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替硝唑与甲硝唑治疗阿米巴肝脓肿的对比研究:一项随机对照试验。

Comparative study of tinidazole versus metronidazole in treatment of amebic liver abscess: A randomized control trial.

作者信息

Pandey Sudhakar, Gupta Gaurav Kumar, Wanjari Shashank J, Nijhawan Sandeep

机构信息

Department of Gastroenterology, Sawai Man Singh, Medical College, J L N Marg, Jaipur, 302 004, India.

出版信息

Indian J Gastroenterol. 2018 May;37(3):196-201. doi: 10.1007/s12664-018-0848-7. Epub 2018 Jun 14.

Abstract

BACKGROUND

Metronidazole is a drug of choice for amebic liver abscess (ALA), but has long course and significant side effects. Thus, drugs like tinidazole with a better tolerability record need evaluation.

METHODS

We conducted a randomized controlled trial at the Department of Gastroenterology, SMS Hospital, Jaipur, India. One hundred and fifty admitted patients were randomized into two treatment groups, metronidazole (group M, n = 75) and tinidazole (group T, n = 75). Patients were observed for clinical response, laboratory parameters, imaging, and side effects. Early clinical response (ECR) was defined as the absence of fever and abdominal pain within 72 h of treatment. Symptomatic clinical response (SCR) was defined as the absence of fever and abdominal pain irrespective of duration of treatment required. Follow up was done at 1, 3, and 6 months.

RESULTS

ECR was 62.3% in group T vs. 37.7% in group M (p = 0.02). SCR was shorter in group T than group M (3.29 ± 1.61 days vs. 5.67 ± 2.93, p ≤ 0.001). Mean residual volume at the end of 1 month was lower in group T (130.7 ± 108.1 vs. 184.7 ± 143.3 mL, p = 0.01) and no significant difference was seen at 3 and 6 months. Tinidazole was better tolerated with fewer side effects. Low socioeconomic status, baseline abscess volume > 500 mL, hypoalbuminemia, pleural effusion, and history of ethanol use were associated with a late clinical response on univariate analysis of which low socioeconomic status was the only associated factor.

CONCLUSION

Tinidazole, as compared to metronidazole, has early clinical response, shorter treatment course, favorable rate of recovery, and high tolerability; thus, tinidazole can be preferred over metronidazole in ALA.

摘要

背景

甲硝唑是治疗阿米巴肝脓肿(ALA)的首选药物,但疗程长且副作用显著。因此,像替硝唑这类耐受性更好的药物需要进行评估。

方法

我们在印度斋浦尔SMS医院胃肠病科进行了一项随机对照试验。150名入院患者被随机分为两个治疗组,甲硝唑组(M组,n = 75)和替硝唑组(T组,n = 75)。观察患者的临床反应、实验室参数、影像学表现及副作用。早期临床反应(ECR)定义为治疗72小时内无发热及腹痛。有症状的临床反应(SCR)定义为无论所需治疗时长,均无发热及腹痛。在1、3和6个月时进行随访。

结果

T组的ECR为62.3%,M组为37.7%(p = 0.02)。T组的SCR短于M组(3.29±1.61天对5.67±2.93天,p≤0.001)。1个月末T组的平均残余体积较低(130.7±108.1对184.7±143.3 mL,p = 0.01),3个月和6个月时未见显著差异。替硝唑耐受性更好,副作用更少。单因素分析显示,社会经济地位低、基线脓肿体积>500 mL、低白蛋白血症、胸腔积液及乙醇使用史与临床反应延迟相关,其中社会经济地位低是唯一相关因素。

结论

与甲硝唑相比,替硝唑具有早期临床反应、疗程短、恢复率高及耐受性好的特点;因此,在ALA治疗中,替硝唑可优先于甲硝唑使用。

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