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跟腱病的注射疗法。

Injection therapies for Achilles tendinopathy.

作者信息

Kearney Rebecca S, Parsons Nick, Metcalfe David, Costa Matthew L

机构信息

Warwick Medical School, University of Warwick, Coventry, UK, CV4 7AL.

出版信息

Cochrane Database Syst Rev. 2015 May 26;2015(5):CD010960. doi: 10.1002/14651858.CD010960.pub2.

Abstract

BACKGROUND

Achilles tendinopathy is a common condition, often with significant functional consequences. As a wide range of injection treatments are available, a review of randomised trials evaluating injection therapies to help inform treatment decisions is warranted.

OBJECTIVES

To assess the effects (benefits and harms) of injection therapies for people with Achilles tendinopathy.

SEARCH METHODS

We searched the following databases up to 20 April 2015: the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, AMED, CINAHL and SPORTDiscus. We also searched trial registers (29 May 2014) and reference lists of articles to identify additional studies.

SELECTION CRITERIA

We included randomised and quasi-randomised controlled trials evaluating injection therapies in adults with an investigator-reported diagnosis of Achilles tendinopathy. We accepted comparison arms of placebo (sham) or no injection control, or other active treatment (such as physiotherapy, pharmaceuticals or surgery). Our primary outcomes were function, using measures such as the VISA-A (Victorian Institute of Sport Assessment-Achilles questionnaire), and adverse events.

DATA COLLECTION AND ANALYSIS

Two review authors independently extracted data from the included studies. We assessed treatment effects using mean differences (MDs) and 95% confidence intervals (CIs) for continuous variables and risk ratios (RRs) and 95% CIs for dichotomous variables. For follow-up data, we defined short-term as up to six weeks, medium-term as up to three months and longer-term as data beyond three months. We performed meta-analysis where appropriate.

MAIN RESULTS

We included 18 studies (732 participants). Seven trials exclusively studied athletic populations. The mean ages of the participants in the individual trials ranged from 20 years to 50 years. Fifteen trials compared an injection therapy with a placebo injection or no injection control, four trials compared an injection therapy with active treatment, and one compared two different concentrations of the same injection. Thus no trials compared different injection therapies. Two studies had three trial arms and we included them twice in two different categories. Within these categories, we further subdivided injection therapies by mode of action (injury-causing versus direct repair agents).The risk of bias was unclear (due to poor reporting) or high in six trials published between 1987 and 1994. Improved methodology and reporting for the subsequent trials published between 2004 and 2013 meant that these were at less risk of bias.Given the very low quality evidence available from each of four small trials comparing different combinations of injection therapy versus active treatment and the single trial comparing two doses of one injection therapy, only the results of the first comparison (injection therapy versus control) are presented.There is low quality evidence of a lack of significant or clinically important differences in VISA-A scores (0 to 100: best function) between injection therapy and control groups at six weeks (MD 0.79, 95% CI -4.56 to 6.14; 200 participants, five trials), three months (MD -0.94, 95% CI -6.34 to 4.46; 189 participants, five trials) or between six and 12 months (MD 0.14, 95% CI -6.54 to 6.82; 132 participants, three trials). Very low quality evidence from 13 trials showed little difference between the two groups in adverse events (14/243 versus 12/206; RR 0.97, 95% CI 0.50 to 1.89), most of which were minor and short-lasting. The only major adverse event in the injection therapy group was an Achilles tendon rupture, which happened in a trial testing corticosteroid injections. There was very low quality evidence in favour of the injection therapy group in short-term (under three months) pain (219 participants, seven trials) and in the return to sports (335 participants, seven trials). There was very low quality evidence indicating little difference between groups in patient satisfaction with treatment (152 participants, four trials). There was insufficient evidence to conclude on subgroup differences based on mode of action given that only two trials tested injury-causing agents and the clear heterogeneity of the other 13 trials, which tested seven different therapies that act directly on the repair pathway.

AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised controlled trials to draw conclusions on the use, or to support the routine use, of injection therapies for treating Achilles tendinopathy. This review has highlighted a need for definitive research in the area of injection therapies for Achilles tendinopathy, including in older non-athletic populations. This review has shown that there is a consensus in the literature that placebo-controlled trials are considered the most appropriate trial design.

摘要

背景

跟腱病是一种常见病症,常伴有严重的功能后果。由于有多种注射治疗方法可供选择,因此有必要对评估注射疗法的随机试验进行综述,以帮助指导治疗决策。

目的

评估注射疗法对跟腱病患者的效果(益处和危害)。

检索方法

我们检索了截至2015年4月20日的以下数据库:Cochrane骨、关节和肌肉创伤小组专业注册库、Cochrane对照试验中央注册库(CENTRAL)、MEDLINE、EMBASE、AMED、CINAHL和SPORTDiscus。我们还检索了试验注册库(2014年5月29日)和文章的参考文献列表,以识别其他研究。

选择标准

我们纳入了随机和半随机对照试验,这些试验评估了在研究者报告诊断为跟腱病的成年人中进行注射疗法的效果。我们接受安慰剂(假注射)或不注射对照的比较组,或其他积极治疗(如物理治疗、药物治疗或手术)。我们的主要结局是功能,采用如VISA - A(维多利亚运动评估 - 跟腱问卷)等测量方法,以及不良事件。

数据收集与分析

两位综述作者独立从纳入的研究中提取数据。对于连续变量,我们使用均值差(MDs)和95%置信区间(CIs)评估治疗效果;对于二分变量,我们使用风险比(RRs)和95% CIs。对于随访数据,我们将短期定义为至多六周,中期定义为至多三个月,长期定义为超过三个月的数据。我们在适当的情况下进行了荟萃分析。

主要结果

我们纳入了18项研究(732名参与者)。七项试验专门研究运动员群体。各试验中参与者的平均年龄在20岁至50岁之间。十五项试验将注射疗法与安慰剂注射或不注射对照进行比较,四项试验将注射疗法与积极治疗进行比较,一项试验比较了同一注射剂的两种不同浓度。因此,没有试验比较不同的注射疗法。两项研究有三个试验组,我们在两个不同类别中各纳入了两次。在这些类别中,我们根据作用方式(致伤剂与直接修复剂)进一步细分注射疗法。1987年至1994年间发表的六项试验中,偏倚风险不明确(由于报告不佳)或较高。随后在2004年至2013年间发表的试验方法和报告有所改进,这意味着这些试验的偏倚风险较低。鉴于四项比较不同注射疗法组合与积极治疗的小型试验以及一项比较一种注射疗法两种剂量的试验提供的证据质量极低,仅呈现了第一个比较(注射疗法与对照)的结果。在六周时(MD 0.79,95% CI -4.56至6.14;200名参与者,五项试验)、三个月时(MD -0.94,95% CI -6.34至4.46;189名参与者,五项试验)或六至十二个月时(MD 0.14,95% CI -6.54至6.82;132名参与者,三项试验),注射疗法组与对照组在VISA - A评分(0至100:最佳功能)方面缺乏显著或临床重要差异的证据质量较低。来自13项试验的极低质量证据表明,两组在不良事件方面差异不大(14/243对12/206;RR 0.97,95% CI 0.50至1.89),其中大多数不良事件轻微且持续时间短。注射疗法组唯一的主要不良事件是跟腱断裂,发生在一项测试皮质类固醇注射的试验中。在短期(三个月以内)疼痛(219名参与者,七项试验)和恢复运动方面(335名参与者,七项试验),有极低质量证据支持注射疗法组。在患者对治疗的满意度方面(152名参与者,四项试验),有极低质量证据表明两组之间差异不大。鉴于仅两项试验测试了致伤剂,而其他13项试验测试了七种直接作用于修复途径的不同疗法,存在明显异质性,因此没有足够证据得出基于作用方式的亚组差异结论。

作者结论

随机对照试验中没有足够证据就注射疗法治疗跟腱病的使用得出结论或支持其常规使用。本综述强调了在跟腱病注射疗法领域进行确定性研究的必要性,包括在老年非运动员群体中。本综述表明,文献中存在共识,即安慰剂对照试验被认为是最合适的试验设计。

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