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硝酸甘油局部治疗(GTN)和离心运动治疗中段跟腱腱病(NEAT 试验):一项随机、双盲、安慰剂对照试验。

Topical glyceryl trinitrate (GTN) and eccentric exercises in the treatment of mid-portion achilles tendinopathy (the NEAT trial): a randomised double-blind placebo-controlled trial.

机构信息

Discipline of Physiotherapy, School of Medicine, Trinity College Dublin, Dublin, Ireland

Physiotherapy, Connolly Hospital Blanchardstown, Dublin, Ireland.

出版信息

Br J Sports Med. 2024 Sep 9;58(18):1035-1043. doi: 10.1136/bjsports-2023-108043.

Abstract

OBJECTIVES

To investigate if daily treatment with glyceryl trinitrate (GTN) ointment, over 24 weeks combined with a 12-week eccentric exercise programme is more effective for chronic mid-portion Achilles tendinopathy than placebo ointment and eccentric exercise.

METHODS

This was a single-site randomised double-blind placebo-controlled trial at an acute hospital, Dublin, Ireland. Patients with chronic mid-portion Achilles tendinopathy were randomised to either 24 weeks of daily GTN ointment or placebo ointment. Both groups received an identical 12-week eccentric exercise programme. The primary outcome measure was the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire at 24 weeks, which measures pain, function and activity. Secondary outcomes included pain severity, self-reported physical function, calf muscle function, pressure pain thresholds and ultrasound changes. Statistical analyses were performed according to intention-to-treat principles.

RESULTS

76 patients (30 women; 46 men, mean age±SD, 45.6±8.2 years) were recruited for the trial. Significant improvements in VISA-A scores occurred in both groups at 6-week, 12-week and 24-week follow-up. The increase was not significantly different between groups, adjusted mean between-group difference from baseline to week 6, -1.33 (95% CI -6.96 to 4.31); week 12, -1.25 (95% CI -8.0 to 5.49) and week 24, -3.8 (95% CI -10.6 to 3.0); negative values favour GTN. There was no significant between-group difference in any of the secondary outcome measures at 6, 12 and 24 weeks.

CONCLUSIONS

Adding daily GTN ointment over 24 weeks to a 12-week eccentric exercise programme did not improve pain, function and activity level in patients with chronic mid-portion Achilles tendinopathy when compared with placebo ointment.

摘要

目的

研究 24 周内每天使用硝化甘油软膏(GTN)联合 12 周的离心运动方案治疗慢性中段跟腱病是否比安慰剂软膏和离心运动更有效。

方法

这是一项在爱尔兰都柏林一家急性医院进行的单站点随机双盲安慰剂对照试验。将慢性中段跟腱病患者随机分为每日 GTN 软膏组或安慰剂软膏组,两组均接受相同的 12 周的离心运动方案。主要结局测量指标为 24 周时的维多利亚运动评估-跟腱(VISA-A)问卷,该问卷测量疼痛、功能和活动。次要结局指标包括疼痛严重程度、自我报告的身体功能、小腿肌肉功能、压痛阈值和超声变化。统计分析根据意向治疗原则进行。

结果

该试验共招募了 76 名患者(30 名女性;46 名男性,平均年龄±标准差,45.6±8.2 岁)。两组患者在 6 周、12 周和 24 周随访时 VISA-A 评分均显著改善。组间增加无显著差异,从基线到第 6 周的组间平均差值为-1.33(95%可信区间-6.96 至 4.31);第 12 周为-1.25(95%可信区间-8.0 至 5.49),第 24 周为-3.8(95%可信区间-10.6 至 3.0);负值表示 GTN 组更好。在第 6、12 和 24 周时,任何次要结局指标在两组间均无显著差异。

结论

与安慰剂软膏相比,在 12 周的离心运动方案基础上,每天使用 GTN 软膏 24 周并未改善慢性中段跟腱病患者的疼痛、功能和活动水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4976/11420712/6a198659017e/bjsports-2023-108043f03.jpg

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