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口腔中的药物和器械不良反应:监测与报告

Adverse drug and device reactions in the oral cavity: surveillance and reporting.

作者信息

Zavras Athanasios I, Rosenberg Gregory E, Danielson Jared D, Cartsos Vassiliki M

机构信息

Columbia University Medical Center, 622 W. 168th St., Suite PH17-306, New York, NY 10032, USA.

出版信息

J Am Dent Assoc. 2013 Sep;144(9):1014-21. doi: 10.14219/jada.archive.2013.0228.

DOI:10.14219/jada.archive.2013.0228
PMID:23989840
Abstract

BACKGROUND

According to the U.S. Centers for Disease Control and Prevention, 48 percent of Americans (roughly 144 million people) used at least one prescribed medication in the preceding month; 11 percent used five or more. The authors describe the U.S. Food and Drug Administration's (FDA's) MedWatch program, the safety surveillance system for drugs and devices in the United States, and the dentist's role with regard to voluntary reporting of adverse effects (AEs). They also identify the most frequent AEs in the oral cavity as reported in the FDA Adverse Event Reporting System (FAERS).

METHODS

The authors reviewed the literature regarding MedWatch, and they mined data in the FAERS public database for the 100 most commonly prescribed medications and their associated AEs.

RESULTS

Pharyngitis was the most common AE. Cough, dysgeusia and dysphagia also were common.

CONCLUSION

The MedWatch program and its related databases contain useful information about AEs of pharmaceuticals and devices manifested in the oral cavity. Increased participation in the reporting of suspected adverse reactions will improve the national surveillance system and ultimately will protect patients' safety.

PRACTICAL IMPLICATIONS

As pharmaceutical consumption increases exponentially for a growing segment of the population, and as innovation in dental technology and devices flourishes, dentists have a distinct role in safeguarding patients' well-being. Promptly reporting AEs in the oral cavity improves quality of care and protects patients' well-being.

摘要

背景

根据美国疾病控制与预防中心的数据,48%的美国人(约1.44亿人)在前一个月至少使用过一种处方药;11%的人使用了五种或更多种。作者介绍了美国食品药品监督管理局(FDA)的MedWatch计划,这是美国药品和器械的安全监测系统,以及牙医在自愿报告不良反应(AE)方面的作用。他们还确定了FDA不良事件报告系统(FAERS)中报告的口腔中最常见的不良反应。

方法

作者回顾了有关MedWatch的文献,并在FAERS公共数据库中挖掘了1百种最常用处方药及其相关不良反应的数据。

结果

咽炎是最常见的不良反应。咳嗽、味觉障碍和吞咽困难也很常见。

结论

MedWatch计划及其相关数据库包含有关口腔中药物和器械不良反应的有用信息。增加对疑似不良反应报告的参与将改善国家监测系统,并最终保护患者安全。

实际意义

随着越来越多的人群中药物消费量呈指数级增长,以及牙科技术和器械创新蓬勃发展,牙医在保障患者健康方面发挥着独特作用。及时报告口腔中的不良反应可提高护理质量并保护患者健康。

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