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使用可植入网片增强修复肩袖撕裂:系统评价和荟萃分析。

Use of implantable meshes for augmented rotator cuff repair: a systematic review and meta-analysis.

机构信息

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, Oxfordshire, UK

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, Oxfordshire, UK.

出版信息

BMJ Open. 2020 Dec 7;10(12):e039552. doi: 10.1136/bmjopen-2020-039552.

Abstract

OBJECTIVE

To appraise studies reporting on clinical effectiveness and safety of surgical meshes used to augment rotator cuff repairs (RCRs).

DESIGN

Systematic review and meta-analysis.

DATA SOURCES

MEDLINE, Embase and Cochrane databases were searched between April 2006 and April 2020.

ELIGIBILITY CRITERIA

All studies evaluating adults (≥18 years) undergoing RCR were considered. There were no language restrictions.

DATA EXTRACTION AND SYNTHESIS

Screening, data extraction and quality appraisal were conducted by two independent reviewers. Meta-analysis was conducted using a random-effects models if ≥2 comparative studies reported the same outcome measure. Risk of bias assessment was undertaken for randomised (RoB2, Cochrane) and comparative studies (ROBINS-I, Cochrane).

RESULTS

We included 60 studies, consisting of 7 randomised controlled trials, 13 observational comparative studies and 40 observational case series. All comparative studies reported on shoulder-specific functional outcome scores, 18 on the radiographic occurrence of re-tear and 14 on pain score metrics. All studies contained some risk of bias.Compared with non-augmented repair, a small improvement in shoulder-specific function or pain scores was observed for synthetic patches with a mean improvement of 6.7 points on the University of California Los Angles (UCLA) shoulder score (95% CI 0.1 to 13.4) and 0.46 point reduction on the Visual Analogue Scale (95% CI -0.74 to -0.17), respectively. A reduced likelihood of radiologically observed re-tear was observed for synthetic (risk ratio (RR) 0.41, 95% CI 0.27 to 0.61) and allograft (RR 0.34, 95% CI 0.18 to 0.65) patches. A total of 49 studies reported on the occurrence of complications. Slightly higher crude complication rates were observed following patch-augmented repair (2.1%) than standard repair (1.6%).

CONCLUSIONS

While several studies suggest a decreased failure rate and small improvements in shoulder function and pain following augmented RCR, a paucity of rigorous clinical evaluation, for both effectiveness and safety, prevents firm recommendations.

PROSPERO REGISTRATION NUMBER

CRD42017057908.

摘要

目的

评价报道外科补片增强肩袖修复术(RCR)临床疗效和安全性的研究。

设计

系统评价和荟萃分析。

资料来源

2006 年 4 月至 2020 年 4 月期间,检索 MEDLINE、Embase 和 Cochrane 数据库。

入选标准

所有评估接受 RCR 的成年人(≥18 岁)的研究均被纳入。无语言限制。

资料提取和综合

两名独立审查员进行筛选、资料提取和质量评估。如果≥2 项比较研究报告了相同的结局测量指标,则采用随机效应模型进行荟萃分析。对随机对照试验(RoB2,Cochrane)和比较研究(ROBINS-I,Cochrane)进行偏倚风险评估。

结果

共纳入 60 项研究,包括 7 项随机对照试验、13 项观察性比较研究和 40 项观察性病例系列研究。所有比较研究均报告了与肩部特定功能相关的评分,18 项研究报告了再撕裂的放射学发生率,14 项研究报告了疼痛评分指标。所有研究均存在一定程度的偏倚。与非增强修复相比,合成补片修复后肩部特定功能或疼痛评分略有改善,加州大学洛杉矶分校(UCLA)肩部评分平均提高 6.7 分(95%CI 0.1 至 13.4),视觉模拟评分(VAS)降低 0.46 分(95%CI -0.74 至 -0.17)。合成补片(风险比[RR]0.41,95%CI 0.27 至 0.61)和同种异体移植物(RR 0.34,95%CI 0.18 至 0.65)补片可降低放射学观察到的再撕裂的可能性。共有 49 项研究报告了并发症的发生情况。补片增强修复后的总并发症发生率(2.1%)略高于标准修复(1.6%)。

结论

尽管一些研究表明,增强 RCR 后失败率降低,肩部功能和疼痛略有改善,但由于有效性和安全性的严格临床评估缺乏,无法做出明确的推荐。

PROSPERO 注册号:CRD42017057908。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f548/7722806/61e86f8350b6/bmjopen-2020-039552f01.jpg

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