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评估合生元补充剂作为帕金森病辅助治疗的随机对照试验。

Randomized controlled trial evaluating synbiotic supplementation as an adjuvant therapy in the treatment of Parkinson's disease.

作者信息

Ramadan Mohamed E, Mostafa Tarek M, Ghali Azza A, El-Afify Dalia R

机构信息

Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, 31111, Egypt.

Neuropsychiatry Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

出版信息

Inflammopharmacology. 2025 May 28. doi: 10.1007/s10787-025-01752-8.

Abstract

BACKGROUND AND AIM

Neuroinflammatory mechanisms have been closely related to the microbiota-gut-brain axis and could lead to degeneration of dopaminergic neurons with subsequent development and progression of Parkinson's disease (PD). Targeting this pathway for the treatment of PD has sparked a lot of interest. Hence, this study investigates the therapeutic potential of a synbiotic supplement, in conjunction with L-dopa for the management of PD.

METHODS

This randomized controlled trial enrolled 66 Parkinson's disease patients, who were randomly assigned to two groups: a control group (n = 33) receiving standard L-dopa/carbidopa (100/25 mg) therapy three times daily for three months, and a synbiotic group (n = 33) receiving the same L-dopa/carbidopa regimen with two sachets of the synbiotic supplement daily for three months. The outcome measures included assessment of Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and serum levels of tumor necrosis factor-alpha (TNF-α), malondialdehyde (MDA), brain-derived neurotrophic factor (BDNF), and α-synuclein (α-Syn). Blood samples were collected from all patients for biomarker analysis in serum.

RESULTS

Three months after intervention, the synbiotic group demonstrated significantly greater improvement in motor and non-motor symptoms compared to the control group evidenced by the change in the scores of each part of the MDS-UPDRS. Concurrently, the synbiotic group exhibited significantly lower serum levels of pro-inflammatory marker TNF-α and oxidative stress marker MDA, and significantly higher levels of the neuroprotective factor BDNF.

CONCLUSION

Supplementing with synbiotics exhibits promising neuroprotective and therapeutic effects in the treatment of Parkinson's disease patients.

GOV REGISTRATION NUMBER

NCT05576818. Retrospectively registered in October 2022.

摘要

背景与目的

神经炎症机制与微生物-肠道-脑轴密切相关,可导致多巴胺能神经元变性,进而引发帕金森病(PD)的发生与发展。针对该途径治疗PD已引发了广泛关注。因此,本研究探讨了一种合生元补充剂联合左旋多巴治疗PD的潜力。

方法

本随机对照试验纳入了66例帕金森病患者,将其随机分为两组:对照组(n = 33),每天接受3次标准左旋多巴/卡比多巴(100/25 mg)治疗,为期3个月;合生元组(n = 33),接受相同的左旋多巴/卡比多巴治疗方案,同时每天服用两包合生元补充剂,为期3个月。观察指标包括运动障碍协会统一帕金森病评定量表(MDS-UPDRS)评估以及血清肿瘤坏死因子-α(TNF-α)、丙二醛(MDA)、脑源性神经营养因子(BDNF)和α-突触核蛋白(α-Syn)水平检测。采集所有患者的血样进行血清生物标志物分析。

结果

干预3个月后,合生元组在运动和非运动症状方面的改善明显优于对照组,这在MDS-UPDRS各部分得分变化中得到体现。同时,合生元组血清促炎标志物TNF-α和氧化应激标志物MDA水平显著降低,神经保护因子BDNF水平显著升高。

结论

补充合生元在帕金森病患者治疗中显示出有前景的神经保护和治疗作用。

政府注册号

NCT05576818。于2022年10月进行回顾性注册。

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