混合血浆的人血浆成分浓缩物的肝炎风险（作者译）

[Hepatitis risk of human plasma-fraction concentrates of pooled plasma (author's transl)].

作者信息

Ohlmeier H, Dahmen E, Hoppe I

出版信息

Dtsch Med Wochenschr. 1978 Oct 27;103(43):1700-3. doi: 10.1055/s-0028-1129326.

Abstract

In 1975/76 the risk of hepatitis from human clotting preparations (fibrinogen, prothrombin complex) prepared from pooled plasma was studied prospectively in patients who had undergone open-heart surgery with cardiopulmonary bypass. Of 247 patients 25 (10%) developed hepatitis postoperatively, while of 17 recipients of plasma-fraction concentrates 12 developed hepatitis (71%). Even taking into account other potential risk factors this rate of hepatitis is statistically significant. It demonstrates that even with the most modern screening methods it is not possible to produce clotting preparations from "large pool" human plasma which is free of hepatitis risk, unless additional virus-inactivating measures are taken.

摘要

1975/1976年，对接受体外循环心脏直视手术的患者进行了前瞻性研究，以探讨从混合血浆制备的人凝血制剂（纤维蛋白原、凝血酶原复合物）导致肝炎的风险。247名患者中，25名（10%）术后发生肝炎，而17名接受血浆浓缩物的患者中，12名发生肝炎（71%）。即使考虑到其他潜在风险因素，这种肝炎发生率在统计学上也具有显著意义。这表明，即使采用最现代的筛查方法，除非采取额外的病毒灭活措施，否则不可能从“大量混合”人血浆中制备出无肝炎风险的凝血制剂。