安全警示对 2 岁以下儿童咳嗽和感冒药处方率的影响。
Effects of safety warnings on prescription rates of cough and cold medicines in children below 2 years of age.
机构信息
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands.
出版信息
Br J Clin Pharmacol. 2011 Jun;71(6):943-50. doi: 10.1111/j.1365-2125.2010.03860.x.
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
• Cough and cold medicines are frequently used in children to treat upper respiratory tract infections without solid proof of benefits. • Safety issues have been raised about the use of these drugs in young children. • In 2007 international warnings were issued advising against use of these drugs in young children.
WHAT THIS STUDY ADDS
• Cough and cold medicines prescribing by primary care physicians has not really been influenced by international warnings in the Netherlands, where no additional national warnings were made and only partially in Italy. • A concerted action should be taken in Europe to advise strongly against the OTC use and prescription of cough and cold medicines in young children.
AIM
The aim of the study was to assess the influence of national and international warnings on the prescription rates of cough and cold medicines (CCMs) in the youngest children (<2 years) in the Netherlands and Italy.
METHODS
Analysis of outpatient electronic medical records of children <2 years in Italy and the Netherlands was carried out. Age and country specific prescription prevalence rates were calculated for the period 2005-08. Comparisons of prescription rates in 2005 (pre) and 2008 (post) warnings were done by means of a chi-square test.
RESULTS
The cohort consisted of 99,176 children <2 years of age. After international warnings, overall prescription rates for CCMs decreased slightly from 83 to 77/1000 person years (P= 0.05) in Italy and increased in the Netherlands from 74 to 92/1000 children per year. Despite the international warnings, prescription rates for nasal sympathomimetics and opium alkaloids increased in the Netherlands (P < 0.01). In Italy a significant decrease in the prescription rates of opium alkaloids and other cough suppressants (P < 0.01) was observed, and also a significant reduction in use of combinations of nasal sympathomimetics.
CONCLUSION
Despite the international safety warnings and negative benefit-risk profiles, prescription rates of cough and cold medicines remain substantial and were hardly affected by the warnings, especially in the Netherlands where no warning was issued. The hazards of use of these medicines in young children should be explicitly stipulated by the European Medicines Agency and all national agencies, in order to increase awareness amongst physicians and caretakers and reduce heterogeneity across the EU.
已知关于本主题的信息
咳嗽和感冒药常被用于治疗儿童上呼吸道感染，但缺乏获益的确切证据。
这些药物在婴幼儿中的使用安全性问题已受到关注。
2007 年，国际上发布了关于避免在婴幼儿中使用这些药物的警告。
本研究的发现
在荷兰，由于没有发布额外的国家警告，仅在意大利部分发布了警告，因此，初级保健医生开具咳嗽和感冒药的情况并没有真正受到国际警告的影响。
应在欧洲采取协调行动，强烈建议不要在婴幼儿中自行使用或开具咳嗽和感冒药。
目的
本研究旨在评估国家和国际警告对荷兰和意大利 2 岁以下儿童咳嗽和感冒药（CCM）处方率的影响。
方法
对意大利和荷兰 2 岁以下儿童的门诊电子病历进行了分析。计算了 2005-08 年期间按年龄和国家划分的处方流行率。通过卡方检验比较了 2005 年（警告前）和 2008 年（警告后）的处方率。
结果
共纳入了 99176 名 2 岁以下儿童。在国际警告之后，意大利 CCM 的总体处方率从 83 降至 77/1000 人年（P=0.05），而荷兰则从 74 升至 92/1000 名儿童年。尽管有国际警告，荷兰鼻用拟交感神经药和鸦片生物碱的处方率仍有所增加（P<0.01）。在意大利，观察到鸦片生物碱和其他镇咳药的处方率显著下降（P<0.01），并且鼻用拟交感神经药的联合使用也显著减少。
结论
尽管有国际安全性警告和负面的获益-风险特征，咳嗽和感冒药的处方率仍然很高，且这些警告几乎没有影响，尤其是在没有发布警告的荷兰。欧洲药品管理局和所有国家机构应明确规定这些药物在婴幼儿中的使用风险，以提高医生和护理人员的认识，并减少欧盟各国之间的差异。
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