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关节镜治疗退行性膝病的随机对照试验:关节镜检查前是否适当尝试了保守治疗?

Randomized Controlled Trials for Arthroscopy in Degenerative Knee Disease: Was Conservative Therapy Appropriately Tried Prior to Arthroscopy?

机构信息

Department of Paediatric Orthopaedics and Paediatric Traumatology, Clinic for Paediatric Surgery, Inselspital, University of Bern, Switzerland.

Department of Paediatric Orthopaedics and Paediatric Traumatology, Clinic for Paediatric Surgery, Inselspital, University of Bern, Switzerland.

出版信息

Arthroscopy. 2018 May;34(5):1680-1687.e6. doi: 10.1016/j.arthro.2017.12.016. Epub 2018 Feb 1.

Abstract

PURPOSE

We aimed to determine if the randomized controlled trials (RCTs) evaluated in the most recent meta-analysis on arthroscopic surgery for degenerative knee arthritis included documented trials of appropriate conservative treatment prior to randomization.

METHODS

We selected all RCTs of the most recent meta-analysis by Brignardello-Petersen and recorded for each RCT, if physiotherapy prior to randomization was mandatory. We compared the treatment effect of arthroscopy in studies in which physiotherapy prior to randomization was mandatory versus studies in which it was not. This review was registered in the PROSPERO database (CRD42017070091).

RESULTS

Of the 13 RCTs in the meta-analysis, there were 2 in which physiotherapy prior to randomization was mandatory. In 1 additional multicenter RCT, prior conservative treatment was mentioned as mandatory in the publication, but not in the protocol. The treatment effects attributed to arthroscopy in terms of short-term pain (P = .0037), short-term function (P = .0309), and long-term function (P = .0012) were larger in studies in which prior physiotherapy was mandatory.

CONCLUSIONS

Although the most recent meta-analysis claims that it is based "on patients who do not respond to conservative treatment," physiotherapy was mandatory prior to randomization only in 2 of the 13 studies. As several orthopaedic guidelines recommend that the first line of treatment in patients with degenerative arthritis of the knee should be conservative, for instance with physiotherapy, and the question of performing arthroscopy arises once conservative treatment fails, 11 of the 13 RCTs failed to adhere to these accepted guidelines. Therefore, patient selection in these 11 studies may not represent the typical indications for arthroscopy, where patients have tried conservative management prior to being offered surgery. When comparing studies where prior physiotherapy was mandatory to studies in which it was not mandatory, there were statistically significant effects favoring arthroscopy in terms of pain in the short term, and for function both in the short and the long term. These findings suggest that the treatment effects attributed to arthroscopy were higher when prior physiotherapy was mandatory. Given these findings, the external validity of most of these RCTs, and the resulting "strong recommendation against the use of arthroscopy in nearly all patients with degenerative knee disease," is called into question.

LEVEL OF EVIDENCE

Level II, systematic review of Level I and II studies.

摘要

目的

我们旨在确定最近一项关于关节镜手术治疗退行性膝关节炎的荟萃分析中评估的随机对照试验(RCT)是否包括在随机分组前有记录的适当保守治疗试验。

方法

我们选择了 Brignardello-Petersen 最近的荟萃分析中的所有 RCT,并为每项 RCT 记录了在随机分组前是否强制进行物理治疗。我们比较了在随机分组前强制进行物理治疗的研究与未强制进行物理治疗的研究中关节镜手术的治疗效果。本综述已在 PROSPERO 数据库(CRD42017070091)中注册。

结果

荟萃分析中的 13 项 RCT 中有 2 项在随机分组前强制进行物理治疗。在另外一项多中心 RCT 中,尽管在出版物中提到了在随机分组前进行保守治疗,但在方案中并未提及。在随机分组前强制进行物理治疗的研究中,关节镜手术在短期疼痛(P=0.0037)、短期功能(P=0.0309)和长期功能(P=0.0012)方面的治疗效果更大。

结论

尽管最近的荟萃分析声称它是基于“对保守治疗无反应的患者”,但在 13 项研究中只有 2 项在随机分组前强制进行物理治疗。由于一些骨科指南建议退行性膝关节炎患者的一线治疗应是保守治疗,例如物理治疗,并且只有在保守治疗失败后才会考虑进行关节镜手术,因此 13 项 RCT 中有 11 项未能遵守这些公认的指南。因此,这些研究中的患者选择可能无法代表典型的关节镜手术适应证,因为患者在接受手术前已经尝试了保守治疗。在比较随机分组前强制进行物理治疗的研究与未强制进行物理治疗的研究时,短期疼痛方面关节镜手术具有统计学意义的优势,短期和长期功能方面也具有统计学意义的优势。这些发现表明,在随机分组前强制进行物理治疗时,关节镜手术的治疗效果更高。鉴于这些发现,这些 RCT 中的大多数的外部有效性,以及由此产生的“强烈反对在几乎所有退行性膝疾病患者中使用关节镜手术”的建议,受到了质疑。

证据等级

二级,对一级和二级研究的系统评价。

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