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Gwaji na Hadin Kai

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Gwaji na Hadin Kai
inquiry (en) Fassara da clinical trial (en) Fassara
Bayanai
Laƙabi Public health emergency SOLIDARITY trial of treatments for COVID-19 infection in hospitalized patients
Muhimmin darasi SARS-CoV-2 (mul) Fassara da Koronavirus 2019
Mawallafi Ana Maria Henao-Restrepo (en) Fassara
Sunan mawallafi Vasee Moorthy da Marie-Pierre Preziosi
Ranar wallafa 25 ga Maris, 2020
Tashin lafiyar soja

Gwajin Solidarity don jiyya gwaji ne na asibiti na ƙasa da ƙasa na Mataki na III-IV wanda Hukumar Lafiya ta Duniya (WHO) da abokan haɗin gwiwa suka shirya don kwatanta jiyya huɗu waɗanda ba a gwada su ba ga mutanen da ke asibiti masu fama da cutar COVID-19.[1][2] An sanar da gwajin a ranar 18 ga Maris 2020,[1] kuma har zuwa 6 ga Agusta 2021, an dauki marasa lafiya 12,000 a cikin kasashe 30 don shiga gwajin.[3]

A watan Mayu, WHO ta ba da sanarwar hadin gwiwar kasa da kasa don samar da alluran rigakafin 'yan takara da yawa a lokaci guda don hana cutar COVID-19, tana mai kiran wannan kokarin gwajin hadin kai na alluran rigakafi .[4]

Magungunan da ake binciken sune remdesivir, lopinavir/ritonavir hade, lopinavir/ritonavir hade da interferon-beta, da hydroxychloroquine ko chloroquine . An dakatar da binciken Hydroxychloroquine ko chloroquine a watan Yuni 2020 saboda yanke shawarar cewa bai bayar da wata fa'ida ba.

Gwajin hadin kai don masu neman magani

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Gwajin yana da niyyar tantance dubunnan mutanen da suka kamu da cutar ta COVID-19 cikin hanzari don yuwuwar ingancin magungunan rigakafin da ba a tantance ba tukuna musamman don cutar COVID-19, wani tsari da ake kira "sakewa" ko "sakewa" magani da aka rigaya ya amince da shi. ga wata cuta daban.[2][5]

An tsara aikin Solidarity don ba da saurin fahimta ga mahimman tambayoyin asibiti:[2][5]

  • Shin ɗayan magungunan yana rage mace-mace?
  • Shin ɗayan magungunan yana rage lokacin da majiyyaci ke kwance a asibiti?
  • Shin maganin yana shafar buƙatun mutanen da ke fama da cutar huhu ta COVID-19 don samun iska ko kiyaye su cikin kulawa mai zurfi ?
  • Shin za a iya amfani da irin waɗannan magungunan don rage rashin lafiyar kamuwa da cutar COVID-19 a cikin ma'aikatan kiwon lafiya da mutanen da ke cikin haɗarin kamuwa da cuta mai tsanani?

Ana sauƙaƙa yin rajistar mutane masu kamuwa da cutar ta COVID-19 ta hanyar amfani da bayanan shigar da bayanai, gami da sanarwar da aka sani, akan gidan yanar gizon WHO.[2] Bayan ma'aikatan gwajin sun tantance magungunan da ake samu a asibiti, gidan yanar gizon WHO ya keɓanta wanda ke kwance a asibiti zuwa ɗayan magungunan gwaji ko ma'aunin kulawa na asibiti don kula da COVID-19. Likitan gwaji ya rubuta kuma ya ba da bayanan biyo baya game da matsayin batun da jiyya, yana kammala shigar da bayanai ta hanyar yanar gizo ta WHO Solidarity.[2] Tsarin gwajin Solidarity ba makafi biyu ba ne – wanda yawanci shine ma'auni a cikin gwajin asibiti mai inganci – amma WHO na buƙatar sauri tare da inganci don gwajin a duk asibitoci da ƙasashe da yawa.[2] Kwamitin sa ido kan aminci na duniya na likitocin WHO suna nazarin sakamakon wucin gadi don taimakawa yanke shawara kan aminci da ingancin magungunan gwaji, da canza ƙirar gwaji ko ba da shawarar ingantaccen magani.[2][5] Irin wannan binciken na tushen yanar gizo zuwa Solidarity, wanda ake kira "Gano", an fara shi a cikin Maris a cikin ƙasashe bakwai ta INSERM ( Paris, Faransa ).[2][6]

Gwajin Solidarity yana neman aiwatar da daidaituwa a cikin ɗaruruwan wuraren asibitoci a cikin ƙasashe daban-daban – gami da waɗanda ke da ƙarancin haɓaka kayan aikin gwajin asibiti – duk da haka ana buƙatar aiwatar da su cikin sauri. Kamar yadda John-Arne Røttingen, shugaban zartarwa na Research Council of Norway kuma shugaban Solidarity fitina duniya kwamitin shirya, da fitina za a yi la'akari tasiri idan hanyoyin kwantar da hankali ake yi niyyar su "rage yawan marasa lafiya da bukatar ventilators ta, ka ce, 20 %, hakan na iya yin tasiri sosai ga tsarin kula da lafiya na kasa."[7]

Zane mai daidaitawa

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A cewar Darakta Janar na WHO, makasudin gwajin shi ne "a rage lokacin da ake bukata don samar da kwararan hujjoji game da abin da kwayoyi ke aiki",[8] wani tsari ta amfani da "tsari mai daidaitawa".[9][10] Haɗin kai da Gwajin Ganowar Turai suna amfani da ƙira mai daidaitawa don canza sigogin gwaji da sauri lokacin da sakamako daga dabarun gwajin gwaji guda huɗu suka bayyana.[6][11]

Zane-zane masu dacewa a cikin gwaje-gwajen asibiti na Mataki na III-IV mai gudana – kamar Haɗin kai da ayyukan Gano – iya rage lokacin gwaji da amfani da ƴan batutuwa, maiyuwa haɓaka yanke shawara don ƙarewa da wuri don adana farashi idan sakamakon wucin gadi ya kasance mara kyau. [6][9][10] Idan aikin Solidarity ya nuna farkon shaidar nasara, za a iya yin canje-canjen ƙira a duk wuraren aikin na duniya cikin sauri don haɓaka sakamakon gaba ɗaya na mutanen da abin ya shafa da kuma hanzarta amfani da magungunan warkewa.[1][6]

Masu neman magani a ƙarƙashin karatu

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Mutum ko haɗin magungunan da ake nazari a cikin ayyukan Solidarity da Discovery an riga an yarda da su don wasu cututtuka.[2] Su ne: [2][6]

  • Remdesivir
  • Lopinavir/ritonavir a hade
  • Lopinavir/ritonavir hade da interferon-beta
  • Hydroxychloroquine ko chloroquine (an daina saboda babu fa'ida, Yuni 2020)[12]

Sakamakon damuwa na aminci da shaidar cututtukan zuciya da ke haifar da hauhawar mace-mace, WHO ta dakatar da hannun hydroxychloroquine na gwajin Solidarity a ƙarshen Mayu 2020,[13][14] sannan ta dawo da shi,[15] sannan ta sake janye ta lokacin wani ɗan lokaci. Binciken da aka yi a watan Yuni ya nuna cewa hydroxychloroquine bai ba da wani fa'ida ga mutanen da ke kwance a asibiti da suka kamu da cutar ta COVID-19 ba.[12]

A watan Oktoba na 2020, gwajin hadin kai na Hukumar Lafiya ta Duniya ya fitar da wani rahoto na wucin gadi wanda ya kammala cewa "remdesivir, hydroxychloroquine, lopinavir da interferon sun bayyana ba su da wani tasiri ko kuma ba su da wani tasiri a kan COVID-19 na asibiti, kamar yadda aka nuna ta gaba daya mace-mace, fara samun iska da tsawon lokaci. na zaman asibiti."[16] Gileyad – wanda ya kera remdesivir – soki tsarin gwajin Solidarity bayan bai nuna wani fa'idar jiyya ba, yana mai da'awar cewa yanayin gwajin Solidarity na duniya rauni ne, yayin da masana da yawa ke kallon binciken na kasa da kasa a matsayin karfi.[17] Yarjejeniyar siya tsakanin EU da Gileyad don sake gyarawa da ba da izinin Amfani da Gaggawa ta FDA ta Amurka a watan Oktoba masana kimiyyar gwajin Solidarity sun yi tambaya ba bisa ingantattun bayanan gwaji na asibiti ba, lokacin da bincike na wucin gadi na gwajin Solidarity ya gano remdesivir ya kasance. m.[17]

Taimako da shiga

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A cikin Maris, kudade don gwajin hadin kai ya kai US$108 daga gudummawar mutane 203,000 na daidaiku, kungiyoyin agaji da gwamnatoci, tare da kasashe 45 da ke da hannu wajen bayar da kudade ko sarrafa gwaji.[1][18] Ya zuwa ranar 1 ga Yuli 2020, kusan marasa lafiya 5,500 a cikin ƙasashe 21 na 39 waɗanda ke da izinin ɗaukar aiki an ɗauke su don shiga cikin gwajin. Fiye da kasashe 100 a duk yankuna 6 na WHO sun nuna sha'awar shiga.[13]

Gwajin hadin kai don masu neman rigakafin

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WHO ta haɓaka haɗin gwiwar masana kimiyyar rigakafin rigakafi na ƙasa da ƙasa waɗanda ke ma'anar Bayanan Samfurin Target na Duniya (TPP) don COVID-19, suna gano kyawawan halaye na amintattun alluran rigakafi a ƙarƙashin manyan nau'ikan guda biyu: "alurar rigakafi don dogon lokaci na kariya ga mutanen da ke cikin haɗari mafi girma. na COVID-19, kamar ma'aikatan kiwon lafiya", da sauran alluran rigakafi don samar da rigakafin gaggawa don sabbin barkewar cutar.[4] An kafa ƙungiyar TPP ta ƙasa da ƙasa don 1) tantance ci gaban mafi kyawun rigakafin rigakafin ɗan takara; 2) Taswirar rigakafin 'yan takara da gwajin asibiti a duk duniya, suna buga "tsarin yanayi" akai-akai na maganin rigakafi a cikin ci gaba;[19] 3) kimantawa da sauri da kuma bincika mafi kyawun allurar rigakafin ɗan takara lokaci guda kafin a gwada su a cikin ɗan adam; da 4) ƙira da daidaita rukunin yanar gizo da yawa, gwajin sarrafa bazuwar duniya – Gwajin Solidarity don rigakafin[20] – don ba da damar kimanta fa'idodi da kasada na 'yan takarar rigakafin daban-daban a ƙarƙashin gwajin asibiti a cikin ƙasashen da ke da hauhawar cutar COVID-19, tabbatar da fassarar sauri da raba sakamako a duniya. [4] Ƙungiyar rigakafi ta WHO za ta ba da fifiko ga waɗanne alluran rigakafin da ya kamata su shiga cikin gwaji na asibiti na Mataki na II da na III, da kuma ƙayyade ƙa'idojin da suka dace da Mataki na III don duk allurar rigakafin da za su cimma matakin gwaji mai mahimmanci .[4]

Gwajin Solidarity Plus

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Hukumar ta WHO ta sanar a watan Agustan 2021 cewa za ta kaddamar da gwajin hadin kai na gaba a karkashin sunan gwajin Solidarity PLUS a kasashe 52. Gwajin za ta yi rajistar marasa lafiya a asibiti don gwada sabbin magunguna uku don yuwuwar maganin COVID-19. Wadannan kwayoyi sun hada da artesunate, imatinib da infliximab . Wani kwamitin kwararru mai zaman kansa na WHO ne ya yi zaben wadannan hanyoyin kwantar da hankali. An riga an yi amfani da waɗannan magungunan don wasu alamomi: ana amfani da artesunate don zazzabin cizon sauro, imatinib don ciwon daji, da infliximab, ana amfani da wakili na TNF don cutar Crohn da cututtuka na rheumatoid. Za a ba da gudummawar magungunan don manufar gwaji ta masana'antun su.

Duba kuma

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Hanyoyin haɗi na waje

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Manazarta

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  1. ↑ 1.0 1.1 1.2 1.3 "UN health chief announces global 'solidarity trial' to jumpstart search for COVID-19 treatment" (in Turanci). United Nations, World Health Organization. 18 March 2020. Retrieved 2 April 2020.
  2. ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 Kupferschmidt, Kai; Cohen, Jon (22 March 2020). "WHO launches global megatrial of the four most promising coronavirus treatments". Science (in Turanci). AAAS. Retrieved 2 April 2020.
  3. ↑ "'Solidarity' clinical trial for COVID-19 treatment". www.who.int (in Turanci). World Health Organization. Retrieved 2020-04-22.
  4. ↑ 4.0 4.1 4.2 4.3 "Update on WHO Solidarity Trial – Accelerating a safe and effective COVID-19 vaccine". World Health Organization. 2020-04-27. Retrieved 2020-05-02. It is vital that we evaluate as many vaccines as possible as we cannot predict how many will turn out to be viable. To increase the chances of success (given the high level of attrition during vaccine development), we must test all candidate vaccines until they fail. WHO is working to ensure that all of them have the chance of being tested at the initial stage of development. The results for the efficacy of each vaccine are expected within three to six months and this evidence, combined with data on safety, will inform decisions about whether it can be used on a wider scale
  5. ↑ 5.0 5.1 5.2 Branswell H (18 March 2020). "WHO to launch multinational trial to jumpstart search for coronavirus drugs". STAT. Retrieved 28 March 2020.
  6. ↑ 6.0 6.1 6.2 6.3 6.4 "Launch of a European clinical trial against COVID-19". INSERM. 22 March 2020. Retrieved 5 April 2020. The great strength of this trial is its 'adaptive' nature. This means that ineffective experimental treatments can very quickly be dropped and replaced by other molecules that emerge from research efforts. We will therefore be able to make changes in real time, in line with the most recent scientific data, in order to find the best treatment for our patients
  7. ↑ Mullard, Asher (2020-04-18). "Flooded by the torrent: the COVID-19 drug pipeline". The Lancet (in Turanci). 395 (10232): 1245–1246. doi:10.1016/S0140-6736(20)30894-1. PMC 7162641. PMID 32305088.
  8. ↑ Miller, Anna Medaris. "A patient in Norway is the first to enroll in a global 'solidarity trial' testing 4 coronavirus treatments". Business Insider. Retrieved 2 April 2020.
  9. ↑ 9.0 9.1 "Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry". US Food and Drug Administration. 1 November 2019. Retrieved 3 April 2020.
  10. ↑ 10.0 10.1 Pallmann P, Bedding AW, Choodari-Oskooei B, Dimairo M, Flight L, Hampson LV, et al. (February 2018). "Adaptive designs in clinical trials: why use them, and how to run and report them". BMC Medicine. 16 (1): 29. doi:10.1186/s12916-018-1017-7. PMC 5830330. PMID 29490655.
  11. ↑ Kotok A (19 March 2020). "WHO beginning Covid-19 therapy trial". Technology News: Science and Enterprise. Retrieved 7 April 2020.
  12. ↑ 12.0 12.1 Thomas Mulier (2020-06-17). "Hydroxychloroquine halted in WHO-sponsored COVID-19 trials". Bloomberg. Retrieved 2020-06-17.
  13. ↑ 13.0 13.1 "WHO Director-General's opening remarks at the media briefing on COVID-19 - 25 May 2020". World Health Organization. 2020-05-25. Retrieved 2020-05-27.
  14. ↑ Maria Cheng, Jamey Keaten (2020-05-25). "WHO pauses hydroxychloroquine coronavirus trial over safety concerns". Global News. The Associated Press. Retrieved 2020-05-27.CS1 maint: uses authors parameter (link)
  15. ↑ Davey M, Kirchgaessner S, Boseley S (3 June 2020). "Surgisphere: governments and WHO changed Covid-19 policy based on suspect data from tiny US company". The Guardian. Retrieved 4 June 2020.
  16. ↑ Samfuri:Cite document
  17. ↑ 17.0 17.1 Jon Cohen, Kai Kupferschmidt (28 October 2020). "The 'very, very bad look' of remdesivir, the first FDA-approved COVID-19 drug". Science. doi:10.1126/science.abf4549.CS1 maint: uses authors parameter (link)
  18. ↑ "WHO Director-General's opening remarks at the media briefing on COVID-19 - 27 March 2020" (in Turanci). United Nations, World Health Organization. Retrieved 2 April 2020.
  19. ↑ "Draft landscape of COVID 19 candidate vaccines". World Health Organization. 2020-05-05. Retrieved 2020-05-09.
  20. ↑ "An international randomised trial of candidate vaccines against COVID-19". World Health Organization. 2020-04-19. Retrieved 2020-05-09.
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