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低剂量氧氟沙星与阿莫西林/克拉维酸治疗慢性支气管炎急性加重期的双盲对照研究

A double-blind comparison of low-dose ofloxacin and amoxycillin/clavulanic acid in acute exacerbations of chronic bronchitis.

作者信息

Rademaker C M, Sips A P, Beumer H M, Hoepelman I M, Overbeek B P, Möllers M J, Rozenberg-Arska M, Verhoef J

机构信息

Department of Clinical Microbiology, University Hospital, Utrecht, The Netherlands.

出版信息

J Antimicrob Chemother. 1990 Nov;26 Suppl D:75-81. doi: 10.1093/jac/26.suppl_d.75.

DOI:10.1093/jac/26.suppl_d.75
PMID:2286595
Abstract

The efficacy and safety of ofloxacin 400 mg once daily and amoxycillin/clavulanic acid 500/125 mg three times daily were compared in a double-blind manner in patients with an acute exacerbation of chronic bronchitis. Of 102 patients enrolled, 95 (93%) could be assessed for effectiveness. Treatment success was achieved in 41 (84%) of 49 patients in the ofloxacin group compared with 41 (89%) of 46 patients in the amoxycillin/clavulanic acid group. One patient who received ofloxacin and four patients in the amoxycillin/clavulanic acid group stopped medication because of unacceptable side effects. Microbiological results were evaluable in 47% of the patients. Predominant initial pathogens were Haemophilus influenzae, Streptococcus pneumoniae, sometimes in combination, and less frequently Branhamella catarrhalis. In two patients with clinical failure, randomized to ofloxacin, the initial pneumococcal strains persisted in the sputum after treatment.

摘要

在慢性支气管炎急性加重期患者中,以双盲方式比较了每日一次400毫克氧氟沙星与每日三次500/125毫克阿莫西林/克拉维酸的疗效和安全性。在纳入的102例患者中,95例(93%)可进行有效性评估。氧氟沙星组49例患者中有41例(84%)治疗成功,而阿莫西林/克拉维酸组46例患者中有41例(89%)治疗成功。1例接受氧氟沙星治疗的患者和阿莫西林/克拉维酸组的4例患者因不可接受的副作用而停药。47%的患者微生物学结果可评估。主要的初始病原体是流感嗜血杆菌、肺炎链球菌,有时为混合感染,卡他莫拉菌较少见。在随机分配至氧氟沙星组的2例临床治疗失败患者中,治疗后痰液中初始肺炎球菌菌株持续存在。

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