體外震波碎石術前使用預防性抗生素的必要性(前瞻性隨機雙盲性試驗)及術後併發症之統計探討
劉英博 謝政興 張尚仁 林佳達 楊緒棣
佛教台北慈濟綜合醫院泌尿科
Do we need prophylactic antibiotics prior to extracorporeal shock wave lithotripsy ? A randomized control trial with prospective follow-up of associated complications
Yin-Buh Liu, Cheng-Hsing Hsieh, Shang-Jen Chang, Chia-Da Lin and Stephan Yang
Division of Urology, Taipei Tzu Chi Hospital, The Buddhist Tzuchi Medical Foundation; School of Medicine, Buddhist Tzu-Chi University, Hualien, Taiwan
Purpose: To compare the efficacy of prophylactic antibiotics in reduction of post-surgical infections in patients undergoing extracorporeal shock wave lithotripsy (ESWL).
Materials and Methods: The study is a double-blind, prospective, randomized placebo control trial. Between 2012 and 2014, patients with preoperative sterile urine undergoing ESWL were randomly allocated by the randomization ratio of 1:1 to receive prophylactic antibiotics with single-dose oral levofloxacin (500mg) or no treatment (control group), respectively. Urine analysis and urine cultures were obtained between postoperative day 5 and 7. Pyuria was defined as ≧10 WBC/hpf. Significant bacteriuria was defined as ≧105cfu uropathogens/ml. Febrile urinary tract infection (fUTI) was defined as body temperature of 38.0 Celsius degree with pyuria or significant bacteriuria within 7 days post-operatively.
Results: Initially, 274 patents underwent randomization with 139 and 135 patients in the control and levofloxacin group, respectively. Finally, 206 patients (106 with placebo and 100 with levofloxacin) with complete followup of urine analysis were eligible for analysis. The rates of postoperative pyuria were not significantly different in patients with and without prophylaxis (8% vs. 4.7%p=0.33). There was also no significant difference in rates of bacteriuria in patients with and without prophylaxis (0% v.s. 1%, p=0.49). Patients without followup of urine analysis and urine culture were contacted with telephone and there was only patients with post-operative fever in the levofloxacin group (0% vs. 0.7%, p=0.49). As preliminary results of the interim analysis revealed no benefit of levofloxacin in preventing post-ESWL pyuria, bacteriuria and febrile urinary tract infection, we terminated the study early before pre-planned sample size is achieved.
Conclusion: The incidence of asymptomatic and febrile urinary tract infection is low in patient underwent ESWL with pre-operative sterile urine. Therefore, prophylactic antibiotics in these patients may be unnecessary.