BACKGROUND Monitoring the safety of antiretroviral therapy (ART) remains a challenge in resource-constrained countries such as Eritrea due to their serious adverse drug reactions (ADRs). This study was aimed at assessing the prevalence, nature, seriousness and possible risk factors of ART associated ADRs in Halibet National Referral Hospital in Eritrea. METHOD A three month retrospective, longitudinal, descriptive study of patients treated with ART between September 2005 and December 2016 was conducted in Halibet National Referral Hospital. Demographic characteristics, treatment details, reaction and outcome details, laboratory investigations and other information was abstracted manually from patients' clinical cards. Statistical analysis was conducted using both univariate and multivariate analysis and statistical significance was tested using 95% confidence intervals and/or p-value. A P-value < 0.05 was regarded as being statistically significant. RESULTS Of the 309 patients screened, 62.8% encountered at least one ADR and 29.8% of the reactions were serious with similar male to female ratio. Gastrointestinal symptoms were the most common ADR and were associated mostly with Atripla followed by AZT + 3TC + NVP drug combinations, but lipodystrophy followed by peripheral neuropathy which were both commonly associated with Stavudine and anemia associated with Zidovudine were the most serious. Patients with CD4 count below 200 were more likely to develop ADRs (p = 0.000). CONCLUSION ADRs associated with ART drugs in Halibet hospital were found to be highly prevalent. Furthermore, CD4 count below 200, was identified as a major risk factor that predisposes patients to ADRs. This is burdensome to resource constrained countries such as Eritrea who have limited drug options and high HIV prevalence, therefore these findings will help patients and healthcare professionals understand the nature as well as seriousness of these ADRs and identify the risks involved with ART medications which can help minimize ART associated ADRs early on.

中文翻译：

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Halibet 国家转诊医院抗逆转录病毒药物不良反应的性质和发生率：一项回顾性研究。

背景技术在厄立特里亚等资源有限的国家，由于严重的药物不良反应（ADR），监测抗逆转录病毒疗法（ART）的安全性仍然是一个挑战。本研究旨在评估厄立特里亚 Halibet 国家转诊医院 ART 相关不良反应的患病率、性质、严重性和可能的​​危险因素。方法 在 Halibet 国家转诊医院对 2005 年 9 月至 2016 年 12 月期间接受 ART 治疗的患者进行了为期三个月的回顾性、纵向、描述性研究。人口统计特征、治疗细节、反应和结果细节、实验室检查和其他信息是从患者的临床卡中手动提取的。使用单变量和多变量分析进行统计分析，并使用 95% 置信区间和/或 p 值测试统计显着性。P值<0.05被认为具有统计显着性。结果 309例筛查患者中，62.8%的患者出现过至少一种ADR，29.8%的患者反应严重，男女比例相似。胃肠道症状是最常见的不良反应，主要与 Atripla 相关，其次是 AZT + 3TC + NVP 药物组合，但脂肪代谢障碍其次是周围神经病变，这两者通常与司他夫定相关，而与齐多夫定相关的贫血最严重。CD4 计数低于 200 的患者更有可能出现 ADR (p = 0.000)。结论 Halibet 医院与 ART 药物相关的不良反应非常普遍。此外，CD4 计数低于 200 被认为是导致患者出现 ADR 的主要危险因素。这对于厄立特里亚等资源有限的国家来说是一个负担，因为这些国家的药物选择有限且艾滋病毒感染率较高，因此这些发现将帮助患者和医疗保健专业人员了解这些不良反应的性质和严重性，并确定 ART 药物所涉及的风险，这可以帮助尽早减少与 ART 相关的不良反应。