839加蚯蚓蛋白补充剂对帕金森病运动及部分非运动症状的影响：一项随机临床试验
Effect of 839 + earthworm protein supplement on motor and some non-motor symptoms of Parkinson's disease: a randomized clinical trial.
作者信息
Zeng Ting, Lin Chuhui, Deng Yuhong, Zhu Weiwen
机构信息
Department of Clinical Nutrition, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Institute of Neuroscience and Department of Neurology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
出版信息
Front Neurol. 2024 Sep 6;15:1371791. doi: 10.3389/fneur.2024.1371791. eCollection 2024.
INTRODUCTION
Some studies have found that probiotics have the potential to treat PD, and earthworm protein is a traditional Chinese medicine used for the treatment of PD. The purpose of this study was to evaluate the safety and efficacy of 839 (839) + earthworm protein supplement as an adjunctive therapy for PD and to observe changes in the gut microbiota.
METHODS
Forty-six patients with PD were recruited for a 12-week 1:1 randomized, double-blind, placebo-controlled clinical trial to evaluate changes in motor and some non-motor symptom scores and detect metagenomic changes in the gut microbiota.
RESULTS
From baseline to 12 weeks, compared with placebo, the trial group showed significant reductions in the United Parkinson's Disease Rate Scale (UPDRS) total score (-7.74 ± 5.92 vs. -1.83 ± 4.14, < 0.001), UPDRS part I (-0.72 ± 0.81 vs. -0.20 ± 0.72, = 0.026), UPDRS part II (-2.50 ± 2.24 vs. -0.22 ± 1.98, = 0.001), UPDRS part III (-3.43 ± 3.42 vs. -1.33 ± 2.65, = 0.024), and UPDRS part IV (-1.13 ± 1.19 vs. -0.15 ± 0.57, = 0.001). Significant reductions in the Hamilton Depression Scale-24 score (-3.91 ± 3.99 vs. +1.15 ± 3.42, < 0.001), Self-Rating Anxiety Scale scores (-7.04 ± 5.71 vs. -1.23 ± 2.34, < 0.001), and Constipation scoring system scores (-8.59 ± 4.75 vs. 0.27 ± 1.24, < 0.001), were also noted. In the trial group, one patient experienced mild eczema and one suffered low blood pressure, which could not be conclusively attributed to supplementation. Compared to the placebo group, the trial group showed a marked increase in and a decrease in
CONCLUSION
This study is the first to report that probiotics plus earthworm protein can remarkably improve the motor and some non-motor symptoms of PD without serious adverse effects. However, further clinical trials and exploration of the underlying mechanisms are required.
CLINICAL TRIAL REGISTRATION
Clinical trial registry http://www.chictr.org.cn/, Identification No: ChiCTR2000035122.
引言
一些研究发现益生菌有治疗帕金森病（PD）的潜力，而地龙蛋白是一种用于治疗PD的中药。本研究的目的是评估839（839）+地龙蛋白补充剂作为PD辅助治疗的安全性和有效性，并观察肠道微生物群的变化。
方法
招募46例PD患者进行为期12周的1:1随机、双盲、安慰剂对照临床试验，以评估运动和一些非运动症状评分的变化，并检测肠道微生物群的宏基因组变化。
结果
从基线到12周，与安慰剂相比，试验组的统一帕金森病评定量表（UPDRS）总分显著降低（-7.74±5.92对-1.83±4.14，P<0.001），UPDRS第一部分（-0.72±0.81对-0.20±0.72，P=0.026），UPDRS第二部分（-2.50±2.24对-0.22±1.98，P=0.001），UPDRS第三部分（-3.43±3.42对-1.33±2.65，P=0.024），以及UPDRS第四部分（-1.13±1.19对-0.15±0.57，P=0.001）。汉密尔顿抑郁量表-24评分（-3.91±3.99对+1.15±3.42，P<0.001）、自评焦虑量表评分（-7.04±5.71对-1.23±2.34，P<0.001）和便秘评分系统评分（-8.59±4.75对0.27±1.24，P<0.001）也显著降低。在试验组中，1例患者出现轻度湿疹，1例患者出现低血压，不能明确归因于补充剂。与安慰剂组相比，试验组的[此处原文缺失相关内容]显著增加，[此处原文缺失相关内容]减少。
结论
本研究首次报道益生菌加地龙蛋白可显著改善PD的运动和一些非运动症状，且无严重不良反应。然而，需要进一步的临床试验和对潜在机制的探索。
临床试验注册
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