Here's the dilemma.
Very little research is done on children to examine their responses to adult-tested medications. So when we pediatricians then need to prescribe a medication, the effectiveness is often unclear, the risks are often unknown, and the dose is often an educated guess.
I know - not exactly what you as a parent want to hear about the 'science' of prescribing 'off-label' (meaning untested, which most are) medications for your kids. I agree. I'm not comfortable or happy about this state of affairs. Still, like all pediatricians, despite the lack of scientific evidence, I soldier on and continue to prescribe those medications to my little patients. Should I do otherwise?
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This question arises when we read disturbing stories about medications that, unexpectedly, are not helpful or are even harmful in kids (e.g., cough and cold medicines - see my recent post on this:
ROUND 2: The FDA and OTC Cold Medications for Infants). When that happens, everyone clucks:
How could pediatricians have used these medications when there was no evidence of benefits for kids and when the risks were unknown? It's shameful! Certainly, we all would like to see more research done on children. Or would we, really?
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Let me make this issue personal:
Would you allow your child to be enrolled in a research study that would be of no benefit to him/her and might have some risks, even if the information derived from the study might some day benefit other peoples' kids? An interesting new study* asked 81 parents just that question, followed by differential risks: "a chance of getting a headache for a few hours" or "a small chance of a broken bone" or "a one in a million chance of dying" or "the same risk as riding in a car". How would you respond?
Results: - 79% of parents said they would let their child participate if there were only the risk of getting a headache.
- 24% would allow it if there was a small risk of a broken bone.
- 18% of parents would OK the research if there were a one in a million chance of death.
- 93% of parents said OK if the risks were the same as riding in a car. (By the way, the risk of being killed while riding in a car is about one in a million!).
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Dr. P Comments So there you have it. We indignantly condemn the lack of studies on medications for kids but - quite understandably and justifiably - most of us wouldn't allow
our kids to be involved in such research.
So the next time a bad side effect of a medication generates lots of heat and everyone
tut tuts the fact that it was used in children without scientific evidence, ask yourself: what was the alternative? Should we
never use any medications in children for which there is little or no scientific validation? If that were to happen we'd almost never use medications in kids at all. Welcome back to the 19th century.
If you are unwilling to enroll your children in research, then maybe you too will have to embrace our imperfect solution: to keep giving these adult-tested meds to kids, to hope they help and not hurt, and to be ever vigilant for evidence of no benefit and possible harm.
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*Study cited:
"Children's and their parents views on facing research risks for the benefits of others."
Wendler D and Jenkins T. Archives of Pediatric and Adolescent Medicine. January 2008 Related Topics: Technorati Tags: pediatrics, medicine, colds, clincial trials
译文:
无好处的调查：你会给你的孩子报名吗？
如今有个进退两难的问题。只有很少部分的调查着眼于考察孩子对成人药物的反应。因此当我们的儿科医生开出药物时，人们往往不清楚它的效果，这样的风险经常被人忽视，而服药量也通常只是大概估量。
我并不是很准确的知道你作为一个父母，关于对孩子如何科学的描述“无标签”（即未经检验的，大部分都是这意思）药物想知道些什么。我承认，我对于这种现状感到了不满或不开心。不过，像所有的儿科医生一样，尽管缺少科学依据，我还是坚持继续向我的小病人们描述那些药物。除此之外，我还能做什么呢？
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当我们开始发现药物副作用的时候，这个问题就变得严重了，但意料之外的是，这些药物对孩子没帮助却也没害处（例如，咳嗽感冒药--看看我最近相关的帖子吧：《第二篇：FAD&OTC感冒药和婴幼儿》）。当以上这个问题发生时，每个人都要念叨：儿科医生怎么能在大家都不知道这个风险的时候用这些对孩子没有好处的药呢？这太没责任感了！
毫无疑问，我们都想看到有更多对孩子的这种调查出现。我们能看到么？确定？
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让我把这个话题个人话一些：你会允许你的孩子加入一个对他或她没什么好处或许还有些风险的调查研究，即使从这个研究中获得的信息在某天会受益于他人的孩子吗？
一个全新的有趣研究就刚才那个问题分别以不同的风险假设询问了81位家长：“得上头痛病几个小时”或者“小小的骨折一下”或者“致死几率极小极小的风险测试”或者“类似在汽车里骑车的小风险”。对此，你会作何回答？
调查结果：
79%的家长表示，会让孩子参与头疼的风险
24%的家长会让孩子参与骨折的风险
18% 的家长同意孩子参与致死几率极小的风险测试
93%的家长会让孩子参与类似在汽车里骑车的风险（顺便提一下，在汽车里骑车时出现不测致死的风险是极小的）
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P医生的解说：
所以有了这种现象。我们愤怒的责备在给孩子使用的药物上缺少研究，但是--也很合理很可以理解的是--我们大部分都不愿意让孩子参与相关的调查。
所以下次吃药时，药物的副作用就引起了发热，然后人们就念叨着用在孩子身上的药没有科学依据。问问你自己：应该怎么选择？我们应该因为对药物没有或只有较少科学依据而不用在孩子身上？如果这样做，那我们几乎永远没法给孩子吃药了。如此这般，那就欢迎大家回到19世纪。
如果你不愿意让你的孩子参加调查，那么也许你会很乐意接受我们这个不完美的解决方法：继续给你的宝贝吃成人药物，并希望它们有作用还不会伤害孩子，并且时刻警惕药物零作用或者有害的证据。
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引用的研究资料：
《孩子和其家长对有益于他人的风险调查所持的观点》
Wendler D 和 Jenkins T。《有关青少年和幼儿的药物的资料》。2008年一月
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Technorati标签：儿科，药物，感冒。医院测试