Prince A M, Szmuness W, Mann M K, Vyas G N, Grady G F, Shapiro F L, Suki W N, Friedman E A, Stenzel K H
N Engl J Med. 1975 Nov 20;293(21):1063-7. doi: 10.1056/NEJM197511202932103.
A randomized, double-blind, multicenter study of hepatitis prevention by immune serum globulin with high anti-HBs titer ("hepatitis B immune globulin") was carried out among 318 new patients and 296 staff members of renal dialysis units. Three milliliters of high titer globulin, repeated at four months, was compared with equal doses of intermediate or normal titer globulin. Among staff members, the cumulative percentages developing hepatitis or HBs Ag, or both, within eight months were 6.9, 11.7, and 11.1 in the high, intermediate, and normal titer groups respectively. The lower incidence associated with high titer globulin was not significant (P greater than 0.05). However, among the patients the respective percentages were 7.9, 21.3, and 23.1 and the lower incidence in the high titer globulin group was significant.
在318名新患者和296名肾透析单位工作人员中开展了一项关于高抗-HBs滴度免疫血清球蛋白(“乙肝免疫球蛋白”)预防肝炎的随机、双盲、多中心研究。将3毫升高滴度球蛋白(4个月后重复给药)与等量的中滴度或正常滴度球蛋白进行比较。在工作人员中,高滴度、中滴度和正常滴度组在8个月内发生肝炎或HBs Ag或两者皆有的累积百分比分别为6.9%、11.7%和11.1%。高滴度球蛋白组较低的发病率无统计学意义(P大于0.05)。然而,在患者中,相应的百分比分别为7.9%、21.3%和23.1%,高滴度球蛋白组较低的发病率具有统计学意义。