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国家药监局深夜通报:注射人艾滋病毒检测为阴性

Global Times 环球时报GlobalTimes 2019-03-29

国家药监局公布上海新兴相关产品初步调查情况:上海方面对涉事批次静注人免疫球蛋白进行的艾滋病、乙肝、丙肝三种病毒核酸检测,结果均为阴性;江西方面对患者的艾滋病病毒核酸检测,结果为阴性。

National and local health and drug authorities have begun an investigation after media reported that blood plasma products produced by a Shanghai pharmaceutical company were tested HIV-positive. However, the chances to get infected with HIV are slim, authorities announced Wednesday.  

在媒体报道一家上海制药公司的血浆产品被检测为HIV阳性后,国家药监局与上海市药监局立即开展现场检查。2月6日深夜,国家药监局官网公布了相关产品的初步调查情况,称患者感染艾滋病病毒的机会微乎其微。



The product is intravenous immunoglobulin, an immune therapy treatment made of human blood plasma, and is aimed at curing immune diseases. It was produced by China Meheco Xinxing Pharma Co., a Shanghai-based company.

涉事产品是静脉注射免疫球蛋白,一种由人血浆制成的免疫疗法,用于治疗免疫性疾病。它是由总部位于上海的新兴医药股份有限公司生产的。


According to media reports, test results showed that the HIV antibody of certain batches of the products were positive and the company was ordered to suspend production of the products.

据媒体报道,检测结果显示,部分产品的HIV抗体呈阳性,公司已被勒令停止生产相关产品。


A total of 12,226 50ml bottles of the product were issued and approved by the Shanghai food and drug testing institute under the Shanghai Food and Drug Administration, according to The Beijing News, noting that those batches of products are due to expire in June 2021. 

据《新京报》报道,上海食品药品监督管理局上海食品药品检验所共发放并批准了12226瓶50毫升的该产品,并指出这些批次的产品将于2021年6月到期。


The National Health Commission (NHC) and Shanghai Food and Drug Administration on Wednesday confirmed that they have begun an investigation on this case.

周三,国家卫生健康委(NHC)和上海市食品药品监督管理局(FDA)证实,他们已经开始对此案进行调查。


The NHC has ordered hospitals to suspend the use of the batches of products and plans to visit and closely monitor relevant patients.

国家卫生健康委已下令医院暂停使用该批产品,并做好相关患者的病情观察和监测。



The Shanghai administration begun retesting the sample and ordered the company to suspend its production and launch a recall of the products. The national drug watchdog also sent experts to assist in the investigation. 

上海市政府开始重新测试样品,并要求企业停产,启动紧急召回。国家卫健委也已第一时间派出工作组赴地方指导工作,并召集专家对有关问题进行分析研判。


The NHC said that the possibility for patients to get infected with HIV is slim due to the immune treatment's characteristics of an inactive virus and its PH value.

国家卫健委在回应中指出,根据国际相关文献报道,结合该药品灭活病毒的生产工艺特点和产品PH值等因素,专家认为使用该药品的患者感染艾滋病的风险很低。


"If a positive HIV antibody were detected in blood products it means that it has been contaminated by blood from HIV-positive people," Wang Yuedan, a doctor from Peking University Health Science Center, told The Beijing News. 

北京大学医学部免疫学系副主任王月丹接受新京报记者采访时表示,“血液制品检出艾滋病抗体,应该就是意味着被来自HIV感染者的血液或者其成分污染了。”


Wang said that plasma in blood banks or the company's blood plasma station could be contaminated. 

王月丹称,目前血浆被污染的源头可能有两种,血站、血车,或是企业的单采血浆站进行检测时出现问题。


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Wang also said the chance is slim for people to be infected with HIV, because the proportion of contaminated plasma in the product remains unknown and some virus will be inactive during the production process. 

王月丹表示该产品注射后产生HIV感染的几率很小,因为需要参考该抗体的阳性值来判断污染的血浆在总量中的占比,目前这一比值尚未明确。其次就是产品在加工过程中病毒会有部分被灭活。


The Shanghai company was founded in 2000, and its main business is producing and distributing blood products. The company was penalized in 2016 for illegally producing human fibrinogen, the China News Service reported.   

上海新兴医药股份有限公司公司成立于2000年,主营血液制品的生产和销售。据中新社报道,2016年该公司因未按规生产人类纤维蛋白原而受到处罚。


来源:Global Times, 新京报, 国家卫生健康委


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