FDA ta Amince Regorafenib Bi da Ciwon Cancer na rect GIST 丨 HCC
AASraw yana samar da NMN da NRC foda a cikin girma!

Regorafenib

 

  1. Menene Regorafenib?
  2. Me yasa FDA ta Amince da Regorafenib?
  3. Ta yaya Regorafenib yake Aiki?
  4. Menene Babban Amfani da Regorafenib?
  5. Waɗanne Fa'idodin Regorafenib aka nuna a Nazarin?
  6. Waɗanne Haɗari / Illolin da Regorafenib zai Iya Kawo?
  7. Ta yaya zan adana da / ko jefa Regorafenib?
  8. Makomar gaba na Regorafenib
  9. Kammalawa

 

Mene ne Regorafenib?

Regorafenib (CAS: 755037-03-7), wanda aka sayar a ƙarƙashin sunan suna Stivarga da sauransu, na baka ne mai hanawa mai yawa-kinase ci gaba ta hanyar Bayer wacce ke amfani da angiogenic, stromal da oncogenic receptor tyrosine kinase (RTK). Regorafenib yana nuna aikin anti-angiogenic saboda ƙaddararsa ta VEGFR2-TIE2 tyrosine kinase mai hana biyu. Tun shekara ta 2009 aka yi nazarinsa azaman hanyar zaɓin magani a cikin nau'o'in ƙari da yawa. A shekara ta 2015 tana da izinin Amurka biyu don ci gaba da cutar kansa.

 

Me yasa Regorafenib yake Tabbas ta FDA

The Hukumar Kula da Magungunan Turai yanke shawarar cewa fa'idodin Regorafenib sun fi haɗarinsa haɗari kuma sun ba da shawarar cewa a amince da shi don amfani da EU. Kwamitin ya lura cewa a cikin cutar kansar kai tsaye fa'idodi dangane da fadada rayuwar masu haƙuri ba su da kyau, amma sun yi la'akari da cewa sun fi haɗarin da ke tattare da marasa lafiyar wanda ba sauran sauran hanyoyin magance su. Koyaya, idan aka ba da illa, CHMP ta ɗauki mahimmancin neman hanyoyin gano kowane rukuni na marasa lafiya waɗanda za su iya amsa Stivarga.

Game da GIST da HCC, Kwamitin ya lura cewa hangen nesa ba shi da kyau ga marasa lafiya waɗanda cutar ta yi kamari duk da maganin da ya gabata. An nuna Stivarga don jinkirta mummunan cutar a cikin waɗannan marasa lafiya. Ga marasa lafiya tare da HCC, wannan ya haifar da ci gaba a cikin tsawon lokacin da marasa lafiya ke rayuwa. Illolin Stivarga suna iya sarrafawa.

 

Yaya Yaya Regorafenib Aiki? 

Regorafenib wani ɗan ƙaramin ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar ƙwayar cuta da ke tattare da ayyukan salula na yau da kullun kuma a cikin tsarin tafiyar da cututtuka irin su oncogenesis, tumor angiogenesis, da kuma kiyaye ƙwayar ƙwayar ƙwayar cuta. In in vitro biochemical ko salon salula na gwaji, regorafenib ko babban ɗan adam da ke aiki M-2 da M-5 sun hana ayyukan RET, VEGFR1, VEGFR2, VEGFR3, KIT, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, TrkA, Eph2A, RAF-1, BRAF, BRAFV600E, SAPK2, PTK5, da Abl a mahimmancin regorafenib waɗanda aka samu ta hanyar asibiti. A cikin yanayin rayuwa, regorafenib ya nuna aikin anti-angiogenic a cikin ƙirar ƙirar bera, da hana hana ciwace ciwace da kuma aiki na rigakafin metastatic a cikin wasu nau'ikan ƙwayoyin xenograft da yawa waɗanda suka haɗa da wasu don cutar kansa ta mutum.

AASraw shine ƙwararren masanin masana'antar Regorafenib.

Da fatan za a danna nan don bayanin zance: Saduwa da mu

 

Mene ne Regorafenib Babban Amfani Don?

Regorafenib magani ne na ciwon daji wanda ya ƙunshi abu mai aiki regorafenib foda. Ana amfani dashi don kansa don magance cututtukan daji masu zuwa:

Cancer Ciwon kansa (kansar hanji da dubura) wanda ya yadu zuwa wasu sassan jiki;

Or Ciwon ciki na ciwon hanji (GIST, ciwon daji na ciki da hanji) wanda ya bazu ko ba za a iya cire shi ta hanyar tiyata ba;

P Hepatocellular carcinoma (HCC, ciwon daji na hanta).

Ana amfani da Regorafenib a cikin marasa lafiya waɗanda tuni an ba su magani tare da, ko waɗanda ba za a iya ba su ba, sauran magungunan da ake da su. Don cutar kansa ta kai-tsaye, waɗannan sun haɗa da maganin ƙwaƙwalwa bisa ga magunguna da ake kira fluoropyrimidines da magani tare da wasu ciwon daji magunguna da aka sani da anti ‑ VEGF da kuma maganin ‑ EGFR. Marasa lafiya tare da GIST ya kamata su gwada magani tare da imatinib da sunitinib kuma marasa lafiya da HCC ya kamata su gwada sorafenib kafin fara magani tare da Regorafenib.

 

Regorafenib

 

Menene Amfanin Regorafenib an nuna a Nazarin?

 Colorectal ciwon daji

A cikin babban binciken da ya shafi marasa lafiya 760 da ke fama da cutar kansa wanda ya ci gaba bayan ingantaccen magani, an kwatanta Regorafenib da placebo (magani na dumi) kuma babban ma'aunin tasiri shi ne cikakken rayuwa (tsawon lokacin da marasa lafiya suka rayu). Duk marasa lafiya sun sami kulawa na tallafi, gami da magungunan ciwo da kuma maganin cututtuka. Binciken ya nuna cewa Regorafenib ya inganta rayuwa, tare da marasa lafiyar da aka kula da rayuwa tsawon watanni 6.4 a matsakaita, idan aka kwatanta da watanni 5 ga waɗanda aka ba placebo.

 

 GASKIYA(Ci gaban Ciwon astroananan Stromal Tumors)

A wani babban binciken, an kwatanta Regorafenib tare da placebo a cikin marasa lafiya 199 tare da GIST wanda ya bazu ko ba shi da aiki kuma waɗanda kuma aka ba su kyakkyawar kulawa. Taimakon kulawa ya haɗa da jiyya kamar saukaka ciwo, maganin rigakafi, da ƙarin jini wanda ke taimakon mai haƙuri amma ba tare da magance shi ba ciwon daji. Binciken ya nuna cewa Regorafenib tare da kulawa na taimako yana da tasiri wajen tsawan lokacin da marasa lafiya ke rayuwa ba tare da cutar ta tsananta ba. Marasa lafiya da aka yi wa magani tare da Regorafenib sun rayu tsawon watanni na 4.8 ba tare da cutar ta ci gaba da taɓarɓarewa ba idan aka kwatanta da watanni 0.9 don marasa lafiya da ke shan placebo da kulawa mai taimako.

 

 HCC(Cutar Ciwon Cutar Ciwon Cutar Ciwon Hanta)

A cikin wani babban binciken da ya shafi marasa lafiya 573 tare da HCC wanda ya ta'azzara bayan jiyya da sorafenib, Regorafenib an kwatanta shi da placebo kuma babban ma'aunin tasiri shine rayuwa gabaɗaya. Duk marasa lafiya suma sun sami kulawa na goyan baya. Binciken ya nuna cewa Stivarga ya kara tsawon lokacin da marasa lafiya ke rayuwa gaba daya, tare da marasa lafiyar da aka kula da su tare da Regorafenib suna rayuwa tsawon watanni 10.6 a matsakaita, idan aka kwatanta da watanni 7.8 ga wadanda aka ba su placebo.

 

Abin da Risks / Side effects yake yi Regorafenib Iya Kawo?

Ikamuwa da cuta. Regorafenib na iya haifar da haɗarin kamuwa da cututtuka musamman na hanyoyin fitsari, hanci, maƙogwaro da huhu. Regorafenib na iya haifar da haɗarin haɗarin fungal na ƙwayoyin mucous membrane, fata ko jiki. Faɗa wa likitanka nan da nan idan ka kamu da zazzabi, tari mai tsanani tare da ko ba tare da ƙaruwa ba a alƙarya (sputum), ciwon makogwaro mai tsanani, numfashi mai zafi, zafi ko zafi yayin fitsari, fitowar farji ko haushi, jan ido, kumburi ko ciwo a kowane sashin jiki

Szubar jini mai tsanani. Regorafenib na iya haifar da zub da jini, wanda kan iya zama mai tsanani kuma wani lokacin ya kan kai ga mutuwa. Faɗa wa likitanka idan kana da alamun zub da jini yayin shan Regorafenib, gami da: amai jini ko kuma idan amai yana kama da ruwan kofi, fitsari mai ruwan hoda ko ruwan kasa, ja ko baƙi (yana kama da kujerun tar), tari na jini ko ciwan jini, zubar jinin haila wanda ya fi nauyi fiye da al'ada, jinin al'ada na al'ada, jinin jini wanda ke faruwa sau da yawa, rauni, da saurin kai.

A tsagewa a cikin ciki ko bangon hanji (hanjin ciki). Regorafenib na iya haifar da hawaye a cikin ciki ko bangon hanji wanda zai iya zama mai tsanani kuma wani lokacin yakan haifar da mutuwa. Tuntuɓi mai ba da kiwon lafiya kai tsaye idan ka lura da azaba mai tsanani ko kumburi a yankinka (ciki), zazzaɓi, sanyi, tashin zuciya, amai, ko rashin ruwa a jiki.

A matsalar fata da ake kira saurin fatar hannu-ƙafa da kuma tsananin fata. Hannun fata na ƙafa-ƙafa na kowa ne kuma wani lokacin na iya zama mai tsanani. Faɗa wa mai kula da lafiyar ka kai tsaye idan ka sami ja, zafi, kumburi, zub da jini, ko kumburi a tafin hannayenka da tafin ƙafafunka, ko kuma mummunan kumburi.

High hawan jini. Yakamata a duba hawan jininka kowane mako don farkon makonni 6 na fara Regorafenib. Yakamata a duba hawan jininka a kai a kai kuma duk wani hawan jini ya kamata ayi magani yayin karbar Regorafenib. Faɗa wa likitan lafiyar ku idan kuna da matsanancin ciwon kai, rashin haske, ko canje-canje a cikin hangen nesa.

Dfarin jini ya kwarara zuwa zuciya da bugun zuciya. Nemi taimakon gaggawa idan kana fama da ciwon kirji, ko numfashi, ko jin jiri, ko jin kamar wucewa.

A yanayin da ake kira cututtukan cutar leukoencephalopathy na baya (RPLS). Kira likitocin ku nan da nan idan kun sami matsanancin ciwon kai, kamuwa, rikicewa, canji a hangen nesa, ko matsalolin tunani

Risk na matsalolin warkar da rauni. Rauni bazai warke yadda yakamata ba yayin maganin Regorafenib. Faɗa wa mai ba ku kiwon lafiya idan kuna shirin yin wani aikin tiyata kafin farawa ko yayin jiyya tare da Regorafenib.

Ya kamata ku daina shan Regorafenib aƙalla makonni 2 kafin shirin tiyata.

Should Ya kamata likitocin ku su gaya muku lokacin da zaku fara shan Regorafenib bayan tiyata.

Abubuwan da suka fi dacewa tare da Regorafenib sun haɗa da ciwo ciki har da yankin ciki (ciki); gajiya, rauni, kasala; gudawa (yawan yawaitawa ko kwancewar hanji); rage yawan ci; kamuwa da cuta; canjin murya ko rashi; karuwa a cikin wasu gwaje-gwajen aikin hanta; zazzaɓi; kumburi, zafi, da kuma jan layin a bakin, makogwaro, ciki, da hanji (mucositis); da kuma rage kiba.

AASraw shine ƙwararren masanin masana'antar Regorafenib.

Da fatan za a danna nan don bayanin zance: Saduwa da mu

 

Ta yaya zan adana da / ko jefa Regorafenib?

Adana Allunan a cikin akwati na ainihi a zafin ɗakin. Kiyaye murfin sosai. Kar a fitar da kwalin antimoisture ko fakiti.

Jefa duk wani ɓangaren da ba'a yi amfani dashi ba makonni 7 bayan buɗe kwalbar.

♦ Ajiye a wuri bushe. Kada a ajiye a bandaki.

A ajiye dukkan kwayoyi a cikin amintaccen wuri. Kiyaye duk ƙwayoyi daga inda yara da dabbobin gida zasu isa wurin su.

Row Yi watsi da ƙwayoyi marasa amfani ko waɗanda sun ƙare. Kada a zubar da bandaki ko zuba magudanar ruwa sai dai idan aka ce ka yi. Duba tare da likitan ku idan kuna da tambayoyi game da hanya mafi kyau don fitar da kwayoyi. Zai yiwu a sami shirye-shiryen dawo da miyagun ƙwayoyi a yankinku.

 

Regorafenib

 

Bayanan gaba of Regorafenib

Shekaru biyar bayan amincewarsa, regorafenib ya kasance magani tare da iyakantaccen kulawar asibiti. Amincewa da amfani a cikin sankarar launi, GIST da HCC ne kawai don ci gaban cututtukan metastatic. Haɗe tare da tsada mai tsada, a halin yanzu akwai ƙaramar fa'ida ga marasa lafiya. Bugu da ƙari, ana gudanar da gwaji daban-daban don ayyana shi azaman sabon zaɓi na jiyya. Hanyoyi na gaba don wannan magani sun haɗa da gudanar da osteosarcoma. Wani gwajin wuribo na baya-bayan nan, gwajin makafi guda biyu a Faransa ya nuna karuwar rashin cigaban ci gaba ta hanyar kashi 3 a cikin marasa lafiya masu fama da cutar osteosarcoma wanda ya gaza kowane layi na magani. Comparfafawa, waɗannan sabbin bayanan suna nuna fa'ida akan cututtukan cututtukan ƙwayoyin cuta azaman makoma ta ƙarshe, daidai da duk amfanin da aka yarda dashi yanzu.

Bayanai na baya-bayan nan sun nuna yiwuwar aiki tare tsakanin regorafenib da masu hana kariya, kamar yadda aka nuna a gwajin REGONIVO. Wani gwaji na lokaci daya na kwatanta regorafenib da haɗuwarsa tare da nivolumab a cikin marasa lafiya masu fama da ciwon daji na ciki ko ciwan kansa, ya nuna kashi 38% na amsar da aka ba mutum (44% a cikin ciwon daji na ciki da 36% a cikin cutar kansa) da kuma bayanin haɗin sakamako mai haƙuri a cikin ƙungiyar haɗin gwiwa. Wannan fa'idar mai ban sha'awa na iya zama saboda raguwar macrophages masu alaƙa da regorafenib, yana ƙaruwa da ƙwarewar tumour ga nivolumab. A halin yanzu, gwajin REGONIVO phase II yana kan hanya kuma nan bada jimawa ba zai iya tabbatar da wannan tunanin. Bugu da ƙari, wani lokaci na ƙarshe na gwaji na asibiti na biyu ya nuna cewa regorafenib ya fi na lomustine a cikin ci gaba da sake komawa glioblastoma. Gwajin REGOMA, a Italiya, ya nuna babban ci gaba a cikin rayuwa gabaɗaya (ƙimar haɗari 0.50; 95% tazarar tazarar 0.33-0.75; matsayi-matsayi p = 0.0009) idan aka kwatanta da maganin lomustine.

An gudanar da karatun REVERSE tare da regorafenib da cetuximab a cikin maganin cututtukan cututtukan cikin gida. Sakamakon da aka samo akan jerin amfani da irin waɗannan kwayoyi wajen maganin wannan cutar kansa yana nuna cewa tsari mafi kyau shine farkon tsarin regorafenib wanda cetuximab zai biyo baya, wanda yasha banbanta da ƙa'idar yarjejeniya da ake amfani dashi yanzu. Sakamakon ya nuna ingantaccen rayuwar marasa lafiya kuma fa'idar kamar ana tura ta galibi ta babban aikin cetuximab fiye da regorafenib azaman magani na biyu.

GASKIYA gwaji na regorafenib monotherapy a cikin ciwon daji na ciki ya nuna cewa wannan maganin yana da juriya da kyau kuma babu lalacewar yanayin rayuwar marasa lafiya idan aka kwatanta da waɗanda suka karɓi placebo kuma hakan bai bayyana yana da mummunar tasiri akan waɗannan sigogin daga yawan guba. Ayyukan bincike sun nuna cewa matakan farko na ciwo, ci abinci, maƙarƙashiya, da kuma aiki na jiki an gano su ne manyan mahimman abubuwan hangen nesa don rayuwa. Har ila yau, wannan gwajin ya nuna cewa regorafenib yana da aiki mai mahimmanci a cikin ƙarshen rayuwar rashin ci gaba na gaba. Bugu da ƙari, lokaci na II An gudanar da gwajin REDOS daga 2015-2018 kuma marubuta sun nuna cewa dabarun haɓaka kashi don regorafenib shine madaidaicin madadin zuwa daidaitaccen tsarin dogo na regorafenib na 160 mg / day, musamman ma marasa lafiya da ke fama da cutar kansa. Haka kuma an gano cewa marasa lafiya da aka bi da su tare da haɓaka kashi suna da maɗaukakiyar ƙarfin ci gaba bayan ci gaba da kuma yawan rayuwa gabaɗaya.

Game da haƙuri na regorafenib lokacin da ake aiki don magance cutar kansa, ana samun iyakantattun bayanai kan haƙuri a cikin tsofaffin masu haƙuri, kuma dole ne a yanke shawara idan aka yi la’akari da ƙarancin amfanin rayuwa da kuma bayanin cutar mai guba. La'akari da wannan magani a cikin maganin HCC, ayyukan bincike sun nanata cewa akwai bayanin yarda da haƙuri kuma regorafenib yana samar da fa'idar rayuwa. GIST magani, marubuta da yawa sun bayyana cewa an sake jure wa regorafenib ba tare da wani haɗari mai haɗari ba.

Ana buƙatar ci gaba da bincike don sanin ko waɗanne marasa lafiya ne za su iya cin riba sosai daga wannan magani. Kamar na 2019, gwaje-gwaje masu gudana suna gwada ko regorafenib na iya inganta sakamako a cikin sarcomas mai taushi, kamar su osteogenic sarcoma, liposarcoma, Ewing sarcoma da rhabdomyosarcoma.

 

Kammalawa

Duk da amincewa da shekaru 5 da kuma ingancin magani mai inganci, regorafenib ya nuna iyakance, amma yana da mahimmancin lissafi, fa'idodi ga nau'o'in ciwace-ciwace masu ƙarfi. Alamomin da aka yiwa lakabi sun haɗa da cutar kansa, GIST da HCC. Gwajin zamani na II na yau da kullun ya nuna ingantaccen ci gaba a rayuwa don ciwon daji na ciki, glioblastoma da osteosarcoma, wanda na iya nuna shigar gaba a cikin alamun alamun.

Magungunan haɗin haɗin gwiwa tare da masu hana kariya daga abubuwan bincike an nuna su a matsayin masu fa'ida a cikin gwaji na I, kuma ana yin gwajin lokaci na II. A halin yanzu, ana sake binciken regorafenib don sauran cututtukan kansa. Za'a iya amfani da yawancin tasirin mutum ɗaya azaman alamomi don kyakkyawan sakamako tare da magani. Daga cikin waɗannan, cututtukan ƙafa-ƙafa da hypothyroidism sune mafi alaƙa da ingantaccen rayuwa. A taƙaice, nazarin ya nuna cewa regorafenib na iya haɓaka rayuwa da mahimmanci tare da karɓar haƙuri cikin nau'ikan ciwace-ciwace masu ƙarfi.

AASraw shine ƙwararren masanin masana'antar Regorafenib.

Da fatan za a danna nan don bayanin zance: Saduwa da mu

 

reference

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[4] Shinkai A, Ito M, Anazawa H, et al. Taswirar shafukan da ke cikin haɗin ligand da rarrabuwa a cikin ƙananan yankuna na kinase saka mai karɓar yankin wanda ke dauke da mai karɓa don haɓakar haɓakar ƙarancin jijiyoyin jini. J Biol Chem. 1998; 273: 31283-8.

[5] Fuh G, Li B, Crowley C, kuma al. Abubuwan buƙatu don ɗaure da siginar mai karɓar yankin kinase don haɓakar haɓakar ƙarancin jijiyoyin jini. J Biol Chem. 1998; 273: 11197–204.

[6] Eriksson A, Cao R, Roy J, et al. Proteinaramin haɗin GTP mai ɗaure Rac shine mahimmin matsakanci game da haɓakar haɓakar ƙarancin jijiyoyin jiki-haifar da fushin endothelial da haɓakar jijiyoyin jini. Kewaya. 2003; 107: 1532-8.

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[9] Bruix J, Qin S, Merle P, et al. Regorafenib ga marasa lafiya da ke fama da cutar sankarar hanta wanda ya ci gaba kan maganin sorafenib (RESORCE): bazuwar, makafi biyu, mai sarrafa wuribo, gwajin lokaci na 3. Lancet. 2017; 389: 56-66.

[10] Martin AJ, Gibbs E, Sjoquist K, da sauransu. Ingancin rayuwar da ke da alaƙa da kiwon lafiya tare da maganin regorafenib a cikin ƙarancin ci gaban adenocarcinoma na ciki. Ciwon Cikin Ciki. 2018; 21: 473-80.

[11] Heo YA, Syed YY. Regorafenib: nazari a cikin cututtukan hanta na hanta. Kwayoyi. 2018; 78: 951-8.

[12] Yin X, Yin Y, Shen C, Chen H, Wang J, Cai Z, et al. Rashin haɗarin abubuwan haɗari da ke haɗuwa da regorafenib wajen kula da ciwan ciwan ci gaba mai ƙarfi: meta-bincike na gwajin gwaji da bazuwar. Onco Targets Ther. 2018; 11: 6405-14.

[13] Lombardi G, De Salvo GL, Brandes AA, et al. Regorafenib idan aka kwatanta da lomustine a cikin marasa lafiya tare da sake dawo da cutar glioblastoma (REGOMA): multicentrere, lakabin buɗewa, bazuwar, sarrafawa, gwajin 2 lokaci. Lancet Oncol. 2019; 20: 110–9.

[14] Bekaii-Saab T. Duba mafi kyau a regorafenib. Clin Adv Hematol Oncol. 2018; 16: 667-9.

[15] Yoshino K, Manaka D, Kudo R, et al. Metastatic colorectal cancer mai amsa regorafenib na shekaru 2: rahoton harka. J Med Case Rep. 2017; 11: 227.

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