A systematic review of the reporting of adverse events associated with medical herb use among children.
A systematic review of the reporting of adverse events associated with medical herb use among children.
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DOI：
10.7453/gahmj.2012.071
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发表时间：
2013-03-01
影响因子：
--
通讯作者：
Vohra, Sunita
中科院分区：
文献类型：
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作者：
Gardiner, Paula;Adams, Denise;Vohra, Sunita
目得：有关草药安全性的信息通常来自医学文献中发表的病例报告，因此需要对这些不良事件进行高质量的报告。本研究的目的是进行系统的全面性审查报告发表的病例报告的不良事件与草药使用在pediatric population.METHODS：电子文献检索包括7个数据库和手动检索检索的文章从成立到2010年。我们纳入了已发表的病例报告和病例系列，这些病例报告和病例系列报告了与18岁以下儿童暴露于草药产品相关的不良事件。我们使用描述性统计。基于国际流行病学学会的“提交不良事件报告的出版指南”，我们制定并分配了一个准则的遵守评分（0-17），每个case report.RESULTS：96个独特的期刊论文被确定，并代表128例。在这128例病例中，37%发生在2岁以下儿童，38%发生在2至8岁之间，23%发生在9至18岁之间。29%的病例是故意摄入的结果，而36%是无意摄入的结果。52%的病例记录了草药成分的拉丁二项式; 41%记录了植物部分。32%的病例报告了草药的实验室检测，20%记录了产品的制造商，22%包括对可能影响不良事件的潜在伴随治疗的评估。平均指南依从性评分为12.5（范围6-17）。结论：有相当大的需要改善报告不良事件的儿童使用草药。如果没有更高质量的报告，不良事件报告就无法得到可靠的解释，也无法以有意义的方式指导草药的使用。
PURPOSE: Information about the safety of herbal medicine often comes from case reports published in the medical literature, thus necessitating good quality reporting of these adverse events. The purpose of this study was to perform a systematic review of the comprehensiveness of reporting of published case reports of adverse events associated with herb use in the pediatric population.METHODS: Electronic literature search included 7 databases and a manual search of retrieved articles from inception through 2010. We included published case reports and case series that reported an adverse event associated with exposure to an herbal product by children under the age of 18 years old. We used descriptive statistics. Based on the International Society of Epidemiology's "Guidelines for Submitting Adverse Events Reports for Publication," we developed and assigned a guideline adherence score (0-17) to each case report.RESULTS: Ninety-six unique journal papers were identified and represented 128 cases. Of the 128 cases, 37% occurred in children under 2 years old, 38% between the ages of 2 and 8 years old, and 23% between the ages of 9 and 18 years old. Twenty-nine percent of cases were the result of an intentional ingestion while 36% were from an unintentional ingestion. Fifty-two percent of cases documented the Latin binomial of the herb ingredients; 41% documented plant part. Thirty-two percent of the cases reported laboratory testing of the herb, 20% documented the manufacturer of the product, and 22% percent included an assessment of the potential concomitant therapies that could have been influential in the adverse events. Mean guideline adherence score was 12.5 (range 6-17).CONCLUSIONS: There is considerable need for improvement in reporting adverse events in children following herb use. Without better quality reporting, adverse event reports cannot be interpreted reliably and do not contribute in a meaningful way to guiding recommendations for medicinal herb use.