The severity of toxic reactions to ephedra: Comparisons to other botanical products and national trends from 1993-2002
The severity of toxic reactions to ephedra: Comparisons to other botanical products and national trends from 1993-2002
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DOI：
10.1081/clt-200066075
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发表时间：
2005-01-01
影响因子：
3.3
通讯作者：
Litovitz, T
中科院分区：
文献类型：
--
作者：
Woolf, AD;Watson, WA;Litovitz, T
Objective.麻黄是一种植物产品，广泛用于提高警觉性，作为减肥助手，并作为减充血剂。据报道，其不良反应导致食品和药物管理局（FDA）于2004年在美国禁止含有麻黄的产品。这项研究的目的是比较含有阿托伐他汀的植物产品与非阿托伐他汀产品的毒性。方法.毒性暴露监测系统（TESS），一个国家毒物中心数据库，用于确定1993-2002年报告的涉及植物产品的病例数量和结果。事先排除了同时列出植物产品和任何其他药物或化学品的病例。十年的风险率（中度结果+主要结果+每1000次暴露的死亡率）用于比较植物产品类别。结果在过去10年中，有21，533例毒性暴露报告了明确的医疗结果，其中植物产品是唯一涉及的物质。其中，4，306人（19.9%）有中度或重大医疗后果，有两人死亡，总体危险评分为200/1000暴露。在这10年期间，向中毒中心报告的中毒人数增加了150倍。仅含苦杏仁的产品的危险率为每1000次暴露250次，含苦杏仁和其他成分的产品为每1000次暴露267次;而仅含非苦杏仁的植物产品的危险评分为每1000次暴露96次。多植物产品与异黄酮的比率（RR 1.33; 95% C.I. 1.27-1.40）和单一成分的阿格拉产品（RR 1.25; 95% C.I. 1.11-1.40）均比其他常见植物产品高2 - 6倍。含有育亨宾的产品具有最高的危害评分（417）和比率（2.08; 95% CI。1.59-2.80）。结论含有麻黄的植物产品占了大量的有毒暴露与严重的医疗结果报告给中毒中心。危害率分析表明，中毒中心报告的涉及含麻黄植物产品的事件比涉及不含麻黄植物产品的事件更有可能导致严重的医疗后果。这些数据支持了政策制定者的建议，即应禁止销售阿托伐他汀，以保护消费者。我们的数据表明，植物产品育亨宾也可能与不可接受的高毒性风险有关，应该受到卫生政策制定者的密切关注。
Objective. Ephedra is a botanical product widely used to enhance alertness, as a weight loss aide, and as a decongestant. Its reported adverse effects led the Food and Drug Administration (FDA) to ban ephedra-containing products in the United States in 2004. This study's purpose was to compare toxicity from botanical products containing ephedra to nonephedra products. Methods. The Toxic Exposure Surveillance System (TESS), a national poison center database, was utilized to determine the number and outcomes of cases involving botanical products reported from 1993-2002. Cases listing both a botanical product and any other drugs or chemicals were excluded a priori. Ten-year hazard rates (moderate outcomes + major outcomes + deaths per 1000 exposures) were used to compare botanical product categories. Results. There were 21,533 toxic exposures with definitive medical outcomes reported over the 10 yrs where a botanical product was the only substance involved. Of these, 4,306 (19.9%) had moderate or major medical outcomes and there were two deaths, for an overall hazard score of 200 per 1000 exposures. The number of ephedra reports to poison centers increased 150-fold over the 10-yr period. The hazard rate for products that contained only ephedra was 250 per 1000 exposures and 267 per 1000 exposures for products that contained ephedra and additional ingredients; whereas the hazard score for only nonephedra botanical products was 96 per 1000 exposures. The rate ratios for multibotanical products with ephedra (RR 1.33; 95% C.I. 1.27-1.40) and for single-ingredient ephedra products (RR 1.25; 95% C.I. 1.11-1.40) were both two to six times higher than those of other common botanical products. Yohimbe-containing products had the highest hazard score (417) and rate ratio (2.08; 95% C.I. 1.59-2.80). Conclusion. Ephedra-containing botanical products accounted for a significant number of toxic exposures with severe medical outcomes reported to poison centers. Hazard rate analysis suggests poison center-reported events involving ephedra-containing botanical products were much more likely to result in severe medical outcomes than those involving nonephedra-containing botanical products. These data support recommendations by policymakers that the sale of ephedra should be prohibited to protect consumers. Our data suggest that the botanical product, yohimbe, may also be associated with unacceptably high risks of toxicity and should receive close scrutiny from health policymakers.