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789
有专家怀疑是采血浆的过程出漏洞。
(上海8日综合电)上海新兴医药公司生产的静脉注射人体免疫球蛋白,其中一批约1.2万余支针剂,日前被揭感染爱滋病病毒,已停止销售。中国专家表示,怀疑是采血浆的过程出漏洞。因涉及不同血浆收集站,可能涉及逾千名捐血者,相信污染源头难以追查。事件引起社会各界恐慌,担心涉事药厂的生产及采集出现问题,而监管当局未有及时发现。
当地媒体引述北京大学医学部免疫学系副主任王月丹称,血制品抗体对爱滋病抗体呈阳性,说明有人感染爱滋病病毒后才去捐血。他推测,目前血浆被污染的源头可能有两种,包括捐血站、捐血车,或采血浆站进行检测时出现问题,惟要等调查有结果才可定夺。
王月丹指,血浆可能在捐血站、捐血车,或单采血浆站进行检测时出问题。
中国疾病预防控制中心爱滋病首席专家邵一鸣指,只有感染爱滋病人士,才会在体内产生抗体,抗体亦正是诊断爱滋病的标记物。他亦指,血液制品的生产过程要求非常严格,他推断是采血浆过程出漏洞,将爱滋病患者的血浆混进生产线。
邵续指,若企业使用技术彻底去除病毒与消灭处理,生产出来的蛋白即使混有爱滋病病毒,会在生产过程中被杀灭,不会造成使用者受感染。
邵一鸣表示,应是采血浆过程中误将爱滋病患者的血浆混进生产线。
据中国食品药品检定研究院官网信息,本次问题产品共计12,226瓶,签发日期为2018年10月12日。负责检测的上海市食品药品检验所,以“该批制品符合规定,建议予以签发(可销售)”。另一内媒报道,上海市食品药品检验所对的产品检测,并不包括爱滋病病毒检测,暗示检测或有漏洞。
中国医药健康产业股份有限公司在官网发声明指,对于子公司“上海新兴”的产品出问题高度重视,已成立专项工作小组,并派员进驻上海新兴督导,并将全力配合当局核查。该批次产品全面停售及封存,公司将全面清查,一旦发现违规,将严肃追究责任。
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