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喜炎平被召回,中药注射液还能不能用?

2017-09-27 07:46:54   

近日,国家药品不良反应监测中心监测发现,江西青峰药业有限公司生产的喜炎平注射液在甘肃(涉事批号:2017041303)、黑龙江(涉事批号:2017042303)、江苏(涉事批号:2017061003)共发生十多例寒战、发热等严重不良反应。事发地食品药品监管部门对涉事产品正在检验。目前,国家食品药品监督管理总局要求所有医疗机构立即停止使用上述批号产品。

消息一出,“妈妈群”里炸了锅。要知道,喜炎平可是儿童发烧感冒时的常用药之一。喜炎平到底出了什么问题?安不安全?中药注射液还能不能用?

上海市儿童医院药剂科李志玲博士介绍,喜炎平注射液是中药注射液,成分是穿心莲内酯磺化物,药物说明书上写着“清热解毒,止咳止痢”,用于支气管炎、扁桃体炎、细菌性痢疾等多种疾病。临床上,这个药多用于儿童,是一种家长比较熟悉的中药注射液,上市已超过30年。

即便上市已久,应用颇广,可喜炎平真的安全吗?李志玲博士直言,喜炎平的药效并不明确,安全性也未经认证,并不推荐使用。其实,在此之前,中药注射液就已不止一次出现过不良反应的报道,也有专家呼吁,在安全性未经认证前,尽量少用中药注射液。

李志玲博士解释,按照现在的程序,一种新的药物,上市前要经过基础研究、动物试验和人体临床试验等程序,以确认其有效性、适应证和安全性。然而在喜炎平上市的年代,中药注射液的审批机制并不完善,它的疗效也一直缺乏高质量研究数据的支持。

儿童用药本身就要更小心。李志玲博士指出,喜炎平的疗效本身就不明确,加上是注射液,药物直接进入血液。一旦制作工艺中有杂质或者纯度不够,这些不明成分进入血液后,就容易导致过敏、血管栓塞等情况。严重的药物不良反应,那是可以致命的。

实际上,国药监局也早意识到这个问题。2006-2008年间,由于鱼腥草注射液、刺五加注射液、炎毒清注射液、复方蒲公英注射液、金鱼注射液等多个品种不良事件集中爆发,使得监管部门不得不重视中药注射液的安全问题。此后,一系列有关中药注射液的再评价通知出台。

“再评价的过程不可能一蹴而就,需要一批一批来。”李志玲博士强调,并不是要一棍子打翻所有中药注射液,也不是说临床上就一定不能用中药注射液。只是,在使用之前,得先搞清楚这个药到底有什么疗效,安全性如何,不能用的不明不白。

对于一些疗效、安全性还不明确的中药注射液,李志玲博士建议尽量少用,或者不用。就以喜炎平为例,其清热解毒、抗病毒的作用,都有其他安全有效的药物可以替代,没必要“一棵树上吊死”,去承担本可以避免的安全风险。

有关儿童用药安全,李志玲博士建议父母要稍微了解一些医学常识。例如,儿童发烧有病毒性和细菌性之分,都有相应的诊疗常规,尤其对于单纯病毒性感冒有一个自限性的过程,不要盲目用药,也不要总认为中药就一定比西药安全。

另外,网络信息铺天盖地的时代,医疗资讯到处都有。父母需筛选一些高质量、靠谱的媒体,不要轻信网络传言。

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