中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2017, Vol. 12 ›› Issue (5): 831-840.doi: 10.4103/1673-5374.206655

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合募配穴针刺治疗功能性消化不良的中枢响应机制：随机平行对照临床试验方案

  

  • 收稿日期:2017-05-09 出版日期:2017-05-15 发布日期:2017-05-15
  • 基金资助:

    国家科技基金委员会项目（81473602）; 教育部新世纪优秀人才支撑计划; 全国优秀博士学位论文作者专项资金（201486）; 四川省科技厅青年基金（15QNJJ0008）; 国家自然科学基金项目——优秀青年基金（81622052）;四川2011协同创新中心——针灸经穴效应协同创新中心

Cerebral mechanism of puncturing at He-Mu point combination for functional dyspepsia: study protocol for a randomized controlled parallel trial

Shuai Yin1, 2, Yuan Chen1, Du Lei3, Rui-rui Sun1, Ting-ting Ma4, Pei-min Feng4, Zhao-xuan He1, Xue-ling Suo3, Pei-hong Ma1, Yu-zhu Qu1, Ke Qiu1, Miao-miao Jing1, Qi-yong Gong3, Fan-rong Liang1, Jiao Chen1, Fang Zeng1   

  1. 1 Acupuncture and Tuina School/The Third Affiliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China; 2 First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, China; 3 Huaxi MR Research Center, Department of Radiology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China; 4 First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China
  • Received:2017-05-09 Online:2017-05-15 Published:2017-05-15
  • Contact: Fan-rong Liang or Jiao Chen, M.D., acuresearch@126.com or cjthz@126.com.
  • Supported by:

    The study was financially supported by the National Scientific Foundation Committee in China, No. 81473602; the Education Ministry’s New Century Excellent Talents Supporting Plan in China; the Foundation for the Author of National Excellent Doctoral Dissertation of China, No. 201486; the Youth Foundation of Science and Technology Department of Sichuan Province in China, No. 15QNJJ0008; the National Natural Science Foundation—Excellent Youth Foundation in China, No. 81622052; the 2011 Co-Innovation Center of Sichuan Province named Acupoint Effects of Acupuncture Co-Innovation Center.

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摘要：

针灸广泛用于治疗功能性消化不良，且临床效果满意。研究显示合募配穴对治疗功能性消化不良具有协同作用，但作用机制仍不明确。为此，成都中医药大学进行随机对照平行临床试验，采用静息态功能磁共振对功能性消化不良患者的中枢响应机制进行分析。招募105例符合标准的功能性消化不良患者随机等分为合募配穴组、下合穴组及募穴组，分别刺激足三里和/或中脘，均在4周内接受20次针灸治疗，每次治疗针刺深度1-2寸，捻转90°-180°，提插0.3-0.5cm，刺激的频率为60-90次/min，刺激10min留针30min。在治疗前及针灸治疗20次后进行磁共振扫描。主要观察指标以尼平消化不良指评价治疗前及针灸后患者症状的改善情况；次要观察指标为治疗前及针灸治疗10次及20次后以利兹消化不良问卷评分、焦虑自评量表、抑郁自评量表、Beck焦虑量表、Beck抑郁量表、目测类比评分及针感和针刺后出现的不良反应做治疗效果的转化评价。试验结果可揭示合募配穴与单穴针灸治疗功能性消化不良的中枢响应差异提供理论依据。试验已于2015-05-13在中国临床试验注册中心注册(ChiCTR-IOR-15006402)。

 ORCID：0000-0001-8518-9268(Fan-rong Liang);0000-0003-2774-7174(Jiao Chen)

关键词: 神经再生, 消化不良, 配穴, 针灸, 中医, 神经机制, 静息态功能磁共振, 临床试验, 试验方案

Abstract:

Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlying mechanisms remain unclear. Therefore, a randomized controlled parallel clinical trial is currently underway at Chengdu University of Traditional Chinese Medicine, China. This trial is designed to explore the efficacy of and central responses to the He-Mu point combination in patients with functional dyspepsia using functional magnetic resonance imaging. A total of 105 patients with functional dyspepsia will be allocated into 3 groups: the low-He point group (puncturing at Zusanli (ST36)), Mu point group (puncturing at Zhongwan (CV12)), and He-Mu point combination group (puncturing at ST36 and CV12). Every participant will receive 20 sessions of manual acupuncture for 4 weeks. The needles will be inserted perpendicularly to a depth of 1 to 2 cun. The angle of rotation and twisting will range from 90 to 180 degrees, while lifting and thrusting will range from 0.3 to 0.5 cm. The various manipulations will be performed 60 to 90 times per minute. The needles will remain in place for 30 minutes, during which manipulation will be applied every 10 minutes. Magnetic resonance imaging will be performed before and after 20 sessions of acupuncture. The primary outcome is symptom improvement according to the Chinese version of the Nepean Dyspepsia Index. Secondary outcomes include the Leeds dyspepsia questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Beck Anxiety Inventory, Beck Depression Inventory, and visual analogue scale scores before and after 10 and 20 sessions of acupuncture. Needle sensaGraphicaldistion and adverse events will be used to assess the therapeutic effects. This study will promote more widespread awareness of the benefits of acupoint combination in the clinical setting and provide a further explanation of the neuromechanism by which acupuncture at the He-Mu point combination for functional dyspepsia. Registration: Chinese Clinical Trial Registry, ChiCTR-IOR-15006402.

Key words: nerve regeneration, dyspepsia, acupoint combination, acupuncture, traditional Chinese medicine, neuromechanism, functional magnetic resonance imaging, clinical trial, protocol, neural regeneration