Pharmacology Unit and Research Team, Department of Pharmacy, College of Health Sciences, Debre Tabor University, P.O. Box 272, Debre Tabor, Amhara, Ethiopia.
Biomed Res Int. 2021 Jun 16;2021:6613519. doi: 10.1155/2021/6613519. eCollection 2021.
Hepatotoxicity was found in different case reports and studies in tenofovir disoproxil fumarate- (TDF-) based regimen. However, there was no data regarding liver enzymes, glucose, and hemoglobin in Ethiopian patients receiving TDF-based regimen. The aim of this study was to determine elevated liver enzymes and its associated factors as well as elevated fasting plasma glucose and anemia. A hospital-based observational prospective cohort study was conducted on conveniently selected 63 patients in Tikur Anbessa Specialized Hospital (TASH) from January to September 2019. Laboratory values were determined at pre-TDF-based regimen baseline and six-month follow-up. The data was analyzed by using SPSS version 21.0, and multivariate logistic regression was used to determine associated factors with elevated liver enzymes. The overall elevated liver enzymes were found in 26 (41.3%) participants. From this, elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) comprise 3 (4.8%), 3 (4.8%), and 20 (31.8%), respectively. Elevated fasting plasma glucose (FPG) was found in 9 (14.3%) and 14 (22.2%) of participants at baseline and six-month visit, respectively. At six-month visit, 4 (6.4%) of participants experienced anemia. The mean value of ALP and FPG at six months was significantly higher than their respective baseline mean values (mean difference (MD) = +63.38, 95% CI (39.84, 86.92), = 0.0001; MD = +6.64, 95% CI (2.63, 10.64), = 0.002, respectively). The mean value of ALT, AST, and Hg at six months was slightly increased compared to their respective baseline mean values, but the difference was not significant. In multivariate analysis, only female sex was significantly associated with elevated ALP (AOR = 4.5, 95% CI (1.03, 19.6), = 0.045). Overall mild and moderate hepatotoxicity was found to be high (26, 41.3%) in the present study, and from this, the majority was comprised by elevated ALP (20, 31.8%). The proportion of participants with hyperglycemia was increased at the end of follow-up compared to its baseline value, but anemia was not. Female sex was significantly associated with elevated ALP. This study warrants monitoring of liver enzymes and glucose in TDF-based regimen.
在替诺福韦二吡呋酯（TDF）为基础的方案中，不同的病例报告和研究发现了肝毒性。然而，在接受 TDF 为基础方案的埃塞俄比亚患者中，没有关于肝酶、葡萄糖和血红蛋白的数据。本研究旨在确定升高的肝酶及其相关因素，以及空腹血糖升高和贫血。这是一项在 2019 年 1 月至 9 月期间在提克里克安巴塞斯专科医院（TASH）进行的基于医院的前瞻性队列研究，对方便选择的 63 名患者进行了研究。在 TDF 为基础方案的基线和 6 个月随访时，测定实验室值。使用 SPSS 版本 21.0 对数据进行分析，并使用多变量逻辑回归来确定与升高的肝酶相关的因素。在 26 名（41.3%）参与者中发现了总体升高的肝酶。其中，丙氨酸氨基转移酶（ALT）、天门冬氨酸氨基转移酶（AST）和碱性磷酸酶（ALP）升高的比例分别为 3 名（4.8%）、3 名（4.8%）和 20 名（31.8%）。在基线和 6 个月就诊时，分别有 9 名（14.3%）和 14 名（22.2%）的参与者出现空腹血糖升高。在 6 个月就诊时，有 4 名（6.4%）参与者出现贫血。6 个月时 ALP 和 FPG 的平均值明显高于各自的基线平均值（平均差值（MD）=+63.38，95%CI（39.84，86.92），=0.0001；MD=+6.64，95%CI（2.63，10.64），=0.002）。与各自的基线平均值相比，6 个月时 ALT、AST 和 Hg 的平均值略有升高，但差异无统计学意义。在多变量分析中，只有女性性别与 ALP 升高显著相关（AOR=4.5，95%CI（1.03，19.6），=0.045）。在本研究中，总体上轻度和中度肝毒性（26 名，41.3%）较高，其中大多数由 ALP 升高（20 名，31.8%）组成。与基线值相比，随访结束时血糖升高的参与者比例增加，但贫血没有增加。女性性别与 ALP 升高显著相关。本研究需要监测 TDF 为基础方案中的肝酶和葡萄糖。
