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): 826-830.doi: 10.4103/1673-5374.206654

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眶内电针治疗糖尿病外展神经麻痹的有效性：前瞻性、单中心、随机对照临床试验方案

  

  • 收稿日期:2017-04-20 出版日期:2017-05-15 发布日期:2017-05-15
  • 基金资助:

    国家自然科学基金项目（81674052），黑龙江省市自然科学基金重点项目（zd201211）和哈尔滨医科大学创新科研项目（2016lczx49）

Efficacy of intraorbital electroacupuncture for diabetic abducens nerve palsy: study protocol for a prospective single-center randomized controlled trial

Ling-yun Zhou, Xue-mei Li, Tie-juan Liu, Xiao-jie Ji, Ming Zhao, Chang Su, Ji-chao Liu, Jiang-yun Sun   

  1. Ocular Motility Disorder Treatment & Rehabilitation Center, Department of Acupuncture, the First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China
  • Received:2017-04-20 Online:2017-05-15 Published:2017-05-15
  • Contact: Ling-yun Zhou, M.D., Ph.D., no1zhly@163.com.
  • Supported by:

    This work was supported by the National Natural Science Foundation of China, No. 81674052; the Key Project of Natural Science Foundation of Heilongjiang Province of China, No. ZD201211; a grant from the Project of Innovational Scientific Research of Harbin Medical University of China, No. 2016LCZX49.

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摘要：

糖尿病患者易出现外展神经麻痹，目前治疗效果尚不明确。针刺作为中医传统治疗方法对周围神经损伤的修复有一定疗效，但尚缺乏随机对照试验的证据来验证。我们设计了一项前瞻性、单中心、随机对照临床试验方案，验证眶内电针疗法治疗糖尿病外展神经麻痹的有效性。试验预计纳入60例糖尿病外展神经麻痹的患者，随机分为治疗组和对照组，两组均进行降糖药物治疗，对照组给予口服营养神经药物治疗。治疗组在对照组治疗基础上给与眶内电针治疗，连续6周后观察治疗有效率变化。在治疗前、治疗第2，4，6周后分别进行检测患者复视角度，眼球移动距离、视力、空腹血糖及糖化血红蛋白水平的变化。治疗结束后1个月对患者的结局指标再次进行随访。本项目已于2015年1月16日在中国临床试验中心网站注册(注册号：ChiCTR-IPR-15005836)。试验已通过哈尔滨医科大学附属第一医院伦理委员会许可(伦理批准号：201452)。试验将遵循世界医学大会修订版赫尔辛基声明。所有受试者均需对试验内容知情，并签署知情同意书。我们希望通过此试验为该方法的临床推广提供可靠的依据。

ORCID：0000-0001-6659-3839(Ling-yun Zhou)

关键词: 神经再生, 第六对颅神经麻痹, 周围神经损伤, 电针, 糖尿病, 眼球运动, 复视, 康复, 眼球运动障碍, 干预, 随机对照试验

Abstract:

Abducens nerve palsy (ANP) is commonly seen in patients with diabetes mellitus. The validity of acupuncture as a traditional Chinese medicine method in peripheral nerve repair is well established. However, its efficacy in randomized controlled trials remains unclear. Herein, we designed a protocol for a prospective, single-center, randomized controlled trial to investigate the effect of intraorbital electroacupuncture on diabetic ANP. We plan to recruit 60 patients with diabetic ANP, and randomly divide them into treatment and control groups. Patients in both groups will continue their glucose-lowering therapy. A neural nutrition drug will be given to both groups for six weeks. The treatment group will also receive intraorbital electroacupuncture therapy. We will assess efficacy of treatment, eyeball movement, diplopia deviation and the levels of fasting blood-glucose and glycosylated hemoglobin before treatment at 2, 4, and 6 weeks after treatment. The efficacy and recurrence will be investigated during follow-up (1 month after intervention). This protocol was registered at Chinese Clinical Trial Registry on 16 January 2015 (ChiCTR-IPR-15005836). This study was approved by the Ethics Committee of First Affiliated Hospital of Harbin Medical University of China (approval number: 201452). All protocols will be in accordance with Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be provided by participants. We envisage that the results of this clinical trial will provide evidence for promoting clinical use of this new therapy for management of ANP.

Key words: nerve regeneration, sixth cranial nerve, peripheral nerve injury, electroacupuncture, diabetes mellitus, eyeball movement, diplopia, rehabilitation, ocular motility disorder, intervention, randomized controlled trail, neural regeneration