麝香草与常规左旋多巴治疗帕金森病的比较疗效:一项来自亚洲的药代动力学和临床观点的随机对照试验

IF 3.2 4区 医学 Q2 CLINICAL NEUROLOGY
Thanatat Boonmongkol, Onanong Phokaewvarangkul, Sornkanok Vimolmangkang, Thitima Wattanavijitkul, Virunya Komenkul, Roongroj Bhidayasiri
{"title":"麝香草与常规左旋多巴治疗帕金森病的比较疗效:一项来自亚洲的药代动力学和临床观点的随机对照试验","authors":"Thanatat Boonmongkol, Onanong Phokaewvarangkul, Sornkanok Vimolmangkang, Thitima Wattanavijitkul, Virunya Komenkul, Roongroj Bhidayasiri","doi":"10.1007/s00702-025-02914-2","DOIUrl":null,"url":null,"abstract":"<p><p>Levodopa remains central to Parkinson's disease (PD) treatment, but long-term use can cause motor complications, highlighting the need for additional therapies. Mucuna pruriens (MP), a natural source of levodopa, shows potential in managing these complications. Further research is needed to compare its pharmacokinetics (PK) and clinical outcomes with traditional levodopa formulations. This randomised, single-blind, crossover trial compared the PK, clinical outcomes, and safety of MP powder against levodopa/benserazide dispersible tablets (Levodopa DT) in PD patients with motor complications. Twelve participants were recruited to receive either 30 g of MP powder or two 100/25 levodopa DT in separate sessions with a two-week washout between sessions. Key PK parameters (AUC, Cmax, Tmax, and t<sub>½</sub>) were measured. Clinical assessments used standard rating scales and adverse events were recorded. Data from 11 participants were analysed after one withdrawal. MP powder demonstrated significantly higher overall drug exposure, with a geometric mean AUC<sub>0-∞</sub> of 12,424.81 compared to 7981.69 ng·h/mL for levodopa DT. The geometric mean ratio was 155.67% (90% CI 134.59-180.04), exceeding the bioequivalence acceptance range of 80-125%. However, the two treatments exhibited similar Tmax and t₁/₂ values, indicating comparable rates of absorption and elimination. Clinically, MP provided a longer ON state without dyskinesia-232.2 min versus 161.8 min for levodopa DT (p = 0.01). Mild and transient adverse events, such as nausea and dizziness, were more frequently associated with MP. MP offers superior drug exposure and extends the ON state without increasing dyskinesia, positioning it as a promising alternative to synthetic levodopa for managing motor symptoms. These findings support MP's potential role in alleviating motor complications in PD treatment.</p>","PeriodicalId":16579,"journal":{"name":"Journal of Neural Transmission","volume":" ","pages":""},"PeriodicalIF":3.2000,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative efficacy of Mucuna pruriens and conventional levodopa in Parkinson's disease: a randomized controlled trial on pharmacokinetics and clinical perspectives from Asia.\",\"authors\":\"Thanatat Boonmongkol, Onanong Phokaewvarangkul, Sornkanok Vimolmangkang, Thitima Wattanavijitkul, Virunya Komenkul, Roongroj Bhidayasiri\",\"doi\":\"10.1007/s00702-025-02914-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Levodopa remains central to Parkinson's disease (PD) treatment, but long-term use can cause motor complications, highlighting the need for additional therapies. Mucuna pruriens (MP), a natural source of levodopa, shows potential in managing these complications. Further research is needed to compare its pharmacokinetics (PK) and clinical outcomes with traditional levodopa formulations. This randomised, single-blind, crossover trial compared the PK, clinical outcomes, and safety of MP powder against levodopa/benserazide dispersible tablets (Levodopa DT) in PD patients with motor complications. Twelve participants were recruited to receive either 30 g of MP powder or two 100/25 levodopa DT in separate sessions with a two-week washout between sessions. Key PK parameters (AUC, Cmax, Tmax, and t<sub>½</sub>) were measured. Clinical assessments used standard rating scales and adverse events were recorded. Data from 11 participants were analysed after one withdrawal. MP powder demonstrated significantly higher overall drug exposure, with a geometric mean AUC<sub>0-∞</sub> of 12,424.81 compared to 7981.69 ng·h/mL for levodopa DT. The geometric mean ratio was 155.67% (90% CI 134.59-180.04), exceeding the bioequivalence acceptance range of 80-125%. However, the two treatments exhibited similar Tmax and t₁/₂ values, indicating comparable rates of absorption and elimination. Clinically, MP provided a longer ON state without dyskinesia-232.2 min versus 161.8 min for levodopa DT (p = 0.01). Mild and transient adverse events, such as nausea and dizziness, were more frequently associated with MP. MP offers superior drug exposure and extends the ON state without increasing dyskinesia, positioning it as a promising alternative to synthetic levodopa for managing motor symptoms. These findings support MP's potential role in alleviating motor complications in PD treatment.</p>\",\"PeriodicalId\":16579,\"journal\":{\"name\":\"Journal of Neural Transmission\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.2000,\"publicationDate\":\"2025-03-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Neural Transmission\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00702-025-02914-2\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Neural Transmission","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00702-025-02914-2","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0

摘要

左旋多巴仍然是帕金森病(PD)治疗的核心,但长期使用可引起运动并发症,强调需要额外的治疗。左旋多巴的天然来源——麻豆(Mucuna pruriens, MP)在治疗这些并发症方面显示出潜力。需要进一步的研究来比较其药代动力学(PK)和临床结果与传统左旋多巴制剂。这项随机、单盲、交叉试验比较了MP粉末与左旋多巴/苯塞拉肼分散片(左旋多巴DT)在PD运动并发症患者中的PK、临床结果和安全性。12名参与者分别接受30克MP粉末或两次100/25左旋多巴DT治疗,两次治疗之间有两周的洗脱期。测定关键PK参数(AUC、Cmax、Tmax和t1 / 2)。临床评估采用标准评定量表,并记录不良事件。11名参与者的数据在一次戒毒后被分析。MP粉末显示出更高的整体药物暴露,几何平均AUC0-∞为12,424.81,而左旋多巴DT为7981.69 ng·h/mL。几何平均比值为155.67% (90% CI 134.59 ~ 180.04),超过80 ~ 125%的生物等效性接受范围。然而,两种处理表现出相似的Tmax和t 1 / 2值,表明相似的吸收和消除率。临床上,MP提供更长的国家没有运动障碍- 232.2分和161.8分左旋多巴DT (p = 0.01)。轻度和短暂的不良事件,如恶心和头晕,更常与MP相关。MP提供了优越的药物暴露,延长了ON状态,而不会增加运动障碍,将其定位为一种有希望的替代合成左旋多巴来控制运动症状。这些发现支持MP在PD治疗中减轻运动并发症的潜在作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Comparative efficacy of Mucuna pruriens and conventional levodopa in Parkinson's disease: a randomized controlled trial on pharmacokinetics and clinical perspectives from Asia.

Levodopa remains central to Parkinson's disease (PD) treatment, but long-term use can cause motor complications, highlighting the need for additional therapies. Mucuna pruriens (MP), a natural source of levodopa, shows potential in managing these complications. Further research is needed to compare its pharmacokinetics (PK) and clinical outcomes with traditional levodopa formulations. This randomised, single-blind, crossover trial compared the PK, clinical outcomes, and safety of MP powder against levodopa/benserazide dispersible tablets (Levodopa DT) in PD patients with motor complications. Twelve participants were recruited to receive either 30 g of MP powder or two 100/25 levodopa DT in separate sessions with a two-week washout between sessions. Key PK parameters (AUC, Cmax, Tmax, and t½) were measured. Clinical assessments used standard rating scales and adverse events were recorded. Data from 11 participants were analysed after one withdrawal. MP powder demonstrated significantly higher overall drug exposure, with a geometric mean AUC0-∞ of 12,424.81 compared to 7981.69 ng·h/mL for levodopa DT. The geometric mean ratio was 155.67% (90% CI 134.59-180.04), exceeding the bioequivalence acceptance range of 80-125%. However, the two treatments exhibited similar Tmax and t₁/₂ values, indicating comparable rates of absorption and elimination. Clinically, MP provided a longer ON state without dyskinesia-232.2 min versus 161.8 min for levodopa DT (p = 0.01). Mild and transient adverse events, such as nausea and dizziness, were more frequently associated with MP. MP offers superior drug exposure and extends the ON state without increasing dyskinesia, positioning it as a promising alternative to synthetic levodopa for managing motor symptoms. These findings support MP's potential role in alleviating motor complications in PD treatment.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Journal of Neural Transmission
Journal of Neural Transmission 医学-临床神经学
CiteScore
7.20
自引率
3.00%
发文量
112
审稿时长
2 months
期刊介绍: The investigation of basic mechanisms involved in the pathogenesis of neurological and psychiatric disorders has undoubtedly deepened our knowledge of these types of disorders. The impact of basic neurosciences on the understanding of the pathophysiology of the brain will further increase due to important developments such as the emergence of more specific psychoactive compounds and new technologies. The Journal of Neural Transmission aims to establish an interface between basic sciences and clinical neurology and psychiatry. It intends to put a special emphasis on translational publications of the newest developments in the field from all disciplines of the neural sciences that relate to a better understanding and treatment of neurological and psychiatric disorders.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信