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生理盐水注射对外侧肱骨上髁炎症状的影响:随机临床试验的系统评价和荟萃分析。

Effect of Normal Saline Injections on Lateral Epicondylitis Symptoms: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

机构信息

Universidad Autonoma de Nuevo Leon, Orthopedics and Traumatology Service, Facultad de Medicina y Hospital Universitario Dr José Eleuterio González, Monterrey, Mexico.

Universidad Autonoma de Nuevo Leon, Plataforma Invest-KER Unit Mexico, Facultad de Medicina, Monterrey, Mexico.

出版信息

Am J Sports Med. 2020 Oct;48(12):3094-3102. doi: 10.1177/0363546519899644. Epub 2020 Feb 11.

Abstract

BACKGROUND

Lateral epicondylitis, or tennis elbow, is a painful degenerative disorder that commonly occurs in adults between 40 and 60 years of age. Normal saline (NS) injections have been used as placebo through a large number of randomized controlled trials (RCTs) focused on the treatment of lateral epicondylitis.

PURPOSE

This meta-analysis of RCTs aimed to assess the therapeutic effect of NS injections on lateral epicondylitis symptoms and compare results with established minimal clinically important difference criteria.

STUDY DESIGN

Systematic review and meta-analysis.

METHODS

MEDLINE, Embase, Web of Science, and Scopus databases were searched for clinical trials reporting pain and joint function with the visual analog scale, Patient-Rated Tennis Elbow Evaluation, and Disabilities of the Arm, Shoulder and Hand in patients with lateral epicondylitis. The meta-analysis was conducted with a random effects model and generic inverse variance method. Heterogeneity was tested with the statistic index.

RESULTS

A total of 15 RCTs included in this meta-analysis revealed a significant improvement in pain (mean difference, 3.61 cm [95% CI, 2.29-4.92 cm]; < .00001; = 88%; visual analog scale) and function (mean difference, 25.65 [95% CI, 13.30-37.99]; < .0001; = 82%; Patient-Rated Tennis Elbow Evaluation / Disabilities of the Arm, Shoulder and Hand) after NS injection (≥6 months).

CONCLUSION

NS injections yielded a statistically significant and clinically meaningful improvement in pain and functional outcomes in patients with lateral epicondylitis. New research should focus on better methods to diminish the potential confounders that could lead to this effect because NS injections could mask the real effect of an active therapeutic intervention in RCT.

REGISTRATION

CRD42019127547 (PROSPERO).

摘要

背景

外侧肱骨上髁炎,又称网球肘,是一种常见于 40 岁至 60 岁成年人的疼痛性退行性疾病。生理盐水 (NS) 注射已被大量随机对照试验 (RCT) 用作安慰剂,这些试验主要关注外侧肱骨上髁炎的治疗。

目的

本 RCT 荟萃分析旨在评估 NS 注射治疗外侧肱骨上髁炎症状的疗效,并与既定的最小临床重要差异标准进行比较。

研究设计

系统评价和荟萃分析。

方法

检索 MEDLINE、Embase、Web of Science 和 Scopus 数据库,以查找报告外侧肱骨上髁炎患者疼痛和关节功能的临床研究,使用视觉模拟量表、患者自评网球肘评估量表和上肢功能障碍量表。荟萃分析采用随机效应模型和通用倒数方差法进行。采用 统计量检验异质性。

结果

本荟萃分析共纳入 15 项 RCT,结果显示 NS 注射后疼痛(平均差值,3.61cm[95%CI,2.29-4.92cm];<0.00001; = 88%;视觉模拟量表)和功能(平均差值,25.65[95%CI,13.30-37.99];<0.0001; = 82%;患者自评网球肘评估量表/上肢功能障碍量表)有显著改善。

结论

NS 注射在外侧肱骨上髁炎患者中可显著改善疼痛和功能结局,且具有临床意义。新的研究应侧重于更好的方法,以减少可能导致这种效应的潜在混杂因素,因为 NS 注射可能会掩盖 RCT 中积极治疗干预的真实效果。

登记

CRD42019127547(PROSPERO)。

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