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一项比较阿米卡星与左氧氟沙星联合方案和单独使用左氧氟沙星在经直肠前列腺穿刺活检中作为预防用药的前瞻性随机试验。

A Prospective Randomized Trial Comparing a Combined Regimen of Amikacin and Levofloxacin to Levofloxacin Alone as Prophylaxis in Transrectal Prostate Needle Biopsy.

作者信息

Miyazaki Yu, Akamatsu Shusuke, Kanamaru Sojun, Kamiyama Yuki, Sengiku Atsushi, Iguchi Ryo, Sano Takeshi, Takahashi Akira, Ito Masaaki, Takenawa Jun, Ito Noriyuki, Ogura Keiji

机构信息

Department of Urology, Japanese Red Cross Otsu Hospital, 1-35 Nagara 1-Chome Otsu City, Shiga, 520-8511, Japan.

Department of Urology, Kyoto University Graduate School of Medicine, 54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.

出版信息

Urol J. 2016 Mar 5;13(1):2533-40.

PMID:26945658
Abstract

PURPOSE

We investigated whether addition of amikacin to levofloxacin-based antimicrobial prophylaxis reduces febrile urinary tract infections after transrectal ultrasound-guided prostate needle biopsy (TRUSB).

MATERIALS AND METHODS

A total of 447 patients undergoing TRUSB were prospectively randomized into two groups. The 230 patients in Group A were given one oral dose of levofloxacin 400 mg prior to TRUSB; the 217 patients in Group B each received the same dose of levofloxacin and one 200 mg intravenous dose of amikacin. Patients' characteristics were assessed prior to TRUSB and their symptoms were checked after the TRUSB.

RESULTS

Both regimens were well tolerated with no side effects. No statistically significant difference in patients' characteristics, or in incidence of inflammation- or infection-related symptoms was seen between the two groups; nor any significant difference among those who developed fever and those who did not. Two Group A patients and one Group B patient developed febrile urinary tract infections. Accountable pathogens determined by urine and blood cultures were fluoroquinolone-resistant E.coli and extended-spectrum β-lactamase-producing E.coli. All pathogens isolated were levofloxacin-resistant, amikacin-susceptible species.

CONCLUSION

Although the present study was under-powered by unexpectedly low overall incidence of febrile urinary tract infections, addition of one intravenous administration of amikacin to one oral administration of levofloxacin showed no advantage compared with levofloxacin alone as antimicrobial prophylaxis in TRUSB. Strikingly, all pathogens isolated from febrile patients were sensitive to amikacin in vitro. Therefore, further understanding of amikacin's drug kinetics in the prostate is necessary to develop a more efficient drug delivery system for amikacin.

摘要

目的

我们研究了在基于左氧氟沙星的抗菌预防方案中添加阿米卡星是否能降低经直肠超声引导下前列腺穿刺活检(TRUSB)后发热性尿路感染的发生率。

材料与方法

共有447例行TRUSB的患者被前瞻性随机分为两组。A组230例患者在TRUSB前口服一剂400 mg左氧氟沙星;B组217例患者每人接受相同剂量的左氧氟沙星和一剂200 mg静脉注射阿米卡星。在TRUSB前评估患者特征,并在TRUSB后检查其症状。

结果

两种方案耐受性良好,均无副作用。两组患者的特征、炎症或感染相关症状的发生率均无统计学显著差异;发热患者和未发热患者之间也无显著差异。A组有2例患者和B组有1例患者发生了发热性尿路感染。通过尿液和血液培养确定的致病病原体为耐氟喹诺酮大肠杆菌和产超广谱β-内酰胺酶大肠杆菌。分离出的所有病原体均为耐左氧氟沙星、对阿米卡星敏感的菌种。

结论

尽管本研究因发热性尿路感染的总体发生率意外较低而效能不足,但在TRUSB的抗菌预防中,与单独使用左氧氟沙星相比,在口服一剂左氧氟沙星的基础上静脉注射一剂阿米卡星并无优势。引人注目的是,从发热患者中分离出的所有病原体在体外对阿米卡星敏感。因此,有必要进一步了解阿米卡星在前列腺中的药代动力学,以开发一种更有效的阿米卡星给药系统。

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