Safety and efficacy of super mini flexible ureteroscope in management of upper urinary stones: a prospective randomized study
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摘要: 目的：报告一项前瞻性随机对照研究(randomized controlled trial，RCT)对比分析7.5Fr和9.2Fr输尿管软镜治疗肾结石的安全性和有效性。方法：160例肾结石患者纳入本RCT，以1∶1的比例分别进入7.5Fr组或9.2Fr组，采用输尿管软镜碎石术(retrograde intrarenal surgery，RIRS)治疗，对比分析2组患者手术成功率、结石清除率、术后感染等指标。结果：2组患者结石大小等术前资料差异无统计学意义。7.5Fr组和9.2Fr组患者中，分别有11例和8例首次置入12/14Fr输尿管通道鞘(ureteral access sheath，UAS)失败，但前者均成功置入10/12Fr的UAS完成手术，后者置入内支架二期手术，因此7.5Fr组手术成功率高于9.2Fr组(100% vs 90%，P=0.004)。7.5Fr组手术时间较9.2Fr组更短[(35.6±9.4) min vs(45.1±11.4) min，P < 0.001]，灌注液使用量更少[(1 353.9±283.8) mL vs(2 274.5±865.2) mL，P < 0.001]。9.2Fr组术后发热率高于7.5F组(16.25% vs 6.25%，P=0.045)，2组术后尿源性脓毒症发生率差异无统计学意义(0 vs 2.5%，P=0.316)。7.5Fr组术后结石清除率高于9.2Fr组(93.75% vs 83.75%，P=0.045)。2组住院时间[(1.1±0.4) d vs.(1.2±0.6) d，P=0.689]以及其他指标均差异无统计学意义。结论：最新研发的7.5Fr超细输尿管软镜能够在无法插入常规UAS时，有机会使用更细的UAS，保障了手术的顺利开展；同时也能保持RIRS术中良好的视野，所需灌注液减少，具有更高的结石清除率和更低的术后发热率。Abstract: Objective: To report initial results of a RCT comparing the safety and efficacy between 7.5Fr and 9.2Fr flexible ureteroscope(FUS) in the management of renal calculi. Methods: 160 patients with renal stones were enrolled and received retrograde intrarenal surgery(RIRS) with either 7.5Fr or 9.2Fr FUS. The operation success rate, stone free rate(SFR) and postoperative fever were compared. Results: There was no significant difference in the stone size or other preoperative indexes between the two groups. Eleven cases and eight cases in 7.5Fr group and 9.2Fr group respectively failed to insert 12/14Fr UAS(P=0.463). However, 10/12Fr UAS was inserted and RIRS were all successful in 7.5Fr group, while JJ stent was inserted and second session RIRS was required in 9.2Fr group.Thus, the RIRS success rate in 7.5Fr group was higher than that in 9.2Fr group(100% vs 90%, P=0.004). The operation time in 7.5Fr group was shorter than that in 9.2Fr group([35.6±9.4]min vs. [45.1±11.4]min, P < 0.001). Less irrigation was required in 7.5Fr group([1 353.9±283.8]mL vs[2 274.5±865.2]mL, P < 0.001). The postoperative fever rate in 9.2Fr group was higher than that in 7.5Fr group(16.25% vs 6.25%, P=0.045). There was no significant difference in sepsis(0 vs 2.5%, P=0.316). The finial SFR in 7.5Fr group was higher than that in 9.2Fr group(93.75% vs 83.75%, P=0.045). No significant difference was noted in hospital stay([1.1±0.4]d vs. [1.2±0.6]d, P=0.689) or others between the two groups. Conclusion: The newly developed 7.5Fr super-mini flexible uretesoscope has the opportunity to use a smaller size UAS when conventional UAS cannot be inserted, ensuring the smooth progress of RIRS. At the same time, it can also maintain a good visual field during RIRS, less infusion fluid, a higher SFR and lower postoperative fever rate.
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表 1 患者一般资料比较
例(%)，X±S 项目 7.5Fr组
(80例)9.2Fr组
(80例)P值 年龄/岁 49.5±13.7 45.9±11.5 0.202 性别 0.521 男 45(56.3) 49(61.3) 女 35(43.7) 31(38.7) 合并症 16(20.0) 18(22.5) 0.699 BMI/(kg/m2) 22.9±2.6 23.5±2.7 0.493 结石侧 0.057 左 43(53.7) 31(38.7) 右 37(46.3) 49(61.3) 结石大小/cm 1.5±0.3 1.6±0.4 0.797 结石CT/HU 1 063.7±214.8 1 127.3± 353.5 0.669 术前血红蛋白/(g/L) 126.8±13.2 130.2±19.1 0.792 术前血肌酐/(μmol/L) 102.1±51.2 98.9±45.5 0.854 中段尿培养阳性 14(17.5) 17(21.25) 0.548 
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表 2 手术结果及并发症比较
例(%)，X±S 项目 7.5Fr组
(80例)9.2Fr组
(80例)P值 12/14Fr UAS置入失败 11(13.75) 8(10.00) 0.463 手术成功率 80(100.0) 72(90.0) 0.004 手术时间/min 35.6±9.4 45.1±11.40 < 0.001 灌注量/mL 1 353.9±283.8 2 274.5± 865.2 < 0.001 血红蛋白下降/(g/L) 9.8±5.3 7.9±4.8 0.967 住院时间/d 1.1±0.4 1.2±0.6 0.689 SFR 75(93.75) 67(83.75) 0.045 感染并发症 发热(Grade Ⅰ) 5(6.25) 13(16.25) 0.045 尿源性脓毒症
(Grade Ⅳb)0(0) 2(2.5) 0.316
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