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儿童安全型口服处方药包装的安全效果。二十年的经验。

The safety effects of child-resistant packaging for oral prescription drugs. Two decades of experience.

作者信息

Rodgers G B

机构信息

Directorate for Economic Analysis, US Consumer Product Safety Commission, Washington, DC 20207, USA.

出版信息

JAMA. 1996 Jun 5;275(21):1661-5.

PMID:8637140
Abstract

OBJECTIVE

To evaluate the effectiveness of child-resistant packaging in reducing the mortality rate for children younger than 5 years from the unintentional ingestion of oral prescription drugs.

DESIGN

Annual mortality rates for children younger than 5 years associated with the unintentional ingestion of oral prescription drugs are constructed for 1964 through 1992. The effect of child-resistant packaging on the child mortality rate during the postintervention period (1974 through 1992) is evaluated with a multivariate time series regression model. The analysis controls for changes in the consumption of oral prescription drugs over time and for long-term safety trends.

SETTING

United States.

SUBJECTS

Children younger than 5 years.

MAIN OUTCOME MEASURE

Estimated reductions in the child mortality rate associated with the use of child-resistant packaging.

RESULTS

After controlling for covariates, the use of child-resistant packaging was associated with an annual reduction in the oral prescription drug-related mortality rate of 1.40 (95% confidence interval, 0.85-1.95) deaths per million children younger than 5 years. This suggests a reduction of about 460 child deaths from 1974, the year oral prescription drugs became subject to child-resistant packaging requirements, through 1992-a mortality rate reduction of about 45% from levels projected without the child-resistant requirements.

CONCLUSION

Child-resistant packaging reduces child mortality from the unintentional ingestion of oral prescription drugs.

摘要

目的

评估儿童安全包装在降低5岁以下儿童因意外误服口服处方药导致的死亡率方面的有效性。

设计

构建1964年至1992年期间5岁以下儿童因意外误服口服处方药的年度死亡率。采用多元时间序列回归模型评估干预后时期(1974年至1992年)儿童安全包装对儿童死亡率的影响。该分析控制了口服处方药消费量随时间的变化以及长期安全趋势。

地点

美国。

研究对象

5岁以下儿童。

主要观察指标

使用儿童安全包装相关的儿童死亡率估计降低情况。

结果

在控制协变量后,使用儿童安全包装与5岁以下儿童每百万人口中口服处方药相关死亡率每年降低1.40例(95%置信区间,0.85 - 1.95)相关。这表明从1974年(口服处方药开始实行儿童安全包装要求的年份)到1992年,约减少了460例儿童死亡——与没有儿童安全包装要求时预计的死亡率相比,死亡率降低了约45%。

结论

儿童安全包装可降低因意外误服口服处方药导致的儿童死亡率。

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