评价硝唑尼特治疗非复杂性阿米巴肝脓肿的疗效。

Evaluating the efficacy of nitazoxanide in uncomplicated amebic liver abscess.

作者信息

Goel Vasudha, Jain Anubhav, Sharma Garima, Jhajharia Ashok, Agarwal Vishnu Kumar, Ashdhir Prachis, Pokharna Rupesh, Chauhan Virender

机构信息

Department of Gastroenterology, SMS Medical College and Hospital, Jaipur 302 004, India.

Department of Pathology, SMS Medical College and Hospital, Jaipur, 302 004, India.

出版信息

Indian J Gastroenterol. 2021 Jun;40(3):272-280. doi: 10.1007/s12664-020-01132-w. Epub 2021 May 15.

DOI:10.1007/s12664-020-01132-w

PMID:33991310

Abstract

BACKGROUND

Amebic liver abscess is treated successfully with metronidazole or another nitroimidazole drug followed by a luminal amebicide. Metronidazole has long been preferred, but has been associated with several adverse effects including intolerance in certain clinical situations. Mechanisms of metronidazole resistance and mutagenic potential have been described. Effects of the use of drug in pregnant women and infants of lactating women are unknown. Nitazoxanide was proven to be efficacious in treating invasive intestinal amebiasis. Therefore, the present study was undertaken to assess the efficacy and safety of nitazoxanide as compared to metronidazole in patients with uncomplicated amebic liver abscess.

METHODS

Patients with clinical and ultrasonography features suggestive of liver abscess, positive amebic serology, and/or anchovy sauce appearance on aspiration of the pus were included in the study and randomized into two parallel treatment groups. Group M received metronidazole, 2-2.5 g/day intravenous (IV), for inpatients, or 2-2.4 g/day oral, for outpatients in three divided doses for 14 days. Group N received nitazoxanide 500 mg BD per oral for 10 days.

RESULTS

A total of sixty subjects fulfilling the inclusion criteria were randomized equally into two groups, group M and group N. Number of patients achieving symptomatic clinical response (SCR) was similar in the two groups (80% vs. 76.7%, p = 1.00), though time to achieve symptomatic clinical response was significantly lower in metronidazole group as compared to that in nitazoxanide group. Greater proportion of patients achieved early clinical response (ECR) in metronidazole group as compared to nitazoxanide group. Complete resolution of abscess, at 6 months, was noted in 18 (60%) patients in the M group and 22 (73.3%) patients in the N group (p = 0.273). Metronidazole was associated with significantly greater frequency of adverse effects than nitazoxanide.

CONCLUSIONS

This study shows equivalent efficacy of nitazoxanide in uncomplicated amebic liver abscess as compared to metronidazole, with better tolerability and advantage of simultaneous luminal clearance, thus reducing chances of recurrence.

TRIAL REGISTRATION

CTRI/2019/01/017249.

摘要

背景

甲硝唑或其他硝基咪唑类药物联合肠腔杀阿米巴药可成功治疗阿米巴肝脓肿。长期以来，甲硝唑一直是首选药物，但它与多种不良反应相关，包括在某些临床情况下不耐受。甲硝唑耐药机制和致突变潜力已有描述。其在孕妇及哺乳期妇女婴儿中的用药效果尚不清楚。硝唑尼特已被证明对治疗侵袭性肠道阿米巴病有效。因此，本研究旨在评估硝唑尼特与甲硝唑相比，在治疗非复杂性阿米巴肝脓肿患者中的疗效和安全性。

方法

具有肝脓肿临床及超声特征、阿米巴血清学阳性和/或脓液抽吸呈鱼酱样外观的患者纳入本研究，并随机分为两个平行治疗组。M组接受甲硝唑治疗，住院患者静脉注射2 - 2.5g/天，门诊患者口服2 - 2.4g/天，分三次服用，共14天。N组接受硝唑尼特口服，500mg，每日两次，共10天。

结果

共有60名符合纳入标准的受试者被平均随机分为两组，M组和N组。两组达到症状性临床反应（SCR）的患者数量相似（80%对76.7%，p = 1.00），尽管甲硝唑组达到症状性临床反应的时间显著低于硝唑尼特组。与硝唑尼特组相比，甲硝唑组有更大比例的患者实现了早期临床反应（ECR）。6个月时，M组18例（60%）患者脓肿完全消退，N组22例（73.3%）患者脓肿完全消退（p = 0.273）。甲硝唑的不良反应发生率显著高于硝唑尼特。