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“儿童神药”频被质疑,责任还得监管方来背
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Topic: “儿童神药”频被质疑,责任还得监管方来背 (Read 67 times)
soerklike
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“儿童神药”频被质疑,责任还得监管方来背
January 08, 2018, 02:13:14 AM
#1
进入寒冬,因为空气干、气温低,流感肆虐全国。在许多地方,尤其是幼儿园、学校,因为孩子年龄小、抵抗力差、人群密集,导致了较大规模的流感疫情。也因此,各大医院、诊所纷纷陷入人满为患的情形。而对儿童流感的治疗中,一种名叫“匹多莫德”的药物被相关专家指出,存在临床疗效和安全性均不明确和滥用的问题。
针对匹多莫德的质疑并非近期才有,但之前并没有掀起真正的讨论,这一轮率先发出质疑的专家是北京和睦家医院医生、中国协和医科大学药学硕士冀连梅。据她透露,匹多莫德在国外医学临床试验尚处于小白鼠阶段,疗效尚不明确,但在我国却摇身一变成了价格昂贵的“神药”,在各大医院儿科滥用,销售额预计达到40亿元。为此,冀连梅建议相关部门对匹多莫德的临床疗效进行再评价。
公开资料显示,匹多莫德可分为胶囊、颗粒剂、分散片、口服液四种剂型。其中颗粒剂、胶囊、分散片均为国产药,价格每盒三四十元,而口服液是意大利进口药,价格昂贵,单盒原价194元,促销售价140元。尽管是进口药,但冀连梅还是列出了四点理由证明该药存在临床疗效和安全的不确定性。
一个较为关键的差别在于,国际权威循证医学库考科兰(C ochrane)里并没有关于匹多莫德用于儿童安全有效的研究证实文献,但国内的研究结果却对多种疾病的治疗显示了良好的疗效。在针对儿童免疫力提升的治疗中,匹多莫德也被寄予厚望,成为许多医生开药的必备选项。不过,正如多位儿科医生所指出的,因为学龄前儿童的免疫系统还在发育成熟中,不应轻易冠上免疫力低下的帽子而随意用药。
所以,中国儿科医生对匹多莫德的青睐,可能并非是药物本身的疗效所致,而是冀连梅所提到的几点原因。其一,医药公司的鼓励使用,这背后依旧存在着医药公司与医生直接的利益关联。其二,大部分医生照说明书机械开药。冀连梅指责有些医生不太关注真实疗效如何,部分医生从来不查原始文献,说明书怎么写他就怎么开药。其三,医生明知道没什么效果,当安慰剂在使用。
冀连梅的分析是否存在偏颇暂且不论,但是她直指匹多莫德存在疗效不明确和滥用问题,却引起了不少业内同行的认可。甚至连邻国巴基斯坦准备上市该款药时,因为它没有被收录到任何一本标准的药理学教材,也没有被欧盟药品监管部门和美国药品监管部门批准上市,所以被专家列入不推荐上市名录。
匹多莫德因为产值巨大,所以获得多家医药公司的持续力推并不令人意外。不过,在科学研究结论不足以支撑的前提下,从医生、医院到药品生产企业和监管方都应该重视问题所在。当然,这中间最重要的一方就在于国家食品药品监督管理总局(C FD A)。冀连梅指责一些医生“机械开药”遭到了一些人的质疑。的确,如果药品监管方没有做好监管工作,要求医生专门针对某一种药物看文献、做实验存在要求过高的嫌疑。
而据南方医药经济研究所发布的《2016年儿童用药安全调查报告白皮书》显示,我国儿童药物不良反应率是成人的2倍,新生儿达到4倍,但我国儿童专属药品占比却不足2%。全国6000多家药厂中,专门生产儿童药品的仅10余家,有儿童药品生产部门的企业也仅有30多家。这意味着在儿童用药上,从生产、监管到治疗,儿童的受保护程度远远不足。匹多莫德只是冰山一角,只是被曝光的案例之一。
匹多莫德疗效、安全性问题,最终应该由科学界来做出,而不是一位或几位医生。所以,面对争议,我们也期待更多的医生、药师加入讨论,最终则应该由C FD A介入,组织启动对该药的再评审。通过更为严格、规范的评审流程,让广大医生在开药时更有信心,也让中国儿童不至于一直充当小白鼠。
milltake
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Re: “儿童神药”频被质疑,责任还得监管方来背
January 08, 2018, 02:21:53 AM
#2
政府的不作为,让那些企业肆无忌惮的利用这些来牟利,还危害儿童的健康。
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