Prophylactic using of levofloxacin in transrectal prostate biopsy: a prospective, multicenter, randomized, effective drug control and open-label clinical study

Abstract

Objective To find an efficacy,safety and economic prophylactic regimen after the transrectal ultrasound-guided prostate biopsy (TRUSPBs) by comparing the results of infection complications after the oral levofloxacin application with other intravenous prophylaxis antibiotics.Methods It was a prospective,randomized,multicenter,effective drug control and open-label clinical study.From October 2011to December 2012,296 patients who had indications of prostate biopsy in 8 medical centers were randomized into two groups:test group (n=150,levofloxacin,500 mg,po,qd for 3 days) and control group (n=146 intravenous antibiotics of any kinds,3 days).All those antibiotics were used on the day of biopsy and within two days after the biopsy.The average age in test group and control group was (67.6±8.6) years vs (68.7± 8.8) years,the average PSA level in test group and control group was (105.8±638.1) μg/L vs (174.6±861.4) μg/L,respectively (P＞0.05).In test group and control group,the mean duration of present illness was (0.6±2.3) months and (0.4± 1.2) months.The positive rate after the digital rectal examination was 45.3％ (68/150) in test group and 51.4％ (75/146) in control group.All patients underwent TRUSPB.The infectious complications and the expenditure of medicine in two groups were compared.Results The occurrences of infection complications in test group and control group were 6.0％ (9/150) and 6.2％ (9/146).Meanwhile,the rate of asymptomatic bacteriuria was 4.7％ (7/150) in test group and 3.4％ (5/146) in control group.In those groups,the rate of symptomatic urinary tract infection was 0 vs 0.7％ (1/146),the rate of fever was 0 vs 0.7％ (1/146),the rate of bacteremia was 1.3％ (2/150) vs 0 and the rate of urosepsis was 0 vs 1.4％ (2/146),respectively (P＞0.05).The average costs of medicine in test group and control group were (43.0±3.8) yuan and (403.7±277.6) yuan,respectively (P＜0.05).Conclusions Levofloxacin (500 mg,po,qd for 3 days) is an effective and safe regimen for infection prevention after the TRUSPB.Additionally,levofloxacin 500 mg 3 days regimen has significant cost benefit as well. Key words: Levofloxacin; Transrectal prostate biopsy; Infection; Prophylaxis