Devogelaere R, Maes P
Infection. 1986;14 Suppl 4:S283-9. doi: 10.1007/BF01661295.
This study aimed at determining the clinical efficacy and clinical and biological safety of ofloxacin compared to amoxicillin. 44 patients were included, and 41 were evaluable. 33 patients were treated according to the randomization list, whereas 11 patients were treated in an open study. All patients were suffering from acute, recurrent or chronic, lower respiratory tract infections. 29 patients started ofloxacin treatment with a dosage of 200 mg or 300 mg b.i.d., and 15 other patients received 1 g amoxicillin b.i.d. or t.i.d. Three patients of this last group were treated with ofloxacin after amoxicillin treatment failure. Bacteriological eradication was achieved in 95% of ofloxacin-treated and in 78% of amoxicillin-treated patients. Clinical cure occurred in 86% of ofloxacin- and in 55% of amoxicillin-treated patients. Successful treatment (bacteriologic eradication associated with clinical cure) was observed in 75% of patients from the ofloxacin-group and in 36% of the amoxicillin-group. No clinical adverse reactions were seen in amoxicillin-treated patients, whereas one patient in the ofloxacin-group was complaining of mild, definitely drug-related, hypochondrial pain. No major drug-related disturbances of biological parameters were observed neither in the ofloxacin- nor in the amoxicillin-group.
本研究旨在确定氧氟沙星与阿莫西林相比的临床疗效以及临床和生物学安全性。纳入了44例患者，其中41例可进行评估。33例患者按照随机分组列表接受治疗，而11例患者在开放性研究中接受治疗。所有患者均患有急性、复发性或慢性下呼吸道感染。29例患者开始使用氧氟沙星治疗，剂量为200毫克或300毫克，每日两次，另外15例患者接受阿莫西林治疗，剂量为1克，每日两次或每日三次。最后一组中有3例患者在阿莫西林治疗失败后改用氧氟沙星治疗。氧氟沙星治疗组的细菌清除率为95%，阿莫西林治疗组为78%。氧氟沙星治疗组的临床治愈率为86%，阿莫西林治疗组为55%。氧氟沙星组75%的患者和阿莫西林组36%的患者获得了成功治疗（细菌清除且临床治愈）。阿莫西林治疗组未观察到临床不良反应，而氧氟沙星组有1例患者主诉有轻度的、明确与药物相关的季肋部疼痛。在氧氟沙星组和阿莫西林组中均未观察到与药物相关的主要生物学参数紊乱。
