labarai

A yau, wani ɗan ƙaramin ƙwayar ƙwayar ƙwayar cuta mai sarrafa kansa ta China, Zenotevir, yana cikin jirgin. NEJM> . Wannan binciken, wanda aka buga bayan ƙarshen cutar ta COVID-19 kuma cutar ta shiga sabon matakin annoba na yau da kullun, yana bayyana tsarin binciken asibiti mai wahala na maganin da aka ƙaddamar yayin bala'in, kuma yana ba da kyakkyawar gogewa don amincewar gaggawa na barkewar sabbin cututtukan da ke gaba.

Bakan rashin lafiya da ke haifar da kamuwa da kwayar cutar ta numfashi yana da faɗi, gami da kamuwa da cutar asymptomatic, kamuwa da cuta mai saurin kamuwa da cuta (lauka masu laushi zuwa matsakaici ba tare da asibiti ba), mai tsanani (na buƙatar asibiti), da mutuwa. Zai yi kyau idan za a iya haɗa waɗannan ma'aunin lura na asibiti a cikin gwaji na asibiti don kimanta fa'idar maganin rigakafi, amma ga nau'in da ke zama ƙasa da kamuwa da cuta yayin bala'in cutar, yana da mahimmanci a zaɓi fifikon kulawa na farko na asibiti kuma da gaske kimanta ingancin maganin rigakafi.

Manufofin bincike na magungunan rigakafin za a iya raba su da yawa zuwa rage mace-mace, inganta haɓakar cututtuka mai tsanani, rage cututtuka mai tsanani, rage tsawon lokacin bayyanar cututtuka da hana kamuwa da cuta. A matakai daban-daban na annoba, wuraren da aka zaɓa na asibiti galibi suna bambanta sosai. A halin yanzu, babu wani maganin rigakafin cutar ta Covid-19 da aka nuna yana da inganci wajen rage mace-mace da inganta mugunyar gafara.

Don magungunan rigakafin cutar COVID-19, Nematavir/Ritonavir sun gudanar da gwajin asibiti na EPIC-HR (NCT04960202) [1], EPIC-SR (NCT05011513) da EPIC-PEP (NCT05047601), bi da bi. Makasudin uku shine don rage cututtuka mai tsanani, rage tsawon lokacin bayyanar cututtuka da kuma hana kamuwa da cuta. Nematavir/ritonavir kawai ya nuna ta EPIC-HR don rage rashin lafiya mai tsanani, kuma ba a sami sakamako mai kyau ga ƙarshen ƙarshen biyu ba.

Tare da sauya nau'in cutar COVID-19 zuwa omicron da gagarumin haɓakar adadin allurar rigakafi, yanayin canja wurin nauyi a cikin ƙungiyoyi masu haɗari ya ragu sosai, kuma yana da wahala a sami sakamako mai kyau ta hanyar ɗaukar ƙirar gwaji mai kama da EPIC-HR tare da canja wurin nauyi a matsayin ƙarshen ƙarshen. Misali, NEJM ta buga nazarin kwatancen na VV116 da Nematavir/Ritonavir [2] yana nuna cewa tsohon bai fi na ƙarshe ba dangane da lokaci don ci gaba da farfadowa na asibiti a cikin manya tare da Covid-19 mai sauƙi zuwa matsakaici waɗanda ke cikin haɗarin ci gaba. Duk da haka, gwaji na farko na asibiti na VV116 ya yi amfani da juyawa mai nauyi a matsayin ƙarshen binciken, kuma tare da saurin juyin halitta na annoba, yana da wuya a lura da adadin abubuwan da aka sa ran. Wadannan nazarin sun ba da shawarar cewa yadda za a kimanta tasirin asibiti na sabon magani da kuma abin da ya kamata a yi amfani da shi na farko a matsayin ma'auni don ƙima mai mahimmanci ya zama mahimmancin matsalolin bincike na asibiti a cikin yanayin saurin cutar cututtukan cututtuka, musamman ma saurin raguwar nauyin juzu'i.

Gwajin Nematavir/Ritonavir EPIC-SR, wanda ya ɗauki alamun COVID-14 14 kuma yayi amfani da lokacin ƙudurin alamar a matsayin ƙarshen ƙarshen, shima ya ba da sakamako mara kyau. Za mu iya yin hasashe guda uku: 1. Ma'aunin inganci abin dogaro ne, wanda ke nufin nematavir ba shi da tasiri wajen inganta alamun asibiti na COVID-19; 2. Magunguna suna da tasiri, amma ka'idodin inganci ba su da tabbas; 3. Ma'auni na inganci ba abin dogara ba ne, kuma miyagun ƙwayoyi kuma ba shi da tasiri a cikin wannan alamar.

Yayin da sabbin magungunan rigakafin cutar Covid-19 na kasar Sin ke tashi daga dakin gwaje-gwaje zuwa matakin gwaji na asibiti, muna fuskantar wata muhimmiyar matsala - rashin ka'idojin tantance ingancin asibiti. An san cewa kowane muhimmin mahimmanci na ƙirar gwaji na asibiti daidai ne, kuma yana yiwuwa a tabbatar da ingancin magani. Yadda za a yi tunani game da waɗannan sakamako mara kyau, yana tabbatar da ko magungunan ƙirƙira masu zaman kansu na kasar Sin na iya yin nasara.

Idan lokacin bacewar alamun Covid-19 bai dace da ƙarshen kimanta magungunan SARS-CoV-2 ba, hakan yana nufin cewa sabbin magunguna masu zaman kansu na kasar Sin za su iya ci gaba da kimantawa da rage nauyi kawai don tabbatar da ingancinsu, kuma za a kammala wannan hanyar bincike da ci gaba bayan barkewar cutar cikin sauri ta kammala kamuwa da cutar a duniya kuma sannu a hankali an kafa rigakafin garken garken. Tagar don cimma burin bincike na asibiti tare da nauyi mai nauyi yayin da farkon ƙarshen ƙarshen yana rufewa.

A ranar 18 ga Janairu, 2023, gwajin asibiti na kashi 2-3 na maganin kamuwa da cutar coronavirus mai matsakaicin matsakaici ta Cenotevir wanda Cao Bin et al ya gudanar. An buga shi a cikin New England Journal of Medicine (NEJM) [3]. Binciken su ya nuna hikima kan yadda za a shawo kan rashin ma'auni don kimanta ingancin magungunan rigakafin COVID-19 a cikin gwaji na asibiti.

Wannan gwajin asibiti, wanda aka yi rajista a kan clinicaltrials.gov a ranar 8 ga Agusta, 2021 (NCT05506176), shine farkon lokaci na 3 da ke sarrafa placebo na wani sabon maganin rigakafin COVID-19 na 'yan asalin kasar Sin. A cikin wannan lokaci 2-3 makafi sau biyu, bazuwar, gwajin sarrafa wuribo, marasa lafiya tare da COVID-19 mai sauƙi zuwa matsakaici a cikin kwanaki 3 na farawa an ba da izini 1: 1 zuwa ko dai senotovir/ritonavir na baka (750 mg/100 mg) sau biyu kullum ko placebo na kwanaki 5. Babban mahimmin mahimmancin ƙarshen shine tsawon tsayin tsayin daka na ainihin alamun alamun 11, watau farfadowa da alamun ya dade har tsawon kwanaki 2 ba tare da komawa ba.

Daga wannan labarin, zamu iya samun sabon maƙasudin ƙarshen "alamomin asali 11" na rashin lafiya mai laushi. Masu binciken ba su yi amfani da alamun COVID-14 14 na gwajin asibiti na EPIC-SR ba, kuma ba su yi amfani da canja wurin nauyi a matsayin farkon ƙarshen ƙarshe ba.

An yi rajistar marasa lafiya 1208, 603 daga cikinsu an sanya su zuwa rukunin jiyya na senotevir da 605 zuwa rukunin jiyya na placebo. Sakamakon binciken ya nuna cewa a tsakanin marasa lafiya na MIT-1 da suka karbi maganin miyagun ƙwayoyi a cikin sa'o'i 72 na farko, tsawon lokacin ƙuduri na alamun COVID-19 a cikin ƙungiyar senotevir ya fi guntu fiye da wannan a cikin rukunin placebo (180.1 hours [95% CI, 162.1-201.6] vs. 216.0 hours [925% 3, 4] -35.8 hours [95% CI, -60.1 zuwa -12.4]; P = 0.006). A ranar 5 na shiga, raguwar nauyin ƙwayar cuta daga asali ya fi girma a cikin ƙungiyar senotevir fiye da a cikin rukunin placebo (ma'anar bambanci [± SE], -1.51 ± 0.14 log10 kofe / ml; 95% CI, -1.79 zuwa -1.24). Bugu da ƙari, sakamakon binciken a cikin duk ƙarshen ƙarshen sakandare da ƙididdigar yawan jama'a sun ba da shawarar cewa zenotevir na iya rage tsawon lokacin bayyanar cututtuka a cikin marasa lafiya na COVID-19. Wadannan sakamakon sun nuna cikakken cewa Cenotevir yana da fa'ida mai mahimmanci a cikin wannan nuni.

Abin da ke da kima sosai game da wannan binciken shi ne ya ɗauki sabon ma'auni don kimanta inganci. Za mu iya gani daga abin da aka makala zuwa takarda cewa mawallafa sun ba da lokaci mai yawa don nuna amincin wannan tasiri na ƙarshe, ciki har da daidaito na maimaita matakan 11 core bayyanar cututtuka, da haɗin gwiwa tare da alamun 14. Jama'a masu rauni, musamman masu fama da rashin lafiya da kuma masu kiba, sun fi amfana da binciken. Wannan yana tabbatar da amincin binciken daga kusurwoyi da yawa, kuma yana nuna cewa Cenotevir ya tashi daga ƙimar bincike zuwa ƙimar asibiti. Fitar da sakamakon wannan binciken ya ba mu damar ganin nasarar da masu binciken kasar Sin suka samu wajen warware matsalolin da kasashen duniya suka amince da su ta hanyar kirkire-kirkire. Tare da haɓaka sabbin magunguna a cikin ƙasarmu, babu makawa za mu fuskanci wasu matsaloli na ƙira na gwaji na asibiti waɗanda ke buƙatar warwarewa nan gaba.