儿科门诊患者的药物不良反应和超说明书用药
Adverse drug reactions and off-label drug use in paediatric outpatients.
作者信息
Horen Benjamin, Montastruc Jean-Louis, Lapeyre-Mestre Maryse
机构信息
Laboratoire de Pharmacologie Médicale et Clinique, Centre Midi-Pyrénées de Pharmacovigilance, de Pharmacoépidémiologie et dInformations sur le médicament, Faculté de Médecine.
出版信息
Br J Clin Pharmacol. 2002 Dec;54(6):665-70. doi: 10.1046/j.1365-2125.2002.t01-3-01689.x.
AIMS
To investigate the potential relationship between off-label drug use and increased risk of adverse drug reactions in paediatric outpatients.
METHODS
A prospective pharmacovigilance survey of drug prescribing in office based paediatricians was carried out in Haute-Garonne County (south west of France).
RESULTS
The study involved a sample of 1419 children under 16 years old. Forty-two percent of patients were exposed to at least one off-label prescription. The incidence of adverse drug reactions was 1.41% (95% CI 0.79, 2.11). Off-label drug use was significantly associated with adverse drug reactions (relative risk 3.44; 95% CI 1.26, 9.38), particularly when it was due to an indication different than that defined in the Summary Product Characteristics (relative risk 4.42; 95% CI 1.60, 12.25).
CONCLUSIONS
Our data suggest an increasing risk of adverse drug reactions related to off-label drug use. This risk would be acceptable if further studies prove the potential benefit of such a drug use.
目的
调查儿科门诊患者中使用未标明适应证药物与药物不良反应风险增加之间的潜在关系。
方法
在法国西南部上加龙省开展了一项针对在诊所工作的儿科医生所开处方的前瞻性药物警戒调查。
结果
该研究纳入了1419名16岁以下儿童样本。42%的患者至少接受过一次未标明适应证的处方。药物不良反应发生率为1.41%（95%置信区间0.79，2.11）。使用未标明适应证药物与药物不良反应显著相关（相对风险3.44；95%置信区间1.26，9.38），特别是当适应证与药品说明书中规定的不同时（相对风险4.42；95%置信区间1.60，12.25）。
结论
我们的数据表明，与使用未标明适应证药物相关的药物不良反应风险在增加。如果进一步研究证明这种用药方式有潜在益处，那么这种风险是可以接受的。
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