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新一代铥光纤激光用于输尿管镜检查和碎石术的疗效与安全性的比较研究

[Comparative study of the efficacy and safety of a new generation of thulium fiber lasers for ureteroscopy and lithotripsy].

作者信息

Martov A G, Ergakov D V, Andronov A S, Dutov S V, Adilkhanov M M

机构信息

GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.

Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, Moscow, Russia.

出版信息

Urologiia. 2023 May(2):90-98.

Abstract

INTRODUCTION

The development and implementation in clinical practice of a 3rd generation thulium fiber laser with the possibility of computer control (modulation) of the shape, amplitude and pulse repetition rate opens up new possibilities for thulium fiber laser lithotripsy.

AIM

To carry out a comparative study of the efficacy and safety of thulium fiber laser lithotripsy using a of the 2nd (FiberLase U3) and 3rd generation devices (FiberLase U-MAX).

MATERIALS AND METHODS

A total of 218 patients with solitary ureteral stones, who underwent to ureteroscopy with lithotripsy using 2nd and 3rd generation thulium fiber lasers (IRE-Polus, Russia) from January 2020 to May 2022 with the same peak power (500 W), laser settings of 1 joule, 10 Hz and with a laser fiber diameter of 365 m, were included in the prospective study. For lithotripsy using FiberLase U-MAX laser a new original modulated pulse, which was found and optimized in a preclinical study, was used. Depending on the laser, the patients were divided into 2 groups. In 111 patients, stone fragmentation was performed on FiberLase U3 (2nd generation), while 107 patients were undergone to lithotripsy on a new laser device FiberLase U-MAX (3rd generation). Stone size ranged from 6 mm to 28 mm (11+/-4 mm). The duration of procedure and lithotripsy, the quality of the endoscopic picture during fragmentation (from 0 to 3 points, 0-bad, 3-excellent), the frequency of retrograde migration of stones, as well as damage to ureteral mucosa (of 1-3 degrees) were evaluated.

RESULTS

The time of lithotripsy was significantly lower in the group 2 than in the group 1 (12.3+/-4.6 vs. 24.7+/-6.2 min; p<0.05). The average quality of the endoscopic picture was significantly better in the group 2 (2.5+/-0.4 vs. 1.8+/-0.2 points; p<0.05). Clinically significant retrograde migration of stone or its fragments (the need for additional ESWL, flexible ureteroscopy) was noted in 16% vs. 8% of patients in group 1 and 2, respectively (p<0.05). Damage to ureteral mucosa of the 1st and 2nd degree due to laser exposure in the group 1 was noted in 24 (22%) and 8 (7%) cases, compared to 21 (20%) and 7 (7%) cases in group 2, respectively. Stone-free state was 84% in group 1 and 92% in group 2.

CONCLUSION

Modulation of the laser pulse shape allowed to improve endoscopic visibility, increase the speed of lithotripsy, reduce the frequency of retrograde stone migration without increasing the trauma to ureteral mucosa.

摘要

引言

第三代掺铥光纤激光器的研发及其在临床实践中的应用,使得计算机能够控制(调制)激光的形状、幅度和脉冲重复率,这为掺铥光纤激光碎石术开辟了新的可能性。

目的

对第二代(FiberLase U3)和第三代设备(FiberLase U-MAX)进行掺铥光纤激光碎石术的疗效和安全性进行对比研究。

材料与方法

2020年1月至2022年5月期间,共有218例孤立性输尿管结石患者接受了输尿管镜检查及使用第二代和第三代掺铥光纤激光器(俄罗斯IRE-Polus公司)进行碎石术,激光峰值功率均为500W,激光设置为1焦耳、10赫兹,激光光纤直径为365微米,这些患者被纳入前瞻性研究。使用FiberLase U-MAX激光进行碎石术时,采用了在临床前研究中发现并优化的新的原始调制脉冲。根据所使用的激光,将患者分为两组。111例患者使用FiberLase U3(第二代)进行结石破碎,而107例患者在新型激光设备FiberLase U-MAX(第三代)上接受碎石术。结石大小范围为6毫米至28毫米(11±4毫米)。评估了手术和碎石的持续时间、碎石过程中内镜图像的质量(0至3分,0分-差,3分-优)、结石逆行迁移的频率以及输尿管黏膜损伤(1至3度)情况。

结果

第二组的碎石时间明显低于第一组(12.3±4.6分钟对24.7±6.2分钟;p<0.05)。第二组内镜图像的平均质量明显更好(2.5±0.4分对1.8±0.2分;p<0.05)。第一组和第二组分别有16%和8%的患者出现具有临床意义的结石或其碎片的逆行迁移(需要额外进行体外冲击波碎石术、软性输尿管镜检查)(p<0.05)。第一组因激光照射导致的1级和2级输尿管黏膜损伤分别有24例(22%)和8例(�%),相比之下,第二组分别为21例(20%)和7例(7%)。第一组的结石清除率为84%,第二组为92%。

结论

激光脉冲形状的调制能够提高内镜视野清晰度,加快碎石速度,降低结石逆行迁移频率且不增加输尿管黏膜的创伤。

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