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先天性马蹄内翻足的干预措施。

Interventions for congenital talipes equinovarus (clubfoot).

作者信息

Gray Kelly, Pacey Verity, Gibbons Paul, Little David, Burns Joshua

机构信息

Department of Physiotherapy, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, New South Wales, Australia, 2145.

出版信息

Cochrane Database Syst Rev. 2014 Aug 12;2014(8):CD008602. doi: 10.1002/14651858.CD008602.pub3.

Abstract

BACKGROUND

Congenital talipes equinovarus (CTEV), which is also known as clubfoot, is a common congenital orthopaedic condition characterised by an excessively turned in foot (equinovarus) and high medial longitudinal arch (cavus). If left untreated it can result in long-term disability, deformity and pain. Interventions can be conservative (such as splinting or stretching) or surgical. The review was first published in 2012 and we reviewed new searches in 2013 (update published 2014).

OBJECTIVES

To evaluate the effectiveness of interventions for CTEV.

SEARCH METHODS

On 29 April 2013, we searched CENTRAL (2013, Issue 3 in The Cochrane Library), MEDLINE (January 1966 to April 2013), EMBASE (January 1980 to April 2013), CINAHL Plus (January 1937 to April 2013), AMED (1985 to April 2013), and the Physiotherapy Evidence Database (PEDro to April 2013). We also searched for ongoing trials in the WHO International Clinical Trials Registry Platform (2006 to July 2013) and ClinicalTrials.gov (to November 2013). We checked the references of included studies. We searched NHSEED, DARE and HTA for information for inclusion in the Discussion.

SELECTION CRITERIA

Randomised controlled trials (RCTs) and quasi-RCTs evaluating interventions for CTEV. Participants were people of all ages with CTEV of either one or both feet.

DATA COLLECTION AND ANALYSIS

Two authors independently assessed risk of bias in included trials and extracted the data. We contacted authors of included trials for missing information. We collected adverse event information from trials when it was available.

MAIN RESULTS

We identified 14 trials in which there were 607 participants; one of the trials was newly included at this 2014 update. The use of different outcome measures prevented pooling of data for meta-analysis even when interventions and participants were comparable. All trials displayed bias in four or more areas. One trial reported on the primary outcome of function, though raw data were not available to be analysed. We were able to analyse data on foot alignment (Pirani score), a secondary outcome, from three trials. Two of the trials involved participants at initial presentation. One reported that the Ponseti technique significantly improved foot alignment compared to the Kite technique. After 10 weeks of serial casting, the average total Pirani score of the Ponseti group was 1.15 (95% confidence interval (CI) 0.98 to 1.32) lower than that of the Kite group. The second trial found the Ponseti technique to be superior to a traditional technique, with average total Pirani scores of the Ponseti participants 1.50 lower (95% CI 0.72 to 2.28) after serial casting and Achilles tenotomy. A trial in which the type of presentation was not reported found no difference between an accelerated Ponseti or standard Ponseti treatment. At the end of serial casting, the average total Pirani scores in the standard group were 0.31 lower (95% CI -0.40 to 1.02) than the accelerated group. Two trials in initial cases found relapse following Ponseti treatment was more likely to be corrected with further serial casting compared to the Kite groups which more often required major surgery (risk difference 25% and 50%). There is a lack of evidence for different plaster casting products, the addition of botulinum toxin A during the Ponseti technique, different types of major foot surgery, continuous passive motion treatment following major foot surgery, or treatment of relapsed or neglected cases of CTEV. Most trials did not report on adverse events. In trials evaluating serial casting techniques, adverse events included cast slippage (needing replacement), plaster sores (pressure areas) and skin irritation. Adverse events following surgical procedures included infection and the need for skin grafting.

AUTHORS' CONCLUSIONS: From the limited evidence available, the Ponseti technique produced significantly better short-term foot alignment compared to the Kite technique and compared to a traditional technique. The quality of this evidence was low to very low. An accelerated Ponseti technique may be as effective as a standard technique, according to moderate quality evidence. Relapse following the Kite technique more often led to major surgery compared to relapse following the Ponseti technique. We could draw no conclusions from other included trials because of the limited use of validated outcome measures and lack of available raw data. Future randomised controlled trials should address these issues.

摘要

背景

先天性马蹄内翻足(CTEV),又称马蹄足,是一种常见的先天性骨科疾病,其特征为足部过度内翻(马蹄内翻)和高内侧纵弓(高弓足)。若不治疗,可能导致长期残疾、畸形和疼痛。干预措施可以是保守的(如夹板固定或拉伸)或手术治疗。该综述首次发表于2012年,我们在2013年进行了新的检索(2014年发表更新版)。

目的

评估先天性马蹄内翻足干预措施的有效性。

检索方法

2013年4月29日,我们检索了Cochrane系统评价数据库(CENTRAL,2013年第3期)、医学期刊数据库(MEDLINE,1966年1月至2013年4月)、荷兰医学文摘数据库(EMBASE,1980年1月至2013年4月)、护理学与健康领域数据库(CINAHL Plus,1937年1月至2013年4月)、联合和补充医学数据库(AMED,1985年至2013年4月)以及物理治疗证据数据库(PEDro,至2013年4月)。我们还在世卫组织国际临床试验注册平台(2006年至2013年7月)和美国国立医学图书馆临床试验数据库(ClinicalTrials.gov,至2013年11月)中检索了正在进行的试验。我们检查了纳入研究的参考文献。我们检索了英国国家卫生服务经济评价数据库(NHSEED)、英国卫生技术评估数据库(DARE)和英国卫生技术评估数据库(HTA)以获取纳入讨论的信息。

选择标准

评估先天性马蹄内翻足干预措施的随机对照试验(RCT)和半随机对照试验。参与者为所有年龄段单足或双足患有先天性马蹄内翻足的人。

数据收集与分析

两位作者独立评估纳入试验的偏倚风险并提取数据。我们联系纳入试验的作者获取缺失信息。当试验中有不良事件信息时,我们进行收集。

主要结果

我们确定了14项试验,共607名参与者;其中一项试验是在本次2014年更新时新纳入的。即使干预措施和参与者具有可比性,但由于使用了不同的结局指标,仍无法合并数据进行荟萃分析。所有试验在四个或更多领域存在偏倚。一项试验报告了功能的主要结局,但未提供可分析的原始数据。我们能够分析三项试验中作为次要结局的足部对线(皮拉尼评分)数据。其中两项试验纳入了初次就诊的参与者。一项试验报告称,与凯特技术相比,庞塞蒂技术显著改善了足部对线。在连续石膏固定10周后,庞塞蒂组的平均皮拉尼总分比凯特组低1.15(95%置信区间(CI)0.98至1.32)。第二项试验发现庞塞蒂技术优于传统技术,在连续石膏固定和跟腱切断术后,庞塞蒂组参与者的平均皮拉尼总分低1.50(95%CI 0.72至2.28)。一项未报告就诊类型的试验发现,加速庞塞蒂治疗或标准庞塞蒂治疗之间没有差异。在连续石膏固定结束时,标准组的平均皮拉尼总分比加速组低0.31(95%CI -0.40至1.02)。两项针对初发病例的试验发现,与凯特组相比,庞塞蒂治疗后复发的情况更有可能通过进一步的连续石膏固定得到纠正,而凯特组更常需要进行大手术(风险差异分别为25%和50%)。对于不同的石膏固定产品、在庞塞蒂技术中添加A型肉毒毒素、不同类型的足部大手术、足部大手术后的持续被动运动治疗或先天性马蹄内翻足复发或被忽视病例的治疗,缺乏证据。大多数试验未报告不良事件。在评估连续石膏固定技术的试验中,不良事件包括石膏滑脱(需要更换)、石膏溃疡(受压部位)和皮肤刺激。手术操作后的不良事件包括感染和皮肤移植需求。

作者结论

根据现有有限证据,与凯特技术和传统技术相比,庞塞蒂技术在短期足部对线方面效果显著更好。该证据的质量低至极低。根据中等质量证据,加速庞塞蒂技术可能与标准技术同样有效。与庞塞蒂技术后的复发相比,凯特技术后的复发更常导致大手术。由于验证结局指标使用有限且缺乏可用原始数据,我们无法从其他纳入试验中得出结论。未来的随机对照试验应解决这些问题。

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