Petersen E E, Wingen F, Fairchild K L, Halfhide A, Hendrischk A, Links M, Schad M, Scholz H R, Schürmann N, Siegmann S
Universitäts-Frauenklinik, Freiburg, West Germany.
J Antimicrob Chemother. 1990 Oct;26 Suppl B:147-52. doi: 10.1093/jac/26.suppl_b.147.
In a double-blind multicentre study the efficacy and safety of a single-dose treatment with pefloxacin (800 mg) was compared with a five-day treatment regimen of 960 mg co-trimoxazole twice daily in the therapy of acute uncomplicated cystitis in women. In order to maintain blindness, patients in the pefloxacin group received placebo to complement the full number of tablets. Nine centres were involved; 155 patients received pefloxacin and 161 patients received co-trimoxazole. Of these, 140 patients treated with pefloxacin and 145 with co-trimoxazole were considered valid for efficacy and safety analysis. At the first follow-up, after seven to ten days, 97.1% of the pefloxacin group and 95.2% of the co-trimoxazole group were bacteriologically cured. At the second follow-up visit, after 28 to 42 days, the urine culture was negative in 95.0% of the pefloxacin group and 90.3% of the co-trimoxazole group. A single dose of 800 mg pefloxacin was demonstrated to be as safe and at least as effective as a five-day regimen of co-trimoxazole in the treatment of uncomplicated cystitis.
在一项双盲多中心研究中，将培氟沙星单剂量治疗（800毫克）与复方新诺明960毫克每日两次的五日治疗方案用于女性急性单纯性膀胱炎的治疗，并比较二者的疗效和安全性。为保持盲法，培氟沙星组患者服用安慰剂以补足片剂总数。该研究涉及九个中心；155例患者接受了培氟沙星治疗，161例患者接受了复方新诺明治疗。其中，140例接受培氟沙星治疗的患者和145例接受复方新诺明治疗的患者被纳入疗效和安全性分析。在首次随访时，即7至10天后，培氟沙星组97.1%的患者和复方新诺明组95.2%的患者细菌学治愈。在第二次随访时，即28至42天后，培氟沙星组95.0%的患者尿培养呈阴性，复方新诺明组为90.3%。在治疗单纯性膀胱炎方面，单剂量800毫克培氟沙星被证明与复方新诺明五日治疗方案一样安全且疗效至少相当。
