Kapoor D A, Klimberg I W, Malek G H, Wegenke J D, Cox C E, Patterson A L, Graham E, Echols R M, Whalen E, Kowalsky S F
Department of Urologic Surgery, Veterans Administration Medical Center, Minneapolis, Minnesota, USA.
Urology. 1998 Oct;52(4):552-8. doi: 10.1016/s0090-4295(98)00296-9.
To determine whether antimicrobial prophylaxis could prevent infections after transrectal needle biopsy of the prostate using automated biopsy devices.
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.
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.
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%.
确定使用自动活检装置经直肠前列腺穿刺活检后，抗菌药物预防是否能预防感染。
我们进行了一项前瞻性、随机、双盲、多中心试验，共有537例患者在经直肠前列腺穿刺活检前接受口服500毫克环丙沙星或安慰剂治疗。在活检后2至6天以及活检后9至15天进行重复的尿培养和尿液分析。疗效的主要决定因素是在9至15天的随访评估中的细菌学反应（菌尿症[超过10(4)菌落形成单位（CFU）/毫升]与无菌尿症）。
269例环丙沙星治疗患者中的227例（84%）和268例安慰剂治疗患者中的230例（86%）可进行疗效分析，其中平均进行了四次活检。六例接受环丙沙星治疗的患者（3%）和19例接受安慰剂治疗的患者（8%）在术后出现菌尿症（超过10(4)CFU/毫升）（P = 0.009）。六例环丙沙星接受者（3%）和12例安慰剂接受者（5%）有尿路感染（UTI）的临床体征和症状（P = 0.15）。此外，与4例接受安慰剂治疗的患者（2%）相比，术后没有环丙沙星治疗的患者因发热性UTI住院。与安慰剂相比，环丙沙星使活检后治疗感染并发症的预期净成本每位患者降低23美元，在五个研究组中每年总体节省68,195美元。
与安慰剂相比，单剂量口服环丙沙星可降低经直肠前列腺活检患者活检后的菌尿症，并具有经济优势。此外，本研究确定了在没有抗生素预防的情况下经直肠前列腺穿刺活检后菌尿症的实际发生率为8%，UTI的临床发生率为5%，住院率为2%。
