冻干低pH静注免疫球蛋白传播丙型肝炎病毒危险性观察与探讨

Observation of and Inquiring into Risk of Hepatitis C Virus Transmission by Freezedried Intravenous Immunoglobulin with Low pH

通过对冻干低ｐＨ静注免疫球蛋白成品的检测和临床使用观察，发现对献血者进行抗－ＨＣＶ抗体筛选，可使成品抗－ＨＣＶ阳性率大幅度降低。由于筛选方法的限制和ＨＣＶ感染后空窗期的存在，合并后的原料血浆污染ＨＣＶ在所难免；冻干低ｐＨ静注免疫球蛋白成品无论其抗－ＨＣＶ是阴性还是阳性，ＰＣＲ检测ＨＣＶ－ＲＮＡ均为阴性的实验结果提示制备工艺过程可以去除ＨＣＶ。临床初步观察和回顾性调查中均未发现ＨＣＶ传播的迹象。

It was found by detection and clinical observation of the final products of freezedried intravenous immunoglobulin with low pH that the screening of HCVAb in blood donors could significantly reduce the positive rate of test for HCVAb in the final products.Because of the limitation of screening method and the presence of latency after HCV infection,it was difficult to prevent the pooled raw plasma from HCV contamination.Whether the results of testing the final products of freeze-dried IVIG with low pH for HCV are negative or positive,the experimental results,that is,the test of the IVIG for HCVRNA by PCR was negative,suggest that the technological process of IVIG preparation can remove HCV from the final products.There was no any evidence of HCV transmission in the preliminary clinical observation and retrospective study.