(单词翻译:单击)
阅读试题
How Safe Are KIDS' Prescription Drugs?
Drugs prescribed to children and adolescents have been much in the news lately.Health Canada has issued warnings about some drugs that both patients and physicians trusted,and it has withdrawn others from the market.What's going on?Parents should understand these complicated and confusing issues.
How Are Prescription Drugs Approved in Canada?
When a pharmaceutical company has a new drug.it applies to Health Canada for a licence to sell it.Based oninformation the company provides,including the results of clinical trials,the drug is either approved or the application is rejected.
Is There a Difference in the Way Drugs Are Approved for Children and Adults?
Normally.drugs are tested in adults first.Dr.Denis Daneman.a clinical investigator at The Hospital for Sick Children in Toronto,says,“we have to be remarkably careful because children are physiologically different than adults and are seen by physicians as a highly vulnerable group.”
What Happens Once a Drug Is Approved?
“Once approved,” explains Daneman.“it's available on the market and doctors can prescribe it for any indication they'd like to.” Even if it has not been tested specifically in children.he says.“physicians may start to use it either in small trials or what we call off-label (use of a prescription drug to treat a condition for which the drug has not been approved) in children.”
How Common Is Off-label Use?
Dr.Michael Rieder. director of the Adverse Drug Reaction Clinic at the Children's Hospital of Western Ontario,says,“drugs commonly used in children，such as antibiotcs and asthma drugs,are tested in children.” But,he says,“there is a misconception that children take only those drugs.We did a study looking at a million kids in Canada over a year.It turns out they used l,400 different drugs,of which 60 percent have not been tested,or approved for use in children.”
If a Drug Is Safe in Adults,Why Do You Need to Test It in children?
Health Canada's Dr.Siddika Mithani says.“children are not small adults.”Their physiology is different.That goes for adolescents.too.Dr.Eric Wookltorton.an Ottawa-based family physician who writes a column on adverse events for the Canadian Medical Association Journal,says,“Depo Provera is an injectable birth-control product used by women of all ages.No one thought to test it in adolescents until recently.Teenagers arelaying down bone density and this drug decreased bone density.”
Are Older Drugs Safer?
“If I were to use a medication off-label that's been around for some time,I'd be less concerned about it.” advises Dr.Peter Nieman.a Calgary pediatrician.“But if you use a medication that's being promoted as che best thing since sliced bread,and you know it's fairly new and are using it off-label,you are a bit nervous.”
How Many Side Effects Are Reported?
In 2004 Health Canada received 10,238 reports of adverse reactions in people of all ages.The number of reports has been increasing since 1999,when just under 6,000 were sent in.However.Dr.Bruce Carleton.of the pharmaceutical outcomes program at the Children's and Women's Health Centre of British Columbia，says,“95 percent of negative reactions are never reported.”Wooltorton explains:“how do you track the more minor,long-term side effects,the ones where kids are a little bit stunted in growth or they are having learning problems in school.There's no regulation and no financial incentive to report anything at all.”
Should We Be More Careful with Some Drugs?
Dr.Jack Uetrecht,a Canada Research Chair in adverse drug reactions,advises extra caution with drugs that affect the central nervous system.“The effects and long-term outcomes of giving these types of drugs aren't totally understood. Make sure the appropriate tests are given to make as clear a diagnosis as possible.and that the appropriate treatment is given based on that diagnosis.Talking to the patient for a few minutes and prescribing a drug would not be the best method.If there is a severe clinical problem and a clear clinical benefit,then the benefit is worth the risk.”
Can Side Fffects Be Prevented?
If your child has had a reaction to a drug in the past,an allergist can advise if she is still allergic.and if so,what could be used instead.Genome Canada is funding an $8.4-million research project that may helpprevent side effects in the future.led by Carleton and geneticist Michael Hayden,director of the Centre for Molecular Medicine and Therapeutics.It is looking for genetic markers that would signal if a child was at risk for an adverse reaction.“There are genetic differences in the way a lot of physiological processeshappen in the human body,”says Carleton.“It makes sense that those differences would affect the way we process drugs.Therefore,understanding when that situation exists would help us to construct better guidelines.”
What Should You Ask About Your Child's Prescription?
First,be sure it is really necessary,says Wooltorton.“A lot of children don't always need prescriptions for a lot of things.Ear infections are an example of when antibiotics are sometimes,but not always,necessary.But there is a tendency in our society to want our kids to be like us.We want to get back to work.We want them to get back to school.We want a quick fix.But‘how wi11 we know the drug is working?'A child with asthma,for example,is usually given a couple of medications.One will be to open the airways.He should feel better after the First dose.If he doesn't,we have a problem.The other medication is used to reduce inflammation.This will decrease the number of acute breathless episodes,but it takes time to have an effect.”Find out how long your physician has been using the drug,says Rieder,and what the experience has been like.Your doctor may know quite a lot about the drug, even if it is being used off-label.
What Should Parents Watch Out for?
Dr.Michael Kramcr,of the Canadian Institutes of Health Research,says you should contact your physician“ifyour child is very sleepy or is agitated and unable to sleep.You should also be concerned about any rashesthat cause blistering or hivcs.”When you pick up a medication at the drugstore,it often comes with a listof potential side effecfs.Maura MacPhee,who teaches in the School of Nursing at the University of British Columbia,says,“this is generic information.Before leaving the physician's office,make sure you know what side effects are the ones you need to worry about with your child.”
How Safe Is the System?
In the last 25 to 30 years,we have seen significant advances in the treatment of childhood leukemia.“WhenI was training 30 years ago,”says Daneman,“childhood leukemia had an 80-percent mortality rate;now the survival rate is better than 80 percent.”Another important development:More drugs are being tested now in children.Daneman says:“if you look at the number of studies that go on,there are many more in the last five to eight years than there were 20 0r 30 years ago.”
参考译文
儿童处方药有多安全？
最近出现了大量有关儿童和青少年处方药的新闻报道。加拿大卫生部已经对患者和医生都信赖的一些药品发出警告，并且从市场上撤销了另外几种药。到底是怎么回事？父母们应该了解这些复杂而令人费解的问题。
在加拿大处方药是怎样被核准的？
当一家制药公司生产了一种新药，就会向加拿大卫生部申请销售该新药的许可证。[l]卫生部根据公司所提供的信息，包括临床实验结果，要么批准这种药品要么驳回销售许可申请。
儿童药物和成人药物在审批方面有什么不同？
一般来说，药品首先要在成人中进行试验。[2]多伦多儿童医院的临床研究员Denis Daneman医生说，“我们必须非常谨慎，因为儿童的生理特点不同于成年人，医生把儿童看做是非常容易受到伤害的群体。”
一旦药品被批准会怎样？
Daneman医生解释说，“药品一经批准就可以在市场上销售，而医生可以根据病人的病情把该药品开进自己的处方。”他说，“即使这种药并没有针对儿童进行专门的试验，医生也会在给儿童治病过程中开始小范围地尝试使用，或者作为一种我们所称之为非标识药使用（把一种处方药应用到没有得到许可的使用范围）。”
非标识药的使用有多普遍？
西安大略儿童医院药品不良反应门诊部主任，Michael Rieder医生说，“给儿童治疗时普遍使用的药物，如抗生素、哮喘药，都会在儿童当中进行试验。但是，人们有一种误解，认为儿童只使用这些药品。我们进行了一项长达一年时间的研究，在加拿大观察了1OO万名儿童，结果表明：[3]他们服用了1400种不同的药品，其中60%的药品，要么就是没有经过针对儿童的临床实验，要么就是没有得到准许用于治疗儿童疾病。”
如果一种药品对成年人是安全的，为什么还要在儿童中进行试验呢？
加拿走卫生部医生Siddika Mithani说：“儿童不是小大人。”他们的生理机能是不同的。青少年也是如此。Eric Wooltorton医生是一名渥太华市的家庭医生，他负责《加拿大医疗协会》杂志不良反应事件专栏。他说，“甲孕酮是一种用于所有年龄妇女的注射节育产品。直到最近，人们才针对青少年就这种药物进行测试。[4]青少年的骨质密度正在下降，而这又正是一种降低骨质密度的药物。”
药物使用越久越安全吗？
卡尔加里儿科医师Peter Nieman认为：“如果我使用一种已经被使用过一段时间的非标识药物的话，我不会太担心。但是如果你使用的是一种被宣传为出现切片面包以来最好的东西，而你知道它是一种新药，把它当作非标识药物使用，那么你就会感到有点紧张。”
有多少副作用被报道？
2004年，加拿大卫生部收到不同年龄阶段出现药品不良反应的报道10238例，报道的数目自1999年以来一直在增加，而当时只有不到6000例。然而，美国哥伦比亚儿童和妇女健康中心制药规划部门的Bruce Carleton医生说，有95%的不良反应从未被报道过。Wooltorton解释说：“你很难追踪那些更不引人注意的长期的副作用，这些副作用的表现是，孩子长得矮小，或者在校有学习困难。[5]根本没有规定也没有财政机制来保障对这些副作用的报道。”
对于某些药品我们应该更加谨慎吗？
[6]加拿大药物不良反应研究部主任，Jack Uetrecht医生建议，对于影响中枢神经系统的药物要格外谨慎。“人们还没有完全理解使用这类药物所带来的副作用及及其长期后果。[7]一定要确保进行恰当的试验，来使诊断尽可能地明确，而正确治疗必然以明确的诊断为依据。与患者交谈几分钟就开处方不是最佳的方法。如果是一个严重的健康问题，而且可以获得临床治疗效果，那么这个治疗效果才是值得冒险的。”
副作用可以预防吗？
如果你的孩子过去对某种药物有过敏反应，过敏症专科医师可能会建议检查现在是否仍然过敏，如果是的话，医生会建议使用什么替代药物。[8]加拿大基因研究组织正投资一项840万美元的研究项目，该项目也许可以在将来有助于预防副作用。它是由Carleton和分子医学和治疗学中心主任，遗传学者Michael Hayden主持。该项目正在研究当一个孩子有出现不良反应的风险时，会有什么样的遗传标记表现出来。Carleton说，“人体的很多生理过程是存在基因差异的。那些差异会影响我们用药的方法，这一点很重要。所以，了解什么时候会出现这些基因差异有助于我们更好地确立指导方案。”
对于你孩子的处方你应该了解什么？
Wooltorton说，“首先，得确定处方药的确是有必要才用。就很多疾病，多数的孩子并不总是需要药方。耳部感染就是一个很好的例子，耳部感染有时候需要抗生素，但并非总是必不可少的。在我们的社会．人们都倾向于希望孩子们像我们大人一样。我们必须回去上班，我们也希望孩子们回到学校，我们希望问题得到快速解决。但‘我们又怎么知道药物是否正在起作用呢？’例如，一个患有哮喘病的儿童通常会被要求服几种药。其中一种药会使他的气管扩张。服了第一剂后，他应该感觉呼吸顺畅一些。如果他并没有感觉好些，就说明我们用错药了。[9]另一种药用于消炎，是为了减少急性呼吸堵塞症状出现的频率，但需要一定的时间才能见效。”Rieder说，要了解你的医生用这种药用了多长时间，有什么样的临床疗效。或许你的医生非常了解这种药。尽管这是一种非标识药。
家长应慎防什么？
加拿大卫生研究协会的Michael Kramer医生说，“如果你的孩子嗜睡。或表现急躁不安，无法入睡，你就应该跟医生联系。你还应该小心引起高烧或假膜性喉头炎的皮疹。”[10]在药店买的药通常容易带来一系列潜在的副作用。英国哥伦比亚大学护理学院的老师Maura MacPhee说，“这是一般常识。在离开医生的办公室之前，一定要问明白这些用药对你的孩子会有哪些副作用。”
这种机制有多安全？
在过去的25到30年里，我们已经看到了儿童白血病治疗方面的长足进步。Daneman说：“30年前我读医的时候，儿童白血病的死亡率达到80%；而现在治愈率超过了80%。”另外一个重要的进步是：现在更多的药物要在儿童身上做实验。Daneman还说：“如果你看看正在进行的研究项目的数量，就会发现最近5至8年的研究数量大大超过20年或30年以前。”
测试题
1.Which of the following is requested by Health Canada before it permits a drug to be sold?
A) The aize and the weight of the drug.
B) The suggested price of the drug.
C) The results of clinical trials of the drug.
D) The production budget of the drug.
2.Who is seen by Dr.Denis Daneman as a highly vulnerable group?
A) Pregnant women.
B) Children.
C) Elderly people over 70.
D) Middle-aged men.
3.How many kinds of drugs are now used by children off-label?
A) 840.
B) 60.
C) 1400.
D) 560.
4.Depo Provera is a drug that can result in adolescents'_____________.
A) stomach upset
B) low blood pressure
C} high cholesterol
D) decreased bone density
5.Some minor and long-term side effects were not reported due to______________.
A) patients' ignorance
B) lack of financial incentive
C) doctor's irresponsibility
D) shortage of health workers
6.Dr.Jack Uetrecht is most concerned about drugs' side effect on________________.
A) the nervous system
B) the digestive system
C) the respiratory system
D) the skeleton system
7.Dr.Jack Uetrecht suggests that an accurate diagnosis is the basis of________________.
A) appropriate treatment
B) prescribing a new drug
C) avoidance of side effects
D) feasible medical tests
8.The project funded by Genome Canada hopes to prevent adverse reactionsafter identifying relevant______________.
9.If a child with asthma suffers acute breathless episodes,he should take medicine to________________.
10.When buying a medicine in a drugstore or getting it from a physician,parents need to watchout for its__________________.
答案详解
1.[C][定位]根据题干中大写的专有名词Health Canada查找到第1个小标题How Are Prescription Drugs Approved in Canada?部分的第2句。
解析：原文该句中的including...后的内容与选项C相同，因此本题答案为选项C。
2.[B][定位]根据题干中的人名Dr.Denis Daneman查找到第2个小标题Is There a Difference in the Way Drugs Are Approved for Children and Adults?部分的第2句。
解析：原文该句中的children...are seen... as a highly vulnerable group明确表明本题应选B。
3.[A][定位]根据题干中的off-label以及选项是的数字查找到第4个小标题How Common Is Off-label Use?部分的末句。
解析：本题答案需经过简单的计算才能得出，根据原文该段末句提及的1400种药有60%属于off-label可以算出本题答案应为选项A。选项B和C虽然在原文提及，但不符合题意，选项D在原文没有直接提及，也不符合题意。
4.[D][定位]根据题干中的药名Dcpo Provera查找到第5个小标题If a Drug Is Safe in Adults,Why Do You Need to Test It in Children?部分的末句。
解析：原文该句末的this drug指的是该段倒数第3句提到的Depo Provera，末句指出Depo Provera会“decreased bone density”，显然，本题答案应为选项D。
5.[B][定位]根据题干中的minor and long-term查找到第7个小标题How Many Side Effects Are Reported?部分的最后三句。
解析：原文该段倒数第3句描述了如题干所述的现象，末句解释了原因，选项B是末句提到的两个原因之一，为本题答案。
6.[A][定位]根据题干中的人名Dr.Jack Uetrecht查找到第8个小标题Should We Be More Careful with Some Drugs?部分的首句。
解析：原文该句表明Dr.Jack Uetrecht建议对于影响中枢神经系统的药物要格外谨慎，可见“神经系统”(nervous system)是他所关注的领域，因此本题应选A。
7.[A][定位]根据题干中的人名Dr．ack Uetrecht和the basis of查找到第8个小标题Should We Be More Careful with Some Drugs?部分的第3句。
解析：原文中的is...based on...与题目中的is the basis of...意思相反，这两个词组的主语和宾语位置也相反，本题答案应在原文is based on...前作主语，选项A与此处主语相同，由此可见，选项A正确。
8.[genetic markers]
[定位]根据题干中的大写专有名词Genome Canada查找到第9个小标题Can Side Effects Be Prevented?部分的第3句。
解析：空白处应为名词成分，作identifying的宾语。原文该部分第2、3句表明这个计划要做两件事：prevent side effects和look for genetic markers，题止提到了第一件事．而identifying和原文中的looking for功能相同，由此可见，looking for的宾语就是本题答案。
9.[reduce inflammation]
[定位]根据题干中的a child with asthma和acute breathless episodes查找到第10个小标题What Should You Ask About Your Child's Prescription？部分的倒数第3、4句。
解析：to表明空白处应为动词不定式成分。原文该段提到了哮喘的两种情况，本题提到的是第2种情况，倒数第4句指出这种情况可以通过吃药“消炎”来减轻症状，因此本题答案应为“消炎”，即倒数第4句提到的reduce inflammation。
10.[(potential)side effects]
[定位]根据题干中的watch out for查找到第11个小标题What Should Parents Watch Out for?部分的最后三句。
解析：空白处应为名词成分，作for的宾语。原文这三句都是为了解答本部分小标题提出的问题，表明父母要注意的就是药品的副作用，因此side effects就是本题答案。
