肌内效贴治疗中枢性面瘫的疗效：一项前瞻性、随机、假对照、单盲临床试验

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中文摘要

背景： 评估肌内效贴（KT）治疗成人中枢性面瘫（CFP）的安全性和有效性。
方法： 在这项随机单盲临床试验中，121例于2023年6月至2024年9月期间首次发生卒中的患者按1:1:1比例随机分配至3组之一：刺激组（SG，KT+常规康复）、假刺激组（SSG，无张力KT+常规康复）和对照组（CG，仅常规康复而不使用KT）。所有3组均接受常规康复治疗，SG和SSG额外接受KT治疗。治疗持续4周，随后进行4周随访。在基线（T0）、4周后（T1）和8周后（T2）评估House-Brackmann分级量表评分、Sunnybrook面部分级系统、Burres-Fisch系统、面部残疾指数、功能性经口摄食量表和食物残留情况。
结果： 在T1时，所有组在House-Brackmann分级量表、Sunnybrook面部分级系统、Burres-Fisch、面部残疾指数和功能性经口摄食量表评分方面均较T0有显著改善（P<.05）。SG在除FOIS外的所有指标上均较SSG/CG表现出更优的治疗获益（效应量：1.15-2.90，P<.001），且获益持续至T2（SG内T1与T2比较：P>.05）。此外，SG在口腔期疗效方面更优（食物残留情况0级：67.5% vs 45.0%/35.0%，P<.05）。SSG与CG在任何时间点均未出现显著差异（P>.05）。未报告严重不良事件。
结论： 我们的研究表明，施加张力的KT（25%-50%拉伸）可显著改善CFP患者的面部对称性（静态/动态）和吞咽效率，且获益持续≥4周。KT优于SSG/CG，是一种安全的辅助治疗，可增强CFP康复中的运动功能和生活质量。

英文摘要

BACKGROUND: To evaluate the safety and efficacy of Kinesio tape (KT) for managing central facial paralysis (CFP) in adults.
METHODS: In this randomized single-blind clinical trial, 121 patients with a 1st stroke event between June 2023 and September 2024 were randomly assigned to 1 of 3 groups (1:1:1 ratio): stimulated group (SG, KT + routine rehabilitation), sham stimulated group (SSG, KT with no tension applied + routine rehabilitation), and control group (CG, routine rehabilitation without KT). All 3 groups received routine rehabilitation therapy, with SG and SSG receiving additional KT treatment. The treatment lasted for 4 weeks, followed by a 4-week follow-up period. House-Brackmann grading scale score, Sunnybrook facial grading system, Burres-Fisch system, facial disability index, functional oral intake scale, and food residue condition were assessed at baseline (T0), after 4 weeks (T1), and 8 weeks (T2).
RESULTS: At T1, all groups showed significant improvements in House-Brackmann grading scale, Sunnybrook facial grading system, Burres-Fisch , facial disability index, and functional oral intake scale scores versus T0 (P < .05). The SG demonstrated superior therapeutic gains across all metrics except FOIS compared to SSG/CG (effect size: 1.15-2.90, P < .001), with benefits sustained through T2 (T1 vs T2 within SG: P > .05). Moreover, SG showed superior oral-phase efficacy (67.5% vs 45.0%/35.0% food residue condition level 0, P < .05). No significant differences emerged between SSG and CG at any timepoint (P > .05). No serious adverse events were reported.
CONCLUSION: Our study demonstrates that tension-applied KT (25%-50% stretch) significantly improves facial symmetry (static/dynamic) and swallowing efficiency in CFP, with sustained benefits ≥4 weeks. Superior to SSG/CG, KT proves a safe adjunct therapy, enhancing motor function and quality of life in CFP rehabilitation.