中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2018, Vol. 13 ›› Issue (7): 1269-1275.doi: 10.4103/1673-5374.235075

• 原著:退行性病与再生 • 上一篇    下一篇

中药复方滋肾平颤颗粒治疗帕金森病：随机双盲安慰剂对照临床试验

  

  • 收稿日期:2018-03-07 出版日期:2018-07-15 发布日期:2018-07-15
  • 基金资助:

    上海市科委重大项目（15401970100）；中国国家自然科学基金项目（面上项目）（81673726）；上海市科委项目（17401934600）；上海中医药大学附属龙华医院国家中医临床研究基地龙医学者（育苗计划）（LYTD-34）；上海中医药大学医学科技创新项目（ZYKC201601002）

Zishenpingchan granules for the treatment of Parkinson’s disease: a randomized, double-blind, placebo-controlled clinical trial

Qing Ye1, Xiao-Lei Yuan1, Can-Xing Yuan1, Hong-Zhi Zhang2, Xu-Ming Yang3   

  1. 1 Department of Neurology, LONGHUA Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China;
    2 Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China;
    3 Acupuncture and Tuina College of Shanghai University of Traditional Chinese Medicine, Shanghai, China
  • Received:2018-03-07 Online:2018-07-15 Published:2018-07-15
  • Contact: Can-Xing Yuan or Xu-Ming Yang,18917763103@163.com or fslbest@126.com.
  • Supported by:

    This work was supported by a grant from Major Project of Shanghai Committee of Science and Technology of China, No.15401970100; a grant from the National Natural Science Foundation of China (General Program), No. 81673726; a grant from the Project of Shanghai Committee of Science and Technology of China, No. 17401934600; a grant from Longhua Scholar Plan of National Traditional Chinese Medicine Clinical Base of China, No. LYTD-34; a grant from Shanghai Traditional Chinese Medicine Science and Technology Innovation Project, No. ZYKC201601002.

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摘要：

左旋多巴是治疗帕金森病的首选药物，但是长期使用左旋多巴会导致患者会出现运动并发症。由熟地黄、枸杞、桑寄生、天麻、僵蚕、莪术、白芍、天南星、蝎子和蜈蚣制成的中药复方滋肾平颤颗粒。既往临床研究显示其与左旋多巴联合应用治疗帕金森病可显著改善患者的运动障碍，延缓疾病进展，同时在改善帕金森病非运动症状方面也有明显作用，但尚缺乏随机对照试验对此疗效进行验证。试验首先经医院伦理学委员会批准并在中国临床试验注册中心注册（注册号ChiCTR-INR-1701194）。2014年12月至2016年12月开始在上海中医药大学附属龙华医院和曙光医院神经内科招募了128例帕金森病患者，男72例，女56例，年龄65.78 ± 6.34岁，随机等分为治疗组和对照组，在给予多巴胺治疗的同时分别给予滋肾平颤颗粒和安慰剂颗粒治疗24周。以统一帕金森病评定量表、开-关现象、Hoehn-Yahr分级、帕金森病自主神经症状量表、帕金森病睡眠量表、Hamilton焦虑量表、Hamilton抑郁量表、简易精神状态检查表以及帕金森病生活质量问卷评估治疗效果，并用人工神经网络来确定不同参数对帕金森病生活质量问卷影响的权重。数据结果显示滋肾平颤颗粒能明显减少帕金森病患者运动并发症的发生，改善帕金森病的运动障碍和非运动症状，且能减少患者左旋多巴的用量，且未发现明显的副作用。说明滋肾平颤颗粒既能缓解帕金森病症状，又能减少多巴胺能制剂的毒副反映，发挥增效减毒效应。

orcid:0000-0001-6220-7590(Can-Xing Yuan)
        0000-0002-2880-2609(Xu-Ming Yang)

关键词: 左旋多巴, 运动并发症, 非运动症状, 中药治疗, 人工神经网络, 震颤麻痹, 神经再生, 随机对照试验, 神经退行性疾病

Abstract:

Levodopa preparations remain the preferred drug for Parkinson’s disease. However, long-term use of levodopa may lead to a series of motor complications. Previous studies have shown that the combination of levodopa and Zishenpingchan granules (consisting of Radix Rehmanniae preparata, Lycium barbarum, Herba Taxilli, Rhizoma Gastrodiae, Stiff Silkorm, Curcuma phaeocaulis, Radix Paeoniae Alba,Rhizoma Arisaematis, Scorpio and Centipede) can markedly improve dyskinesia and delay the progression of Parkinson’s disease, with especially dramatic improvements of non-motor symptoms. However, the efficacy of this combination has not been confirmed by randomized controlled trials. The current study was approved by the Hospital Ethics Committee and was registered in the Chinese Clinical Trial Register (registration number: ChiCTR-INR-1701194). From December 2014 to December 2016, 128 patients (72 males and 56 females, mean age of 65.78 ± 6.34 years) with Parkinson’s disease were recruited from the Department of Neurology of Longhua Hospital and Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine in China. Patients were equally allocated into treatment and control groups. In addition to treatment with dopamine, patients in treatment and control groups were given Zishenpingchan granules or placebo, respectively, for 24 weeks. Therapeutic efficacy was assessed using the Unified Parkinson’s Disease Rating Scale,on-off phenomenon, Hoehn-Yahr grade, Scales for Outcomes in Parkinson’s disease–Autonomic, Parkinson’s disease sleep scale, Hamilton Anxiety Scale, Hamilton Depression Scale, Mini-Mental State Examination, and the Parkinson’s Disease Quality of Life Questionnaire.Artificial neural networks were used to determine weights at which to scale these parameters. Our results demonstrated that Zishenpingchan granules significantly reduced the occurrence of motor complications, and were useful for mitigating dyskinesia and non-motor symptoms of Parkinson’s disease. This combination of Chinese and Western medicine has the potential to reduce levodopa dosages, and no obvious side effects were found. These findings indicate that Zishenpingchan granules can mitigate symptoms of Parkinson’s disease,reduce toxic side effects of dopaminergic agents, and exert synergistic and detoxifying effects.

Key words: nerve regeneration, levodopa, motion complications, non-motor symptoms, traditional Chinese medicine treatment, artificial neural networks, Zishenpingchan granules, randomized controlled trials, neurodegenerative diseases, neural regeneration