Maganin Cannabinoid don duk EB zafi da ƙaiƙayi (2024)

Wannan gwaji ya gwada wani mai mai suna Transvamix, wanda ke dauke da tabar wiwi na likitanci, don ganin ko ya rage zafi a EB. Manya takwas (maza da mata sama da shekaru 16) tare da EBS, JEB ko DDEB sun kammala binciken ta hanyar sarrafa mai da kansu a ƙarƙashin harshensu. Ba dole ba ne su dakatar da sauran magungunan zafi da suke sha kuma suna iya ƙara yawan amfani da man a cikin makonni biyu har sai ya taimaka, ko kuma sun lura da illa. Wasu an ba su Transvamix da farko, sannan a canza su zuwa wani mai kama, ƙamshi da ɗanɗano iri ɗaya amma ba ya ƙunshi tabar wiwi (wani placebo). Wasu kuma an fara basu man placebo sannan a canza su zuwa Transvamix. Ba mutanen da ke shiga cikin binciken ba ko masu bincike ba su sani ba, a lokacin, ko suna karɓar Transvamix ko placebo kuma an zaɓi tsari ba tare da izini ba ga kowane mutum (gwajin makafi guda biyu).

Gwajin ya ɗauki makonni bakwai ga kowane mutum, lokacin da suka kammala tambayoyin game da alamun EB kuma sun yi gwajin MRI na kwakwalwar su. Binciken ya ƙare a ƙarshen 2024 kuma ya nuna cewa Transvamix ya ba da wasu fa'idodi. Ya rage ciwon neuropathic, kuma rabin mutanen da ke shan wasu magungunan ciwo sun zaɓi ragewa ko dakatar da shi gaba ɗaya yayin amfani da Transvamix. Duk illolin da aka ruwaito an warware su da kansu ba tare da kulawar likita ko sa baki ba. Za a yi cikakken nazari da buga sakamakon sakamakon.

A cikin Nuwamba 2023, masu bincike sun ba da rahoton cewa har yanzu suna daukar ma'aikata don binciken asibiti. Suna buƙatar aƙalla mutane takwas su shiga domin sakamakon ya kasance mai ma'ana. A cikin mutane bakwai da suka shiga ya zuwa yanzu, fiye da rabin sun kammala binciken. Suna tsammanin yin rajistar mutum na takwas a farkon 2024 kuma za su bincika sakamakon da zarar duk mutane takwas sun kammala binciken.

A cikin Afrilu 2023, masu bincike sun ba da rahoton cewa ɗaukar marasa lafiya don wannan binciken ya fara ne a cikin Maris 2022 amma mutane kaɗan sun dace fiye da yadda ake tsammani saboda binciken MRI da aka shirya. Sun canza shirin su don haka mutanen da ba za su iya yin gwajin MRI ba su iya shiga cikin binciken. Ana sa ran marasa lafiya bakwai za su kammala binciken a ƙarshen Agusta 2023.

Masu bincike sun buga ka'idojin gwaji na asibiti a cikin Disamba 2022 kuma ya sami amsoshi da yawa. Suna ba da shawarar buga irin wannan rubutun ga sauran ƙungiyoyin bincike a cikin filin EB.

Cibiyar ta raba sabuntawa a cikin Maris 2022:

UMCG ta fara bincike game da tasirin man cannabis na magani a cikin marasa lafiya na EB

Farfesa Dr André Wolff shi ne shugaban UMCG Pain Center, kujeru UMCG Pelvic Pain Center kuma yana da sha'awa ta musamman ga sababbin (likita) na ciwo mai tsanani da ke da alaka da kulawa da haƙuri. Ayyukansa ya shafi ainihin ganewar asali na ciwo ta hanyoyi masu banƙyama a cikin marasa lafiya na ciwo mai tsanani da kuma gano ciwon neuropathic. Yana kuma aiki a fagen kimiyyar aiwatarwa da ingancin kulawa.

Dr Marieke Bolling, MD, PhD, ƙwararren likitan fata ne wanda ya ƙware a EB da sauran cututtukan fata da aka gada kuma shine mai kula da lafiya na ƙungiyar EB multidisciplinary a Cibiyar Cututtukan Blisting a Cibiyar Kiwon Lafiya ta Jami'ar Groningen. Ta yi nasarar kare karatun digirinta a cikin 2010 mai taken: Epidermolysis Bullosa Simplex. Kwarewar bincikenta da sa ido za su kasance masu mahimmanci ga ingantaccen tsari, aiwatarwa da kuma kammala wannan aikin.

Dokta José Duipmans, An ƙaddamar da haɓakar kulawa ta hanyar sadarwa ta yau da kullum tare da marasa lafiya da kuma reshen DEBRA NL na gida. Yawancin lokacinta an mayar da hankali kan fahimtar bukatun haƙuri, tsammanin iyali da fahimtar manyan matsalolin da yaran da ke zaune tare da EB suka fahimta. José zai shiga cikin kayan aiki na masu haƙuri na wannan binciken kuma ya ba da muhimmiyar ma'anar tuntuɓar a duk lokacin binciken.

Nicholas Schräder, BSc, yana aiki tare da EB tun daga 2010 kuma ya ɗauki matsayi mai mahimmanci a cikin shirye-shiryen ilimi da suka shafi EB da nazarin ciki har da kwarewa a Jami'ar Sinanci na Hong Kong Prince of Wales Hospital, EB Research Center University of Freiburg Medical Center, Great Ormond Street. Asibitin Yara da Cibiyar Kiwon Lafiya ta Jami'ar Groningen. Tun daga 2012, Nicholas ya shiga cikin bincike na kimiyya don EB a karkashin jagorancin Farfesa Marcel Jonkman, tare da kulawa na musamman ga alamun bayyanar cututtuka da ingancin rayuwa. Haɗu da ƙididdiga marasa ƙima na maganin cannabis-amfani don tarin matsalolin da ke da alaƙa da EB, da aiki a cikin tsarin kiwon lafiya na Dutch tare da kafa cibiyar EB-da yawa, ya sami damar ƙarin bincika yiwuwar tasirin cannabis na likita, ko cannabinoids, ga mutane. fama da EB.

Dr Marcel Jonkman ya rasu a watan Janairu, 2019. Ya shahara saboda sabbin hanyoyinsa na binciken kimiyya da ilimi na EB. Ayyukansa da jagorancinsa sun haifar da fahimtar zurfin fahimtar nau'o'in nau'o'in nau'o'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'in nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i nau'i).

"Labarai, labarun da tambayoyi daga marasa lafiya sun kasance masu mahimmanci ga fahimtarmu a halin yanzu game da jurewar magungunan cannabinoid da aka yi amfani da su don alamun EB… rayuwar majinyatan mu da suka sha wahala."

Sunayen Kyauta:

Tabbatar da ingancin mai tushen sublingual phyto-cannabinoid don maganin ciwo da raɗaɗi (itch) a cikin epidermolysis bullosa.

Binciken bincike mai yiwuwa mai sarrafawa akan cannabinoids don magance ciwo na kullum a cikin epidermolysis bullosa.

Transvamix (10% THC / 5% CBD) don kula da ciwo na kullum a cikin epidermolysis bullosa: Wani bincike na bazuwar, mai sarrafa wuribo da kuma binciken tsaka-tsakin makafi sau biyu.

Mutanen da ke da epidermolysis bullosa (EB) suna fuskantar akai-akai, alamu masu rauni, kamar zafi da ƙaiƙayi. Rahotanni na anecdotal daga marasa lafiya na EB sun ba da shawarar cewa magungunan cannabinoid na tushen (CBMs) suna da tasiri don sarrafa alamun.

Kowane mutum yana da tsarin endocannabinoid na kwayoyin halitta da masu karɓa wanda ke taka rawa a cikin ayyuka daban-daban na jiki, ciki har da alamar ciwo da ƙaiƙayi - sa kwakwalwa ta san waɗannan alamun.

Shaida don yawancin cututtuka masu raɗaɗi da ƙaiƙayi, da kuma abubuwan haƙuri na EB, suna ba da shawarar cewa CBMs, waɗanda aka samar a waje na jiki (kamar shukar Cannabis) sun kai matakan kwatankwacin alamun taimako ga magunguna na yau da kullun. Sau da yawa ana amfani da magani fiye da ɗaya don manufa ɗaya (misali don ciwo, opiates & anti-inflammatory ana amfani da su) wanda zai iya haifar da lahani maras so ko mara amfani. Rahotanni na kwanan nan daga marasa lafiya tare da EB a duk faɗin duniya, dalla-dalla abubuwan da suka samu tare da CBMs, duka wajabta da kuma samun kansu, sun kasance da yawa, kuma suna kira ga binciken kimiyya don tantance aminci da tasiri na CBMs. Ana samun CBMs a cikin ƙasashe masu tasowa, gami da Netherlands, duk da haka EB takamaiman ilimi da jagororin sun rasa.
Sabili da haka, a cikin binciken wannan yuwuwar magani, wannan aikin yana da nufin samun fahimta game da ko zai iya inganta yanayin rayuwa a cikin marasa lafiya tare da EB.

A duniya baki daya, masu bincike a halin yanzu suna duba nau'ikan tsarin CBM da nau'ikan gudanarwa don cututtuka da yawa. A cikin Netherlands, ci gaban da aka samu kwanan nan ya haifar da daidaiton tsire-tsire na cannabis don amfani da lafiyar marasa lafiya na Dutch. Game da zaɓin CBM don wannan binciken, waɗannan "phytocannabinoids" (cannabinoid na tushen shuka) ana fitar da su daga tsire-tsire kuma an haɗa su cikin mai wanda aka gudanar azaman digo a ƙarƙashin harshe (sublingually). Samfurin ƙarshe shine mai siyar da magunguna - darajar CBM, kuma a halin yanzu ana rarrabawa ga marasa lafiya a cikin Netherlands waɗanda suka sami takardar sayan magani daga likitan da suka yi rajista.

Amfani da CBMs na tushen tsire-tsire ba jaraba ta jiki bane, kuma ba a haɗa shi da barazanar rayuwa ko rikitarwa masu rauni ba. Kamar yadda a halin yanzu babu isasshen bayani game da tasirin cannabinoid na dogon lokaci akan tsarin juyayi masu tasowa a cikin yara, wannan binciken kawai ga marasa lafiya sama da shekaru 18 ne. Ƙa'idodin haɗawa da ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙayyadaddun ƙa'idodi za su yi la'akari da yanayin tabin hankali kamar yadda amfani da CBM zai iya shafar waɗannan.

Binciken zai bincika idan ƙarin magani tare da wannan man fetur na sublingual zai iya inganta rayuwar manya tare da EB masu fama da ciwo da / ko ƙaiƙayi. Sakamakon man CBM na iya ɗaukar sa'o'i 4-8 don haka ana buƙatar ɗaukar sau 4 kowace rana don kula da matakan jini. Marasa lafiya za su ba da rahoton zafi, ƙaiƙayi da canje-canje a cikin ingancin rayuwarsu kowane wata sama da watanni 6. Za a auna ingancin rayuwa, zafi da ƙaiƙayi ta hanyar yin amfani da tambayoyin haƙuri ko ma'aunin sakamako da aka ruwaito. Za a yi amfani da adadin waɗannan don gano ma'auni mafi mahimmanci ga canje-canje a cikin marasa lafiya tare da EB.
Ba a buƙatar dakatar da magani na yanzu a matsayin ɗan takara na nazari, a yayin gudanar da bincike, ƙungiyar bincike za ta kula da canjin magani-amfani da kowane majiyyaci (kamar raguwar amfani da opiate), kuma a ƙarshe bincika ko wannan ya dace. tare da amfani da mai na CBM.

An yi la'akari da wannan binciken a matsayin mai yiwuwa, buɗaɗɗen lakabi, hujja na nazarin ra'ayi - gwada sabon magani a cikin ƙananan marasa lafiya, inda kowa da kowa ya ɗauki sabon magani don ganin irin amfanin da za a iya gano. Sabili da haka, a cikin binciken wannan yuwuwar magani, wannan aikin yana da nufin samun fahimta game da ko zai iya inganta yanayin rayuwa a cikin marasa lafiya tare da EB.

Kyawawan gogewa da likitoci da marasa lafiya tare da EB suka raba tare da cannabinoids da aka yi amfani da su azaman magungunan warkewa, sun ba da gudummawa sosai ga fahimtarmu. Wannan binciken zai fara aiwatar da nazarin ilimin kimiyya da waɗannan ƙa'idodi kuma yayi aiki zuwa ka'idar magani da jagororin tushen shaida waɗanda zasu iya canza yanayin rayuwar marasa lafiya na EB. Kamar yadda wannan binciken ya ƙunshi amfani da man CBM da aka sarrafa a cikin sublingually, sakamakon da ƙarshe za su kasance masu dacewa da wannan tsari da tsarin gudanarwa na CBM, kamar yadda sauran nau'o'in tsari da tsarin gudanarwa na jikin ɗan adam ke sarrafa su ta hanyoyi daban-daban.

Binciken bincike mai yiwuwa mai sarrafawa akan cannabinoids don magance ciwo na kullum a cikin epidermolysis bullosa.

Transvamix (10% THC / 5% CBD) don kula da ciwo na kullum a cikin epidermolysis bullosa: Wani bincike na bazuwar, mai sarrafa wuribo da kuma binciken tsaka-tsakin makafi sau biyu.

An kammala aikin shirye-shirye da ka'idoji don gwaji na asibiti. Baya ga amincewar ɗabi'a, an saita dabaru don haɗin gwiwar magunguna, hoton rediyo da fom ɗin rahoton rahoton kan layi (babban bayanai) kuma an yarda dasu. Tun daga 15-03-2022 an fara daukar ma'aikata don shiga. Tsawon lokacin haɗawa shine watanni 6. Rufewar da ake tsammanin ya biyo baya ta hanyar nazarin bayanai shine Q4 2022.

Ƙungiyar binciken ta ci karo da jinkiri mai mahimmanci saboda tsarin tantance da'a. Wannan ya haifar da sake fasalin tsarin gwaji na asibiti yana inganta inganci da ƙarfin binciken - tare da ƙayyadaddun ƙayyadaddun ma'auni na bayanai (fMRI-amfani, sarrafa placebo, ƙirar giciye). Bugu da kari, duk batutuwan da suka shafi cutar ta COVID, da ka'idojin da suka biyo baya, sun ba da ƙarin jinkiri. Kamar yadda aka ambata a sama, sauye-sauyen hanyoyin suna rage nauyin shiga, kuma suna ba da damar tattarawa mai ƙarfi da nazarin sakamako. Tun lokacin da aka amince da fara ayyukan bincike, hankalin kafofin watsa labaru ya karu, DEBRA-UK ana lura da su azaman masu rarraba tallafi. (Daga rahoton ci gaba na 2022).

Gabatarwa

Binciken C4EB ya ƙare a ƙarshen 2024. An ƙaddamar da wannan aikin ta hanyar ƙungiyar binciken mu a Cibiyar Kiwon Lafiya ta Jami'ar Groningen, tare da mai da hankali kan binciken da ke inganta rayuwar yau da kullum. Ƙungiyar ta haɗa da ƙungiyar masana daban-daban: José Duipmans (Mai aikin jinya), Marieke Bolling (Masanin ilimin likitancin fata), André Wolff (Masanin Ciwon Ciwo), Roy Stewart (Kwararren Kwayar cuta), Karin Vermeulen (Mai ilimin hanyoyin magani), Peter Söros (Kwararren likitan Neurologist / Neurophysiologist), da Nicholas Schräder (Likita / PhD Researcher).

Binciken C4EB ya yi niyya don bincika ko magani na tushen cannabinoid, Transvamix (cannabis na magani a cikin nau'in mai da ake amfani da shi a ƙarƙashin harshe), zai iya taimakawa rage jin zafi a cikin marasa lafiya da Epidermolysis Bullosa (EB). Wani kantin magani ne ya shirya maganin binciken kuma ya ƙunshi cannabinoids guda biyu: THC da CBD. A cikin 'yan shekarun nan, bincike ya nuna yiwuwar amfanin cannabinoids don sarrafa ciwo da ƙaiƙayi a cikin yanayi daban-daban, ciki har da EB. Yayin da marasa lafiya sukan bayar da rahoton sakamako masu kyau, yana da mahimmanci don nazarin waɗannan magunguna a ƙarƙashin yanayin sarrafawa don fahimtar yadda suke aiki da yadda suke da tasiri.

Tun da wannan binciken ya ƙunshi magani na likita, an kafa tsauraran sharuɗɗa don wanda zai iya shiga da kuma kimantawa da za su yi. Masu shiga dole ne su zama manya masu shekaru 16 ko tsufa, kuma suna buƙatar jin zafi a matsayin alamar EB a lokacin haɗawa. Binciken ya ɗauki makonni 7 ga kowane ɗan takara, a lokacin da suka sami duka Transvamix da man placebo (wanda ya dubi, wari, da dandana daidai da maganin binciken). Don tabbatar da ingantaccen sakamako, mahalarta ko masu binciken ba su san tsarin da aka ba da Transvamix ko placebo ba.

Mahalarta a hankali sun ƙara yawan adadin su sama da makonni biyu har sai sun sami sauƙi daga alamun su ko kuma sun lura da illa. Baya ga kammala binciken game da ciwo da kuma yadda suka jimre da shi, mahalarta sun kuma yi gwajin MRI. Wadannan binciken sun taimaka wa masu bincike su lura da yadda kwakwalwa ke tafiyar da siginar ciwo, kama da ƙirƙirar "rikodin bidiyo" na ayyukan kwakwalwa. A cikin binciken, an ba da damar mahalarta su ci gaba da maganin ciwo na yau da kullum da kuma daidaita matakan su kamar yadda ake bukata.

results

Jimlar marasa lafiya 9 tare da EB sun shiga cikin binciken. Abin takaici, ɗaya ɗan takara ya fita da wuri, kodayake wannan baya da alaƙa da Transvamix ko placebo. Sauran mahalarta sun wakilci nau'ikan EB iri-iri, gami da EB Simplex, Junctional EB, da Dominant Dystrophic EB.

Babban abin da aka fi mayar da hankali ga binciken shine binciken ciwo wanda ya rarraba ciwo zuwa nau'i hudu. Don uku daga cikin waɗannan nau'o'in-ci gaba da ciwo mai tsanani, ciwo mai tsanani, da kuma ciwo mai raɗaɗi (ma'auni na jin zafi) - babu wani bambanci mai mahimmanci a cikin sauƙi tsakanin placebo da Transvamix. Duk da haka, don ciwon neuropathic (ciwo da ke da alaƙa da rashin aikin jijiya), mahalarta sun ba da rahoton karin taimako lokacin amfani da Transvamix idan aka kwatanta da placebo.

Bugu da ƙari, a cikin mahalarta waɗanda ke shan maganin ciwo a lokacin binciken, rabi sun iya rage yawan adadin su ko dakatar da maganin su gaba ɗaya yayin amfani da Transvamix. Mahimmanci, duka mahalarta da masu bincike sun ba da rahoton duk wani sakamako masu illa (mummunan abubuwan da suka faru) da suka faru a lokacin binciken, ko sun shafi placebo ko Transvamix. Dukkanin illolin da aka ruwaito an yi la'akari da su mai sauƙi ko matsakaici kuma an warware su da kansu, yawanci a cikin 'yan sa'o'i, ba tare da buƙatar kulawar likita ko sa baki ba.

Bayanan da za a sarrafa

Bayanan MRI da aka tattara a lokacin binciken yana buƙatar ƙididdiga masu rikitarwa da cikakken bincike, wanda har yanzu yana gudana. A cikin 'yan makonni masu zuwa, ƙungiyarmu za ta kammala sakamakon da kuma shirya cikakken taƙaitaccen bayani don bugawa a cikin mujallar kimiyya, ba da damar EB da masu bincike na EB a duniya su koyi daga bincikenmu.

karshe

Wannan binciken shine na farko don kimanta amfani da magungunan cannabinoid na tushen don sarrafa ciwo a cikin marasa lafiya tare da EB. Duk da yake ba za a yi la'akari da sakamakon da aka yi ba, suna ba da haske mai mahimmanci. Transvamix, lokacin da aka yi amfani da shi a cikin yanayi mai sarrafawa da aminci, ya nuna yiwuwar amfani ga wasu marasa lafiya tare da EB, musamman a kula da ciwon neuropathic. Ragewar yin amfani da wasu magunguna masu zafi da kuma yanayin yanayi mai laushi na sakamakon da aka ruwaito ya kara tallafawa yiwuwar maganin cannabinoid na tushen jin zafi na EB.

Makasudin gaba

Ta hanyar wannan binciken, muna fatan za mu zaburar da sauran masu bincike da likitoci don yin irin wannan binciken, duka a cikin aikin asibiti da bincike. Kowane mai haƙuri tare da EB na musamman ne, kuma akwai hanyoyi masu ban sha'awa da yawa don bincika jiyya na tushen cannabinoid. Waɗannan sun haɗa da bambance-bambance a cikin cannabinoids (CBD vs. THC), nau'ikan gudanarwa (mai, kirim, tururi), da magance wasu ƙalubalen da marasa lafiya ke fuskanta, irin su ƙaiƙayi, raunuka na yau da kullun, da tabo. Bugu da ƙari, tsarin wannan binciken-ta amfani da ƙaramin rukuni na mahalarta da kuma haɗa wuribo-yana ba da kyakkyawan tsari don bincike na gaba. Ƙungiyarmu a halin yanzu tana aiki akan aikin COSEB (Mahimmin Sakamakon Sakamakon don EB), wanda ke nufin daidaita kayan aiki da ma'auni da aka yi amfani da su a cikin binciken EB. Muna farin cikin amsa duk wata tambaya da za ku iya yi game da wannan binciken. Da fatan za a yi haƙuri da mu yayin da muke shirin buga cikakkun bayanai da wuri-wuri. Da fatan za a duba hanyoyin haɗin gwiwar da ke ƙasa, labaran labarai da ke magana akan aikinmu.

links:

UMCG ta fara binciken kimiyya a cikin man cannabis don ciwo mai tsanani a cikin Epidermolysis Bullosa Nuwamba 2021

Amfanin man cannabis a cikin kula da jin zafi ga marasa lafiya EB

UMCG ta fara bincike game da tasirin man cannabis na magani a cikin marasa lafiya na EB Maris 2022

UMCG ta fara bincike kan maganin cannabis na Epidermolysis Bullosa Maris 2022

UMCG ta fara bincike kan illolin man cannabis na magani Maris 2022

(Daga rahoton ci gaba na ƙarshe na 2024.)