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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.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
J Clin Diagn Res. 2017 Jun;11(6):FC01-FC04. doi: 10.7860/JCDR/2017/25252.9955. Epub 2017 Jun 1.
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本文引用的文献

1
Toward an Improved Scale for Assessing Symptom Severity in Children With Acute Otitis Media.迈向用于评估急性中耳炎患儿症状严重程度的改良量表。
J Pediatric Infect Dis Soc. 2015 Dec;4(4):367-9. doi: 10.1093/jpids/piu062. Epub 2014 Jul 31.
2
The diagnosis and management of acute otitis media.急性中耳炎的诊断与治疗。
Pediatrics. 2013 Mar;131(3):e964-99. doi: 10.1542/peds.2012-3488. Epub 2013 Feb 25.
3
Treatment of acute otitis media in children under 2 years of age.儿童急性中耳炎的治疗。
N Engl J Med. 2011 Jan 13;364(2):105-15. doi: 10.1056/NEJMoa0912254.
4
The interaction between respiratory viruses and pathogenic bacteria in the upper respiratory tract of asymptomatic Aboriginal and non-Aboriginal children.无症状的原住民和非原住民儿童上呼吸道中呼吸道病毒和致病菌的相互作用。
Pediatr Infect Dis J. 2010 Jun;29(6):540-5. doi: 10.1097/INF.0b013e3181d067cb.
5
Theories of otitis media pathogenesis, with a focus on Indigenous children.中耳炎发病机制理论,重点关注原住民儿童。
Med J Aust. 2009 Nov 2;191(S9):S50-4. doi: 10.5694/j.1326-5377.2009.tb02927.x.
6
Development and preliminary evaluation of a parent-reported outcome instrument for clinical trials in acute otitis media.急性中耳炎临床试验中家长报告结局工具的开发与初步评估
Pediatr Infect Dis J. 2009 Jan;28(1):5-8. doi: 10.1097/INF.0b013e318185a387.
7
Large dosage amoxicillin/clavulanate, compared with azithromycin, for the treatment of bacterial acute otitis media in children.大剂量阿莫西林/克拉维酸与阿奇霉素治疗儿童细菌性急性中耳炎的比较。
Pediatr Infect Dis J. 2005 Jun;24(6):525-32. doi: 10.1097/01.inf.0000164794.50281.1a.
8
Comparative efficacy and safety evaluation of cefaclor vs amoxycillin + clavulanate in children with Acute Otitis Media (AOM).头孢克洛与阿莫西林+克拉维酸治疗儿童急性中耳炎(AOM)的疗效与安全性比较评估
Indian J Pediatr. 2005 Mar;72(3):233-8.
9
Diagnosis and management of acute otitis media.急性中耳炎的诊断与管理
Pediatrics. 2004 May;113(5):1451-65. doi: 10.1542/peds.113.5.1451.
10
Bacteriologic and clinical efficacy of high dose amoxicillin/clavulanate in children with acute otitis media.高剂量阿莫西林/克拉维酸治疗儿童急性中耳炎的细菌学及临床疗效
Pediatr Infect Dis J. 2001 Sep;20(9):829-37. doi: 10.1097/00006454-200109000-00002.

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.

DOI:10.7860/JCDR/2017/25252.9955
PMID:28764189
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5535382/
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。