Guibert J, Capron M H, Giacomino A
Hôpital Saint-Joseph, Paris.
Presse Med. 1996 Sep 28;25(28):1271-5.
Compare the acceptability of a 3-day regimen with that of a single-dose regimen of fluoroquinolones for the treatment of lower urinary tract infection in women.
A multicentric, randomized open trial was conduced in 595 patients by general practitioners to determine acceptability, efficacy and tolerance of lomefloxacine 400 mg in a once a day dose given for three days compared with a once-a-day 800 mg dose of pefloxacin for the treatment of lower urinary tract infection in women.
The delay to symptom relief was greater than 24 hours in both treatment groups. Symptom relief was observed after treatment onset in only 23% of the patients. Clinical success rate at day 14 was 94.2% for lomefloxacin and 95.7% for pefloxacin. The rates of bacteriological eradication were 90.6% and 92.8% respectively with no significant difference. Adverse events were reported in 27.1% and 33.3% of the patients respectively, digestive disorders (abdominal pain, nausea) and neurosensorial disorders (headache, dizziness) predominated. There was no serious adverse event. The incidence of adverse events related to the treatment according to the investigator was smaller with lomefloxacin (16.1%) than with pefloxacin (23.5%) (p = 0.026).
Acceptability, assessed at day 14, was not significantly different between the two treatment groups. Lomefloxacin was the only antibiotic currently authorized for use in a three-day regimen for the treatment of lower urinary tract infections.
比较氟喹诺酮类药物三日疗法与单剂量疗法治疗女性下尿路感染的可接受性。
全科医生对595例患者进行了一项多中心随机开放试验,以确定400毫克洛美沙星每日一次服用三天与每日一次800毫克培氟沙星治疗女性下尿路感染的可接受性、疗效和耐受性。
两个治疗组症状缓解延迟均超过24小时。仅23%的患者在治疗开始后出现症状缓解。洛美沙星在第14天的临床成功率为94.2%,培氟沙星为95.7%。细菌清除率分别为90.6%和92.8%,无显著差异。分别有27.1%和33.3%的患者报告了不良事件,以消化系统疾病(腹痛、恶心)和神经感觉系统疾病(头痛、头晕)为主。无严重不良事件。根据研究者评估,洛美沙星治疗相关不良事件的发生率(16.1%)低于培氟沙星(23.5%)(p = 0.026)。
在第14天评估的可接受性方面,两个治疗组之间无显著差异。洛美沙星是目前唯一被批准用于三日疗法治疗下尿路感染的抗生素。