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本文报道自1972年10月1日至1973年10月28日美国30个医疗中心协作研究静脉内注射乙型肝炎免疫球蛋白以治疗暴发性乙型肝炎的效果。选例原则:(1)病急起,符合急性病毒性肝炎;(2)无混淆诊断或影响预后的慢性肝病;(3)从症状初起至出现脑病不超过6周;(4)入院24小时内凝血酶元时间≥1.5倍于正常值;(5)入院48小时内检查 HBsAg 阳性;(6)未接受过含抗-HBs 的血或血制品;(7)神经系统症状从嗜睡以至昏迷分Ⅱ～Ⅳ度。研究方法:用中心计算机程序,随机抽取病例进行静脉注射含抗-HBs 的超免疫球蛋白或白蛋白安慰剂治疗,最初6个月(第一阶段)的25例中14例用1.32克超免疫球蛋白,11例用2克白蛋白安慰剂;以后的7个月(第二阶段)的28例中11例用5.28克超免疫球蛋白,17例用8克白蛋白安慰剂;用对流电泳法测定开始治疗前及治疗后24小时血清 HBsAg 的滴度。结果:第一阶段(小剂量)在安慰剂组治疗前及治疗后血清 HBsAg 的几何平均滴度分别为1:23及1:16,在超免疫球蛋白组分别为1:26及1:18,两组间未见差别;第二阶段(大剂量)作同样比较,两组间亦无显著差异,说明两种剂量的超免疫球蛋白,均未能消除抗原血症。在安慰剂组:昏迷Ⅱ度的8例中死亡4例,Ⅲ度的8例中死亡5例,Ⅳ度的12例中死亡10例;在超免疫球蛋白组:昏迷Ⅱ度的5例中死亡2例,Ⅲ度的12例中死亡10例,Ⅳ度的8例中死亡6例,两组间的死亡率无显著差异,说明外源性抗体治疗,既不能消除抗原血症,亦不能降低死亡率。全部53例中,有8例在治疗前的血清中亦可找到抗-HBs,其滴度为1:4～1:64,其中在1:4～1:8的抗-HBs 的4例中有1例存活,1:16～1:64抗-HBs 的4例中也有1例存活,而45例未检出抗-HBs 的患者中14例(31%)存活,说明内源性特异抗体的存在,并不能改善患者的不幸结局。作者指出:在急性肝衰竭时,血中HBsAg 的滴度及其动态改变,与预后无关,外源性抗-HBs 并不能补偿机体的某些不足,因此作者认为:用抗-HBs 作暴发性乙型肝炎免疫治疗,似乎没有价值。
This article reports the effect of intravenous injection of hepatitis B immunoglobulin in the treatment of fulminant hepatitis B in 30 U.S. medical centers from October 1, 1972 to October 28, 1973. The principle of selection: (1) acute onset, consistent with acute viral hepatitis; (2) no confound diagnosis or prognosis of chronic liver disease; (3) from the onset of symptoms until encephalopathy does not exceed 6 weeks; (4) admission 24 (5) 48 hours after admission to check HBsAg positive; (6) did not receive anti-HBs containing blood or blood products; (7) neurological symptoms from lethargy and coma Points Ⅱ ~ Ⅳ degrees. METHODS: Central computerized procedures were used to randomize patients for intravenous injection of anti-HBs-containing hyperimmune or albumin placebo. In the first 6 months (stage I), 14 of the 25 patients were immunized with 1.32 g of hyperimmune 11 cases with 2 g of albumin placebo; 11 of 28 cases in the next 7 months (stage II) with 5.28 g of hyperimmune globulin and 17 cases with 8 g of albumin placebo; with convective gel electrophoresis Act to determine the serum HBsAg titers before treatment and 24 hours after treatment. Results: The geometric mean titers of serum HBsAg in the first phase (small dose) before and after treatment in the placebo group were 1:23 and 1:16, respectively, and in the super-immunoglobulin group were 1:26 and 1:18 , No difference between the two groups; the second phase (high dose) for the same comparison, there was no significant difference between the two groups, indicating that the two doses of hyper-immunoglobulin failed to eliminate anti-hyperlipidemia. In the placebo group, 4 were killed in 8 cases of coma II, 5 died in 8 cases of grade 3, and 10 died in 12 cases of grade IV. In the hyper-immunoglobulin group: 5 cases of coma II There were 2 deaths, 10 deaths in 12 patients of grade III, and 6 deaths in 8 patients of grade IV, with no significant difference in mortality between the two groups, indicating that exogenous antibody treatment neither abolished antigens or prevented Reduce mortality. Anti-HBs were also found in 8 of the 53 patients in pre-treatment sera with titers of 1: 4 to 1: 64, among 4 of 1: 4 to 1: 8 anti-HBs One of the 4 surviving, 1: 16- to 1: 64 anti-HBs-positive survivors was found in one of the 45 patients, whereas the remaining 45 (31%) of 45 non-HBs-resistant patients survived, indicating that endogenous specific antibodies The existence of, and can not improve the patient’s unfortunate outcome. The authors point out that in acute liver failure, the titer of HBsAg in the blood and its dynamic changes have nothing to do with the prognosis, and exogenous anti-HBs can not compensate for some of the body’s deficiencies. Therefore, the author believes that the use of anti-HBs for fulminant Hepatitis B immunotherapy does not seem worthwhile.