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用于治疗帕金森病的颗粒剂:一项随机、双盲、安慰剂对照的临床试验。

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

作者信息

Ye Qing, Yuan Xiao-Lei, Yuan Can-Xing, Zhang Hong-Zhi, Yang Xu-Ming

机构信息

Department of Neurology, LONGHUA Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

Department of Neurology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Neural Regen Res. 2018 Jul;13(7):1269-1275. doi: 10.4103/1673-5374.235075.

DOI:10.4103/1673-5374.235075
PMID:30028337
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6065246/
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.

摘要

左旋多巴制剂仍然是帕金森病的首选药物。然而,长期使用左旋多巴可能会导致一系列运动并发症。先前的研究表明,左旋多巴与紫参平颤颗粒(由熟地黄、枸杞子、桑寄生、天麻、僵蚕、莪术、白芍、天南星、全蝎和蜈蚣组成)联合使用可显著改善运动障碍并延缓帕金森病的进展,对非运动症状的改善尤为显著。然而,这种联合用药的疗效尚未得到随机对照试验的证实。本研究经医院伦理委员会批准,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,从中国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(男性72例,女性56例,平均年龄65.78±6.34岁)。患者被平均分为治疗组和对照组。除多巴胺治疗外,治疗组和对照组患者分别给予紫参平颤颗粒或安慰剂,疗程为24周。使用统一帕金森病评定量表、开关现象、Hoehn-Yahr分级、帕金森病自主神经功能结局量表、帕金森病睡眠量表、汉密尔顿焦虑量表(Hamilton Anxiety Scale)、汉密尔顿抑郁量表、简易精神状态检查表和帕金森病生活质量问卷评估治疗效果。使用人工神经网络确定这些参数的加权值。我们的结果表明,紫参平颤颗粒可显著降低运动并发症的发生率,有助于减轻帕金森病的运动障碍和非运动症状。这种中西医结合疗法有可能减少左旋多巴的用量,且未发现明显副作用。这些发现表明,紫参平颤颗粒可减轻帕金森病症状,降低多巴胺能药物的毒副作用,并发挥协同和解毒作用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d70c/6065246/40d2fb2d74a4/NRR-13-1269-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d70c/6065246/6c30772cecba/NRR-13-1269-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d70c/6065246/40d2fb2d74a4/NRR-13-1269-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d70c/6065246/6c30772cecba/NRR-13-1269-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d70c/6065246/40d2fb2d74a4/NRR-13-1269-g004.jpg

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