7.5 Fr和9.5 Fr输尿管软镜一期治疗最大径<1.5 cm上尿路结石的安全性和有效性比较

Comparison of safety and efficacy of 7.5 Fr and 9.5 Fr flexible ureteroscopy in the primary treatment of upper urinary tract calculi with maximum diameter<1.5 cm

目的比较应用7.5 Fr和9.5 Fr输尿管软镜一期治疗最大径<1.5 cm上尿路结石的安全性和有效性。方法采用前瞻性随机对照研究方法,选取2020年8月—2022年5月首都医科大学附属北京友谊医院泌尿外科收治的96例最大径<1.5 cm的上尿路结石患者为研究对象,采用随机数字表法将患者分为两组:试验组和对照组,每组各48例。试验组患者接受7.5 Fr输尿管软镜碎石手术,对照组患者接受9.5 Fr输尿管软镜碎石手术。收集两组患者术前、术中和术后的数据,包括患者的输尿管工作鞘置入成功率、手术时间、碎石时间、清石率、输尿管损伤情况以及并发症发生情况等。计量资料以均数±标准差(x±s)表示,组间比较采用Student-t检验;计数资料组间比较采用χ^(2)检验,等级资料组间比较采用Mann-Whitney U检验。结果试验组患者的一期置鞘成功率为93.8%(45/48),对照组为79.2%(38/48),两组比较差异具有统计学意义(P<0.05)。试验组和对照组患者的手术时间[(52.0±11.0)min比(55.1±11.4)min]、碎石时间[(26.0±9.3)min比(23.7±8.7)min]比较,差异均无统计学意义(P>0.05)。术后4周,试验组患者的清石率为93.3%(42/45),对照组为97.4%(37/38),两组比较差异无统计学意义(P>0.05)。输尿管损伤程度方面:试验组患者出现0级损伤17例,1级损伤27例,2级损伤4例,3级损伤0例;对照组患者出现0级损伤9例,1级损伤23例,2级损伤13例,3级损伤3例;两组比较差异具有统计学意义(P<0.05)。并发症方面:试验组患者出现血尿22例,疼痛9例,膀胱痉挛8例,轻度发热2例;对照组患者出现血尿24例,疼痛12例,膀胱痉挛9例,轻度发热1例;两组比较差异无统计学意义(P>0.05)。结论应用7.5 Fr输尿管软镜和9.5 Fr输尿管软镜一期治疗最大径<1.5 cm上尿路结石均能获得良好清石率,但7.5 Fr输尿管软镜置鞘成功率更高,且对输尿管损伤较小。

Objective To compare the safety and efficacy of 7.5 Fr and 9.5 Fr flexible ureteroscopy in the primary treatment of upper urinary tract calculi with maximum diameter<1.5 cm.Methods Using a prospective randomized controlled study method,96 patients with upper urinary tract calculi with maximum diameter<1.5 cm admitted to the Department of Urology,Beijing Friendship Hospital,Capital Medical University from August 2020 to May 2022 were selected as the study subjects.The patients were divided into two groups by random number table method:the experimental group and the control group,with 48 patients in each group.The experimental group patients underwent 7.5 Fr flexible ureteroscopic lithotripsy,while the control group patients underwent 9.5 Fr flexible ureteroscopic lithotripsy.Collect preoperative,intraoperative,and postoperative data from these patients,including success rate of ureteral access sheath insertion,surgical time,lithotripsy time,stone-free rate,ureteral injury status,and complications status.The measurement data were expressed as mean±standard deviation(x±s),Student-t test was used for comparison between groups;the Chi-square test was used for inter-group comparison of count data,and the Mann-Whitney U test was used for inter-group comparison of rank data.Results The success rate of primary sheath insertion in the experimental group was 93.8%(45/48),and that in the control group was 79.2%(38/48),the difference between the two groups was statistically significant(P<0.05).There were no statistically significant difference between the experimental group and the control group in terms of surgical time[(52.0±11.0)min vs(55.1±11.4)min,P>0.05]and lithotripsy time[(26.0±9.3)min vs(23.7±8.7)min,P>0.05].At four weeks after surgery,the stone-free rate in the experimental group was 93.3%(42/45),while that in the control group was 97.4%(37/38),there was no statistically significant difference between the two groups(P>0.05).In terms of the degree of ureteral injury,there were 17 patients had grade 0 injury,27 patients had grade 1 injury,4 patients had grade 2 injury,and no patient had grade 3 injury in the experimental group;there were 9 patients had grade 0 injury,23 patients had grade 1 injury,13 patients had grade 2 injury,and 3 patients had grade 3 injury in the control group;the difference between the two groups was statistically significant(P<0.05).In terms of complications,there were 22 cases of hematuria,9 cases of pain,8 cases of bladder spasm,and 2 cases of mild fever in the experimental group;there were 24 cases of hematuria,12 cases of pain,9 cases of bladder spasm,and 1 case of mild fever in the control group;there was no statistically significant difference between the two groups(P>0.05).Conclusion The application of 7.5 Fr flexible ureteroscopy and 9.5 Fr flexible ureteroscopy in the primary treatment of upper urinary tract calculi with maximum diameter<1.5 cm can achieve good stone-free rates,but the 7.5 Fr flexible ureteroscopy has a higher success rate of sheath insertion and less damage to the ureter.