経尿道的前立腺切除術(TUR-P)における予防的抗生剤投与法の検討 : 経口剤投与法と注射剤投与法の比較

Abstract

1)TUR-P術前に尿路感染症のない前立腺肥大症患者を対象に, 注射剤と経口剤の感染予防効果を比較検討するため, multicenter prospective randomized studyを施行した。2)注射剤としてcefotiam(CTM), 経口剤としてtosufloxacin(TFLX)を用いた。手術当日より7日間, CTM 4g/日あるいはTFLX 300mg/日投与の無作為割り付けをした。3)登録は150症例であったが, 124例は術前のカテーテルかつ尿路感染の既往なしのlow risk groupであった。Low risk groupでは発熱の頻度の差は, 点推定でTFLX投与群がCTM投与群より4.4%少なかったが, 統計学的に有意な差ではなかった。4)複雑性尿路感染症発症率は, 術後4～5日目, 9～12日目, 23～27日目および37～40日目の各検査時でCTM投与群, TFLX投与群両群間に有意な差を認めなかった。Low risk groupの感染率はCTM投与群で, それぞれ8.3%, 16.4%, 25.0%および23.9%またTFLX投与群で6.7%, 16.7%, 29.6%および36.7%であった

To compare the prophylactic effect of oral and intravenous antibiotics against postoperative fever and urinary tract infection (UTI) after transurethral resection of the prostate (TUR-P), we conducted a multi-center prospective randomized study. The incidence of pyrexia over 38 degrees C was defined as the primary endpoint. One hundred and fifty patients with sterile urine before TUR-P were entered into this study. The patients were allocated randomly into the two arms; arm A cefotiam 4 g a day for 7 days, arm B tosufloxacin 300 mg a day for 7 days, based on the stratification into the 4 groups determined with/without preoperative indwelling catheters and with/without the history of preoperative UTI. Of these patients, 143 were eligible. We divided 124 patients without preoperative UTI and without indwelling catheters as the "low risk group", and the other 19 patients with preoperative UTI and/or with indwelling catheters as the "high risk group". In the low risk group, 9 patients out of 63 (14.3%) in arm A and 6 out of 61 (9.8%) in arm B had pyrexia during 7 postoperative days. The incidence of fever in arm B was 4.4% less than that in arm A and the 95% confidence limit was from -7% to 16%. In the high risk group, 4 out of 11 (36.4%) patients in arm A and none of 8 in arm B had fever but the difference was not significant. The incidence of post operative UTI in the low risk group on the 4 to 5, 9 to 12, 23 to 26 and 37 to 40 postoperative days was 8.3, 16.4, 25.0 and 23.9% in arm A and 6.7, 16.7, 29.6 and 36.7% in arm B, respectively. The prophylactic effect of oral administration of tosufloxacin is equivalent to that of the intravenous administration of cefotiam. The use of oral antibiotics is beneficial to reducing the cost of medication.