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头孢克洛与阿莫西林/克拉维酸治疗慢性支气管炎急性细菌感染的随机多中心研究

Cefaclor af versus amoxycillin/clavulanate in acute bacterial exacerbations of chronic bronchitis: a randomised multicentre study.

作者信息

Bandak S I, Bolzon L D, Turnak M R, Johns D, Henle S K, Allen B S

机构信息

Lilly Research Laboratories, Indianapolis, Indiana 46285, USA.

出版信息

Int J Clin Pract. 1999 Dec;53(8):578-83.

Abstract

Cefaclor and amoxycillin/clavulanate are active against Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis and Staphylococcus aureus--pathogens commonly associated with acute exacerbations of chronic bronchitis (AECB). This randomised, parallel-group, single-blind, multicentre study investigated the comparative efficacy and safety of 7-day treatment regimens of cefaclor AF (750 mg b.d. [n = 73]) and amoxycillin/clavulanate (875/125 mg b.d. [n = 72]) in AECB. A favourable clinical response was obtained in 95.9% of patients on cefaclor AF and 97.2% of patients on amoxycillin/clavulanate. There were no statistically significant differences between the groups for improvement in clinical response measured by pulmonary peak expiratory flow (PPEF), or for common symptoms associated with AECB. Both agents were well tolerated, with no statistically significant differences in overall safety; however, nausea and vomiting, and abdominal pain, the most frequently occurring adverse events in the amoxycillin/clavulanate group, were not reported in the cefaclor group. In conclusion, cefaclor AF and amoxycillin/clavulanate have similar efficacy and safety profiles in the treatment of AECB.

摘要

头孢克洛和阿莫西林/克拉维酸对流感嗜血杆菌、肺炎链球菌、卡他莫拉菌和金黄色葡萄球菌具有活性,这些病原体通常与慢性支气管炎急性加重(AECB)相关。这项随机、平行组、单盲、多中心研究调查了头孢克洛AF(750mg,每日2次[n = 73])和阿莫西林/克拉维酸(875/125mg,每日2次[n = 72])治疗AECB的7天治疗方案的比较疗效和安全性。接受头孢克洛AF治疗的患者中有95.9%获得了良好的临床反应,接受阿莫西林/克拉维酸治疗的患者中有97.2%获得了良好的临床反应。两组之间在通过肺峰值呼气流量(PPEF)测量的临床反应改善方面,或在与AECB相关的常见症状方面,均无统计学上的显著差异。两种药物耐受性良好,总体安全性无统计学上的显著差异;然而,头孢克洛组未报告阿莫西林/克拉维酸组中最常出现的不良事件恶心、呕吐和腹痛。总之,头孢克洛AF和阿莫西林/克拉维酸在治疗AECB方面具有相似的疗效和安全性。

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