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超声引导下腕管综合征经皮神经周围注射葡萄糖时的容量问题:一项随机、双盲、三臂试验

Volume Matters in Ultrasound-Guided Perineural Dextrose Injection for Carpal Tunnel Syndrome: A Randomized, Double-Blinded, Three-Arm Trial.

作者信息

Lin Meng-Ting, Liao Chun-Li, Hsiao Ming-Yen, Hsueh Hsueh-Wen, Chao Chi-Chao, Wu Chueh-Hung

机构信息

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan.

Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan.

出版信息

Front Pharmacol. 2020 Dec 17;11:625830. doi: 10.3389/fphar.2020.625830. eCollection 2020.

Abstract

Ultrasound-guided perineural dextrose injection (PDI) has been reported effective for carpal tunnel syndrome (CTS). Higher volume of injectate may reduce adhesion of median nerve from other tissues, but volume-dependent effects of PDI in CTS remain unknown. We aimed to investigate whether PDI with different injectate volumes had different effects for CTS participants. In this randomized, double-blinded, three-arm trial, 63 wrists diagnosed with CTS were randomized into three groups that received ultrasound-guided PDI with either 1, 2 or 4 ml of 5% dextrose water. All participants finished this study. Primary outcome as visual analog scale (VAS) and secondary outcomes including Boston Carpal Tunnel Questionnaire (BCTQ), Disability of the Arm, Shoulder and Hand score (QuickDASH), electrophysiological studies and cross-sectional area (CSA) of the median nerve at carpal tunnel inlet were assessed before and after PDI at the 1st, 4th, 12th and 24th weeks. For within-group analysis, all three groups (21 participants, each) revealed significant improvement from baseline in VAS, BCTQ and QuickDASH at the 1st, 4th, 12th and 24th weeks. For between-group analysis, 4 ml-group yielded better VAS reduction at the 4th and 12th weeks as well as improvement of BCTQ and QuickDASH at the 1st, 4th, and 12th weeks, compared to other groups. No significant between-group differences were observed in electrophysiological studies or median nerve CSA at any follow-up time points. There were no severe complications in this trial, and transient minor adverse effects occurred equally in the three groups. In conclusion, ultrasound-guided PDI with 4 ml of 5% dextrose provided better efficacy than with 1 and 2 ml based on symptom relief and functional improvement for CTS at the 1st, 4th, and 12th week post-injection, with no reports of severe adverse effects. There was no significant difference between the three groups at the 24th-week post-injection follow-up. www.ClinicalTrials.gov, identifier NCT03598322.

摘要

超声引导下经皮神经内葡萄糖注射(PDI)已被报道对腕管综合征(CTS)有效。较高剂量的注射剂可能会减少正中神经与其他组织的粘连,但PDI在CTS中与剂量相关的效应仍不清楚。我们旨在研究不同注射剂量的PDI对CTS患者是否有不同的效果。在这项随机、双盲、三臂试验中,63例诊断为CTS的手腕被随机分为三组,分别接受超声引导下1、2或4毫升5%葡萄糖水的PDI治疗。所有参与者均完成了本研究。主要结局指标为视觉模拟评分(VAS),次要结局指标包括波士顿腕管综合征问卷(BCTQ)、手臂、肩部和手部功能障碍评分(QuickDASH)、电生理研究以及腕管入口处正中神经的横截面积(CSA),在注射后第1、4、12和24周进行PDI前后评估。对于组内分析,所有三组(每组21名参与者)在第1、4、12和24周时VAS、BCTQ和QuickDASH较基线均有显著改善。对于组间分析,与其他组相比,4毫升组在第4和12周时VAS降低更明显,在第1、4和12周时BCTQ和QuickDASH改善更明显。在任何随访时间点的电生理研究或正中神经CSA方面,组间均未观察到显著差异。本试验未出现严重并发症,三组中短暂的轻微不良反应发生率相同。总之,基于注射后第1、4和12周时CTS的症状缓解和功能改善,超声引导下4毫升5%葡萄糖的PDI比1毫升和2毫升的疗效更好,且无严重不良反应报告。注射后第24周随访时三组之间无显著差异。ClinicalTrials.gov,标识符NCT03598322。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c27f/7773892/1420f277dc16/fphar-11-625830-g001.jpg

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