CAJ | 학술논문

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500 mg/片,于穿刺前1～6h及穿刺后第1、2天早饭后30 min分别口服l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-效果比分别是45.8和430.4. 结论口服左氧氟沙星500 mg,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-效果比的方案.
목적 비교경직장전렬선천자환자위수술기구복좌양불사성여전통급약방안하감염성병발증적구별,선택일개안전유효、방편합리、구유최가약물성본-효과비적예방감염용약방안.방법 본연구위다중심、수궤、대조、개방림상연구.2011년10월지2012년12월,취진우8가의원비뇨외과유전렬선천자지정적환자296례,채용수궤호마표법분위:시험조150례,응용좌양불사성편500 mg/편,우천자전1～6h급천자후제1、2천조반후30 min분별구복l편;대조조146례,우천자당천급천자후제1、2천정맥적주연구단위상용적항균약물.시험조화대조조환자적평균년령분별위(67.6±8.6)세화(68.7±8.8)세,평균병정위(0.6±2.3)개월화(0.4±1.2)개월,PSA수평분별위(105.8±638.1)μg/L화(174.6±861.4)μg/L,직장지검양성솔분별위45.3％ (68/150)화51.4％ (75/146),차이균무통계학의의(P＞0.05).소유환자균채용초성인도하경직장전렬선천자,비교량조적감염성병발증발생정황、약물불량반응발생솔화약물적성본-효과비. 결과 시험조화대조조적총체감염성병발증발생솔분별위6.0％ (9/150)화6.2％ (9/146),기중무증상균뇨발생솔분별위4.7％(7/150)화3.4％ (5/146),유증상뇨로감염발생솔분별위0화0.7％(1/146),발열발생솔분별위0화0.7％(1/146),균혈증발생솔분별위1.3％ (2/150)화0,뇨농독혈증발생솔분별위0화1.4％(2/146),차이균무통계의의(P＞0.05).시험조화대조조적평균비용분별위(43.0±3.8)원화(403.7±277.6)원,차이유통계의의(P＜0.05),량조적성본-효과비분별시45.8화430.4. 결론 구복좌양불사성500 mg,1차/d,련속3d방안작위초성인도하경직장전렬선천자위수술기적예방감염용약시일충안전유효、방편합리、구유최가약물성본-효과비적방안.
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 levofloxacin application with other intravenous prophylaxis antibiotics.Methods It was a prospective,randomized,multicenter,effective drug control and open-label clinical study.From October 2011to 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 mg,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 occurrences 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.