Clinical and bacteriological outcome of different doses and duration of pivmecillinam compared with placebo therapy of uncomplicated lower urinary tract infection in women: The LUTIW project

Clinical and bacteriological outcome of different doses and duration of pivmecillinam compared with placebo therapy of uncomplicated lower urinary tract infection in women: The LUTIW project
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DOI:
10.1080/02813430601183074
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发表时间:
2007-01-01
影响因子:
2.1
通讯作者:
Monsen, Tor J.
Monsen, Tor J.
中科院分区:
医学3区
文献类型:
--
作者:
Ferry, Sven A.;Holm, Stig E.;Monsen, Tor J.

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客观的。分析女性无并发症下尿路感染 (LUTIW) 症状与菌尿之间的关联,并评估匹美西林或安慰剂三种不同方案的治疗结果。设计。前瞻性、多中心、随机、双盲、安慰剂对照治疗研究。在入组时、治疗期间以及 8-10 天和 35-49 天后的随访时记录症状。根据现行欧洲指南定义的显着菌尿。环境。瑞典北部共有 18 个初级保健中心。科目。 18岁及以上有尿急、尿痛、耻骨上或腰部疼痛症状的女性。主要成果衡量标准。治疗期间和治疗后的症状和菌尿以及症状、菌尿及其组合。结果。纳入时,未发现症状评分与菌尿、细菌计数或菌种之间存在关联或显着差异。对 884 名有明显菌尿的患者(77%)进行了随访。所有 pivmecillinam 疗法均优于安慰剂 (p < 0.001)。从第六天到第一次随访,与 7 天治疗方案(93-94%,p < 0.001)相比,三天首次随访时所有症状的平均值较高(84%),而细菌学治愈率较低。最终随访时,所有匹美西林方案的临床治愈率 (65-72%) 与细菌学治愈率 (83-89%) 相似。与安慰剂相比,匹美西林几乎没有低度至轻度不良反应。结论。症状对于 LUTIW 的诊断并不是决定性的。 Pivmecillam 疗法优于安慰剂,7 天疗法比 3 天疗法更有效。建议将 Pivmecillinam 200 mg x 2 x 7 天作为 LUTIW 的一线治疗。
Objective. To analyse associations between symptoms and bacteriuria in uncomplicated lower urinary tract infection in women (LUTIW) and to evaluate outcome of therapy with three different regimens of pivmecillinam or placebo. Design. Prospective, multicentre, randomized, double-blind, and placebo-controlled therapy study. Symptoms registered at inclusion, during therapy and at follow-up visits after 8-10 and 35-49 days. Significant bacteriuria defined according to current European guidelines. Setting. A total of 18 primary healthcare centres in northern Sweden. Subjects. Women aged 18 years and above with symptoms of urgency, dysuria, suprapubic or loin pain. Main outcome measures. Symptoms and bacteriuria at inclusion and course of symptoms, bacteriuria, and their combinations during and post-therapy. Results. At inclusion, no associations or significant differences were found between symptom scores and bacteriuria, bacterial counts, or species. The 884 patients (77%) with significant bacteriuria were followed up. All pivmecillinam therapies were superior to placebo (p < 0.001). From day six until first follow-up, the mean values of all symptoms were higher and the bacteriological cure was lower at first follow-up in the three days (84%) compared with the seven days regimens (93-94%, p < 0.001). At final follow-up clinical cure was similar in all pivmecillinam regimens (65-72%) as was bacteriological cure (83-89%). Pivmecillinam had few low to mild adverse reactions, comparable to placebo. Conclusions. Symptoms are not conclusive for diagnosis of LUTIW. Pivmecillinam therapies are superior to placebo and seven days regimens are more efficient than three days. Pivmecillinam 200 mg x 2 x 7 days is recommended as a first-line therapy for LUTIW.