比较多次、单次、零剂量的环丙沙星预防性用药对输尿管软镜取石术后感染性并发症的影响：一项前瞻性随机对照试验

发布时间：2018-05-21 20:42

本文选题：预防性抗生素 + 输尿管软镜取石术　；参考：《广州医科大学》2017年硕士论文

【摘要】：【研究背景】目前输尿管软镜碎石取石术(retrograde intrarenal surgery,RIRS)在肾结石的治疗中应用越来越广泛。而随着手术技术不断的提高,以及腔内微创设备的快速发展,逆行输尿管软镜取石术以其微创、安全、有效的特点,成为了处理复杂性上尿路结石特别是肾盂肾盏内结石的重要手段之一,并且相关的并发症亦相应地在不断下降,然而术后感染性并发症仍然是RIRS术后最主要的并发症,据报道,其发生率高达25%。术后感染性并发症不但会提高住院天数和再住院率、增加抗生素的使用量,而且严重威胁患者生命安全。因此,加强术前相关危险因素的评估和围手术期抗生素的管理,预防术后感染的发生,在临床工作中已越来越受到重视。预防性抗生素现已广泛应用于泌尿外科手术,对降低术后感染性并发症的发生率起着重要的作用,但是过度使用抗生素亦会导致细菌耐药性的增加。所以,预防性抗生素的使用原则应是使用最小的剂量来达到最佳的预防感染的效果,同时减少细菌耐药性的产生和患者的医疗支出。同为治疗肾结石的经皮肾镜碎石取石术(percutaneous nephrolithotomy,PCNL),目前已有多项研究对其围手术期预防性抗生素的使用进行了报道,虽然对于预防性抗生素使用的维持时间结论并不一致,但都认可预防性抗生素的必要性和有效性。而作为更加微创的RIRS手术,目前对于围手术期预防性抗生素的用药方式仍缺乏相关的研究报道。而且,国内、外指南推荐的也没有专门关于RIRS围手术期预防性抗生素使用的具体推荐方案。故研究者希望通过本次单中心的前瞻性随机对照临床试验来研究RIRS术前无尿路感染的患者,围手术期预防性抗生素的合理用药方式,以避免不必要的,或者不合适的抗生素的应用,可一定程度减少抗生素滥用引起的细菌耐药性,具有十分重要的临床意义。【目的】比较RIRS围手术期零剂量、单剂量和多剂量预防性抗生素的使用对术后感染性并发症的影响,探讨RIRS围手术期预防性抗生素的合理使用方案。【方法】2014年8月至2016年11月共计300例术前检查未发现尿路感染的患者参与该项前瞻性随机对照试验。按照随机码表随机分配为3组(1、术前、术后不用抗生素,2、术前30分钟预防性使用环丙沙星200mg一次,静脉滴注,3、术前30分钟及术后6小时内各使用环丙沙星200mg一次,静脉滴注)。记录比较三组患者术前一般情况、结石大小、结石位置、结石密度、肾积水、术前及术后血白细胞、血红蛋白、肌酐、手术时间、术中灌注量、结石成分、住院时间、结石清除率及术后并发症,连续性变量使用单因素方差,分类变量使用卡方检验或Fisher确切概率法,前瞻性分析这3组患者的病例资料,并比较患者术后发生全身炎症反应综合征(systemicin inflammatory response syndrome,SIRS)的比例是否存在差异。【结果】1、将符合纳入标准的肾结石患者300例,按照盲法和随机分配的原则分为三组,其中35个患者因术中发现尿液浑浊、结石表面覆盖有脓苔、输尿管狭窄及软镜无法到达结石部位改行PCNL而排除出组,最后共有265个患者入组成功,零剂量组:88人,单剂量组:88人,多剂量组:89人。2、三组间,术前一般情况,如年龄、性别、体质指数(body mass index,BMI)、高血压病史、既往手术史、结石部位、结石大小、结石CT值、是否肾积水、术前及术后血白细胞、血红蛋白、肌酐、手术时间、术中灌注量、结石成分、住院时间、结石清除率无明显统计学差异(p0.05)。3、共有12(4.5%)个患者术后发生SIRS,零剂量组术后有8(9.1%)个病人发生SIRS,单剂量组有3(3.4%)个病人发生SIRS,多剂量组有1(1.1%)个病人发生SIRS(零剂量vs单剂量,p=0.119,零剂量vs多剂量,p=0.016,单剂量vs多剂量,p=0.306),结果无统计学意义。遂将数据按结石面积200mm2分组,进行亚组分析,当结石面积小于200mm2时,三组间术后SIRS发生率无统计学差异(5.0%vs 5.1%vs 0%,p=0.257),而当结石面积大于200mm2时,零剂量组术后SIRS的发生率明显偏高(17.9%vs 0%vs 2.7%,p=0.011)。这12个术后发生SIRS的患者经积极治疗后,均可痊愈,未进一步发展为脓毒血症。【结论】1、对于术前无泌尿系感染的患者,当结石面积小于200mm2时,RIRS围手术期预防性抗生素的使用并不会明显改变术后的SIRS的发生率,建议可以不预防性使用抗生素;2、而当结石面积大于200mm2时,RIRS围手术期预防性使用抗生素可以明显降低术后的SIRS的发生率,而术前单次与术前、术后各一次并无明显差异,推荐术前仅用一次预防性抗生素即可;3、本研究结果仍需更大样本量的多中心前瞻性研究进一步验证。
[Abstract]:[background] retrograde intrarenal surgery (RIRS) is becoming more and more widely used in the treatment of renal calculi. With the continuous improvement of the surgical technique and the rapid development of the minimally invasive equipment in the cavity, the retrograde ureteroscopic lithotripsy is a minimally invasive, safe and effective treatment. It is one of the important means of urinary calculi, especially in the renal pelvic and renal calycalcite, and the related complications are also decreasing. However, the postoperative infectious complication is still the most important complication after RIRS. It is reported that the incidence of infectious complications after 25%. not only increases the number of days of hospitalization and the rate of rehospitalization, but also increases the rate of hospitalization and rehospitalization. The use of antibiotics is also a serious threat to the safety of the patient. Therefore, it is becoming more and more important in clinical work to strengthen the assessment of preoperative risk factors and the management of perioperative antibiotics and prevent the occurrence of postoperative infection. Preventive antibiotics are now widely used in Department of urology surgery to reduce postoperative infection and The incidence of hair disease plays an important role, but excessive use of antibiotics can also lead to an increase in bacterial resistance. Therefore, the principle of using prophylactic antibiotics should be to use the minimum dose to achieve the best effect of infection prevention, reduce the production of bacterial resistance and the medical expenditure of the patients. Percutaneous nephrolithotomy (PCNL), a number of studies have been reported on the use of preventive antibiotics in the perioperative period. Although the conclusion of the maintenance time for preventive antibiotics is not consistent, the necessity and effectiveness of prophylactic antibiotics are recognized as a more minimally invasive RIRS. There is still a lack of relevant research on the way of using prophylactic antibiotics in the perioperative period. Moreover, there are no specific recommendations on the use of prophylactic antibiotics in the RIRS perioperative period. Therefore, the researchers hope to study RIRS through this single center prospective randomized controlled clinical trial. It is of great significance to reduce the rational use of prophylactic antibiotics in the perioperative period to avoid unnecessary and inappropriate antibiotics, and to reduce the antibiotic resistance caused by antibiotic abuse to a certain extent. [Objective] to compare the zero dose, single dose and multiple dose of RIRS in the perioperative period. The effect of the use of prophylactic antibiotics on postoperative infectious complications and the rational use of preventive antibiotics in RIRS perioperative period. [Methods] a total of 300 patients who did not find urinary tract infection during the period from August 2014 to November 2016 were involved in the prospective randomized, randomized trial. A random code table was randomly assigned to 3 groups. 1, preoperative, postoperative antibiotics, 2, 30 minutes before the operation of the preventive use of ciprofloxacin 200mg, intravenous drip, 3, 30 minutes before the operation and 6 hours after the operation of ciprofloxacin 200mg once, intravenous drip). Record comparison of three groups of patients before the general conditions, stone, stone location, stone density, hydronephrosis, preoperative and postoperative blood white fine Cell, hemoglobin, creatinine, operation time, intraoperative perfusion, stone composition, hospitalization time, stone clearance rate and postoperative complications, continuous variables using single factor variance, classified variables using chi square test or Fisher exact probability method, prospectively analyzed the case data of these 3 groups, and compared the patients with systemic inflammatory response after operation. Whether there was a difference in the proportion of systemicin inflammatory response syndrome (SIRS). [results] 1, 300 patients with renal calculi were divided into three groups according to the principle of blindness and random distribution. Among them, 35 patients were found cloudy in the urine, the surface of the stone was covered with purulent moss, ureteral stenosis and the soft mirror could not be reached. A total of 265 patients were replaced with PCNL and a total of 265 patients were excluded from the group. A total of 88 people, a single dose group, 88 people, a multi dose group, 89 people, and three groups, such as age, sex, body mass index (body mass index, BMI), high blood pressure (index, BMI), history of high blood pressure, previous operation history, stone site, stone size, CT value of calculi, stone CT value, and kidney accumulation Water, blood leucocyte, hemoglobin, creatinine, operation time, intraoperative perfusion, stone composition, hospitalization time and stone clearance rate had no significant difference (P0.05).3. There were 12 (4.5%) patients with SIRS after operation, 8 (9.1%) patients with SIRS after the zero dose group, and 3 (3.4%) patients in a single dose group with SIRS and multiple dose groups. There were 1 (1.1%) patients with SIRS (zero dose vs single dose, p=0.119, zero dose vs multi dose, p=0.016, single dose vs multi dose, p=0.306), and the results were not statistically significant. Then the data were grouped according to the stone area 200mm2, and the subgroup analysis was carried out. When the stone area was less than 200mm2, there was no statistical difference between the three groups (5.0%vs 5.1%vs 0%). 0.257), when the stone area was greater than 200mm2, the incidence of SIRS after the zero dose group was significantly higher (17.9%vs 0%vs 2.7%, p=0.011). These 12 postoperative patients with SIRS were cured after active treatment and were not further developed into sepsis. [Conclusion] 1, for patients with no urinary tract infection before operation, when the stone area is less than 200mm2, The use of prophylactic antibiotics in the perioperative period of RIRS does not significantly alter the incidence of postoperative SIRS. It is suggested that antibiotics can be used without preventive use. 2, when the stone area is greater than 200mm2, the preventive use of antibiotics in RIRS perioperative period can significantly reduce the incidence of SIRS after the operation, but one time before and before the operation is not clear before and after the operation. Significant difference is recommended for the use of only one preventive antibiotic before surgery. 3, the results of this study still need further validation of a larger sample multicenter prospective study.
【学位授予单位】：广州医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R699

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