Uphenyo Olusha Lomtholampilo Lugunyazwe Ukwelashwa Kwesifo I-Parkinson's Early-Stage

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NgoJanuwari 13, 2022, iGreen Valley (Shanghai) Pharmaceuticals Co., Ltd. yathola incwadi evela kwa-US Food and Drug Administration (FDA) mayelana nesicelo se-Investigational New Drug (IND) sohlolo lomtholampilo lwe-multi-center phase-II global ye-Oligomannate (imakethwa njenge-“GV-971”), umuthi omusha wenkampani wokwelapha isifo i-Alzheimer's (AD). Incwadi ibonise ukuthi “Ucwaningo Lungase Luqhubeke” ngophenyo lomtholampilo oluhlongozwayo ekwelapheni iziguli ezinesifo i-Parkinson’s (PD) esakhula. Idethi yokuqala yokusebenza kwe-IND nguDisemba 16, 2021.

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Njengesifo sesibili esivamile se-neurodeergenerative ngemva kwe-AD, nakuba i-pathogenesis ye-PD ingaziwa kahle, ngokuvamile kukholelwa ukuthi lesi sifo sihlotshaniswa ne-α-synuclein aggregation, neuroinflammation, ukucindezeleka kwe-oxidative, kanye nokungasebenzi kahle kwe-mitochondrial. Eminyakeni yamuva nje, indikimba yobufakazi eyandayo ikhombisile ukuthi i-gut microbiota ihlotshaniswa kakhulu nokuvela nokuthuthuka kwe-PD.

Njengoba iwumuthi wokuqala emhlabeni we-AD oqondise i-axis yobuchopho, i-GV-971 yehlisa ukuvuvukala kwe-peripheral kanye nemaphakathi1 ngokulungisa kabusha i-gut microbiota futhi ivimbele ibhalansi engavamile yama-metabolites atholakala emathunjini. Ngokusekelwe kulokho okutholakele, ithimba labacwaningi e-Green Valley Research Institute lenze ucwaningo lwangaphambili ngomphumela we-GV-971 ku-PD ngokusekelwe endleleni evamile ye-pathological yezifo ze-neurodeergenerative futhi lathola ukuthi umuthi uyakwazi ukulawula i-gut microbiota dysbiosis, ukucindezela i-α-synuclein. ukuhlanganisa kokubili emathunjini nasebuchosheni, kunciphisa i-neuroinflammation, kuvikela ama-neurons e-dopaminergic, futhi kuthuthukise izimpawu zezimoto nezingezona izimoto.

Isivivinyo somtholampilo se-multicenter phase-II somhlaba wonke sizoba amaviki angu-36, okumaphakathi, okungahleliwe, okungaboni kabili, okulawulwa yi-placebo, okulandelwa isikhathi sokunwetshwa kwamalebula avuliwe angama-36. Isivivinyo sihlela ukubhalisa iziguli ze-300 ezine-PD yesigaba sokuqala, futhi sizoqhutshwa ezikhungweni zemitholampilo ze-30 eNyakatho Melika nase-Asia Pacific esifundeni ukuze kuhlolwe ukusebenza nokuphepha kwe-GV-971 ekwelapheni kwe-PD yasekuqaleni.

Ngomhla zi-2 kuNovemba, 2019, Ukuphathwa Kwemikhiqizo Yezokwelapha yase-China kugunyaze i-GV-971 “yokwelashwa kwe-AD emaphakathi kuya kokulingene kanye nokuthuthukisa ukusebenza kwengqondo”, ngemva kokubuyekezwa ngokushesha komuthi. Ukuhlolwa kwesigaba-III se-GV-971 e-China kwenziwa ezibhedlela ze-34 Tier-1 ezweni lonke ezigulini ezingama-818 ezine-AD emaphakathi kuya kokulingene. Imiphumela yocwaningo lwamasonto angu-36 yabonisa ukuthi i-GV-971 yayithuthukise kakhulu ukusebenza kwengqondo ezigulini ze-AD ezimaphakathi kuya kokulingene, futhi yayiphephile futhi ibekezelelwa kahle ngemiphumela engemihle eqhathaniswa ne-placebo1.

Ngo-April 2020, isicelo sohlolo lomtholampilo lwe-multi-center phase-III global lwe-GV-971 sagunyazwa yi-US FDA. Isilingo somhlaba wonke siye sagunyazwa ama-ejensi alawulayo emazweni nasezifundeni ezingu-10, okuhlanganisa , i-Canada, i-China, i-Australia, i-France, i-Czech nezinye. Njengamanje, izikhungo zemitholampilo eziyi-154 kulawa mazwe sezike zasebenza, kwathi iziguli ezingama-949 zahlolwa kwathi ezingama-292 zahlolwa ngokungahleliwe. Ukuqulwa kwecala kuhlelelwe ukuthi kuqedwe ngo-2025, okulandelwa ukuthunyelwa komhlaba wonke kokufakwa kwezidakamizwa ezintsha.

Selokhu yethulwa, i-GV-971 ifakwe ngokulandelana eziqondisweni zomtholampilo zaseShayina zokwelashwa kwezifo. Lokhu kufaka Imihlahlandlela Yokuxilonga Nokwelashwa Kwesifo i-Alzheimer (Ushicilelo luka-2020)2 eshicilelwe yi-National Health Commission General office encoma i-GV-971 yokwelashwa kwe-AD emaphakathi kuya kokulingene, Ukuvumelana Kochwepheshe Ngokuphathwa Kwengqondo Ye-Post-Stroke I-Impairment 20213, I-Expert Consensus on the Nutritional Intervention for Brain Health in Alzheimer's Disease4, Izinkombandlela Zokuxilonga Nokwelashwa Kwezifo Zengqondo (Ushicilelo Lwango-2020)5, Iphepha Elimhlophe Lokwakhiwa Okujwayelekile Kwezikhungo Zokuxilonga Nokwelashwa Kwezinkinga Zokucabanga6, kanye Nemihlahlandlela yaseShayina ye I-Prevention and Treatment of Elderly Dementia eyanyatheliswa yi-Chinese Society of Neurology ngaphansi kwe-Chinese Medical Association ngoDisemba 2021, eklelisa i-GV-971 njengomuthi onconyiwe we-Class-A onobufakazi be-Level-1 bokwelapha i-AD. Ngomhla zi-3 kuZibandlela 2021, i-GV-971 yafakwa ngokusemthethweni ohlwini lwezidakamizwa lwase-China Lwembuyiselo okokuqala ngqa.

Njengesifo se-neurodeergenerative, ukubonakaliswa komtholampilo okuyinhloko kwe-PD kuhlanganisa ukuthuthumela kokuphumula, i-bradykinesia, i-myotonia kanye nokuphazamiseka kwe-postural gait, okungase kuhambisane nezimpawu ezingezona izimoto ezifana nokucindezeleka, ukuqunjelwa kanye nokuphazamiseka kokulala. Ndawonye, ​​anomthelela omubi kwikhwalithi yempilo yeziguli kanye nokusebenza kwansuku zonke. Izibalo zibonisa ukuthi kuneziguli ze-PD ezibalelwa ezigidini eziyi-10 emhlabeni9, okuhlanganisa nezigidi ezi-3 eShayina, futhi izinga lokusabalala kwabantu abangaphezu kweminyaka engama-65 ubudala lingu-1.7%10. Ngenkathi inani labantu emhlabeni wonke elikhulayo likhula, inani leziguli ze-PD lizoqhubeka nokukhula.

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Umhleli omkhulu we-eTurboNew nguLinda Hohnholz. Uzinze e-eTN HQ e-Honolulu, e-Hawaii.

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  • Ngiwubufakazi obuphilayo bokuthi ungelapheka ku-Alzheimer's Disease. Kwatholakala ukuthi ngine-Alzheimer's Disease. Ngaba nenyumoniya ngoMashi ka-2020, eyaqala njengomkhuhlane yase iba yinyumoniya. Cishe ngemva kwezinsuku eziyi-10 ngazizwa ngikahle, kodwa ukuphefumula kwami ​​kwakuhlukile, kunzima ukukuchaza, kodwa kwaba sengathi othile ushintshe isisefo esiphuma emaphashini ami. Ngelashwa ngokwemvelo ngokusetshenziswa kwe( World Rehabilitate Clinic, esikhathini esingamaviki angu-3, ​​ngase ngilulama. Ngo-2021 ngaqala ukubonana noDkt Gomez Sims, onguchwepheshe bezokwelapha zangaphakathi namaphaphu ( worldrehabilitateclinic. com).

  • Umyeni wami kwatholakala ukuthi unesifo sikaParkinson esisheshe saqala eneminyaka engu-67. Izimpawu zakhe kwakuwukunyakazisa izinyawo, ukukhuluma kabi, ukukhuluma ngezwi eliphansi, ukonakala kokubhala ngesandla, amakhono okushayela asabekayo, futhi ingalo yakhe yesokudla ibambe i-engeli engu-45 degree. Wafakwa ku-Sinemet izinyanga ezingu-7 kwase kwethulwa iSifrol ne-rotigotine eyathatha indawo ye-Sinemet kodwa kwadingeka ayeke ngenxa yemiphumela emibi. Sizame wonke amashothi atholakalayo kodwa lutho ukusebenza. Kube khona inqubekelaphambili encane uma ikhona ekutholeni ukwelashwa okuthembekile, ngiyekile imithi yami ngenxa yemiphumela engemihle. Umhlinzeki wethu wokunakekelwa usethule eKycuyu Health Clinic Parkinson yokwelashwa ngamakhambi. Impatho iyisimangaliso. Umyeni wami useluleme kakhulu! Vakashela i-kycuyuhealthclinic. co m

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