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头孢泊肟酯与阿莫西林-克拉维酸钾治疗2岁以下儿童急性中耳炎的疗效与安全性比较:一项前瞻性纵向研究

Comparison of Efficacy and Safety of Cefpodoxime and Amoxicillin-Clavulanate Potassium in Paediatric Acute Otitis Media in Children below Two Years: A Prospective Longitudinal Study.

作者信息

Ghosh Arijit, Chatterjee Sayan

机构信息

Associate Professor, Department of Pharmacology, Malda Medical College, Malda, West Bengal, India.

Assistant Professor, Department of Paediatrics, Malda Medical College, Malda, West Bengal, India.

出版信息

J Clin Diagn Res. 2017 Jun;11(6):FC01-FC04. doi: 10.7860/JCDR/2017/25252.9955. Epub 2017 Jun 1.

Abstract

INTRODUCTION

Acute Otitis Media (AOM) is one of the frequently diagnosed diseases in children below two years. Amoxicillin-clavulanate potassium is the first line drug in treatment of Paediatric AOM (PAOM). Cefpodoxime has good antimicrobial activity against various types of microorganisms that include causative microorganisms of PAOM.

AIM

To compare the efficacy and safety of cefpodoxime and amoxicillin-clavulanate potassium for the treatment of PAOM in children below two years.

MATERIALS AND METHODS

A prospective longitudinal study was conducted on children diagnosed with PAOM. Thirty-six children were included in the study: 17 in the Group A (amoxicillin-clavulanate potassium) and 19 in the Group B (cefpodoxime). Primary outcome of this study was clinical success rate at day 10 visit and secondary outcome was incidence of Adverse Events (AEs).

RESULTS

The clinical success rates were 93.8% in Group A and 88.2 % in Group B. These rates are comparable and no statistically significant difference was observed between the groups. Few mild and self-limiting AEs were observed and both the drugs were well tolerated.

CONCLUSION

The results of this prospective study showed that a 10-day course of cefpodoxime is therapeutically comparable to amoxicillin-clavulanate potassium in terms of both efficacy and safety for the treatment of PAOM in children below two years.

摘要

引言

急性中耳炎(AOM)是两岁以下儿童中经常被诊断出的疾病之一。阿莫西林克拉维酸钾是治疗小儿急性中耳炎(PAOM)的一线药物。头孢泊肟对包括PAOM致病微生物在内的各种类型微生物具有良好的抗菌活性。

目的

比较头孢泊肟和阿莫西林克拉维酸钾治疗两岁以下儿童PAOM的疗效和安全性。

材料与方法

对诊断为PAOM的儿童进行了一项前瞻性纵向研究。36名儿童纳入研究:A组(阿莫西林克拉维酸钾)17名,B组(头孢泊肟)19名。本研究的主要结局是第10天就诊时的临床成功率,次要结局是不良事件(AE)的发生率。

结果

A组临床成功率为93.8%,B组为88.2%。这些比率具有可比性,两组之间未观察到统计学上的显著差异。观察到少数轻度且自限性的AE,两种药物耐受性均良好。

结论

这项前瞻性研究的结果表明,就治疗两岁以下儿童PAOM的疗效和安全性而言,为期10天的头孢泊肟疗程在治疗效果上与阿莫西林克拉维酸钾相当。

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