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埃塞俄比亚南部达罗地区结核病患者中抗结核药物所致肝毒性的发生率及相关危险因素:一项队列研究

Incidence of antituberculosis-drug-induced hepatotoxicity and associated risk factors among tuberculosis patients in Dawro Zone, South Ethiopia: A cohort study.

机构信息

Tercha District Hospital, Dawro Zone, Ethiopia.

Department of Medical Laboratory Science and Pathology, Jimma University, Jimma, Ethiopia.

出版信息

Int J Mycobacteriol. 2016 Mar;5(1):14-20. doi: 10.1016/j.ijmyco.2015.10.002. Epub 2015 Oct 30.

Abstract

BACKGROUND

Antituberculosis drugs cause hepatotoxicity in some individuals leading to acute liver failure, which results in death. Such phenomena limit the clinical use of drugs, contributing to treatment failure that possibly causes drug resistance. Furthermore, associated risk factors for the development of antituberculosis-drug-induced hepatotoxicity (anti-TB-DIH) are found to be controversial among different study findings.

METHODS

A prospective cohort study was conducted from May 2014 to October 2014 in Dawro Zone, Tercha District Hospital Laboratory, South Ethiopia. One hundred and twenty-four new tuberculosis-positive individuals available from Tercha Hospital and five health centers during data collection were consecutively included. The sociodemographic data and anthropometric measurement were obtained. Then, 5mL of venous blood was drawn from each individual, and the alanine transaminase, aspartate transaminase, and total bilirubin were measured photometrically at baseline, and then continuously monitored by measuring these liver enzymes every 2weeks for 2months. Data were analyzed with SPSS version 20 for Windows (SPSS Inc., Chicago, IL, USA).

RESULTS

The incidence of anti-TB-DIH was found to be 8% (10 patients out of 124). Raised serum transaminase and bilirubin level, as well as signs and symptoms of hepatotoxicity (nausea, anorexia, vomiting, malaise, and jaundice), were observed in the cases. The onset of hepatotoxicity ranged from 13days to 58days (median, 26days) after treatment was initiated. Of the various risk factors analyzed, only high alcohol intake was associated with the incidence of anti-TB-DIH (odds ratio=9.3, 95% confidence interval 1.8-47, p<.007). Age, gender, extent of tuberculosis disease, and malnutrition were not significantly associated with anti-TB-DIH.

CONCLUSION

The incidence of anti-TB-DIH in Dawro Zone was high. The drug responsible for the hepatotoxicity was not known. However, chronic high alcohol intake was associated with the development of anti-TB-DIH.

摘要

背景

抗结核药物会在一些个体中导致肝毒性,进而引发急性肝衰竭,最终导致死亡。此类现象限制了药物的临床应用,导致治疗失败,可能引发耐药性。此外,不同研究结果中,抗结核药物所致肝毒性(anti-TB-DIH)发生的相关风险因素存在争议。

方法

2014年5月至2014年10月,在埃塞俄比亚南部特尔查区医院实验室所在的道罗地区开展了一项前瞻性队列研究。数据收集期间,来自特尔查医院和五个健康中心的124名新确诊的结核病阳性个体被连续纳入研究。收集了社会人口统计学数据和人体测量数据。然后,从每个个体抽取5毫升静脉血,在基线时通过比色法测量丙氨酸转氨酶、天冬氨酸转氨酶和总胆红素,随后在2个月内每2周测量这些肝酶以进行持续监测。使用适用于Windows的SPSS 20版软件(SPSS公司,美国伊利诺伊州芝加哥)进行数据分析。

结果

发现anti-TB-DIH的发生率为8%(124例中有10例)。在这些病例中观察到血清转氨酶和胆红素水平升高,以及肝毒性的体征和症状(恶心、厌食、呕吐、不适和黄疸)。肝毒性在治疗开始后13天至58天(中位数为26天)出现。在分析的各种风险因素中,只有高酒精摄入量与anti-TB-DIH的发生率相关(比值比=9.3,95%置信区间1.8 - 47,p<0.007)。年龄、性别、结核病病情严重程度和营养不良与anti-TB-DIH无显著相关性。

结论

道罗地区anti-TB-DIH的发生率较高。导致肝毒性的药物尚不明确。然而,长期高酒精摄入量与anti-TB-DIH的发生有关。

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