比較多次、單次、零劑量的環(huán)丙沙星預防性用藥對輸尿管軟鏡取石術后感染性并發(fā)癥的影響:一項前瞻性隨機對照試驗
發(fā)布時間:2018-05-21 20:42
本文選題:預防性抗生素 + 輸尿管軟鏡取石術。 參考:《廣州醫(yī)科大學》2017年碩士論文
【摘要】:【研究背景】目前輸尿管軟鏡碎石取石術(retrograde intrarenal surgery,RIRS)在腎結(jié)石的治療中應用越來越廣泛。而隨著手術技術不斷的提高,以及腔內(nèi)微創(chuàng)設備的快速發(fā)展,逆行輸尿管軟鏡取石術以其微創(chuàng)、安全、有效的特點,成為了處理復雜性上尿路結(jié)石特別是腎盂腎盞內(nèi)結(jié)石的重要手段之一,并且相關的并發(fā)癥亦相應地在不斷下降,然而術后感染性并發(fā)癥仍然是RIRS術后最主要的并發(fā)癥,據(jù)報道,其發(fā)生率高達25%。術后感染性并發(fā)癥不但會提高住院天數(shù)和再住院率、增加抗生素的使用量,而且嚴重威脅患者生命安全。因此,加強術前相關危險因素的評估和圍手術期抗生素的管理,預防術后感染的發(fā)生,在臨床工作中已越來越受到重視。預防性抗生素現(xiàn)已廣泛應用于泌尿外科手術,對降低術后感染性并發(fā)癥的發(fā)生率起著重要的作用,但是過度使用抗生素亦會導致細菌耐藥性的增加。所以,預防性抗生素的使用原則應是使用最小的劑量來達到最佳的預防感染的效果,同時減少細菌耐藥性的產(chǎn)生和患者的醫(yī)療支出。同為治療腎結(jié)石的經(jīng)皮腎鏡碎石取石術(percutaneous nephrolithotomy,PCNL),目前已有多項研究對其圍手術期預防性抗生素的使用進行了報道,雖然對于預防性抗生素使用的維持時間結(jié)論并不一致,但都認可預防性抗生素的必要性和有效性。而作為更加微創(chuàng)的RIRS手術,目前對于圍手術期預防性抗生素的用藥方式仍缺乏相關的研究報道。而且,國內(nèi)、外指南推薦的也沒有專門關于RIRS圍手術期預防性抗生素使用的具體推薦方案。故研究者希望通過本次單中心的前瞻性隨機對照臨床試驗來研究RIRS術前無尿路感染的患者,圍手術期預防性抗生素的合理用藥方式,以避免不必要的,或者不合適的抗生素的應用,可一定程度減少抗生素濫用引起的細菌耐藥性,具有十分重要的臨床意義!灸康摹勘容^RIRS圍手術期零劑量、單劑量和多劑量預防性抗生素的使用對術后感染性并發(fā)癥的影響,探討RIRS圍手術期預防性抗生素的合理使用方案!痉椒ā2014年8月至2016年11月共計300例術前檢查未發(fā)現(xiàn)尿路感染的患者參與該項前瞻性隨機對照試驗。按照隨機碼表隨機分配為3組(1、術前、術后不用抗生素,2、術前30分鐘預防性使用環(huán)丙沙星200mg一次,靜脈滴注,3、術前30分鐘及術后6小時內(nèi)各使用環(huán)丙沙星200mg一次,靜脈滴注)。記錄比較三組患者術前一般情況、結(jié)石大小、結(jié)石位置、結(jié)石密度、腎積水、術前及術后血白細胞、血紅蛋白、肌酐、手術時間、術中灌注量、結(jié)石成分、住院時間、結(jié)石清除率及術后并發(fā)癥,連續(xù)性變量使用單因素方差,分類變量使用卡方檢驗或Fisher確切概率法,前瞻性分析這3組患者的病例資料,并比較患者術后發(fā)生全身炎癥反應綜合征(systemicin inflammatory response syndrome,SIRS)的比例是否存在差異!窘Y(jié)果】1、將符合納入標準的腎結(jié)石患者300例,按照盲法和隨機分配的原則分為三組,其中35個患者因術中發(fā)現(xiàn)尿液渾濁、結(jié)石表面覆蓋有膿苔、輸尿管狹窄及軟鏡無法到達結(jié)石部位改行PCNL而排除出組,最后共有265個患者入組成功,零劑量組:88人,單劑量組:88人,多劑量組:89人。2、三組間,術前一般情況,如年齡、性別、體質(zhì)指數(shù)(body mass index,BMI)、高血壓病史、既往手術史、結(jié)石部位、結(jié)石大小、結(jié)石CT值、是否腎積水、術前及術后血白細胞、血紅蛋白、肌酐、手術時間、術中灌注量、結(jié)石成分、住院時間、結(jié)石清除率無明顯統(tǒng)計學差異(p0.05)。3、共有12(4.5%)個患者術后發(fā)生SIRS,零劑量組術后有8(9.1%)個病人發(fā)生SIRS,單劑量組有3(3.4%)個病人發(fā)生SIRS,多劑量組有1(1.1%)個病人發(fā)生SIRS(零劑量vs單劑量,p=0.119,零劑量vs多劑量,p=0.016,單劑量vs多劑量,p=0.306),結(jié)果無統(tǒng)計學意義。遂將數(shù)據(jù)按結(jié)石面積200mm2分組,進行亞組分析,當結(jié)石面積小于200mm2時,三組間術后SIRS發(fā)生率無統(tǒng)計學差異(5.0%vs 5.1%vs 0%,p=0.257),而當結(jié)石面積大于200mm2時,零劑量組術后SIRS的發(fā)生率明顯偏高(17.9%vs 0%vs 2.7%,p=0.011)。這12個術后發(fā)生SIRS的患者經(jīng)積極治療后,均可痊愈,未進一步發(fā)展為膿毒血癥。【結(jié)論】1、對于術前無泌尿系感染的患者,當結(jié)石面積小于200mm2時,RIRS圍手術期預防性抗生素的使用并不會明顯改變術后的SIRS的發(fā)生率,建議可以不預防性使用抗生素;2、而當結(jié)石面積大于200mm2時,RIRS圍手術期預防性使用抗生素可以明顯降低術后的SIRS的發(fā)生率,而術前單次與術前、術后各一次并無明顯差異,推薦術前僅用一次預防性抗生素即可;3、本研究結(jié)果仍需更大樣本量的多中心前瞻性研究進一步驗證。
[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.
【學位授予單位】:廣州醫(yī)科大學
【學位級別】:碩士
【學位授予年份】:2017
【分類號】:R699
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