经尿道前列腺切除术围手术期预防性应用抗菌药物的疗效和安全性

Antimicrobial prophylaxis in transurethral resection of the prostate:perioperative application and evaluation

目的比较不同时限的预防性使用抗菌药物在经尿道前列腺切除术围手术期中的安全性和有效性。方法卡本研究为前瞻性随机对照临床研究,选取安徽医科大学第二附属医院2022年7月至2023年12月符合条件的接受经尿道前列腺切除术患者。纳入标准:年龄55~78岁;有良性前列腺增生外科手术适应证;术前尿常规检查无脓尿、菌尿;术前未保留导尿;术后病理检查证实为良性前列腺增生;签署知情同意书。排除标准:严重心肺脑等疾病不能耐受麻醉和手术;合并膀胱结石或膀胱肿瘤;血糖控制不佳的糖尿病患者;使用免疫抑制剂。采用随机区组设计将患者按1:1比例随机分配至试验组和对照组。试验组患者术前30min或2h预防性使用单次剂量头孢类或氟喹诺酮类抗菌药物,对照组患者于首次给药后12、24h再次给药。主要疗效指标为术后1周内尿路感染性发热(体温≥38.5℃)发生率,次要指标为术后1周血常规白细胞计数、C-反应蛋白、血清肝素结合蛋白、尿常规红细胞和白细胞计数、菌尿发生率、肺部感染发生率、术后住院时间,安全性指标为抗菌药物不良反应发生率。结果本研究共纳人180例患者,试验组和对照组均为90例。两组的年龄[(71.7±3.9)岁与(69.9±4.8)岁]、前列腺体积[55.0(39.5,62.0)ml与52.5(45.5,68.5)ml,]、手术时间[(58.8±17.0)min与(60.9±16.7)min]、术后留置尿管时间[3.0(3,4)d与3.8(3,4d]等差异无统计学意义(P>0.05)。试验组和对照组术后1周内尿路感染性发热发生率分别为7.8%(7/90)和5.6%(5/90),差异无统计学意义(P=0.550)。试验组较对照组术后1周血白细胞计数[(10.5±1.2)×10^(9)%/L与(9.7±4.1)×10^(9)/L],C-反应蛋白[(43.0±27.9)mg/L与(53.1±29.9)mg/L],肝素结合蛋白[(44.7±19.4)ng/ml与(37.8±23.5)ng/ml],尿红细胞计数[4768.2(2387.9,10496.5)个/μl与6577.2(3691.5,7636.8)个/μl],尿白细胞计数[447.1(283.9,637.0)个/μl与242.8(10^(9).7,691.8)个/μl)的差异无统计学意义(P>0.05)。试验组和对照组肺部感染发生率分别为3.3%(3/90)和2.2%(2/90),菌尿发生率分别为6.7%(6/90)和8.9%(8/90),术后住院时间分别为4.5(4.0,5.1)d和4.5(4.0,5.5)d,差异均无统计学意义(P>0.05)。试验组和对照组的抗菌药物不良反应发生率分别为3.3%(3/90)和11.1%(10/90),差异有统计学意义(P=0.044)。结论对于术前无脓尿且未留置尿管的经尿道前列腺切除术患者,围手术期预防性使用单次剂量抗菌药物是安全有效的。

Objective To evaluate the safety and validity of perioperative antimicrobial prophylaxis with different administration period in patients undergoing transurethral resection of the prostate(TURP)for benign prostatic hyperplasia(BPH).Methods This prospective randomized controlled clinical trial was conducted on patients who underwent TURP in the Second Affiliated Hospital of Anhui Medical University from July 2022 to December 2023.The patients were randomly assigned to the experimental group and the control group in a 1:1 ratio using a randomized block design.Inclusion criteria:age 55-78 years old,the indication of benign prostatic hyperplasia surgery,preoperative urine routine examination showed no pyuria or bacteriuria,preoperative catheterization being not reserved,postoperative pathology confirmed BPH and informed consent obtained.Exclusion criteria:severe heart,lung,brain and other diseases which could not tolerate anesthesia and surgery,complicated with bladder stones or bladder tumors,diabetic patients with poor glycemic control,immunosuppressive agents being administered.Patients in the experimental group received a single dose of cephalosporins or fluoroquinolones 30 minutes or 2 hours before surgery,while patients in the control group received a second dose 12 hours or 24 hours after the first dose.The primary outcome was the incidence of urinary tract infectious presenting fever(body temperature≥38.5℃)within 1 week after surgery,while the white blood cell count,C-reactive protein concentration,serum heparin-binding protein concentration,red and white blood cell count in urine,the incidence of bacteriuria,pulmonary infection,and postoperative hospital stay were defined as secondary outcomes.The safety index was the incidence of adverse reactions of antibiotics.Results A total of 180 patients were enrolled in this study,including 90 cases in each experimental group or control group.Two groups of patients had no significant dfference(P>0.05)in age[(71.7±3.9)and(69.9±4.8)years],prostate volume[55.0 ml(39.5,62.0)and 52.5(45.5,68.5)ml],operation time[(58.8±17.0)min vs.(60.9±16.7)min],and postoperative indwelling catheter days[3.0(3,4)d vs.3.8(3,4)d].The incidence of fever within 1 week after surgery was 7.8%(7/90)in the experimental group and 5.6%(5/90)in the control group,respectively,and the difference was not statistically significant(P=0.550).Our data demonstrated that the white blood cell count[(10.5±1.2)×10^(9)/L vs.(9.7±4.1)×10^(9)/L],C-reactive protein concentration[(43.0±27.9)mg/L vs.(53.1±29.9)mg/L]and heparin-binding protein concentration[(44.7±19.4)ng/ml vs.(37.8±23.5)ng/ml],urine red blood cell count[4768.2(2387.9,10496.5)/μl vs.6577.2(3691.5,7636.8)/μl],urine white blood cell count[447.1(283.9,637.0)/μl vs 242.8(10^(9).7,691.8)/μl]were mildly elevated in two groups without significant difference(P>0.05).The incidence of postoperative pulmonary infection[3.3%(3/90)]vs.2.2%(2/90)],bacteriuria[6.7%(6/90)vs.8.9%(8/90)],postoperative hospital stay[4.5(4.0,5.1)days vs.4.5(4.0,5.5)days]also showed no significant difference(P>0.05).While the incidence of adverse reactions of antibiotics in the experimental group 3.3%(3/90)was significantly lower than that in the control group 11.1%(10/90)(P=0.044).Conclusions A single-dose antibiotic administration as a perioperative antimicrobial prophylaxis is safe and effective for patients undergoing TURP who do not have preoperative pyuria or indwelling catheter.