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用于治疗尿路感染的新型抗感染药物评估。美国传染病学会和美国食品药品监督管理局。

Evaluation of new anti-infective drugs for the treatment of urinary tract infection. Infectious Diseases Society of America and the Food and Drug Administration.

作者信息

Rubin R H, Shapiro E D, Andriole V T, Davis R J, Stamm W E

机构信息

Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston 02114.

出版信息

Clin Infect Dis. 1992 Nov;15 Suppl 1:S216-27. doi: 10.1093/clind/15.supplement_1.s216.

DOI:10.1093/clind/15.supplement_1.s216
PMID:1477233
Abstract

The term urinary tract infection (UTI) encompasses a broad range of clinical entities that share one characteristic: a positive urine culture. Clinical manifestations and responses to therapy are diverse even when comparable numbers of a particular bacterial species are identified on urine culture. These guidelines include discussion of acute uncomplicated cystitis, acute uncomplicated pyelonephritis, and complicated infections of the urinary tract. It is proposed that the finding of > or = 10(3) cfu/mL of urine defines significant bacteriuria in acute uncomplicated cystitis, > or = 10(4) cfu/mL in acute uncomplicated pyelonephritis and UTI in men, and > or = 10(5) cfu/mL in complicated UTI. The preferred clinical study design is prospective, randomized, and controlled with an active agent. Ideally, treatment with antimicrobial agents should eradicate the infecting organism, bring about the resolution of clinical signs and symptoms, have few adverse effects, and prevent reinfection.

摘要

术语“尿路感染(UTI)”涵盖了一系列具有一个共同特征的临床病症:尿培养呈阳性。即便尿培养中鉴定出的特定细菌种类数量相当,临床表现和对治疗的反应也各不相同。这些指南包括对急性单纯性膀胱炎、急性单纯性肾盂肾炎以及复杂性尿路感染的讨论。有人提议,在急性单纯性膀胱炎中,每毫升尿液中细菌菌落形成单位(cfu)≥10³可定义为显著菌尿;在急性单纯性肾盂肾炎和男性尿路感染中,该数值为≥10⁴ cfu/mL;在复杂性尿路感染中,该数值为≥10⁵ cfu/mL。首选的临床研究设计是前瞻性、随机且有活性药物对照的。理想情况下,使用抗菌药物进行治疗应根除感染病原体,使临床体征和症状得到缓解,不良反应少,并预防再次感染。

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