Doing No Harm? Adverse Events in a Nation-Wide Cohort of Patients with Multidrug-Resistant Tuberculosis in Nigeria
Doing No Harm? Adverse Events in a Nation-Wide Cohort of Patients with Multidrug-Resistant Tuberculosis in Nigeria
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DOI：
10.1371/journal.pone.0120161
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发表时间：
2015-03-17
期刊：
影响因子：
3.7
通讯作者：
Dakum, Patrick Sunday
中科院分区：
文献类型：
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作者：
Avong, Yohanna Kamabi;Isaakidis, Petros;Dakum, Patrick Sunday
背景二线抗结核药物(SLD)的不良反应(AE)相对有较好的文献记载。然而，在方案设置中很少详细描述实际负担。我们调查了尼日利亚全国耐多药结核病(MDR-TB)患者队列中这些事件的发生情况。方法这是一项回顾性的观察性队列研究，使用在尼日利亚所有MDR-TB治疗中心系统收集的药物警戒数据。结果460例患者中男性占62%，中位年龄33岁[四分位数范围：28~42岁]，中位体重51 kg(IQR：45~59)。203名患者(44%)经历了急性脑炎；4例死于与系统性红斑狼疮相关的疾病。胃肠道(n=100)、神经(n=75)、耳毒性(n=72)和精神科(n=60)是最常见的AEs，而耳中毒性和精神科AEs是最令人衰弱的。大多数AEs在治疗1-2个月后发展，并在治疗后不到1个月内消失。一些治疗中心报告不良反应的可能性是其他治疗中心的两倍，这突显了不同治疗中心报告的严重不一致。体重越高的患者发生AEs的风险越高。HIV感染患者与未感染患者发生不良反应的风险无差异。结论尼日利亚耐多药结核病队列中的患者经历了范围广泛的不良反应，其中一些是致残性和致命性的。迫切需要在包括社区在内的各级医疗保健中及早识别和及时管理AEs并进行标准化报告。提倡对耐药结核病采取持续时间最短的更安全的治疗方案。
BackgroundAdverse events (AEs) of second line anti-tuberculosis drugs (SLDs) are relatively well documented. However, the actual burden has rarely been described in detail in programmatic settings. We investigated the occurrence of these events in the national cohort of multidrug-resistant tuberculosis (MDR-TB) patients in Nigeria.MethodThis was a retrospective, observational cohort study, using pharmacovigilance data systematically collected at all MDR-TB treatment centers in Nigeria. Characteristics of AEs during the intensive phase treatment were documented, and risk factors for development of AEs were assessed.ResultsFour hundred and sixty patients were included in the analysis: 62% were male; median age was 33 years [Interquartile Range (IQR): 28-42] and median weight was 51 kg (IQR: 45-59). Two hundred and three (44%) patients experienced AEs; four died of conditions associated with SLD AEs. Gastro-intestinal (n = 100), neurological (n = 75), ototoxic (n = 72) and psychiatric (n = 60) AEs were the most commonly reported, whereas ototoxic and psychiatric AEs were the most debilitating. Majority of AEs developed after 1-2 months of therapy, and resolved in less than a month after treatment. Some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Similarly, age was not significantly associated with AEs.ConclusionPatients in the Nigerian MDR-TB cohort experienced a wide range of AEs, some of which were disabling and fatal. Early identification and prompt management as well as standardized reporting of AEs at all levels of healthcare, including the community is urgently needed. Safer regimens for drug-resistant TB with the shortest duration are advocated.