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一项关于手术和静脉内干预治疗下肢静脉溃疡疾病的系统评价、网状荟萃分析和荟萃回归分析

A Systematic Review Network Meta-Analysis and Meta-Regression on Surgical and Endovenous Interventions for the Treatment of Lower Limb Venous Ulcer Disease.

作者信息

Bontinis Vangelis, Ktenidis Kiriakos, Bontinis Alkis, Koutsoumpelis Andreas, Antonopoulos Constantine N, Giannopoulos Argirios, Rafailidis Vasileios, Chorti Angeliki, Bradbury Andrew W

机构信息

Department of Vascular Surgery, Aristotle University of Thessaloniki, AHEPA University General Hospital, Thessaloniki, Greece.

Department of Vascular Surgery, National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece.

出版信息

J Endovasc Ther. 2025 Jun;32(3):605-615. doi: 10.1177/15266028231193978. Epub 2023 Aug 17.

Abstract

BACKGROUND

Venous leg ulcer (VLU) disease constitutes the most severe form of chronic venous insufficiency. We performed a network meta-analysis and meta-regression to investigate the efficacy and safety of the various available interventions in the treatment of VLU.

METHODS

We conducted a systematic research corresponding to the instructions by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement for studies reporting on surgical or endovenous interventions for the treatment of VLU. Following data extraction, we performed a Bayesian network meta-analysis and meta-regression. Primary endpoints included VLU healing and recurrence. The secondary endpoint was postintervention complications.

RESULTS

Seventeen studies evaluating the impact of compression monotherapy, radiofrequency ablation (RFA), endovenous laser ablation (EVLA), sclerotherapy, and saphenous vein surgery on VLU treatment, consisting of 2156 patients (2186 VLU) were included. When compared to compression monotherapy, RFA was the only treatment displaying a statistically-significant impact on ulcer healing, odds ratio (OR) 5.80 (95% credibility interval (CI): 1.08-35.07), while EVLA, RR 0.06 (95% CI: 0.00-0.57), sclerotherapy, RR 0.07 (95% CI: 0.00-0.68) and RFA, RR 0.12 (95% CI: 0.01-0.91) were the 3 interventions reducing VLU recurrence. EVLA (SUCRA, 69.65) ranked as the most efficient intervention concerning ulcer recurrence reduction. Regarding postintervention complications, EVLA was the only intervention displaying a statistically-significant increased risk compared to compression monotherapy, RR 14.3 (95% CI: 2.03-172.56). Meta-regression analysis exploring the impact of perforator treatment on VLU failed to predict healing, β = -0.27 (95% CI: -2.55 to 1.85), recurrence, β = -0.02 (95% CI: -2.96 to 2.75) and complication outcomes, β = -0.089 (95% CI: -3.13 to 2.85). During sensitivity analysis, RFA and sclerotherapy failed to sustain their effects on ulcer healing and ulcer recurrence, respectively. In addition, sclerotherapy displayed statistically-significant inferior outcomes compared to both EVLA and RFA regarding ulcer recurrence.

CONCLUSION

This is the first network meta-analysis examining the effect of various interventions on VLU disease. While we have demonstrated the efficacy of RFA and ELVA in ulcer recurrence prevention, our results regarding the impact of RFA and sclerotherapy on VLU healing and recurrence, respectively, should be interpreted with caution. In addition, this review raises questions concerning the value of surgery and perforator interventions in the treatment of VLU. Further research through randomized controlled trials is required.Clinical impactOur review has revealed the significant efficacy of endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in effectively reducing the incidence of ulcer recurrence when compared to compression monotherapy. These outcomes hold the potential to provide relevant insights to both medical practitioners and patients, thereby informing a more prudent and enlightened decision-making approach. Such informed decisions, aimed at mitigating the recurring occurrence of venous leg ulcers, carry profound significance given the considerable socioeconomic implications associated with this medical condition.

摘要

背景

下肢静脉溃疡(VLU)疾病是慢性静脉功能不全最严重的形式。我们进行了一项网状Meta分析和Meta回归,以研究各种可用干预措施治疗VLU的疗效和安全性。

方法

我们按照系统评价和Meta分析的首选报告项目(PRISMA)声明的指导方针,对报告手术或腔内干预治疗VLU的研究进行了系统研究。在数据提取之后,我们进行了贝叶斯网状Meta分析和Meta回归。主要终点包括VLU愈合和复发。次要终点是干预后并发症。

结果

纳入了17项评估压迫单一疗法、射频消融(RFA)、腔内激光消融(EVLA)、硬化疗法和大隐静脉手术对VLU治疗影响的研究,共2156例患者(2186处VLU)。与压迫单一疗法相比,RFA是唯一对溃疡愈合有统计学显著影响的治疗方法,优势比(OR)为5.80(95%可信区间(CI):1.08 - 35.07),而EVLA,风险比(RR)为0.06(95%CI:0.00 - 0.57),硬化疗法,RR为0.07(95%CI:0.00 - 0.68)以及RFA,RR为0.12(95%CI:0.01 - 0.91)是减少VLU复发的3种干预措施。EVLA(表面一致性累积排名曲线下面积(SUCRA)为69.65)在减少溃疡复发方面被列为最有效的干预措施。关于干预后并发症,与压迫单一疗法相比,EVLA是唯一显示出统计学显著增加风险的干预措施,RR为14.3(95%CI:2.03 - 172.56)。探索穿通支治疗对VLU影响的Meta回归分析未能预测愈合情况,β = -0.27(95%CI:-2.55至1.85),复发情况,β = -0.02(95%CI:-2.96至2.75)以及并发症结果,β = - .089(95%CI:-3.13至2.85)。在敏感性分析中,RFA和硬化疗法分别未能维持其对溃疡愈合和溃疡复发的影响。此外,在溃疡复发方面,硬化疗法与EVLA和RFA相比均显示出统计学显著较差的结果。

结论

这是第一项研究各种干预措施对VLU疾病影响的网状Meta分析。虽然我们已经证明了RFA和ELVA在预防溃疡复发方面的疗效,但我们关于RFA和硬化疗法分别对VLU愈合和复发影响的结果应谨慎解释。此外,本综述引发了关于手术和穿通支干预在VLU治疗中的价值的问题。需要通过随机对照试验进行进一步研究。临床影响我们的综述揭示了与压迫单一疗法相比,腔内激光消融(EVLA)和射频消融(RFA)在有效降低溃疡复发率方面具有显著疗效。这些结果有可能为医生和患者提供相关见解,从而形成更谨慎和明智的决策方法。鉴于与这种疾病相关的重大社会经济影响,旨在减轻下肢静脉溃疡复发的这种明智决策具有深远意义。

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