An Amince da Sabon Binciken Asibiti don Maganin Farko-Mataki na Cutar Parkinson

A matsayin na biyu mafi yawan cututtukan neurodegenerative bayan AD, kodayake pathogenesis na PD ba a san shi ba, an yi imani da cewa cutar tana hade da α-synuclein aggregation, neuroinflammation, oxidative stress, da mitochondrial dysfunction. A cikin 'yan shekarun nan, ƙara yawan shaidun shaida ya nuna cewa gut microbiota yana da alaƙa sosai da abin da ya faru da ci gaban PD.

Kasancewa magungunan AD na farko na duniya wanda ke kaiwa ga gatari-kwakwalwa axis, GV-971 yana rage kumburi na gefe da na tsakiya1 ta hanyar sake daidaita microbiota na gut da kuma hana ma'auni mara kyau na abubuwan da aka samu na gut microbiota. Dangane da irin wannan binciken, ƙungiyar bincike a Cibiyar Nazarin Green Valley ta gudanar da bincike na musamman akan tasirin GV-971 akan PD dangane da tsarin cututtukan cututtukan cututtukan cututtukan neurodegenerative na yau da kullun kuma sun gano cewa miyagun ƙwayoyi yana iya daidaita ƙwayar microbiota dysbiosis, kashe α-synuclein. tarawa a cikin gut da kwakwalwa, rage neuroinflammation, kare kwayoyin cutar dopaminergic, da inganta alamun mota da marasa motsi.

Gwajin gwaji na asibiti na duniya da yawa na lokaci-II zai zama mako 36, cibiyar da yawa, bazuwar, makafi biyu, gwajin sarrafa wuribo, sannan kuma lokacin tsawaita lakabin na mako-mako na 36. Gwajin yana shirin yin rajistar marasa lafiya na 300 tare da matakin farko na PD, kuma za a gudanar da shi a cibiyoyin asibiti na 30 a Arewacin Amurka da yankin Asiya Pacific don kimanta inganci da amincin GV-971 a cikin jiyya na farkon matakin PD.

A ranar 2 ga Nuwamba, 2019, Hukumar Kula da Kayayyakin Kiwon Lafiyar Jama'a ta kasar Sin ta amince da GV-971 don "maganin matsakaicin matsakaicin AD da kuma inganta aikin fahimi", bayan da aka yi saurin bitar maganin. An gudanar da gwajin GV-971 na kashi-III a kasar Sin a asibitocin Tier-34 1 a fadin kasar a cikin marasa lafiya 818 da ke da matsakaicin matsakaicin matsakaicin AD. Sakamako na gwaji na makonni 36 ya nuna cewa GV-971 ya inganta ingantaccen aikin fahimi a cikin marasa lafiya AD masu sauƙi-zuwa-matsakaici, kuma yana da aminci kuma yana jurewa tare da illa mai kama da placebo1.

A cikin Afrilu 2020, aikace-aikacen don gwajin gwaji na asibiti na GV-971 na duniya-mai yawa-tsakiya na duniya ya sami amincewa da FDA ta Amurka. Hukumomin tsaro sun amince da gwajin na duniya daga baya a cikin ƙasashe da yankuna 10, ciki har da Kanada, China, Australia, Faransa, Czech da sauransu. A halin yanzu, an kunna cibiyoyin jinya 154 a cikin waɗannan ƙasashe, tare da bincikar marasa lafiya 949 da marasa lafiya 292 bazuwar. An shirya kammala gwajin nan da shekarar 2025, sannan kuma a shigar da sabbin magunguna a duniya.

Tun lokacin da aka ƙaddamar da shi, an haɗa GV-971 a jere cikin ƙa'idodin asibiti na China don maganin cututtuka. Waɗannan sun haɗa da Sharuɗɗa don Ganewa da Maganin Cutar Alzheimer (2020 Edition)2 wanda Babban Ofishin Hukumar Lafiya ta Ƙasa ya buga wanda ke ba da shawarar GV-971 don kula da matsakaici-zuwa matsakaici AD, Yarjejeniyar Kwararru akan Gudanar da Fahimtar Fahimi Lalacewar 20213, Ƙwararrun Ƙwararru game da Harkokin Gina Jiki don Lafiyar Kwakwalwa a cikin Cutar Alzheimer 4, Jagororin Bincike da Magance Ciwon Hauka (2020) Yin rigakafi da magani tsofaffi da aka buga da al'ummar likitanci na musamman a cikin kungiyar likitocin kasar Sin a cikin Disamba 5, wanda aka ba da shawarar magunguna da matakin-6 don kula da talla. A ranar 2021 ga watan Disamba, 971, a karon farko, an shigar da GV-1 cikin jerin sunayen magunguna na kasar Sin da aka mayar da kudin fansa.

A matsayin cututtukan neurodegenerative, manyan bayyanar cututtuka na PD sun haɗa da rawar jiki na hutawa, bradykinesia, myotonia da tashin hankali na baya, wanda zai iya kasancewa tare da alamun marasa motsi irin su bakin ciki, maƙarƙashiya da rashin barci. Tare, suna yin mummunan tasiri ga ingancin rayuwar marasa lafiya da ayyukan yau da kullun. Alkaluma sun nuna cewa akwai kimanin majinyata PD miliyan 10 a duniya9, ciki har da miliyan 3 a kasar Sin, kuma yawan mutanen da suka wuce shekaru 65 ya kai kashi 1.7% 10. Yayin da karuwar yawan jama'ar duniya ke tsufa, adadin marasa lafiya na PD zai ci gaba da girma.