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环丙沙星预防尿路感染:脊髓损伤患者的前瞻性、随机、交叉、安慰剂对照研究

Ciprofloxacin as prophylaxis for urinary tract infection: prospective, randomized, cross-over, placebo controlled study in patients with spinal cord lesion.

作者信息

Biering-Sørensen F, Høiby N, Nordenbo A, Ravnborg M, Bruun B, Rahm V

机构信息

Department of TH, Rigshospitalet, National University Hospital, Copenhagen, Denmark.

出版信息

J Urol. 1994 Jan;151(1):105-8. doi: 10.1016/s0022-5347(17)34882-6.

Abstract

To evaluate the efficacy of low-dose long-term treatment with ciprofloxacin in the prevention of recurrent urinary tract infections in patients with spinal cord lesions and neurogenic bladder dysfunction, a prospective, randomized, cross-over, placebo-controlled study was performed. The study period was 12 months long, including 6 months of treatment with 100 mg. ciprofloxacin at night and 6 months of placebo treatment. The study was completed by 18 men and 3 women, median age 38 years (range 19 to 73 years). Within the last 12 months before inclusion into the study, the patients had between 3 and 14 urinary tract infections (mean 5.8) treated with antimicrobial agents. The number of urinary tract infections treated with antimicrobial agents during 6 months of ciprofloxacin prophylaxis was 5 and during the 6 months of placebo treatment it was 59 (p < 0.00005) [corrected]. Fecal specimens showed supercolonization with ciprofloxacin resistant bacteria (Acinetobacter calcoaceticus) in 1 instance. No severe side effects were observed. Ciprofloxacin at a dose of 100 mg. at night was efficacious in preventing urinary tract infections during 6 months in patients with spinal cord lesions and neurogenic bladder dysfunction. After the controlled study 10 of the 21 patients used ciprofloxacin as prophylaxis for up to 39 months with a marked reduction in the pre-study infection frequency. In 1 patient ciprofloxacin resistant Escherichia coli was subsequently found in the feces.

摘要

为评估低剂量长期使用环丙沙星预防脊髓损伤和神经源性膀胱功能障碍患者复发性尿路感染的疗效,进行了一项前瞻性、随机、交叉、安慰剂对照研究。研究为期12个月,包括6个月每晚服用100毫克环丙沙星的治疗期和6个月的安慰剂治疗期。该研究由18名男性和3名女性完成,年龄中位数为38岁(范围19至73岁)。在纳入研究前的最后12个月内,患者接受抗菌药物治疗的尿路感染次数为3至14次(平均5.8次)。环丙沙星预防6个月期间接受抗菌药物治疗的尿路感染次数为5次,安慰剂治疗6个月期间为59次(校正后p<0.00005)。粪便标本有1例显示被耐环丙沙星细菌(醋酸钙不动杆菌)超定植。未观察到严重副作用。每晚服用100毫克环丙沙星对预防脊髓损伤和神经源性膀胱功能障碍患者6个月内的尿路感染有效。对照研究结束后,21名患者中有10名使用环丙沙星作为预防用药长达39个月,研究前的感染频率显著降低。1例患者随后粪便中发现耐环丙沙星大肠杆菌。

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