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“眼注射问题气体”受损患者升至71人 成分仍不明

2016-04-14 11:46:30   澎湃新闻网

报告称,南通大学附院随后对发生严重炎症反应的22人进行了二次补救手术,抽出气体,灌注硅油替代。

而在22名严重炎症反应患者中,有1人单眼无光感,1人单眼眼球萎缩,其他患者仍在观察中。

国家食药监局:高度怀疑该“问题气体”引发毒性反应

澎湃新闻注意到,这份国家食品药品监督管理总局出具的《关于眼用全氟丙烷气体可疑群体不良事件情况的调查报告》还针对可疑群体不良反应事件进行了较为详细的原因分析,排除了两家医院手术室及耗材存储室不符合消毒及储存要求、手术过程不规范等可能因素。

报告分析称,北医三院发生症状的患者中,实施手术的共有12位不同的医生,均严格按照操作程序进行手术,因此可以排除手术操作问题。

报告提及,北医三院有2例患者仅注入气体而未进行玻璃体切除手术,然而也出现了类似症状,因此排除了上述问题。

澎湃新闻从报告中获悉,在发现患者炎症后,院方一般应立即采取激素、抗生素等药物治疗方法。

然而,该不良反应患者群体在医院采用了上述常规治疗方法后,炎症现象不但未缓解,反而加重,并出现视网膜血管闭塞和视网膜坏死,因此可以判断患者为非感染性炎症反应。

同时,影像学还显示,晶状体后膜有渗出物,炎症部位集中在全氟丙烷气体接触部位,气体的吸收速度慢,不符合常规要求(一般在3天内完全吸收)。

该报告还依据通大附院对其院内6月份所做的75台眼科手术进行的流行病学调查,结果发现急性炎症与批号为15040001的全氟丙烷气体的使用关联性明确。

综上所述,报告称,高度怀疑是由全氟丙烷引起了毒性反应。

澎湃新闻还注意到,针对该事件的处理措施建议,该报告除了要求暂停使用和销售该批次气体外,还称应该送检相关批次产品,针对可能存在的有毒物质进行检测。

据一些患者向澎湃新闻称,事发至今已愈9个月,由于该气体成分不明确,受损眼球一直无法进行有针对性的治疗。

对此,多名患者已多次向涉事医院、各级食药监部门、药品生产厂家等相关企业和单位申请,要求检验并公布该问题批次气体的不明成分,但一直没有进展。

4月13日,有患者代表再次与天津晶明公司联系,询问该气体不明成分。然而,该公司负责人孙总经理称,事发后公司已经召回了该批次全部产品,随后也通过送检和自检方式,希望能够检测出该批次气体中的不明成分,然而结果一直均为“检测不出”。

对于患者代表向天津晶明公司提出公开相关检测报告的要求,该公司回复称,由于没有检测出气体成分,因此相关检测机构没有出具检测报告,该公司提到的送检机构包括“中检院”和“杭州院”。

天津晶明公司还承诺,将于近日整理相关资料,就事发后的调查过程和结果向患者公布细节。

4月13日,澎湃新闻也与北医三院党办和宣传处联系,工作人员均以“不了解情况”回复,并称相关负责媒体的领导正在出差中。

责任编辑:翟明 CN040
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