警惕,明星胃药吗丁啉,在美国被限制服用,中国人居然把它当常备药!

2016-08-10 Pancake 温州都市报、健康时报

消化不良找吗丁啉帮忙”,这句在屏幕上活跃多年的广告语深入人心,也逐渐影响着国人用药习惯。然而,这款在国内被不少患者当做助消化药长期使用,在国外却多次被警示甚至建议限制使用。专家认为,以吗丁啉为代表的多潘立酮长时间大剂量使用有心脏方面风险,患者应更谨慎。  在国外屡遭警告多潘立酮是胃肠促动药,国内有不少企业生产。其中,西安杨森旗下的吗丁啉(商品名)是大家最熟知和常用的。不过,这种药在国外的日子并不好

“消化不良找吗丁啉帮忙”,这句在屏幕上活跃多年的广告语深入人心,也逐渐影响着国人用药习惯。然而,这款在国内被不少患者当做助消化药长期使用,在国外却多次被警示甚至建议限制使用。
专家认为,以吗丁啉为代表的多潘立酮长时间大剂量使用有心脏方面风险,患者应更谨慎。
  
在国外屡遭警告

多潘立酮是胃肠促动药,国内有不少企业生产。其中,西安杨森旗下的吗丁啉(商品名)是大家最熟知和常用的。不过,这种药在国外的日子并不好过。

原研药发明地美国对这款药就很不客气,虽然经多次申报,多潘立酮始终没被美国食药监局(FDA)批准为人用药上市使用。2004年,FDA发布警告称,一切含多潘立酮成分的药品均非法,同时拒绝相应的成品药和原料药进入美国。FDA认为,多潘立酮的严重不良反应包括心律失常、心脏骤停、猝死。

在加拿大多潘立酮的道路也很坎坷。该药于1985年在加拿大上市,但自2002年被停止使用。2007年,加拿大卫生部发布了9例与多潘立酮相关的心律失常报告,包括心律不齐、房颤、室性心动过速、心动过缓、心悸、QT间期延长和扭转型室性心动过速等,患者年龄范围为2个月至74岁。


  
 
欧盟则更加严格,2014年4月,欧洲药品管理局(EMA)发布报告,认为多潘立酮与严重心脏疾病风险相关,建议在整个欧盟范围内限制其适应症,仅用于缓解恶心和呕吐症状,不再用于治疗其他适应症如胀气或烧心,并建议在成人和体重超过35kg的青少年中将剂量减小至10mg,每日最多3次,使用不应超过1周。

总体而言,国外针对多潘立酮的警告主要是针对心脏的风险,而建议限制的内容在缩小适应症范围、减少推荐剂量和缩短使用疗程上。

在国内备受欢迎

相比之下,以吗丁啉为代表的多潘立酮在中国则受到了很好的“待遇”。

资料显示,吗丁啉1989年在中国上市,生产企业为西安杨森制药有限公司,目前被归为甲类非处方药,并被列入国家基本药物目录,之后还研发出适用于儿童的混悬液剂型。此药在中国的年销售总额由上市最初的100万元增加到近年的6亿元。在原研药专利到期后,虽有仿制药陆续出现,但西安杨森的吗丁啉仍然占据着最大的市场份额。

尽管在中国销售的吗丁啉说明书中,明确交代了不良反应、禁忌和注意事项,但在使用时长上,加拿大建议“疗程越短越好”,欧盟建议“不应超过一周”,中国版的说明书中则将这一时间限制定为“连续使用不得超过14天”。加拿大卫生部建议的“应先尽可能小的剂量用药”在中国版说明书中没有提示。

此外,适应症仍为“消化不良、腹胀、嗳气、恶心、呕吐、腹部胀痛”,相较欧洲建议的“仅用于缓解恶心和呕吐症状”而言,这一适应症范围更宽泛。

一位在英国的药剂师曾在博客发表观点,建议中国药监部门及厂家尽快跟国际同步,对多潘立酮非处方药采取相应的监管措施,比如将其列为处方药,并尽快更新说明书,取消其对腹胀,腹痛,消化不良等适应症。

不过,相较于医学研究而言,国内对于药品不良反应的监测机制和药品说明书的更新工作往往是相对滞后的。一位不愿具名的北京市著名三甲医院药剂科药师认为,总体而言多潘立酮对于无心脏疾病患者,短期少量用于治疗恶心呕吐症状仍是安全的,但患者有权知晓不良反应信息,并培养科学用药安全意识。

别再当助消化药使用


  

但鉴于该药在北美和欧洲地区被监测到的不良反应问题,国内一些消化科医生和药师选择持有更谨慎的态度,虽然胃动力药主要以物理运动(促进胃肠道的蠕动)来达到促消化目的,但并不建议患者把吗丁啉当做助消化药来长期使用。


杨俭勤医生说,临床上已经开始留意该药的副作用,并逐步纠正患者的用药习惯。一是告诉患者不要长期使用,也不要大剂量使用,二是使用中注意观察心脏是否有不适。除此之外,增强胃动力的药物不只多潘立酮,促消化还可选择消化酶类药物,患者可多尝试些替代方法。而对于那些“只吃吗丁啉最管用”的患者,她建议定期监测心脏功能,且连续服用时间不超过一星期。
  
西安杨森客服热线人员也表示,虽然吗丁啉是甲类OTC药品,但还是建议患者去医院购买此药,严格遵照说明书指示,在医生的医嘱下服药。

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    2017-02-08 okhuali
  2. [GetPortalCommentsPageByObjectIdResponse(id=2023180, encodeId=7103202318032, content=<a href='/topic/show?id=a62748593b0' target=_blank style='color:#2F92EE;'>#常备药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48593, encryptionId=a62748593b0, topicName=常备药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ea6321, createdName=okhuali, createdTime=Wed Feb 08 15:21:00 CST 2017, time=2017-02-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=98839, encodeId=b3f69883997, content=到底森马动力药安全,不然用大山楂, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=36cd1931808, createdName=玲儿呢丫丫, createdTime=Mon Aug 15 13:46:00 CST 2016, time=2016-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1468534, encodeId=f13a146853452, content=<a href='/topic/show?id=1b2e3915253' target=_blank style='color:#2F92EE;'>#吗丁啉#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=39152, encryptionId=1b2e3915253, topicName=吗丁啉)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c73b6911859, createdName=bettycmoon, createdTime=Fri Aug 12 01:21:00 CST 2016, time=2016-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=97460, encodeId=5c699e46010, content=好恐怖啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Thu Aug 11 17:34:00 CST 2016, time=2016-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=97319, encodeId=7f899e319d0, content=任何药长期服用都有副作用!, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Wed Aug 10 17:01:00 CST 2016, time=2016-08-10, status=1, ipAttribution=)]
    2016-08-15 玲儿呢丫丫

    到底森马动力药安全,不然用大山楂

    0

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  4. [GetPortalCommentsPageByObjectIdResponse(id=2023180, encodeId=7103202318032, content=<a href='/topic/show?id=a62748593b0' target=_blank style='color:#2F92EE;'>#常备药#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=0, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=48593, encryptionId=a62748593b0, topicName=常备药)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=ea6321, createdName=okhuali, createdTime=Wed Feb 08 15:21:00 CST 2017, time=2017-02-08, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=98839, encodeId=b3f69883997, content=到底森马动力药安全,不然用大山楂, beContent=null, objectType=article, channel=null, level=null, likeNumber=73, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=36cd1931808, createdName=玲儿呢丫丫, createdTime=Mon Aug 15 13:46:00 CST 2016, time=2016-08-15, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1468534, encodeId=f13a146853452, content=<a href='/topic/show?id=1b2e3915253' target=_blank style='color:#2F92EE;'>#吗丁啉#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=31, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=39152, encryptionId=1b2e3915253, topicName=吗丁啉)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=c73b6911859, createdName=bettycmoon, createdTime=Fri Aug 12 01:21:00 CST 2016, time=2016-08-12, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=97460, encodeId=5c699e46010, content=好恐怖啊, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=/v1.0.0/img/user_icon.png, createdBy=a37a1710612, createdName=oo902, createdTime=Thu Aug 11 17:34:00 CST 2016, time=2016-08-11, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=97319, encodeId=7f899e319d0, content=任何药长期服用都有副作用!, beContent=null, objectType=article, channel=null, level=null, likeNumber=72, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=93f31631454, createdName=1dd8c52fm63(暂无匿称), createdTime=Wed Aug 10 17:01:00 CST 2016, time=2016-08-10, status=1, ipAttribution=)]
    2016-08-11 oo902

    好恐怖啊

    0

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    2016-08-10 1dd8c52fm63(暂无匿称)

    任何药长期服用都有副作用!

    0