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局部皮质类固醇注射与安慰剂治疗腕管综合征的比较。

Local corticosteroid injection versus placebo for carpal tunnel syndrome.

机构信息

Medicine, University of Alberta, Edmonton, Canada.

Electroencephalography (EEG) Department, East Kent Hospitals University NHS Trust, Canterbury, UK.

出版信息

Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD015148. doi: 10.1002/14651858.CD015148.

Abstract

BACKGROUND

Carpal tunnel syndrome (CTS) is a very common clinical syndrome manifested by signs and symptoms of irritation of the median nerve at the carpal tunnel in the wrist. Direct and indirect costs of CTS are substantial, with estimated costs of two billion US dollars for CTS surgery in the USA in 1995 alone. Local corticosteroid injection has been used as a non-surgical treatment for CTS many years, but its effectiveness is still debated.

OBJECTIVES

To evaluate the benefits and harms of corticosteroids injected in or around the carpal tunnel for the treatment of carpal tunnel syndrome compared to no treatment or a placebo injection.

SEARCH METHODS

We used standard, extensive Cochrane search Methods. The searches were 7 June 2020 and 26 May 2022.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) or quasi-randomised trials of adults with CTS that included at least one comparison group of local injection of corticosteroid (LCI) into the wrist and one group that received a placebo or no treatment.

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methods. Our primary outcome was 1. improvement in symptoms at up to three months of follow-up. Our secondary outcomes were 2. functional improvement, 3. improvement in symptoms at greater than three months of follow-up, 4. improvement in neurophysiological parameters, 5. improvement in imaging parameters, 6. requirement for carpal tunnel surgery, 7. improvement in quality of life and 8.

ADVERSE EVENTS

We used GRADE to assess the certainty of evidence for each outcome.

MAIN RESULTS

We included 14 trials with 994 participants/hands with CTS. Only nine studies (639 participants/hands) had useable data quantitatively and in general, these studies were at low risk of bias except for one quite high-risk study. The trials were conducted in hospital-based clinics across North America, Europe, Asia and the Middle East. All trials used participant-reported outcome measures for symptoms, function and quality of life. There is probably an improvement in symptoms measured at up to three months of follow-up favouring LCI (standardised mean difference (SMD) -0.77, 95% confidence interval (CI) -0.94 to -0.59; 8 RCTs, 579 participants; moderate-certainty evidence). Up to six months this was still evident favouring LCI (SMD -0.58, 95% CI -0.89 to -0.28; 4 RCTs, 234 participants/hands; moderate-certainty evidence). There is probably an improvement in function measured at up to three months favouring LCI (SMD -0.62, 95% CI -0.87 to -0.38; 7 RCTs, 499 participants; moderate-certainty evidence). We are uncertain if there is a difference in median nerve DML at up to three months of follow-up (mean difference (MD) -0.37 ms, 95% CI -0.75 to 0.02; 6 RCTs, 359 participants/hands; very low-certainty evidence). The requirement for surgery probably reduces slightly in the LCI group at one year (risk ratio 0.84, 95% CI 0.72 to 0.98; 1 RCT, 111 participants, moderate-certainty evidence). Quality of life, measured at up to three months of follow-up using the Short-Form 6 Dimensions questionnaire (scale from 0.29 to 1.0; higher is better) probably improved slightly in the LCI group (MD 0.07, 95% CI 0.02 to 0.12; 1 RCT, 111 participants; moderate-certainty evidence). Adverse events were uncommon (low-certainty evidence). One study reported 2/364 injections resulted in severe pain which resolved over "several weeks" and 1/364 injections caused a "sympathetic reaction" with a cool, pale hand that completely resolved in 20 minutes. One study (111 participants) reported no serious adverse events, but 65% of LCI-injected and 16% of the placebo-injected participants experienced mild-to-moderate pain lasting less than two weeks. About 9% of participants experienced localised swelling lasting less than two weeks. Four studies (229 participants) reported that they experienced no adverse events in their studies. Three studies (220 participants) did not specifically report adverse events.

AUTHORS' CONCLUSIONS: Local corticosteroid injection is effective for the treatment of mild and moderate CTS with benefits lasting up to six months and a reduced need for surgery up to 12 months. Where serious adverse events were reported, they were rare.

摘要

背景

腕管综合征(CTS)是一种非常常见的临床综合征,表现为腕管中正中神经的刺激症状和体征。CTS 的直接和间接成本都很高,仅美国 1995 年 CTS 手术的估计成本就达到 20 亿美元。局部皮质类固醇注射多年来一直被用作 CTS 的非手术治疗方法,但疗效仍存在争议。

目的

评估与不治疗或安慰剂注射相比,将皮质类固醇注射到腕管内或周围治疗腕管综合征的益处和危害。

搜索方法

我们使用了标准的、广泛的 Cochrane 搜索方法。搜索时间为 2020 年 6 月 7 日和 2022 年 5 月 26 日。

选择标准

我们纳入了成人 CTS 的随机对照试验(RCT)或准随机试验,这些试验包括至少一个局部皮质类固醇(LCI)注射组和一个安慰剂或不治疗组。

数据收集和分析

我们使用了标准的 Cochrane 方法。我们的主要结局是在随访的 3 个月内症状改善。我们的次要结局是 2. 功能改善,3. 随访超过 3 个月时症状改善,4. 神经生理参数改善,5. 影像学参数改善,6. 腕管手术的需要,7. 生活质量改善和 8. 不良事件。我们使用 GRADE 评估每个结局的证据确定性。

主要结果

我们纳入了 14 项试验,涉及 994 名参与者/手部 CTS。只有 9 项研究(639 名参与者/手部)有可用的定量数据,总体而言,这些研究除了一项相当高风险的研究外,其余研究的偏倚风险较低。这些试验是在北美、欧洲、亚洲和中东的医院诊所进行的。所有试验都使用了参与者报告的症状、功能和生活质量的结局测量。在随访的 3 个月内,LCI 治疗组可能会改善症状(标准化均数差(SMD)-0.77,95%置信区间(CI)-0.94 至-0.59;8 项 RCT,579 名参与者;中度确定性证据)。在 6 个月时,这仍然是明显的,LCI 治疗组更优(SMD -0.58,95% CI -0.89 至-0.28;4 项 RCT,234 名参与者/手部;中度确定性证据)。在随访的 3 个月内,LCI 治疗组可能会改善功能(SMD -0.62,95% CI -0.87 至-0.38;7 项 RCT,499 名参与者;中度确定性证据)。我们不确定在随访的 3 个月内,LCI 治疗组和安慰剂治疗组之间正中神经 DML 是否有差异(平均差异(MD)-0.37 ms,95% CI -0.75 至 0.02;6 项 RCT,359 名参与者/手部;极低确定性证据)。LCI 治疗组在 1 年内手术的需求可能会略有减少(风险比 0.84,95% CI 0.72 至 0.98;1 项 RCT,111 名参与者,中度确定性证据)。在随访的 3 个月内,使用简短 6 维度问卷(从 0.29 到 1.0;分数越高越好)衡量的生活质量可能会稍有改善,LCI 治疗组的评分更高(MD 0.07,95% CI 0.02 至 0.12;1 项 RCT,111 名参与者;中度确定性证据)。不良事件并不常见(低确定性证据)。一项研究报告说,364 次注射中有 2/364 次导致严重疼痛,疼痛在“数周”内缓解,1/364 次注射引起“交感反应”,手部发凉苍白,20 分钟内完全缓解。一项研究(111 名参与者)报告没有严重不良事件,但 LCI 注射组和安慰剂注射组分别有 65%和 16%的参与者经历了持续不到两周的轻度至中度疼痛。大约 9%的参与者经历了持续不到两周的局部肿胀。四项研究(229 名参与者)报告说,他们的研究中没有不良事件。三项研究(220 名参与者)没有具体报告不良事件。

作者结论

局部皮质类固醇注射对轻度和中度 CTS 有效,疗效可持续 6 个月,12 个月内手术需求减少。报告严重不良事件的研究中,这些事件很少见。

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