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治疗下肢深静脉瓣膜功能不全的手术

Surgery for deep venous incompetence.

作者信息

Goel Ravi Raj, Abidia Ahmed, Hardy Simon C

机构信息

Vascular Surgery, East Lancashire Hospitals NHS Trust, Royal Blackburn Hospital (Trust HQ), Haslingden Road, Blackburn, UK, BB2 3HH.

出版信息

Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD001097. doi: 10.1002/14651858.CD001097.pub3.


DOI:10.1002/14651858.CD001097.pub3
PMID:25702915
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7052965/
Abstract

BACKGROUND: Chronic deep venous incompetence (DVI) is caused by incompetent vein valves and/or blockage of large-calibre leg veins and causes a range of symptoms including recurrent ulcers, pain and swelling. Most surgeons accept that well-fitted graduated compression stockings (GCS) and local care of wounds serve as adequate treatment for most patients, but sometimes symptoms are not controlled and ulcers recur frequently, or they do not heal despite compliance with conservative measures. In these situations, in the presence of severe venous dysfunction, surgery has been advocated by some vascular surgeons. This is an update of the review first published in 2000. OBJECTIVES: To assess the effects of surgical management of deep venous incompetence in terms of ulcer healing, ulcer recurrence and alleviation of symptoms. SEARCH METHODS: For this update, the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched October 2014) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 9). SELECTION CRITERIA: Randomised controlled trials of surgical treatment for patients with DVI. DATA COLLECTION AND ANALYSIS: For this update, two review authors (RRG and SCH) extracted data independently. All included studies required full risk of bias assessment in line with current procedures of The Cochrane Collaboration. Two review authors (RRG and SCH) independently assessed risk of bias and consulted with a third review author (AA) when necessary. MAIN RESULTS: Four studies with 273 participants were included. All included studies reported clinical outcomes following valvuloplasty. We found no studies investigating other surgical procedures for the treatment of patients with DVI. All included studies investigated primary valve incompetence. We found no trials that investigated the results of surgery for secondary valvular incompetence or the obstructive form of DVI. Because different outcome measures were used, it was not possible to pool the results of included studies. The methodological quality of the included studies was low, mainly because information regarding randomisation and blinding was missing, or because data were incomplete or were presented poorly. Ulcer healing and ulcer recurrence were not reported in one study, and the remaining three studies did not include participants with ulcers or with active ulceration. Three studies reported no significant complications of surgery and no incidence of DVT during follow-up. One study did not report on the occurrence of complications. Clinical changes were assessed by subjective and objective measurements, as specified in the clinical, aetiological, anatomical, and pathophysiological (CEAP) classification score. This requires vascular laboratory measurements of lower limb haemodynamics before and after surgery. Tests include an overall evaluation of venous function with venous refilling time (VRT) or ambulatory venous pressure (AVP). Two small trials comparing external valvuloplasty using limited anterior plication in combination with ligation of incompetent superficial veins against ligation alone (L) showed that ligation plus limited anterior plication produced significant improvement in AVP: The mean difference was -15 mm Hg (95% confidence interval (CI) -20.9 to -9.0) at one year and -15 mm Hg (95% CI -21 to -8.9) at two years. Sustainable statistically significant improvement in AVP and VRT was achieved by ligation and limited anterior plication at 10 years in one study. However, AVP values after surgery remained relatively high, causing its benefit to be questioned. Similarly, another study including participants who were deteriorating preoperatively showed sustained mild clinical improvement for seven years in those subjected to valvuloplasty compared with participants undergoing superficial venous surgery alone. However, this benefit was lost when the condition of participants was stable preoperatively. One small study (n = 40) with grade 3 reflux and no participants with ulcers reported that external valvuloplasty of the femoral vein combined with surgical repair of the superficial venous system improved the haemodynamic status of the lower limbs, restored valvular function more effectively and achieved better outcomes than surgical repair of the superficial venous system alone. AUTHORS' CONCLUSIONS: No evidence was found for benefit or harm of valvuloplasty in the treatment of patients with DVI secondary to primary valvular incompetence. The individual trials included in this review were small; they used different methods of assessment and overall were of poor quality. They did not include participants with severe DVI. Trials investigating the effects of other surgical procedures on deep veins are needed. Until the findings of such trials become available, the benefit of valvuloplasty remains uncertain.

摘要

背景:慢性下肢深静脉功能不全(DVI)由静脉瓣膜功能不全和/或下肢大口径静脉阻塞引起,会导致一系列症状,包括复发性溃疡、疼痛和肿胀。大多数外科医生认为,合适的分级压力弹力袜(GCS)和伤口局部护理对大多数患者来说是足够的治疗方法,但有时症状无法得到控制,溃疡频繁复发,或者尽管遵循了保守治疗措施,溃疡仍无法愈合。在这些情况下,对于存在严重静脉功能障碍的患者,一些血管外科医生主张进行手术治疗。这是对2000年首次发表的综述的更新。 目的:评估手术治疗下肢深静脉功能不全在溃疡愈合、溃疡复发和症状缓解方面的效果。 检索方法:对于本次更新,Cochrane外周血管疾病组试验检索协调员检索了专业注册库(最后检索时间为2014年10月)和Cochrane对照试验中央注册库(CENTRAL)(2014年第9期)。 入选标准:DVI患者手术治疗的随机对照试验。 数据收集与分析:对于本次更新,两位综述作者(RRG和SCH)独立提取数据。所有纳入研究都需要根据Cochrane协作网的现行程序进行全面的偏倚风险评估。两位综述作者(RRG和SCH)独立评估偏倚风险,必要时与第三位综述作者(AA)协商。 主要结果:纳入了4项研究,共273名参与者。所有纳入研究均报告了瓣膜成形术后的临床结果。我们未发现研究其他手术方法治疗DVI患者的研究。所有纳入研究均调查了原发性瓣膜功能不全。我们未发现研究继发性瓣膜功能不全或阻塞型DVI手术结果的试验。由于使用了不同的结局测量指标,因此无法汇总纳入研究的结果。纳入研究的方法学质量较低,主要是因为缺少关于随机化和盲法的信息,或者数据不完整或呈现不佳。一项研究未报告溃疡愈合和溃疡复发情况,其余三项研究未纳入有溃疡或活动性溃疡的参与者。三项研究报告手术无显著并发症,随访期间无深静脉血栓形成(DVT)发生。一项研究未报告并发症的发生情况。临床变化通过临床、病因、解剖和病理生理(CEAP)分类评分中规定的主观和客观测量进行评估。这需要在手术前后对下肢血流动力学进行血管实验室测量。测试包括用静脉充盈时间(VRT)或活动静脉压(AVP)对静脉功能进行全面评估。两项小型试验比较了使用有限前襞术联合结扎功能不全的浅静脉进行外部瓣膜成形术与单纯结扎(L),结果显示结扎加有限前襞术使AVP有显著改善:一年时平均差值为-15 mmHg(95%置信区间(CI)-20.9至-9.0),两年时为-15 mmHg(95%CI -21至-8.9)。一项研究显示,在10年时,结扎和有限前襞术使AVP和VRT实现了可持续的统计学显著改善。然而,术后AVP值仍相对较高,其益处受到质疑。同样,另一项研究纳入术前病情恶化的参与者,结果显示与仅接受浅静脉手术的参与者相比,接受瓣膜成形术的参与者在7年内临床持续有轻度改善。然而,当参与者术前病情稳定时,这种益处就消失了。一项小型研究(n = 40)纳入3级反流患者且无溃疡患者,报告称股静脉外部瓣膜成形术联合浅静脉系统手术修复比单纯浅静脉系统手术修复更能改善下肢血流动力学状态,更有效地恢复瓣膜功能,且效果更好。 作者结论:未发现瓣膜成形术治疗原发性瓣膜功能不全继发的DVI患者有益或有害的证据。本综述纳入的个别试验规模较小;它们使用了不同的评估方法,总体质量较差。它们未纳入严重DVI患者。需要开展研究其他手术方法对深静脉影响的试验。在获得此类试验结果之前,瓣膜成形术的益处仍不确定。

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