An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021.
An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021.
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DOI：
10.1111/cts.13505
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发表时间：
2023-06
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影响因子：
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Kratom是一种广泛使用的亚洲植物，由于认为它可以治疗疼痛，焦虑和阿片类药物戒断症状而在美国受到欢迎。美国Kratom协会估计10-16万人使用kratom. Kratom相关的药物不良反应（ADR）继续被报道，并引起了对Kratom安全性的担忧。然而，缺乏描述kratom相关不良事件总体模式并量化kratom与不良事件之间关联的研究。使用2004年1月至2021年9月向美国食品药品监督管理局不良事件报告系统报告的ADR来解决这些知识差距。进行描述性分析以分析kratom相关不良反应。通过将kratom与所有其他天然产物和药物进行比较，估计了基于观察到的与预期的比值的保守药物警戒信号。基于489份删除重复的kratom相关ADR报告，使用者年轻（平均年龄35.5岁），男性患者（67.5%）多于女性患者（23.5%）。病例主要报告自2018年（94.2%）。在17个系统器官分类类别中生成了52个不成比例的报告信号。观察到/报告的kratom相关意外死亡报告数量是预期的63倍。有八个强烈的信号与成瘾或药物戒断有关。过量的ADR报告是关于kratom相关的药物投诉，各种药物的毒性和癫痫发作。虽然需要进一步的研究来评估kratom的安全性，但临床医生和消费者应该意识到，真实的世界证据表明存在潜在的安全威胁。
Kratom is a widely used Asian botanical that has gained popularity in the United States due to a perception that it can treat pain, anxiety, and opioid withdrawal symptoms. The American Kratom Association estimates 10–16 million people use kratom. Kratom‐associated adverse drug reactions (ADRs) continue to be reported and raise concerns about the safety profile of kratom. However, studies are lacking that describe the overall pattern of kratom‐associated adverse events and quantify the association between kratom and adverse events. ADRs reported to the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021 were used to address these knowledge gaps. Descriptive analysis was conducted to analyze kratom‐related adverse reactions. Conservative pharmacovigilance signals based on observed‐to‐expected ratios with shrinkage were estimated by comparing kratom to all other natural products and drugs. Based on 489 deduplicated kratom‐related ADR reports, users were young (mean age 35.5 years), and more often male (67.5%) than female patients (23.5%). Cases were predominantly reported since 2018 (94.2%). Fifty‐two disproportionate reporting signals in 17 system‐organ‐class categories were generated. The observed/reported number of kratom‐related accidental death reports was 63‐fold greater than expected. There were eight strong signals related to addiction or drug withdrawal. An excess proportion of ADR reports were about kratom‐related drug complaints, toxicity to various agents, and seizures. Although further research is needed to assess the safety of kratom, clinicians and consumers should be aware that real‐world evidence points to potential safety threats.
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影响因子：
--
作者：
Cinosi E;Martinotti G;Simonato P;Singh D;Demetrovics Z;Roman-Urrestarazu A;Bersani FS;Vicknasingam B;Piazzon G;Li JH;Yu WJ;Kapitány-Fövény M;Farkas J;Di Giannantonio M;Corazza O
通讯作者：
Corazza O
影响因子：
5.4
作者：
Chittrakarn, Somsmorn;Sawangjaroen, Kitja;Kempradub, Niwat
通讯作者：
Kempradub, Niwat
影响因子：
33.9
作者：
Olsen, Emily O'Malley;O'Donnell, Julie;Wilson, Nana
通讯作者：
Wilson, Nana
影响因子：
1.6
作者：
Kim, Hae Reong;Sung, MinDong;Park, Ji Ae;Jeong, Kyeongseob;Kim, Ho Heon;Lee, Suehyun;Park, Yu Rang
通讯作者：
Park, Yu Rang
影响因子：
4.2
作者：
Grundmann, Oliver
通讯作者：
Grundmann, Oliver