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意大利静脉内激光治疗工作组的前1000例病例。1999 - 2003年期间的原理及长期结果。

The first 1000 cases of Italian Endovenous-laser Working Group (IEWG). Rationale, and long-term outcomes for the 1999-2003 period.

作者信息

Agus G B, Mancini S, Magi G

机构信息

Institute of Vascular Surgery and Angiology, University of Milan, Milan, Italy.

出版信息

Int Angiol. 2006 Jun;25(2):209-15.

PMID:16763541
Abstract

AIM

The innovations for disease management need to be thoroughly evaluated so that their benefits and potential downsides can be compared with the already existing approaches. Endovascular laser (EVL) treatment for varicose veins offers today several advantages over surgical standard stripping. The Italian Endovenous-laser Working Group (IEWG) is a homogeneous group of surgeons and phlebologists who have been using EVL since 1999 and has undertaken to examine EVL in a multicenter study starting from a well defined rationale, with the benefit of a single protocol to use.

METHODS

In a cooperative, multicenter, clinical study, 1076 limbs in 1050 patients, mean age of 54.5 years, 241 males and 809 females affected by chronic venous insufficiency (CVI) were considered eligible for surgery and stratified by CEAP classification in a four-year period (January 1999 December 2003). Inclusion criteria were insufficiency of the great and/or small saphenous vein at various levels, beyond those accessory saphenous trunks with incompetence in the saphenofemoral junction. In all cases truncular reflux apparead up on duplex scan examination, with or without associated varicosities. All the patients underwent a surgery on the basis of the clinical assessment. All the centres involved performed treatment in conformity with the Food and Drug Administration (FDA) validated procedure, using an endo-laser venous system kit with a 810-980 nm diode. Duplex scan was performed in all patients after 36 months with very few lost to follow-up cases.

RESULTS

In the immediate postoperative period the results have been impressive, with a very effective closure of incompetent great saphenous vein and the other treated varicose veins (the early occlusion rate has been 99%). Major complications have not been detected: in particular, no deep venous thrombosis (DVT) evaluated duplex ultrasound. The patients' acceptability and satisfaction regarding the procedure, have been measured by means of a questionnaire on the quality of life, and the result was 96.7%. After 36 months, the total occusion rate of saphenous trunks has been 97%.

CONCLUSIONS

The first important Italian experience with EVL based on preoperative, perioperative and postoperative duplex control and which is also based on the patients' satisfaction at mid/long-term has indicated some advantages over the standard treatment with the stripping method. In terms of reduced postoperative pain, shorter sick leave, a faster resumption of the normal activities, and, in particular, the total absence of DVT, we can conclude that EVL is a good solution for all patients with anatomic and hemodinamic patterns for saphenous vein surgery.

摘要

目的

疾病管理方面的创新需要进行全面评估,以便将其益处和潜在弊端与现有方法进行比较。与传统的手术剥脱术相比,血管内激光(EVL)治疗静脉曲张具有多项优势。意大利静脉内激光工作组(IEWG)由一群自1999年起就开始使用EVL的外科医生和静脉病学家组成,他们从明确的理论基础出发,采用单一的使用方案,开展了一项多中心研究来检验EVL。

方法

在一项合作性、多中心临床研究中,1050例患者的1076条肢体符合手术条件,患者平均年龄54.5岁,其中男性241例,女性809例,均患有慢性静脉功能不全(CVI)。在四年期间(1999年1月至2003年12月),根据CEAP分类进行分层。纳入标准为大隐静脉和/或小隐静脉在不同水平存在功能不全,不包括那些在隐股交界处功能不全的副隐静脉主干。所有病例在双功超声检查中均显示主干反流,伴或不伴有相关静脉曲张。所有患者均根据临床评估接受手术。所有参与中心均按照美国食品药品监督管理局(FDA)验证的程序进行治疗,使用波长为81​​0 - 980 nm二极管的血管内激光静脉系统套件。36个月后对所有患者进行双功超声检查,失访病例极少。

结果

术后即刻效果显著,大隐静脉及其他治疗的静脉曲张有效闭合(早期闭塞率达99%)。未发现重大并发症:特别是经双功超声评估未发现深静脉血栓形成(DVT)。通过生活质量问卷对患者对该手术的接受度和满意度进行评估,结果为96.7%。36个月后,隐静脉主干的总闭塞率为97%。

结论

意大利首次基于术前、术中及术后双功超声控制以及患者中长期满意度的EVL经验表明,与传统剥脱术相比具有一些优势。在减轻术后疼痛、缩短病假、更快恢复正常活动,尤其是完全不存在DVT方面,我们可以得出结论,对于所有具有适合隐静脉手术的解剖和血流动力学模式的患者而言,EVL是一个很好的解决方案。

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