Iravani A, Tice A D, McCarty J, Sikes D H, Nolen T, Gallis H A, Whalen E P, Tosiello R L, Heyd A, Kowalsky S F
Central Florida Medical Research Center, Orlando.
Arch Intern Med. 1995 Mar 13;155(5):485-94.
Three studies were undertaken to determine the minimum effective dosing regimen of ciprofloxacin for the treatment of acute, symptomatic, uncomplicated lower urinary tract infection.
All studies were multicenter, prospective, randomized, double-blind trials. A total of 970 evaluable patients with a diagnosis of urinary tract infection received oral ciprofloxacin (200 mg to 500 mg daily in one or two divided doses for 1, 3, 5, or 7 days) or norfloxacin (400 mg twice daily [BID] for 7 days). The primary measure of efficacy was bacteriologic eradication at the end of therapy.
In study 1, bacteriologic eradication was reported in 95 (89%) and 101 (98%) of patients in the groups who received ciprofloxacin, 500-mg single dose and 250 mg BID for 7 days, respectively. Clinical success occurred in 101 patients (94%) who received a 500-mg single dose and in 103 patients (100%) who were administered 250 mg BID for 7 days. In study 2, eradication rates in the groups who received ciprofloxacin, 100 mg BID for 3 days, 250 mg BID for 3 days, and 250 mg BID for 7 days, were 98 (93%), 95 (90%), and 98 (93%), respectively. Clinical success was reported in 102 (97%), 105 (100%), and 104 (98%) of the patients, respectively. In study 3, the eradication rates in the groups who received ciprofloxacin in dosages of 500 mg once daily for 3 days and 500 mg once daily for 5 days and norfloxacin in a dosage of 400 mg BID for 7 days were 137 (92%), 134 (90%), and 133 (94%) of the women, respectively. Clinical success was the same (97%) in all three groups. Overall, short-course (either 3- or 5-day) therapy with ciprofloxacin was statistically equivalent to conventional (7-day) therapy with either ciprofloxacin or norfloxacin. Single-dose ciprofloxacin therapy was statistically less effective than conventional treatment.
Ciprofloxacin at a dosage of 100 mg BID for 3 days was the minimum effective dose for the treatment of uncomplicated urinary tract infection in women.
开展了三项研究以确定环丙沙星治疗急性、有症状、非复杂性下尿路感染的最小有效给药方案。
所有研究均为多中心、前瞻性、随机、双盲试验。共有970例诊断为尿路感染的可评估患者接受口服环丙沙星（每日200毫克至500毫克，分1或2次给药，共1、3、5或7天）或诺氟沙星（每日400毫克，分两次给药，共7天）治疗。疗效的主要衡量指标是治疗结束时的细菌清除情况。
在研究1中，接受500毫克单次剂量环丙沙星和每日两次250毫克共7天治疗的组中，分别有95例（89%）和101例（98%）患者细菌清除。接受500毫克单次剂量治疗的101例患者（94%）和接受每日两次250毫克共7天治疗的103例患者（100%）临床治愈。在研究2中，接受每日两次100毫克共3天、每日两次250毫克共3天和每日两次250毫克共7天环丙沙星治疗的组中，细菌清除率分别为98例（93%）、95例（90%）和98例（93%）。分别有102例（97%）、105例（100%）和104例（98%）患者临床治愈。在研究3中，接受每日一次500毫克共3天、每日一次500毫克共5天环丙沙星治疗以及接受每日两次400毫克共7天诺氟沙星治疗的组中，女性患者的细菌清除率分别为137例（92%）、134例（90%）和133例（94%）。三组的临床治愈率相同（97%）。总体而言，环丙沙星短程（即3天或5天）治疗在统计学上等同于环丙沙星或诺氟沙星的传统（7天）治疗。环丙沙星单剂量治疗在统计学上不如传统治疗有效。
每日两次100毫克共3天的环丙沙星剂量是治疗女性非复杂性尿路感染的最小有效剂量。
