[关键词]
[摘要]
背景—已有研究证实刺激迷走神经可改善卒中后遗症期(6月——2年)患者的上肢功能。本研究探讨耳皮内刺作用于迷走神经耳支促进卒中后早期(Brunnstrom Ⅰ)期患者上肢运动功能恢复、加速康复进程的效应及其特征。 方法—本研究是一项随机对照单盲的临床研究,Brunnstrom Ⅰ期的中风患者随机分为耳皮内刺组(耳皮内刺组)(耳皮内刺、标准康复、体针)或假耳皮内刺组(假耳皮内刺组)(假耳皮内刺、标准康复、体针),治疗6天,共治疗1周(6次)。在开始治疗前和治疗3天后(D3)和治疗6天后(D6)治疗后进行评估,观察Brunnstrom分期的进展(Ueda评估)、Fugl-Meyer上肢得分(FMA-UE)及其亚型评分(FM-UEFS、FM-UEES)、Wolf运动功能测试量表(WMFT)、上肢关节活动范围(AROM)、上肢肌群徒手肌力检查(MMT)、Barthel指数(BI)的变化。 结果—在最初接受筛查的332名患者中,招募了70名符合标准的患者。耳皮内刺组35例,其中脱落1例,实际完成34例;假耳皮内刺组35例,无脱落。主要结局指标:耳皮内刺组上田敏(Ueda)分期在D3和D6天治疗结束后均优于假耳皮内刺组(P<0.05、P<0.001)。治疗6天后,耳皮内刺组的FM-UEFS评分明显优于假耳皮内刺组(P<0.05);FM-UEES与FMA-UE的相关性高于FM-UEFS与FMA-UE的相关性(FM-UEFS:r=0.728、P<0.001;FM-UEES:r=0.744、P<0.001);耳皮内刺组的Wolf运动功能测试量表评分(WMFT)在D3和D6天治疗结束后均优于假耳皮内刺组(P<0.05、P<0.05)。次要结局指标:AROM:治疗6天后,耳皮内刺组肩外展的关节活动度较假耳皮内刺组改善更明显(P<0.05)。MMT:耳皮内刺组肘屈曲、肘伸展肌群的肌力治疗6天后的改善程度超过假耳皮内刺组(P<0.05)。Barthel指数(BI):在治疗6天后,耳皮内刺组较治疗前有明显改善(P<0.05)但与假耳皮内刺组比较差异不明显 (P > 0.05)。 结论—耳皮内刺可有效改善中风后软瘫期患者的上肢运动功能,加速卒中偏瘫早期上肢运动功能康复进程。
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[Abstract]
Background and Purpose: Previous studies have demonstrated that stimulation of the vagus nerve improves upper limb function in patients with stroke sequelae (six month —— two years).This study aimed to investigate whether the auricular intradermal acupuncture(AIA) acted on the auricular branch of the vagus nerve can facilitate the recovery of upper limb motor function and expedite the effects and characteristics of rehabilitation processes in flaccid phase after stroke in Phase Brunnstrom I. Methods: This study utilized a randomized controlled single-blinded clinical design. Patients with stroke in Phase Brunnstrom I were randomly assigned to the auricular intradermal acupuncture (AIA) group (AIA, standard rehabilitation, conventional acupuncture) or the sham auricular intradermal acupuncture (sham AIA) group (the sham AIA, standard rehabilitation, conventional acupuncture) for 6 days of 1 week (6 times). We conducted assessments before starting treatment and after 3 and 6 days and observed the Brunnstrom (Ueda Assessment), Fugl-Meyer Assessment of the upper extremity (FMA-UE) and its subtype score (FM-UEFS, FM-UEES), Wolf Motor Function Test Scale (WMFT), Upper limb active range of joint motion (AROM), manual muscle test (MMT) of upper limb muscles, Barthel Index (BI) Results: Of the 332 patients who were initially screened, 70 patients met the criteria and were recruited. There were 35 patients in the AIA group, of which 1 patient was falling off, 34 patients were actually completed; 35 patients in the sham AIA group had no falling off case. Primary outcome measures: The upper Ueda assessment of the AIA group were better than those of the sham AIA group after treatment on days 3 and 6 (P < 0.05, P < 0.001, respectively). The ESM-UE score on days 6 of the AIA group were significantly better than those of the sham AIA group (P < 0.05). FM-UEES of the AIA group was more associated with FMA-UE than FM-UEFS with FMA-UE after treatment on day 6 (FM-UEFS:r=0.728、P<0.001;FM-UEES:r=0.744、P<0.001). After 3 days and 6 days of treatment, the AIA group of the WMFT were significantly improved in the sham AIA group(P < 0.05, P < 0.001, respectively).Secondary outcome measures: AROM :After 6 days of treatment, the AIA group of shoulder abduction were more improved than in the sham AIA group (P < 0.05). MMT :The muscle strength of elbow flexion, and elbow extension muscle improved more in the AIA group than in the sham AIA group (P < 0.05).Barthel Index (BI): After 6 days of treatment, there was a significant improvement in the group compared with before treatment (P <0.05), but no difference compared with the group (P> 0.05). Conclusions: AIA improves the upper limb motor function of patients with post-stroke flaccid hemiplegia and accelerates the rehabilitation process of upper limb motor function. Clinical Trial Registration—The study protocol is registered with http://www.chictr.org.cn (accession number: ChiCTR2200058141)
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[基金项目]
2022年省中医药科技发展计划项目(MS2022118)