Liu Ching-Hsiung, Hsieh Yu-Ting, Tseng Hung-Pin, Lin Hung-Chih, Lin Chun-Liang, Wu Tai-Yi, Lin Shu-Hua, Tsao Szu-Hung, Zhang Hong
Department of Neurology, Lotung Poh-Ai Hospital, Ilan, Taiwan Institute of Traditional Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Department of Physical Medicine and Rehabilitation, Lotung Poh-Ai Hospital, Ilan, Taiwan.
Acupunct Med. 2016 Oct;34(5):349-355. doi: 10.1136/acupmed-2015-010825. Epub 2016 Apr 19.
To determine the required sample size for, and feasibility of, a RCT examining the effectiveness of early acupuncture for acute ischaemic stroke.
Thirty-eight patients aged 40-85 years with a first episode of acute ischaemic stroke presenting within 72 h of stroke onset were randomly assigned to receive manual acupuncture (MA group; n=20) plus standard care or standard care only (control group, n=18). The acupuncture treatment was provided daily for 2 weeks. The primary outcome was the change in the National Institutes of Health Stroke Scale (NIHSS) score between baseline and 4 weeks. Secondary outcomes included changes in the Fugl-Meyer assessment (FMA) and the functional independence measure scores between baseline and 4 weeks, and changes in NIHSS, Barthel Index and modified Rankin Scale scores at 12 weeks.
Thirty-one patients completed the study (dropout rate=18%) and adverse effects were minimal. No significant differences were seen between groups in the improvements in NIHSS scores, although there tended to be a greater reduction in NIHSS score after 1 week in the MA group relative to the control group (p=0.066). The post-stroke motor activity at 4 weeks was associated with a significantly increased FMA score in the acupuncture group compared with the control group (p<0.05), but not supported by intergroup analysis.
This pilot study indicates that acupuncture appears to be safe for patients in the acute stage of ischaemic stroke. A subsequent trial with a larger sample size (estimated at n=122) is required to confirm whether early acupuncture intervention contributes to earlier functional improvement and to assess the longer-term clinical efficacy of acupuncture.
NCT02210988; Results.
确定一项评估早期针刺治疗急性缺血性中风有效性的随机对照试验所需的样本量及可行性。
38例年龄在40 - 85岁、首次发生急性缺血性中风且在中风发作72小时内就诊的患者被随机分为两组，分别接受手法针刺治疗（针刺组；n = 20）加标准护理或仅接受标准护理（对照组，n = 18）。针刺治疗每天进行，持续2周。主要结局指标为国立卫生研究院卒中量表（NIHSS）评分在基线和4周之间的变化。次要结局指标包括Fugl - Meyer评估（FMA）评分以及基线和4周之间功能独立性测量评分的变化，还有12周时NIHSS、Barthel指数和改良Rankin量表评分的变化。
31例患者完成了研究（脱落率 = 18%），且不良反应极小。两组在NIHSS评分改善方面未见显著差异，尽管针刺组在1周后NIHSS评分相对于对照组有更大幅度的降低趋势（p = 0.066）。与对照组相比，针刺组在4周时的中风后运动活动与FMA评分显著增加相关（p < 0.05），但组间分析未支持这一结果。
这项初步研究表明，针刺对缺血性中风急性期患者似乎是安全的。需要随后进行一项更大样本量（估计n = 122）的试验，以确认早期针刺干预是否有助于更早的功能改善，并评估针刺的长期临床疗效。
NCT02210988；结果
