis B, in transfused patients, and in patients with fulminant hepatitis. A single policy board developed protocols that allowed comparisons among the four studies while respecting the unique requirements of each.

摘要

使用来自乙肝抗体（抗-HBs）高滴度人群的血浆生产了一批乙肝“免疫”球蛋白，足以用于四项关于预防或改善乙肝感染的相互关联的临床试验。这些试验在肾透析单位、意外接触乙肝的医护人员、输血患者以及暴发性肝炎患者中进行。一个单一的政策委员会制定了方案，允许在四项研究之间进行比较，同时尊重每项研究的独特要求。