与卡那霉素、阿米卡星、卡普霉素和贝达喹啉有关的不良反应 - VigiAccessTM 研究

Lisa Singh, Varsha Bangalee, Serisha Ramasir, Lehlohonolo John Mathibe
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摘要

背景:耐多药结核病(MDR-TB)是南非和全球普遍存在的健康负担。耐多药结核病的治疗既复杂又困难,因为必须同时使用多种药物才能使患者获得良好的治疗效果。然而,有关这些药物特定不良反应发生率的证据却很缺乏。目的:本研究的主要目的是调查和比较已报告的 MDR-TB 患者服用卡那霉素、卡格雷霉素、阿米卡星和贝达喹啉后出现的特定药物不良反应(ADRs)。研究方法从公共访问数据库 VigiAccessTM 获取 12 个月内收集的二手数据并进行分析。结果卡那霉素的药物不良反应报告急剧增加,主要不良反应包括耳鸣、耳聋和耳鸣,以及呕吐、恶心和腹泻。使用卡那霉素后,气喘和听力减退的情况有所增加,但后者在一段时间后趋于稳定。使用阿米卡星后,皮疹和瘙痒病例增加,死亡病例也增加了;有报告称,使用贝达喹啉的病人除了恶心、呕吐和腹泻外,心电图的 QT 间期也延长了。结论卡那霉素、卡普霉素、阿米卡星和贝达喹啉有许多特殊的不良反应。随着时间的推移,特殊不良反应的病例数也在增加。因此,VigiAccessTM 为报告和了解与 MDR-TB 治疗相关的特定不良反应提供了一个良好的平台。这是进一步研究的重要基石。关键词卡那霉素;阿米卡星;卡普霉素;贝达喹啉。
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Adverse effects associated with Kanamycin, Amikacin, Capreomycin and Bedaquiline -a VigiAccessTM study
Background: Multidrug-resistant tuberculosis (MDR-TB) is a prevalent health burden, both in South Africa and globally. The treatment of MDR-TB is both complex and difficult as multiple drugs have to be used concurrently in order to achieve good treatment outcomes for patients. However, there is a lack in the evidence regarding the incidences of specific adverse effects of these drugs. Objective: The main aim/objective of this study was to investigate and compare reported specific adverse drug reactions (ADRs) associated with kanamycin, capreomycin, amikacin and bedaquiline in MDR-TB patients. Methods: Secondary data collected over a period of 12 months were sourced from a public access data base, VigiAccessTM, and analysed. Results: There was a steep increase in adverse drug reactions reported for kanamycin with the main adverse reactions being hypoacusis, deafness and tinnitus cases, along with vomiting, nausea and diarrhoea. With capreomycin, there were increases in asthenia and hypoacusis although the latter showed a plateau after some point. Rash and pruritus increased along with cases of death with amikacin and there were reports of prolonged QT interval in the electrocardiogram of patients on bedaquiline in addition to nausea, vomiting and diarrhoea. Conclusion: There are many specific adverse effects associated with kanamycin, capreomycin, amikacin and bedaquiline. The number of cases of the specific adverse effects also increased with time. Therefore, VigiAccessTM provides a good platform for reporting and awareness of specific adverse effects associated with MDR-TB therapy. This is a vital stepping stone for further research. Keywords: Kanamycin; Amikacin; Capreomycin; Bedaquiline.
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