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Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy.

Abstract：

OBJECTIVES:To determine whether antimicrobial prophylaxis could prevent infections after transrectal needle biopsy of the prostate using automated biopsy devices. METHODS:We conducted a prospective, randomized, double-blind, multicenter trial in which a total of 537 patients received either oral ciprofloxacin 500 mg or placebo before transrectal needle biopsy of the prostate. Repeated urine cultures and urinalysis were obtained at 2 to 6 days after biopsy and 9 to 15 days after biopsy. The primary determinant of efficacy was bacteriologic response (bacteriuria [more than 10(4) colony-forming units (CFU)/mL] versus no bacteriuria) at the 9- to 15-day follow-up evaluation. RESULTS:Two hundred twenty-seven (84%) of 269 ciprofloxacin patients and 230 (86%) of 268 placebo patients were valid for efficacy analysis in which a mean of four biopsies was performed. Six ciprofloxacin-treated (3%) and 19 placebo-treated (8%) patients had bacteriuria (more than 10(4) CFU/mL) after the procedure (P = 0.009). Six ciprofloxacin recipients (3%) and 12 placebo recipients (5%) had clinical signs and symptoms of a urinary tract infection (UTI) (P = 0.15). In addition, no ciprofloxacin-treated patients compared with 4 placebo-treated patients (2%) were admitted to the hospital for febrile UTI after the procedure. Ciprofloxacin reduced the expected net costs of treating infectious complications after biopsy by $23 per patient for an overall annual savings of $68,195 in the five study groups when compared with placebo. CONCLUSIONS:Single-dose oral ciprofloxacin reduced bacteriuria after biopsy compared with placebo in patients undergoing transrectal prostatic biopsy and provided an economic advantage. In addition, this study establishes the actual rate of bacteriuria after transrectal needle biopsy of the prostate without antibiotic prophylaxis to be 8% with a clinical rate of UTI of 5% and a hospitalization rate of 2%.

journal_name

Urology

journal_title

Urology

authors

Kapoor DA,Klimberg IW,Malek GH,Wegenke JD,Cox CE,Patterson AL,Graham E,Echols RM,Whalen E,Kowalsky SF

doi

10.1016/s0090-4295(98)00296-9

subject

Has Abstract

pub_date

1998-10-01 00:00:00

pages

552-8

issue

eissn

0090-4295

issn

1527-9995

pii

S0090-4295(98)00296-9

journal_volume

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Single-dose oral ciprofloxacin versus placebo for prophylaxis during transrectal prostate biopsy.