摘要
目的比较经直肠前列腺穿刺患者围手术期口服左氧氟沙星与传统给药方案下感染性并发症的区别，选择一个安全有效、方便合理、具有最佳药物成本-效果比的预防感染用药方案。方法本研究为多中心、随机、对照、开放临床研究。2011年10月至2012年12月，就诊于8家医院泌尿外科有前列腺穿刺指征的患者296例，采用随机号码表法分为：试验组150例，应用左氧氟沙星片500mg／片，于穿刺前1～6h及穿刺后第l、2天早饭后30min分别口服1片；对照组146例，于穿刺当天及穿刺后第1、2天静脉滴注研究单位常用的抗菌药物。试验组和对照组患者的平均年龄分别为（67．6±8．6）岁和（68．7±8．8）岁，平均病程为（0．6±2．3）个月和（0．4±1．2）个月，PSA水平分别为（105．8±638．1）μg／L和（174．6±861．4）μg／L，直肠指检阳性率分别为45．3％（68／150）和51．4％（75／146），差异均无统计学意义（P〉0．05）。所有患者均采用超声引导下经直肠前列腺穿刺，比较两组的感染性并发症发生情况、药物不良反应发生率和药物的成本-效果比。结果试验组和对照组的总体感染性并发症发生率分别为6．0％（9／150）和6．2％（9／146），其中无症状菌尿发生率分别为4．7％（7／150）和3．4％（5／146），有症状尿路感染发生率分别为0和0．7％（1／146），发热发生率分别为0和0．7％（1／146），菌血症发生率分别为1．3％（2／150）和0，尿脓毒血症发生率分别为0和1．4％（2／146），差异均无统计意义（P〉0．05）。试验组和对照组的平均费用分别为（43．0±3．8）元和（403．7±277．6）元，差异有统计意义（P〈0．05），两组的成本一效果比分别是45．8和430．4。结论口服左氧氟沙星500mg，1次／d，连续3d方案作为超声引导下经直肠前列腺穿刺围手术期的预防感染用药是一种安全有效、方便合理、具有最佳药物成本一效果比的方案。
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 levofloxaein application with other intravenous prophylaxis antibiotics, Methods It was a prospective, randomized, multieenter, effective drug control and open-label clinical study. From October 2011 to 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 rag, 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 oc- currences 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.
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2014年第11期836-840,共5页
Chinese Journal of Urology
关键词
左氧氟沙星
经直肠前列腺穿刺
感染
预防
Levofloxacin
Transrectal prostate biopsy
Infection
Prophylaxis
