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儿童用药:“少药可选”尴尬何时解?--亲民维稳网络舆情监测室
2013-05-17

  带孩子看病,许多家长最头疼拿药时看见“儿童慎用”或者“儿童酌情减量”等字眼,这一“酌情”就不知道该给孩子吃多少量才最准确。而在家长担忧的同时,医生也常常面临两难境地:选用吧,如果出现副作用甚至严重并发症怎么办?不选吧,又没有合适的替代药物。2012年版国家基本药物目录将于今年5月1日正式实施,其中目录中可用于儿童的药品仅近200种;世界卫生组织2010年发布的《儿童标准处方集》,也仅提供了267个用于0~12岁儿童用药信息。设想一下:将不在此目录的药物都排除在选择之外,则儿童将面临“少药可选”甚至“无药可选”的窘境。儿科专家指出,儿童不是成人的“缩影”,儿童用药不能简单“套用”成人的经验和临床资料。而目前我国6000多家药厂中专业生产儿童用药的企业仅10余家,有儿童用药生产的企业也不过30余家。如何破解当前我国儿童用药的尴尬状况,让儿科用药安全不再是一个“灰色地带”,亟须政府、药企和医院多方合力。

Take children to see a doctor,Many parents see the headache medicine"Children with caution"or"Children take into consideration the reduction"Words such as,This is a"Take into consideration the"Don't know should give children more than eat small amounts to the most accurate.And while parents worry about,Physician often face a dilemma:Choose!,If there is a side effect or even serious complications?Don't choose me,Don't have a suitable replacement drugs.2012 edition of national basic drugs directory will take effect on May 1,The directory can be used for children's medicines only about 200 species;The world health organization (who) published in 2010[Children's standard prescription],Also provide only 267 for children aged 0 ~ 12 drug information.imagine:Will not in the directory of drugs are left out of choice,The children will face"Less medicine is optional"even"No medicine can be chosen"The dilemma of.Pediatric experts point out that,Children not adults"microcosm",Children's drugs can't simple"To paraphrase"Adult experience and clinical data.But at present our country more than 6000 pharmaceutical factory specializing in the production of children's drugs enterprise only more than 10,There are children's drugs production enterprise but also more than 30.How to crack the embarrassment of the current state of the medicine for children in China,Is no longer a pediatric drug use"Grey areas",To the government/Drug companies and hospitals many together.

  家住北京丰台区的王女士经常带两岁多的儿子跑医院。她头疼的一件事是,每次从药房拿了药,就怕看见“儿童慎用”或者“儿童酌情减量”类似的字眼。她总是再三询问医生,生怕有什么差错。相信很多家长也都遇到过类似的情况。

Who lives in Beijing's fengtai wang often take more than two years old son run the hospital.A thing is she had a headache,Each took a medicine from the pharmacy,They were afraid to see"Children with caution"or"Children take into consideration the reduction"Similar words.She always ask the doctor,For fear that there was any mistake.Believe that many parents were also encountered a similar situation.

  而在家长心怀担忧的同时,医生也常常面临两难境地。曾是美国哈佛大学医学院博士后、研究员,如今是中华小儿外科学会全国儿童肿瘤学组委员、江西省赣南医学院副院长的刘潜博士表示,其实遇到这种情况,临床医生也往往很为难:选用吧,如果出现副作用甚至是严重并发症怎么办?而不选吧,又没有合适的替代药物。在刘潜看来,这其实反映了当前儿科用药的尴尬状况:儿科用药安全问题成了一个“灰色地带”。

And while parents worried,Physician often face a dilemma.Was a postdoctoral Harvard University medical school/researcher,Today is the Chinese society for pediatric surgery the national children's cancer group members/Jiangxi gannan, vice President of the school of medicine, Dr LiuQian said,Actually met this situation,Clinicians are often very difficult:Choose!,If there is a side effect or even serious complications?And don't choose me,Don't have a suitable replacement drugs.It seems to LiuQian,It reflects the embarrassment of the current state of the pediatric drug use:Pediatric drug safety has become a problem"Grey areas".

  

儿童药稀缺:家长很担忧,医生也两难 Children's medicine is scarce:Parents worried,The doctor also dilemma

  赵丽是河北石家庄中国人民解放军白求恩国际和平医院儿科的主任,近20年以来,她见证了儿童口服剂型有了很大的发展,例如:糖浆、冲剂、咀嚼片等,基本上一些常见疾病如呼吸道疾病、消化道疾病的药物都有儿童剂型,但其他系统疾病如:高血压、利尿剂等仍没有儿童剂型。而医学研究显示,目前我国白血病发病率5.17/10万,儿童白血病患者以每年3万~4万的速度增加,仅此一例,儿童用药市场就亟待关注。

Zhao Li is hebei shijiazhuang Bethune international peace hospital of the Chinese people's liberation army, director of pediatric,Nearly 20 years since,She saw the children's oral dosage forms had the very big development,Such as the:syrup/Infusion of/Chewable tablets, etc.,Basically, some common diseases such as respiratory disease/The digestive tract disease of drug dosage forms have children,But other system diseases, such as:High blood pressure/Still no children formulations including diuretics.The medical study shows,At present, the incidence of leukemia of 5.17/10,Childhood leukemia patients increased at an annual rate of 30000 ~ 40000,Only one,Children's drugs market needs attention.

  在301医院,刘欢欢教授2003年亲手组建了301儿童保健中心。但如今,作为小儿内科的一线教授,她有时候也经常面临两难的无奈。“我国拥有世界上最好的儿童保健体系。但是,在儿童药品方面,目前儿童用药品种少,尤其是在临床上,经典便宜的适宜家庭使用的药品使用一段时间后,你就会发现,没有了,经常缺货,有时候一缺就是半个月或者一个月。”刘欢欢说,其实,这种现象在基层的乡卫生院更是常见。

In the 301 hospital,Professor LiuHuanHuan 2003 formed the 301 child care centers.But now,As a professor of pediatric medicine line,She sometimes also often face a dilemma."Our country has the world's best children's health care system.but,In the children's medicine,Now children less drug varieties,Especially in clinic,Classic cheap suitable for family use drug use after a period of time,You will find,Without the,Often out of stock,Sometimes a lack is half a month or a month."LiuHuanHuan said,In fact,This kind of phenomenon in grass-roots township hospitals is common.

  另外,刘欢欢教授介绍,液体剂型且口感好的儿童药品更是比较缺乏。液体剂型药品恰恰是适合儿童使用的药品:“儿童尤其是特别小的婴儿用药,应考虑孩子对药物的依从性,液体剂型并口感好的药物孩子依从性就高。国外液体的复合维生素制剂非常好用,我常常无奈地向有条件去国外的家长推荐。其实我多么希望有国产的液体复合维生素制剂啊,因为其对孩子的益处是综合的。”

In addition,Professor LiuHuanHuan is introduced,Liquid formulations and taste good children's medicine is relatively lack.Liquid dosage form drug is suitable for children to use medicine:"Children, especially very small babies drug use,Consideration should be given to the child on medication adherence,Liquid formulations and taste good drug adherence to children is high.Foreign liquid multivitamin preparation is very nice,I often go to foreign parents reluctantly to the conditional recommendation.In fact how I wish have domestic liquid multivitamin preparations,Because of its comprehensive benefits to the child."

  营养不良性缺铁性贫血,是小儿贫血中最常见的一种,6个月~24个月婴幼儿发病率最高。中国疾病预防控制中心妇幼保健中心儿童卫生保健部主任、中华儿科学会儿童保健专业组委员王惠珊说,在自己的工作实践中,经常会感到缺乏婴儿铁剂的滴剂。

Nutrition is not benign iron deficiency anemia,Is one of the most common in children with anemia,Highest incidence of infants and children 6 months to 24 months.The Chinese center for disease control and prevention, the director of maternal and child health care center for children's health care/The Chinese academy of pediatrics child care professional committee member Wang Huishan said,In their own work practice,Often feel lack of infant iron drops.

  而只要来小儿心脏科的,家长都是把孩子的未来和生命甚至家庭的希望托付给了医生。“在我们小儿心脏中心,卡托普利是一种常用药,因只有成人剂型,幼儿按公斤体重每次只能吃1/6片~1/8片,一片分成6份~8份来分次服用,常常导致儿童用药量不准确,影响疗效,也造成浪费。”北京安贞医院小儿心脏科刘应龙主任告诉记者。记者了解到,目前卡托普利片我国有258家获批生产的药企,而卡托普利滴丸却只有一家获批生产的药企。

But as long as to pediatric cardiology,Parents are their children's future and the hope of life and even family entrusted to the doctor."In our pediatric heart center,Captopril is a common medicine,Because only the adult dosage forms,Infant weight is kg can only eat 1/6 ~ 1/8 pills at a time,A is divided into 6 ~ 8 times to take,Often not accurate with the dose in children,Affect curative effect,Also cause waste."Beijing anzhen hospital, director of pediatric cardiology LiuYingLong told reporters.The reporter understands,Captopril tablets at present our country has 258 approved the production of pharmaceutical companies,Dropping pill and captopril is only one approved by the production of pharmaceutical companies.

  

儿童用药:不能简单“套用”成人的经验和资料 Medicine for children:Can't simply"To paraphrase"Adult experience and data

  赵丽主任分析,目前在临床上困扰儿科医生的问题包括以下这些方面:(1)大部分药品说明书上,没有儿童实验数据,没有儿童用量,医生无法选择,这也很容易引起医疗纠纷。(2)目前,一些价格高的药品(主要是合资厂家),又是危重儿童必须用的、临床用量也比较大的药物,都没有小规格的,这同时也给患儿家庭增加了很大的经济负担。

Zhao Li, director of the analysis,Currently in clinical pediatricians problems include the following these aspects:(1)Most of the instructions,No children experimental data,No dosage of children,The doctor couldn't choose,It is also easy to cause medical disputes.(2)At present,Some of the high price of drugs(Mainly is the joint venture factory),And must be critically ill children/Clinical dosage is bigger of the two drugs,No small size,It also adds great economic burden to families.

  “我们都是一支药分几次用,但溶解后的药物放长了,会影响疗效。” 同时,赵丽根据自己医院平时接诊一些基层医院转来的患儿情况,感到在县医院、尤其是乡医院等基层医院,儿童药品很少。

"We are a medicine points several times to use,But after dissolved drug for long,Affect the curative effect." At the same time,Zhao Li hospital accepts some basic-level hospitals at ordinary times according to oneself to children,Feel in county hospital/Especially in township hospitals, basic-level hospitals,The children's medicine is rarely.

  “儿童用药比较特殊。一般按体重或体表面积计算。由于孩子各器官功能发育不完善,特别是肝肾功能,要充分考虑到药物对各器官的影响。儿童的病情变化快,说好就好,加重也快。”河北省保定市白沟新城中心医院的赵如意医生告诉记者。

"Children's drug use is special.Generally calculated according to the weight or body surface area.Due to the immature child each organ function,Especially in the liver and kidney function,To fully consider the drug to the influence of different organs.Children's illness change fast,It is good to say,Increase too fast."Baoding city, hebei province Zhao Ruyi field new town center hospital doctor told reporters.

  既往,大家往往有一种误解,那就是,儿童就是“缩小”的个体,用药嘛,成人能用的,儿童减量使用,按成人的几分之一估算就可以了。刘潜博士认为,儿童不是成人的“缩影”,“儿童尤其是婴幼儿,由于处于特殊的生长发育期,身体机能、生理状况等均与成人有较大差异。比如神经系统,处于发育中的神经元和成熟期的神经元对于机体内外刺激所产生的反应差异显著。”

Always,,People tend to have a misunderstanding,That is,Children is"narrow"Of the individual,Drug use?,Adult can use,Reducing children's use,According to the adult's a fraction of the estimation is ok.Dr LiuQian thought,Children not adults"microcosm","Children, especially infants and young children,Because in a special growth development period,Body function/Physiology and so on all have bigger difference with adults.Such as the nervous system,Neurons in the development and mature neurons for internal and external stimulation produced by the body we have significant difference."

  根据刘潜博士所做的一项动物实验研究中,临床常用的氯胺酮等麻醉药物对未成熟神经细胞有“毒性作用”(诱导其凋亡),这与许多报道中其对成熟神经细胞的“保护性”作用截然不同。对此,刘潜表示:“这提示我们,儿童用药不能简单‘套用’成人的经验和临床资料。”

According to Dr LiuQian did an animal experimental study,Clinical commonly used ketamine anesthesia drug of immature neurons"Toxic effect"(Induction of the apoptosis),This and many reports in the mature nerve cells"protective"Role of completely different.For this,LiuQian said:"This suggests that we,Children's drugs can't simple‘To paraphrase’Adult experience and clinical data."

  

儿童药研发:亟待国家政策大力支持和鼓励 Children's drug research and development:Need national policy support and encouragement

  刘潜博士认为,造成目前儿童药严重匮乏的原因之一,是针对儿童的临床研究及实验研究资料缺乏。他分析,目前,临床药物的研究开发,需要经过实验室筛选、动物实验等临床前研究和Ⅰ-Ⅳ期临床研究等严格控制的阶段。但其中并没有强制要求进行儿童用药安全试验,考虑到这部分工作难度、成本及市场预测等因素,多数企业并没有进行儿童用药安全性验证,代之以在说明书中注明“儿童慎用”或“关于儿童用药安全性数据尚缺乏”等,这就导致了前面所述家长的“疑惑”和医生的“两难”。

Dr LiuQian thought,One of the reason of the serious lack of the current children's medicine,Clinical research and experimental research is targeted at children's lack of information.He analysis,At present,The research and development of clinical medicine,Need to go through screening laboratory/Before the animal experiment and clinical research and Ⅰ - Ⅳ phase of clinical research, etc. Strict control stage.But it is not mandatory for children's medication safety test,Considering the difficulty of this part of the work/Factors such as cost and market forecasts,Most companies have not verified children's medication safety,To indicate it in the manual"Children with caution"or"On children's drug safety data is lacking", etc.,This can lead to parents described earlier"confusion"And the doctor's"The dilemma".

  世界卫生组织2010年发布的《儿童标准处方集》,提供了仅267个用于0~12岁儿童用药信息,如果设想一下:将不在此目录的药物都排除在选择之外,则儿童将面临“少药可选”甚至“无药可选”的窘境。

The world health organization (who) published in 2010[Children's standard prescription],Offers only 267 for children aged 0 ~ 12 drug information,If you imagine:Will not in the directory of drugs are left out of choice,The children will face"Less medicine is optional"even"No medicine can be chosen"The dilemma of.

  对此,刘潜博士建议:解决上述窘境之一的思路,可以采用“老药老办法,新药新办法”。即对“老药”来说,也就是对于已在临床中使用的药物,完善儿童患者药物不良反应监测网络,定期公告政府认可的监测情况,供广大临床医生队伍用药参考,在保护患者安全的同时,也减轻了医生的责任和压力。而对于新药来说:在新药审批中,相关部门能否考虑增加“儿童用药安全评估”内容,从源头上解决这一问题。

For this,Dr LiuQian advice:To solve the dilemma, one of the ideas,Can be used"The old old drugs,New the way to".That is to"Older drugs"for,That is for has set up a file in the clinical use of drugs,Perfect children patients adverse drug reaction monitoring network,Regularly publish government recognised monitoring situation,For the clinical doctors prescription,At the same time to protect the safety of patients,And to reduce the doctor's responsibility and pressure.For new drugs:In the new drug approval,Could you consider increasing the related department"Children's drug safety evaluation"The content,To solve this problem from the source.

  

儿童药生产:需政府、药企、医院多方合力共同改善 Children's medicine production:To the government/Drug companies/Hospital together to improve

  据全国工商联药业商会的调查显示,目前全国6000多家药厂,专业生产儿童用药的企业仅仅10余家,有儿童用药生产的企业也不过30余家。

According to the national federation of industry and pharmaceutical industry chamber of commerce according to the survey,Currently over 6000 companies across the country,Specializing in the production of children's drugs only more than 10 enterprises,There are children's drugs production enterprise but also more than 30.

  儿童用药品种少、剂型单一等问题在国内外普遍存在。在赵如意医生看来,儿童用药剂量安全范围窄,这主要考虑到对儿童器官的影响。涉及问题比较多,不同于成人的特殊器官情况,的确增加了儿童用药的改善难度。

Children less drug varieties/Dosage forms a single problem such as is common at home and abroad.It seems to Zhao Ruyi doctor,Dosage for children safety scope is narrow,This is mainly considering the effects on children's organs.More involved problem,Different from adult's special organ,Indeed increased the difficulty of the improvement of children's drugs.

  刘潜博士则认为,应呼吁全社会关注儿童用药安全问题,希望药企、医疗单位、家长、政府等各方面都齐心协力重视这一问题,共商解决之道。

Dr LiuQian argues,Should call for the whole society pay close attention to children's medication safety,Hope that drug companies/Medical treatment units/parents/Government and so on various aspects are working together to attach importance to this problem,To discuss the solution.

  “可能是生产儿童药不挣钱,不常用的药不生产,常用的药量少,定价高。”在赵丽主任看来,现在的儿童药物一般比较贵,通常一个包装只有6袋(支),对2岁以上孩子连3天的量都不够。她建议,国家应确定几家专门生产儿童药品的厂家,品种全一点,国家可给予相应的补贴。当然,一些便宜的但疗效确切的药物,也可以采用这种办法。

"May be in children's medicine is not to earn money,Not commonly used medicine didn't production,Is less commonly used,Price is high."It seems to Zhao Li director,Medicines for children is generally more expensive now,Generally a package only 6 bags(branch),To more than 2 years old children even quantity isn't enough room for three days.She suggested that,Countries should identify several specialized manufacturer of children's medicine,All varieties is,Countries can give corresponding subsidy.Of course,,Some cheap but the curative effect of drugs,This approach can also be used.

  而药企,显然是很在意和追求利润率的。早在今年“两会”上,刘应龙教授就提出,目前儿科药品的定价机制是按成人药品的剂量差比价定价,这种办法严重影响了企业生产儿科药品的积极性。此外,综合医院进药的“一品双规”制度也限制并挤压了儿童专用药的进入。

But drug firms,Is clearly very care about, and the pursuit of profit margins.As early as this year"The two sessions"On the,Professor LiuYingLong is put forward,Current pediatric drug pricing is based on adult drug dose difference comparison pricing,It seriously affected the enterprise production of pediatric drugs.In addition,General hospital in medicine"Yipin serveral"System also limits and squeezed into children decongestion.

  其实儿童用药改善的空间巨大,如目前药典上没有儿科专用部分。同时,建立完善我国儿童基本药物目录,完善儿童医保目录,使其作为儿科医生用药的指南和依据,这也是小儿科医生刘应龙的心愿。

Medicine for children actually improve space is huge,There is no pediatric special parts such as the current pharmacopoeia.At the same time,Establish and improve the list of essential medicines for children in our country,Improve children's health insurance directory,Make it as a pediatrician and medication guide and basis,This is also a pediatrician LiuYingLong wishes.

  好在,今年3月份,2012年版国家基本药物目录已经发布并将于5月1日正式实施。其中,目录强调注重与常见病、多发病特别是重大疾病以及妇女、儿童用药的衔接。2012年版目录还充实了儿童专用药品、剂型和规格,包括了所有儿童用的国家免疫规划疫苗。目录中可用于儿童的药品近200种,其中,儿童专用剂型、规格70余个,涵盖颗粒剂、口服溶液剂、混悬液、干混悬剂等适宜剂型,一定程度上可以缓解儿童用药不足的需求。

Fortunately,,In march this year,2012 edition of national basic drugs directory has been released and will take effect on May 1.Among them,Directory emphasize attention and common diseases/Frequently-occurring disease especially major disease, as well as women/Children's drugs.2012 version of the directory has enriched the medicines for children/Types and specifications,Includes all children with national immunization programmes.Directory can be used for children's nearly 200 kinds of drugs,Among them,Formulations for children/More than 70 specifications,Cover the granules/Oral solution/Mixed suspension/Dry suspension agent appropriate dosage forms,To some extent, can reduce children's drugs lack of demand.

  但与此同时,卫生部门强调,从根本上解决儿童用药问题仍将是一项长期而复杂的系统工程,涉及生产供应、定价报销、合理使用、质量安全等诸多领域,需要多个部门不断加大支持力度,进一步完善儿童用药政策、加强儿童用药临床综合评价、鼓励研发儿童专用药品、加强儿科临床医师、药师队伍建设等配套政策和措施。

But at the same time,Health department stressed,Fundamentally solve the problem of children's drugs will still be a long and complicated system engineering,Involved in production and supply/Pricing for reimbursement/The rational use of/The quality and safety, and many other fields,Multiple departments need to continue to intensify support,We will further improve the children's drugs policy/Strengthen children's drugs clinical comprehensive evaluation/To encourage research and development drug for children/Strengthen the pediatric clinician/Pharmacist team construction and other supporting policies and measures.

  我国儿童用药现状亟待大力改善,任重而道远。(记者 耿兴敏)

Medicine for children in our country present situation need to improve,A long way to go.(The reporter GengXingMin)


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