左氧氟沙星与洛美沙星治疗复杂性尿路感染的对照试验

A controlled trial of levofloxacin and lomefloxacin in the treatment of complicated urinary tract infection.

作者信息

Klimberg I W, Cox C E, Fowler C L, King W, Kim S S, Callery-D'Amico S

机构信息

Urology Center of Florida, Ocala 34474, USA.

出版信息

Urology. 1998 Apr;51(4):610-5. doi: 10.1016/s0090-4295(97)00708-5.

DOI:10.1016/s0090-4295(97)00708-5

PMID:9586615

Abstract

OBJECTIVES

The efficacy and safety of levofloxacin and lomefloxacin in complicated urinary tract infections (UTIs) were compared in a randomized, open-label, multicenter study.

METHODS

Outpatients were randomized to receive levofloxacin (250 mg once daily) for 7 to 10 days or lomefloxacin (400 mg once daily) for 14 days. Three hundred thirty-six patients (171 with levofloxacin, 165 with lomefloxacin) were evaluable for microbiologic efficacy, and 461 patients (232 with levofloxacin, 229 with lomefloxacin) for safety.

RESULTS

The overall microbiologic eradication rate of pathogens was 95.5% (168 of 176) for levofloxacin and 91.7% (154 of 168) for lomefloxacin. Eradication rates with respect to patients were 95.3% (163 of 171) and 92.1% (152 of 165) for levofloxacin and lomefloxacin, respectively. At the 5 to 9-day post-therapy visit, symptoms were completely resolved in 84.8% of levofloxacin-treated patients and were decreased in 8.2% (93.0% clinical success). Among the lomefloxacin-treated patients, complete resolution was seen in 82.4%, with decreased symptoms in 6.1% (88.5% clinical success). Drug-related adverse events (AEs) were reported by 10 (2.6%) and 18 (5.2%) levofloxacin- and lomefloxacin-treated patients, respectively. Compared with levofloxacin-treated patients, more lomefloxacin-treated patients experienced photosensitivity reactions (3 [1.3%] versus 0) and dizziness (2 [0.9%] versus 0). Nausea (3 [1.3%] versus 1 [0.4%]) was more frequent in the levofloxacin-treated group. Six patients in each treatment group had a gastrointestinal AE (1.7%); rash was reported more frequently with lomefloxacin (4 patients [0.4%]) than with levofloxacin (1 patient [0.4%]). Discontinuation because of AEs was observed in 8 (3.4%) levofloxacin- and 14 (6.1%) lomefloxacin-treated patients.

CONCLUSIONS

Once-daily levofloxacin is as effective as and has a superior tolerability profile than lomefloxacin in the treatment of complicated UTIs.

摘要

目的

在一项随机、开放标签、多中心研究中比较左氧氟沙星和洛美沙星治疗复杂性尿路感染（UTIs）的疗效和安全性。

方法

门诊患者被随机分为接受左氧氟沙星（每日一次，250毫克）治疗7至10天或洛美沙星（每日一次，400毫克）治疗14天。336例患者（171例接受左氧氟沙星治疗，165例接受洛美沙星治疗）可评估微生物学疗效，461例患者（232例接受左氧氟沙星治疗，229例接受洛美沙星治疗）可评估安全性。

结果

左氧氟沙星治疗病原体的总体微生物清除率为95.5%（176例中的168例），洛美沙星为91.7%（168例中的154例）。左氧氟沙星和洛美沙星治疗患者的清除率分别为95.3%（171例中的163例）和92.1%（165例中的152例）。在治疗后5至9天的随访中，84.8%接受左氧氟沙星治疗的患者症状完全缓解，8.2%的患者症状减轻（临床成功率93.0%）。在接受洛美沙星治疗的患者中，82.4%症状完全缓解，6.1%症状减轻（临床成功率88.5%）。分别有10例（2.6%）接受左氧氟沙星治疗的患者和18例（5.2%）接受洛美沙星治疗的患者报告了与药物相关的不良事件（AE）。与接受左氧氟沙星治疗的患者相比，接受洛美沙星治疗的患者出现光敏反应（3例[1.3%]对0例）和头晕（2例[0.9%]对0例）的更多。恶心在接受左氧氟沙星治疗的组中更常见（3例[1.3%]对1例[0.4%]）。每个治疗组各有6例患者出现胃肠道AE（1.7%）；洛美沙星组报告皮疹的频率高于左氧氟沙星组（4例患者[0.4%]对1例患者[0.4%]）。因AE停药的情况在接受左氧氟沙星治疗的8例（3.4%）患者和接受洛美沙星治疗的14例（6.1%）患者中观察到。