DeAbate C A, Henry D, Bensch G, Jubran A, Chodosh S, Harper L, Tipping D, Talbot G H
Medical Research Center, New Orleans, USA.
Chest. 1998 Jul;114(1):120-30. doi: 10.1378/chest.114.1.120.
Comparison of efficacy and safety of sparfloxacin vs ofloxacin for treatment of acute bacterial exacerbations of chronic bronchitis (ABECB).
Multicenter, double-blind, randomized study.
Sixty-eight private offices and outpatient clinics in the United States and Canada.
Seven hundred ninety-eight adults with ABECB, as confirmed by the acute onset of new (or worsened from the immediate premorbid state) cough and sputum production.
Randomization 1:1 to sparfloxacin, 400 mg on day 1, then 200 mg once daily, or ofloxacin, 400 mg twice daily, with matching comparator placebos, given concurrently for 10 consecutive days.
The primary efficacy parameter was overall response in the bacteriologically evaluable population. Overall success rates in this population were 85.3% and 89.3% for sparfloxacin and ofloxacin, respectively. The two-sided 95% confidence interval was -9.9, 1.9, indicating that sparfloxacin was statistically equivalent to ofloxacin. The all-treated population analysis was similar to that in the evaluable population. Bacterial eradication rates were similar in both treatment groups for Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Enterobacter cloacae, and Staphylococcus aureus. The frequency of adverse events overall was comparable in the two treatment groups. The sparfloxacin group had a lower frequency of digestive and nervous system adverse events, but a higher frequency of photosensitivity reactions than the ofloxacin group.
Once-daily oral treatment with 200 mg sparfloxacin (after initial 400 mg dose) is as effective as twice-daily treatment with 400 mg ofloxacin in patients with ABECB.
比较司帕沙星与氧氟沙星治疗慢性支气管炎急性细菌感染（ABECB）的疗效和安全性。
多中心、双盲、随机研究。
美国和加拿大的68个私人诊所和门诊。
798例确诊为ABECB的成人患者，表现为新发（或较病前即刻状态加重）咳嗽和咳痰急性发作。
按1:1随机分为司帕沙星组（第1天400mg，之后每日1次200mg）或氧氟沙星组（每日2次，每次400mg），同时给予匹配的对照安慰剂，连续给药10天。
主要疗效参数是细菌学可评估人群的总体反应。该人群中司帕沙星和氧氟沙星的总体成功率分别为85.3%和89.3%。双侧95%置信区间为-9.9, 1.9，表明司帕沙星在统计学上与氧氟沙星等效。全治疗人群分析与可评估人群相似。流感嗜血杆菌、肺炎链球菌、卡他莫拉菌、肺炎衣原体、副流感嗜血杆菌、肺炎克雷伯菌、阴沟肠杆菌和金黄色葡萄球菌在两个治疗组中的细菌清除率相似。两个治疗组总体不良事件发生率相当。司帕沙星组消化和神经系统不良事件发生率较低，但光敏反应发生率高于氧氟沙星组。
对于ABECB患者，司帕沙星初始剂量400mg后每日1次口服200mg与氧氟沙星每日2次口服400mg疗效相当。
