Guibert J
Hôpital Saint-Joseph, Paris.
Presse Med. 1995 Feb 11;24(6):304-8.
A multicentric double-blind double-placebo randomized trial was conducted to compare the effectiveness and safety of ciprofloxacin versus pefloxacin given in a single oral dose in female out-patients with acute cystitis.
A series of 561 female patients (age range 18-65 years) with signs of uncomplicated community acquired acute cystitis were randomly assigned to parallel groups given a single oral dose of ciprofloxacin (500 mg + placebo) or pefloxacin (800 mg + placebo). Clinical and bacteriological effectiveness was evaluated 12 +/- 2 days after the treatment day.
The clinical outcome was equivalent for the two groups (92 vs 88.9% clinical cure for ciprofloxacin and pefloxacin respectively). Mean time to clinical resolution was about 40 hours in both groups. Urine sterilization was comparable in the two groups (80.8 and 81.1% respectively). Undesirable side effects (mostly digestive tract disorders and neurosensorial complaints) were reported in 16.1% of the patients taking ciprofloxacin and 18.1% of those taking pefloxacin (NS). Single-dose treatment was well accepted by 82.3 and 84.8% of the women respectively.
These findings demonstrate that ciprofloxacin and pefloxacin are equally effective and equally well tolerated as single-dose oral curative therapy for acute cystitis in women.
开展一项多中心双盲双安慰剂随机试验，比较环丙沙星与培氟沙星单剂量口服给药对女性急性膀胱炎门诊患者的有效性和安全性。
将一系列561例有单纯性社区获得性急性膀胱炎体征的女性患者（年龄范围18 - 65岁）随机分为平行组，分别给予单剂量口服环丙沙星（500毫克 + 安慰剂）或培氟沙星（800毫克 + 安慰剂）。在治疗日之后12 ± 2天评估临床和细菌学有效性。
两组的临床结局相当（环丙沙星和培氟沙星的临床治愈率分别为92%和88.9%）。两组的平均临床缓解时间均约为40小时。两组的尿液除菌情况相当（分别为80.8%和81.1%）。服用环丙沙星的患者中有16.1%报告了不良副作用（主要是消化道紊乱和神经感觉不适），服用培氟沙星的患者中有18.1%报告了不良副作用（无显著差异）。单剂量治疗分别被82.3%和84.8%的女性患者良好接受。
这些结果表明，环丙沙星和培氟沙星作为女性急性膀胱炎的单剂量口服治疗药物，有效性相同且耐受性相当。
