描述和比较来自美国食品和药物管理局食品安全和应用营养中心不良事件报告系统(CAERS)和美国毒物控制中心协会国家毒物数据系统(NPDS)的含咖啡因能量饮料不良事件(AE)报告/暴露电话数据。
横截面。
数据来自美国的CAERS报告和NPDS暴露电话,包括报告/曝光呼叫年,年龄,性别,location,单一v.多种产品消费,结果,症状,意向性(仅限NPDS),报告类型,产品名称(仅限CAERS)。
分析通过每个AE报告或暴露电话中指示的含咖啡因能量饮料产品的数量来定义参与者(病例)。单个产品案例包括CAERS的357个和NPDS的12822个;多个产品案例包括CAERS的153个和NPDS的931个。
CAERS诉NPDS单一产品病例年龄较大,更常见的症状是严重的。多重v.单一产品消费者在这两种情况下都较老。在卡尔斯,与NPDS不同,大多数多产品消费者是女性。CAERS单一诉多种产品报告引用了更高比例的危及生命的事件,但较少出现住院和严重事件。NPDS多重v单一产品案例涉及的≤5岁儿童较少,并且更多是故意的。
尽管有限制,这两个数据来源都有助于上市后监测和提高对公共卫生问题的理解.
To describe and compare caffeinated energy drink adverse event (AE) report/exposure call data from the US Food and Drug Administration Center for Food Safety and Applied Nutrition\'s Adverse Event Reporting System (CAERS) and the American Association of Poison Control Centers\' National Poison Data System (NPDS).
Cross-sectional.
Data were evaluated from US-based CAERS
reports and NPDS exposure calls, including report/exposure call year, age, sex, location, single v. multiple product consumption, outcome, symptom, intentionality (NPDS only), report type, product name (CAERS only).
The analysis defined participants (cases) by the number of caffeinated energy drink products indicated in each AE report or exposure call. Single product cases included 357 from CAERS and 12 822 from NPDS; multiple product cases included 153 from CAERS and 931 from NPDS.
CAERS v. NPDS single product cases were older and more frequently indicated serious symptoms. Multiple v. single product consumers were older in both. In CAERS, unlike NPDS, most multiple product consumers were female. CAERS single v. multiple product
reports cited higher proportions of life-threatening events, but less often indicated hospitalization and serious events. NPDS multiple v. single product cases involved fewer ≤5-year-olds and were more often intentional.
Despite limitations, both data sources contribute to post-market surveillance and improve understanding of public health concerns.