{"id":26369,"date":"2023-03-06T14:57:46","date_gmt":"2023-03-06T11:57:46","guid":{"rendered":"https:\/\/www.klimikdergisi.org\/?p=26369"},"modified":"2023-03-21T13:39:14","modified_gmt":"2023-03-21T10:39:14","slug":"inaktif-covid-19-asisi-sonrasi-gelisen-istenmeyen-etkiler","status":"publish","type":"post","link":"https:\/\/www.klimikdergisi.org\/tr\/2023\/03\/06\/inaktif-covid-19-asisi-sonrasi-gelisen-istenmeyen-etkiler\/","title":{"rendered":"COVID-19 Ge\u00e7iren ve Ge\u00e7irmeyen Sa\u011fl\u0131k \u00c7al\u0131\u015fanlar\u0131nda \u0130naktif COVID-19 A\u015f\u0131s\u0131 Sonras\u0131 Geli\u015fen \u0130stenmeyen Etkilerin De\u011ferlendirilmesi"},"content":{"rendered":"

G\u0130R\u0130\u015e<\/h2>\n

SARS-CoV-2 virusuna maruziyet, asemptomatik infeksiyondan \u015fiddetli akut solunum s\u0131k\u0131nt\u0131s\u0131 ve \u00f6l\u00fcme kadar de\u011fi\u015fen bir dizi klinik bulgu ile sonu\u00e7lanabilir (1,2). Bu infeksiyonu \u00f6nlemeye y\u00f6nelik ger\u00e7ekle\u015ftirilen a\u015f\u0131lama uygulamalar\u0131, pandemiyi kontrol alt\u0131na almak i\u00e7in en umut verici yakla\u015f\u0131m olarak kabul edilmektedir. SARS-CoV-2\u2019nin neden oldu\u011fu COVID-19 hastal\u0131\u011f\u0131na kar\u015f\u0131 pek \u00e7ok a\u015f\u0131 geli\u015ftirme \u00e7al\u0131\u015fmas\u0131 y\u00fcr\u00fct\u00fclm\u00fc\u015f olup a\u015f\u0131 adaylar\u0131n\u0131n \u00e7o\u011funda SARS-CoV-2\u2019nin \u201cspike\u201d (S) proteini kullan\u0131lm\u0131\u015ft\u0131r (3). D\u00fcnyan\u0131n farkl\u0131 b\u00f6lgelerinde 2020 y\u0131l\u0131 sonunda birka\u00e7 a\u015f\u0131 kullan\u0131ma haz\u0131r hale gelmi\u015ftir; 40\u2019\u0131n \u00fczerinde aday a\u015f\u0131n\u0131n ise preklinik denemeleri halen devam etmektedir. S\u00f6z konusu a\u015f\u0131lar\u0131n etkinli\u011fini, g\u00fcvenli\u011fini test etmek ve geli\u015ftirmek i\u00e7in acil eylem planlar\u0131 haz\u0131rlanm\u0131\u015f; klinik geli\u015ftirme s\u00fcre\u00e7leri tamamlanmadan acil kullan\u0131m onaylar\u0131 verilmi\u015ftir. SARS-CoV-2 ile m\u00fccadele edecek bir a\u015f\u0131n\u0131n; bir veya iki a\u015f\u0131 uygulamas\u0131 sonras\u0131 etkili olmas\u0131, ba\u011f\u0131\u015f\u0131kl\u0131\u011f\u0131 zay\u0131flam\u0131\u015f bireyler dahil olmak \u00fczere ya\u015fl\u0131 bireyler ve komorbiditesi olanlar gibi hedef pop\u00fclasyonlar\u0131 korumas\u0131 ve en az 6 ay koruma sa\u011flayarak virusun ki\u015filere bula\u015fmas\u0131n\u0131 azaltmas\u0131 beklenmektedir (4,5).<\/p>\n

Yap\u0131lan epidemiyolojik \u00e7al\u0131\u015fmalarda, n\u00f6tralize edici antikorlar\u0131n infeksiyondan korunma ile ili\u015fkili oldu\u011fu \u00f6ne s\u00fcr\u00fclm\u00fc\u015ft\u00fcr. Bu nedenle, yeterli n\u00f6tralize edici yan\u0131t ortaya \u00e7\u0131karan a\u015f\u0131lar, COVID-19\u2019a kar\u015f\u0131 koruma sunabilmektedir. COVID-19 a\u015f\u0131lar\u0131 farkl\u0131 yakla\u015f\u0131mlarla geli\u015ftirilmektedir. Bunlar\u0131n baz\u0131lar\u0131 inaktif veya canl\u0131-aten\u00fce a\u015f\u0131lar olup di\u011ferleri rekombinant proteinler ve vekt\u00f6rler gibi daha yeni platformlarla geli\u015ftirilen a\u015f\u0131lard\u0131r. \u0130naktif a\u015f\u0131lar; h\u00fccre k\u00fclt\u00fcr\u00fcnde SARS-CoV-2 \u00fcretilmesinin ard\u0131ndan virusun kimyasal olarak inaktive edilmesiyle geli\u015ftirilir. Etkisi zay\u0131flat\u0131lm\u0131\u015f olan virus, ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131 olu\u015fturmak i\u00e7in genellikle a\u015f\u0131 i\u00e7inde ba\u015fka bir yard\u0131mc\u0131 madde ile birle\u015ftirilir. \u0130naktive a\u015f\u0131lar tipik olarak kas i\u00e7ine uygulan\u0131r. SARS-CoV-2 ile etkisiz hale getirilmi\u015f bir a\u015f\u0131ya ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131 sadece S proteinini de\u011fil ayn\u0131 zamanda virusun di\u011fer bile\u015fenlerini de hedefleyebilir (5-7). A\u015f\u0131 uygulama b\u00f6lgesi, imm\u00fcn yan\u0131t\u0131 etkileyebilir. A\u015f\u0131lar\u0131n \u00e7o\u011fu kas i\u00e7inden (veya deri i\u00e7inden) uygulan\u0131r ve esas olarak sistemik bir ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131 ortaya \u00e7\u0131kar\u0131r (3). Do\u011fal solunum yolu infeksiyonlar\u0131 ise hem mukozal hem de sistemik ba\u011f\u0131\u015f\u0131kl\u0131k yan\u0131t\u0131 ortaya \u00e7\u0131kar\u0131r. Bu nedenle a\u015f\u0131n\u0131n olu\u015fturdu\u011fu yan\u0131t daha az olmaktad\u0131r. A\u015f\u0131 uygulamalar\u0131 sonras\u0131 enjeksiyon yerinde a\u011fr\u0131, ate\u015f, yorgunluk ve ba\u015f a\u011fr\u0131s\u0131 gibi lokal ve sistemik reaksiyonlar geli\u015febilmektedir. A\u015f\u0131ya veya bile\u015fenlerine kar\u015f\u0131 \u015fiddetli alerjik reaksiyon veya anafilaksi \u00f6yk\u00fcs\u00fc, a\u015f\u0131lama i\u00e7in bir kontrendikasyondur (7,8).\u00a0<\/span><\/p>\n

\u00c7al\u0131\u015fmam\u0131zda, en \u00f6nemli risk gruplar\u0131ndan biri olan sa\u011fl\u0131k \u00e7al\u0131\u015fanlar\u0131nda, daha \u00f6nce SARS-CoV-2 ile infekte olan veya olmayan gruplarda uygulanan birinci doz CoronaVac (Sinovac Life Sciences, Pekin, \u00c7in) a\u015f\u0131s\u0131 sonras\u0131 geli\u015fen istenmeyen etkilerin de\u011ferlendirilmesi ama\u00e7land\u0131.\u00a0<\/span><\/p>\n

Y\u00d6NTEMLER<\/h2>\n

Retrospektif olarak y\u00fcr\u00fct\u00fclen \u00e7al\u0131\u015fmaya, 14-24 Ocak 2021 tarihleri aras\u0131nda birinci doz olarak inaktif CoronaVac a\u015f\u0131s\u0131 (Sinovac Life Sciences, Pekin, \u00c7in) uygulanan 18-65 ya\u015f aras\u0131 g\u00f6n\u00fcll\u00fc 911 sa\u011fl\u0131k \u00e7al\u0131\u015fan\u0131 d\u00e2hil edildi. Kat\u0131l\u0131mc\u0131lara ait demografik bilgiler; d\u00fczenlenen anket arac\u0131l\u0131\u011f\u0131yla ve geli\u015fen yan etkiler nedeniyle a\u015f\u0131 poliklini\u011fine yap\u0131lan ba\u015fvurular\u0131n kay\u0131tlar\u0131ndan elde edildi. S\u00f6z konusu demografik veriler; ya\u015f, cinsiyet, g\u00f6rev ve \u00e7al\u0131\u015ft\u0131\u011f\u0131 birim, kronik hastal\u0131k varl\u0131\u011f\u0131, bilinen alerji \u00f6yk\u00fcs\u00fc, kullan\u0131lan ila\u00e7lar, son bir ay i\u00e7erisinde yap\u0131lan COVID-19 d\u0131\u015f\u0131 a\u015f\u0131 \u00f6yk\u00fcs\u00fc, COVID-19 ge\u00e7irme \u00f6yk\u00fcs\u00fc, ayaktan veya yatarak tedavi alma durumu, yo\u011fun bak\u0131m yat\u0131\u015f \u00f6yk\u00fcs\u00fc, a\u015f\u0131 sonras\u0131 geli\u015fen istenmeyen etkiler, istenmeyen etki s\u00fcresi, m\u00fcdahale gerekip gerekmedi\u011fi gibi bilgilerden olu\u015fmaktayd\u0131 (9,10). Hastalarda geli\u015fen istenmeyen etkiler, Amerikan G\u0131da ve \u0130la\u00e7 Dairesi (U.S. Food and Drug Administration \u2013 FDA) taraf\u0131ndan yay\u0131nlanm\u0131\u015f olan Toksisite Derecelendirme \u00d6l\u00e7e\u011fi K\u0131lavuzuna uygun olarak de\u011ferlendirildi. Bu derecelendirme \u00f6l\u00e7e\u011fine dayal\u0131 olarak; herhangi bir istenmeyen etki yok \u201cderece 0<\/i>\u201d, hafif istenmeyen etki \u201cderece 1<\/i>\u201d, orta dereceli istenmeyen etki, \u201cderece 2<\/i>\u201d, \u015fiddetli istenmeyen etki \u201cderece 3<\/i>\u201d, \u015fiddetli istenmeyen etki ve potansiyel olarak hayat\u0131 tehdit eden olaylar \u201cderece 4<\/i>\u201d olarak tan\u0131mland\u0131 (11).\u00a0 <\/span>Ciddi istenmeyen etki; v\u00fccut s\u0131cakl\u0131\u011f\u0131 \u2265 39.5 \u00b0C olmas\u0131, herhangi bir anafilaksi veya a\u015f\u0131r\u0131 duyarl\u0131l\u0131k reaksiyonu (30 dakika i\u00e7inde geli\u015fen k\u0131zar\u0131kl\u0131k veya \u00fcrtiker) ve sa\u011fl\u0131k durumunda bozulma olarak tan\u0131mland\u0131. Di\u011fer etkiler ise; a\u015f\u0131lama sonras\u0131 lokal a\u011fr\u0131, k\u0131zar\u0131kl\u0131k veya \u015fi\u015flik, ate\u015f, miyalji, halsizlik, gastrointestinal semptomlar (ishal, kar\u0131n a\u011fr\u0131s\u0131, bulant\u0131, kusma) ve kardiyovask\u00fcler semptomlar (\u00e7arp\u0131nt\u0131, hipotansiyon veya hipertansiyon), n\u00f6rolojik bulgular (v\u00fccutta uyu\u015fma, ba\u015f a\u011fr\u0131s\u0131, ba\u015f d\u00f6nmesi) ve a\u011f\u0131zda metalik tat olarak tan\u0131mland\u0131.<\/p>\n

A\u015f\u0131 sonras\u0131 istenmeyen etkiler; COVID-19 ge\u00e7iren ve ge\u00e7irmeyen gruplar\u0131n yan\u0131 s\u0131ra COVID-19 hastal\u0131\u011f\u0131 i\u00e7in yat\u0131\u015f gereken ve gerekmeyen gruplar aras\u0131nda de\u011ferlendirildi.\u00a0<\/span><\/p>\n

\u00c7al\u0131\u015fma i\u00e7in, Erciyes \u00dcniversitesi Giri\u015fimsel Olmayan Klinik Ara\u015ft\u0131rmalar Etik Kurulu\u2019ndan 24 Mart 2021 tarih ve 2021\/225 karar numaras\u0131yla onay al\u0131nd\u0131.<\/p>\n

\u0130statistiksel Analiz<\/h3>\n

Verilerin analizi, SPSS (Statistical Package for the Social Sciences) versiyon 22.0 program\u0131 (IBM Corp., Armonk, NY, ABD) ile yap\u0131ld\u0131.\u00a0De\u011ferlendirmede; y\u00fczde, ortalama, minimum, maksimum de\u011fer gibi tan\u0131mlay\u0131c\u0131 istatistiksel metotlar kullan\u0131ld\u0131. Kategorik de\u011fi\u015fkenler i\u00e7in \u03c72<\/sup> veya Fischer kesin testi, iki grup aras\u0131ndaki farkl\u0131l\u0131klar\u0131 kar\u015f\u0131la\u015ft\u0131rmak i\u00e7in de Mann-Whitney U testi kullan\u0131ld\u0131. Anlaml\u0131l\u0131k d\u00fczeyi t\u00fcm testler i\u00e7in p<\/i><0.05 olarak belirlendi.<\/p>\n

BULGULAR<\/h2>\n
\"\"<\/a>

Tablo 1.<\/strong> Kat\u0131l\u0131mc\u0131lar\u0131n Demografik ve Epidemiyolojik \u00d6zellikleri<\/p><\/div>\n

\u00c7al\u0131\u015fmaya, CoronaVac a\u015f\u0131s\u0131 (Sinovac Life Sciences, Pekin, \u00c7in) uygulanan 911 g\u00f6n\u00fcll\u00fc sa\u011fl\u0131k \u00e7al\u0131\u015fan\u0131 d\u00e2hil edildi. COVID-19 ge\u00e7irme \u00f6yk\u00fcs\u00fc olan kat\u0131l\u0131mc\u0131 say\u0131s\u0131 232 (%25.5) olup 679 (%74.5) ki\u015finin COVID-19 \u00f6yk\u00fcs\u00fc yoktu. S\u00f6z konusu 232 ki\u015finin 22\u2019sinin COVID-19 nedeniyle yatarak tedavi ald\u0131\u011f\u0131 \u00f6\u011frenildi. COVID-19 ge\u00e7iren ve ge\u00e7irmeyen kat\u0131l\u0131mc\u0131 gruplar\u0131n\u0131n epidemiyolojik \u00f6zellikleri ve geli\u015fen istenmeyen etkiler Tablo 1\u2019de verildi.<\/p>\n

SARS-CoV-2 ile infekte sa\u011fl\u0131k \u00e7al\u0131\u015fanlar\u0131n\u0131n ya\u015f ortalamas\u0131 36 (20-66) iken %33.6\u2019s\u0131n\u0131 erkek cinsiyet olu\u015fturuyordu. G\u00f6rev da\u011f\u0131l\u0131mlar\u0131na bak\u0131ld\u0131\u011f\u0131nda; %34.9\u2019u hem\u015fire, %26.7\u2019si doktor ve %20.7\u2019si yard\u0131mc\u0131 sa\u011fl\u0131k personeliydi. COVID-19 ge\u00e7iren \u00e7al\u0131\u015fanlar\u0131n, 155 (%66.8)\u2019inin dahili birimlerde, 62 (%26.7)\u2019sinin cerrahi birimlerde geri kalan\u0131n ise acil, ameliyathane ve y\u00f6netim birimlerinde g\u00f6rev ald\u0131\u011f\u0131 belirlendi. COVID-19 ge\u00e7irme \u00f6yk\u00fcs\u00fc bulunmayan \u00e7al\u0131\u015fanlar\u0131n ise 438 (%64.5)\u2019inin dahili, 178 (%26.2)\u2019inin ise cerrahi birimlerde \u00e7al\u0131\u015ft\u0131\u011f\u0131 tespit edildi.\u00a0 <\/span>Her iki grupta da ya\u015f, cinsiyet, g\u00f6rev yetkisi ve \u00e7al\u0131\u015fma birimleri aras\u0131nda anlaml\u0131 d\u00fczeyde bir fark bulunmad\u0131. Kat\u0131l\u0131mc\u0131lar\u0131n yakla\u015f\u0131k 217 (%23.8)\u2019sinde en az bir kronik hastal\u0131k mevcuttu; COVID-19 \u00f6yk\u00fcs\u00fc olan grupta bu oran %25.9 di\u011fer grupta ise %23.1 idi. Her iki grupta da en s\u0131k g\u00f6r\u00fclen kronik alt hastal\u0131k %5.6 oran\u0131yla ast\u0131md\u0131. Alerji \u00f6yk\u00fcs\u00fc olanlar\u0131n oran\u0131 COVID-19 ge\u00e7irenlerde %4.3, ge\u00e7irmeyenlerde %7.8 idi. Gruplar aras\u0131 anlaml\u0131 d\u00fczeyde bir istatistiksel fark bulunmad\u0131. Son bir ay i\u00e7inde yap\u0131lan inaktif veya canl\u0131-aten\u00fce a\u015f\u0131 uygulamalar\u0131 a\u00e7\u0131s\u0131ndan bak\u0131ld\u0131\u011f\u0131nda; COVID-19 ge\u00e7iren grupta yaln\u0131zca %2.2 oran\u0131nda influenza a\u015f\u0131 \u00f6yk\u00fcs\u00fc mevcut iken COVID-19 ge\u00e7irmeyen grupta %2.8 oran\u0131nda influenza a\u015f\u0131s\u0131, %0.3 oran\u0131nda k\u0131zam\u0131k-kabakulak-su\u00e7i\u00e7e\u011fi a\u015f\u0131s\u0131 ve %0.4 oran\u0131nda tetanos a\u015f\u0131 \u00f6yk\u00fcs\u00fc mevcuttu. Kat\u0131l\u0131mc\u0131lar\u0131n yakla\u015f\u0131k 487 (%53.5)\u2019sinde \u201cderece 1\u201d<\/i> ve \u201cderece 2\u201d<\/i> d\u00fczeyinde istenmeyen etki g\u00f6r\u00fcl\u00fcrken; bu oran COVID-19 \u00f6yk\u00fcs\u00fc olan ki\u015filerde %60.8, ge\u00e7irmeyenler de ise %51\u2019di. \u0130stenmeyen etki geli\u015fme s\u00fcresi her iki grupta da ortalama 1 (1-10) g\u00fcnd\u00fc. Her iki grupta en s\u0131k g\u00f6r\u00fclen etki ba\u015f a\u011fr\u0131s\u0131yd\u0131. COVID-19 ge\u00e7iren grupta %36.6 ile daha y\u00fcksek olan ba\u015f a\u011fr\u0131s\u0131 oran\u0131 istatistiksel olarak da anlaml\u0131 d\u00fczeydeydi (p<\/i>=0.01); ge\u00e7irmeyen grupta bu oran %27.7 olarak tespit edildi. Di\u011fer s\u0131k geli\u015fen istenmeyen etkilere bak\u0131ld\u0131\u011f\u0131nda COVID-19 \u00f6yk\u00fcs\u00fc olan grupta; halsizlik (%28.4), a\u015f\u0131 uygulama b\u00f6lgesinde lokalize a\u011fr\u0131 (%19), miyalji (%16.8) ve a\u011f\u0131zda metalik tat hissi (%6) g\u00f6r\u00fcld\u00fc. COVID-19 \u00f6yk\u00fcs\u00fc olmayan grupta ise halsizlik %24.7, lokalize a\u011fr\u0131<\/p>\n

\"\"<\/a>

Tablo 2.<\/strong> COVID-19 Nedeni ile Yatarak ve Ayaktan Tedavi Alan Hastalarda A\u015f\u0131 Sonras\u0131 Geli\u015fen Yan Etkiler<\/p><\/div>\n

%15, miyalji %12.4 ve a\u011f\u0131zda metalik tat hissi %5.4 oranlar\u0131nda g\u00f6r\u00fcld\u00fc. COVID-19 nedeniyle yat\u0131\u015f \u00f6yk\u00fcs\u00fc olan ki\u015filerde olmayanlara g\u00f6re istenmeyen etki geli\u015fme oranlar\u0131n\u0131n daha y\u00fcksek oldu\u011fu g\u00f6r\u00fcld\u00fc. En s\u0131k geli\u015fen etkiler ba\u015f a\u011fr\u0131s\u0131 (%45.5), enjeksiyon yerinde a\u011fr\u0131 (%22.7) ve myalji (%18.2) idi. Aradaki fark istatistiksel olarak anlaml\u0131 d\u00fczeyde bulunmad\u0131 (Tablo 2). Ayr\u0131ca kat\u0131l\u0131mc\u0131lardan COVID-19 \u00f6yk\u00fcs\u00fc olanlar\u0131n 5 (%2.2)\u2019inde, olmayanlar\u0131n ise 3 (%0.4)\u2019\u00fcnde a\u015f\u0131 sonras\u0131 ge\u00e7ici g\u00f6rme kayb\u0131 oldu\u011fu bildirildi. COVID-19 \u00f6yk\u00fcs\u00fc olanlarda daha y\u00fcksek oranda olmakla birlikte, fark istatistiksel olarak da anlaml\u0131 d\u00fczeyde bulundu. Bu ki\u015filerin n\u00f6rolojik ve g\u00f6z muayene bulgular\u0131 normal iken yap\u0131lan radyolojik g\u00f6r\u00fcnt\u00fcleme y\u00f6ntemlerinde de herhangi bir patolojik bulguya rastlanmad\u0131. A\u015f\u0131 uygulanan kat\u0131l\u0131mc\u0131lar\u0131n hi\u00e7birinde ciddi yan etki bildirilmedi. Yaln\u0131zca v\u00fccudunda d\u00f6k\u00fcnt\u00fcler geli\u015fen 2 ki\u015fide m\u00fcdahale gereklili\u011fi olu\u015ftu ve intraven\u00f6z antihistaminik ve steroid tedavisi sonras\u0131 klinik d\u00fczelme g\u00f6r\u00fcld\u00fc.<\/p>\n

\u0130RDELEME<\/h2>\n

Bug\u00fcne kadar, COVID-19\u2019a kar\u015f\u0131 geli\u015ftirilen inaktif a\u015f\u0131lar\u0131n ve m-RNA a\u015f\u0131lar\u0131n\u0131n faz \u00e7al\u0131\u015fmalar\u0131nda s\u0131kl\u0131kla hafif ve orta derecede istenmeyen etkiler bildirilirken nadir olarak da ciddi etkiler g\u00f6zlenmi\u015ftir (12). Geli\u015ftirilen a\u015f\u0131lardan biri olan CoronaVac a\u015f\u0131s\u0131, inaktive edilmi\u015f COVID-19 a\u015f\u0131s\u0131 olup al\u00fcminyum hidroksit yard\u0131mc\u0131 maddesi i\u00e7ermekte ve iki doz olarak kas i\u00e7ine uygulanmaktad\u0131r. Yap\u0131lan randomize, plasebo kontroll\u00fc faz I-II \u00e7al\u0131\u015fmalarda 18-59 ya\u015flar\u0131 aras\u0131, 60 ya\u015f ve \u00fcst\u00fc sa\u011fl\u0131kl\u0131 bireylerde g\u00fcvenli ve imm\u00fcnojenik bulunmu\u015ftur. CoronaVac a\u015f\u0131s\u0131 i\u00e7in klinik \u00f6ncesi \u00e7al\u0131\u015fmalar kapsam\u0131nda yay\u0131nlanan veriler, yeterli IgG yan\u0131t\u0131 ve n\u00f6tralizan antikor seviyelerinin elde edildi\u011fini g\u00f6stermi\u015ftir (8). Randomize ve \u00e7ift k\u00f6r olarak ger\u00e7ekle\u015ftirilen bir faz II a\u015f\u0131 \u00e7al\u0131\u015fmas\u0131nda 18-59 ya\u015f aras\u0131 yakla\u015f\u0131k 600 kat\u0131l\u0131mc\u0131 14 ve 28 g\u00fcn olmak \u00fczere iki doz program\u0131na ayr\u0131lm\u0131\u015f, her program dahilinde kat\u0131l\u0131mc\u0131lara iki ayr\u0131 doz a\u015f\u0131 veya plasebo uygulanm\u0131\u015ft\u0131r. Enjeksiyon b\u00f6lgesinde a\u011fr\u0131 ve \u015fi\u015flik gibi lokal istenmeyen etkiler hafif-orta \u015fiddette izlenmi\u015ftir. Randomize kontroll\u00fc bu \u00e7al\u0131\u015fmada 14 g\u00fcnl\u00fck programda kat\u0131l\u0131mc\u0131lar\u0131n yakla\u015f\u0131k %20.3\u2019\u00fcnde, 28 g\u00fcnl\u00fck programda ise %10.3\u2019\u00fcnde a\u015f\u0131 sonras\u0131 enjeksiyon b\u00f6lgesinde a\u011fr\u0131 \u015fik\u00e2yeti olmu\u015ftur. Yan etkiler 3 g\u00fcn i\u00e7inde gerilerken ciddi istenmeyen etki bildirilmemi\u015ftir (1). Ba\u015fka bir inaktif COVID-19 a\u015f\u0131s\u0131 i\u00e7in de bu bulgulara benzer \u015fekilde en yayg\u0131n olarak enjeksiyon b\u00f6lgesinde a\u011fr\u0131 g\u00f6r\u00fclm\u00fc\u015ft\u00fcr. Viral vekt\u00f6r a\u015f\u0131larda, DNA veya RNA a\u015f\u0131lar\u0131 gibi di\u011fer COVID-19 a\u015f\u0131 adaylar\u0131yla kar\u015f\u0131la\u015ft\u0131r\u0131ld\u0131\u011f\u0131nda a\u015f\u0131lamadan sonra ate\u015f olu\u015fumu nispeten daha d\u00fc\u015f\u00fck bulunmu\u015ftur. En yayg\u0131n istenmeyen etkiler, enjeksiyon b\u00f6lgesinde a\u011fr\u0131 ve ate\u015f olarak bildirilmi\u015ftir. T\u00fcm bu etkiler hafif (derece 1<\/i> veya derece 2<\/i>), ge\u00e7ici ve kendi kendini s\u0131n\u0131rlayan nitelikte olup herhangi bir tedavi gerektirmemi\u015ftir (13,14). \u00c7al\u0131\u015fmam\u0131zda ise standart dozlarda 28 g\u00fcn arayla uygulanmas\u0131 planlanan CoronaVac a\u015f\u0131s\u0131 sonras\u0131 en s\u0131k bildirilen istenmeyen etkiler ba\u015f a\u011fr\u0131s\u0131 (%30), halsizlik (%25.7), lokalize a\u011fr\u0131 (%16), myalji (%13.5) ve a\u011f\u0131zda metalik tat hissi (%5.6) oldu. Bu etkilerin g\u00f6r\u00fclme oranlar\u0131 COVID-19 ge\u00e7irme \u00f6yk\u00fcs\u00fc olan grupta (%62.9) COVID-19 ge\u00e7irmeyen gruba oranla (%57.1) daha y\u00fcksek bulundu. En s\u0131k g\u00f6r\u00fclen istenmeyen etkilerden biri olan ba\u015f a\u011fr\u0131s\u0131, \u00f6zellikle COVID-19 \u00f6yk\u00fcs\u00fc olan grupta daha s\u0131k g\u00f6r\u00fcld\u00fc. Ayr\u0131ca her iki grup aras\u0131ndaki fark da istatistiksel olarak anlaml\u0131 d\u00fczeyde bulundu (p<\/i>=0.01). \u00dclkemizden yap\u0131lan bir \u00e7al\u0131\u015fmada, CoronaVac a\u015f\u0131s\u0131 sonras\u0131 g\u00f6r\u00fclen en yayg\u0131n sistemik istenmeyen etki yorgunluktur; a\u015f\u0131 grubunda 546 (%8.2), plasebo grubundan ise 248 (%7) bireyde bu etki g\u00f6r\u00fclm\u00fc\u015ft\u00fcr (p<\/i>=0.0228). Ciddi bir istenmeyen etki tan\u0131mlanmam\u0131\u015ft\u0131r. En s\u0131k g\u00f6r\u00fclen lokal istenmeyen etki enjeksiyon yerinde a\u011fr\u0131 olup a\u015f\u0131 grubunda 157 (%2.4), plasebo grubunda ise 40 (%1.1) bireyde g\u00f6r\u00fclm\u00fc\u015ft\u00fcr (p<\/i><0.0001) (12).\u00a0<\/span><\/p>\n

Adenovirus tip-5 vekt\u00f6r COVID-19 a\u015f\u0131lar\u0131 ile ilgili yap\u0131lan \u00e7al\u0131\u015fmalarda ise bildirilen en yayg\u0131n istenmeyen etkiler; hafif veya orta \u015fiddette ate\u015f, yorgunluk, ba\u015f a\u011fr\u0131s\u0131 ve kas a\u011fr\u0131s\u0131d\u0131r. Farkl\u0131 dozlar aras\u0131nda istenmeyen etki insidans\u0131 a\u00e7\u0131s\u0131ndan anlaml\u0131 bir fark bulunmam\u0131\u015ft\u0131r. \u0130nfeksiyonunun neden oldu\u011fu viremi ile ili\u015fkili olabilece\u011fi d\u00fc\u015f\u00fcn\u00fclen semptomlar\u0131n \u015fiddetini, uygulanan y\u00fcksek dozlarda olu\u015fan viral partik\u00fcl y\u00fck\u00fc ile ili\u015fkili geli\u015fen \u015fiddetli reaksiyonun belirledi\u011fi g\u00f6sterilmi\u015ftir. Yakla\u015f\u0131k 108 g\u00f6n\u00fcll\u00fcn\u00fcn dahil edildi\u011fi vekt\u00f6r a\u015f\u0131 uygulamas\u0131nda 87 (%81) ki\u015fide a\u015f\u0131lamadan sonraki ilk 7 g\u00fcn i\u00e7inde en az bir istenmeyen etki bildirilmi\u015ftir. Y\u00fcksek ve d\u00fc\u015f\u00fck doz tedavi gruplar\u0131 aras\u0131nda genel istenmeyen etki oranlar\u0131 a\u00e7\u0131s\u0131ndan \u00f6nemli bir fark g\u00f6zlenmemi\u015ftir. En yayg\u0131n olarak %54 oran\u0131yla enjeksiyon b\u00f6lgesinde a\u011fr\u0131 bildirilmi\u015ftir. Genel olarak en s\u0131k rapor edilen etkiler ise ate\u015f (%46), yorgunluk (%44), ba\u015f a\u011fr\u0131s\u0131 (%39) ve kas a\u011fr\u0131s\u0131 (%17) olmu\u015ftur (13). \u00c7al\u0131\u015fmam\u0131zda ise bu etkilerin \u00e7o\u011fu %53.5 oran\u0131yla hafif veya orta \u015fiddette izlenmekle birlikte \u00e7o\u011funlukla a\u015f\u0131lamadan sonraki ilk 24 saat i\u00e7inde meydana geldi\u011fi g\u00f6r\u00fcld\u00fc. Ayr\u0131ca bu etkiler COVID-19 \u00f6yk\u00fcs\u00fc olan grupta daha y\u00fcksek oranda olup aradaki fark istatistiksel olarak da anlaml\u0131 d\u00fczeyde bulundu.<\/span><\/p>\n

Sonu\u00e7 olarak; COVID-19 ge\u00e7irme \u00f6yk\u00fcs\u00fc olan bireylerde a\u015f\u0131 sonras\u0131 istenmeyen etki oranlar\u0131n\u0131n y\u00fcksek oldu\u011fu g\u00f6r\u00fcld\u00fc. Bu durumun COVID-19 sonras\u0131 geli\u015fen antikor yan\u0131t oranlar\u0131 ile ili\u015fkili olabilece\u011fi d\u00fc\u015f\u00fcn\u00fclse de olgu say\u0131lar\u0131n\u0131n yetersiz olmas\u0131, infeksiyon ve a\u015f\u0131 sonras\u0131 olu\u015fan antikor yan\u0131t\u0131n\u0131n belirlenmemi\u015f olmas\u0131 \u00e7al\u0131\u015fman\u0131n s\u0131n\u0131rl\u0131l\u0131klar\u0131d\u0131r. A\u015f\u0131 sonras\u0131 geli\u015fen istenmeyen etkilerde potansiyel risk fakt\u00f6rlerinin daha iyi anla\u015f\u0131lmas\u0131n\u0131 sa\u011flamak i\u00e7in a\u015f\u0131 g\u00fcvenli\u011fi konusunda daha fazla ba\u011f\u0131ms\u0131z veriye ihtiya\u00e7 vard\u0131r. Ayr\u0131ca, g\u00fcn\u00fcm\u00fczde geli\u015ftirilen a\u015f\u0131 faz \u00e7al\u0131\u015fmalar\u0131 sonucu g\u00fcvenli ve etkili a\u015f\u0131 uygulamalar\u0131 ile birlikte kitlesel a\u015f\u0131lama deneyimlerinin COVID-19 pandemisini kontrol alt\u0131na almada ne kadar etkili oldu\u011fu g\u00f6sterilmi\u015ftir.\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

G\u0130R\u0130\u015e SARS-CoV-2 virusuna maruziyet, asemptomatik infeksiyondan \u015fiddetli akut solunum s\u0131k\u0131nt\u0131s\u0131 ve \u00f6l\u00fcme kadar de\u011fi\u015fen bir dizi klinik bulgu ile sonu\u00e7lanabilir (1,2). Bu infeksiyonu \u00f6nlemeye y\u00f6nelik ger\u00e7ekle\u015ftirilen a\u015f\u0131lama uygulamalar\u0131, pandemiyi kontrol alt\u0131na almak i\u00e7in en umut verici yakla\u015f\u0131m olarak kabul edilmektedir. SARS-CoV-2\u2019nin neden oldu\u011fu COVID-19 hastal\u0131\u011f\u0131na kar\u015f\u0131 pek \u00e7ok a\u015f\u0131 geli\u015ftirme \u00e7al\u0131\u015fmas\u0131 y\u00fcr\u00fct\u00fclm\u00fc\u015f olup a\u015f\u0131 adaylar\u0131n\u0131n […]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[5129],"tags":[4851,5174,3675,3452],"class_list":["post-26369","post","type-post","status-publish","format-standard","hentry","category-ozgun-arastirma","tag-asi","tag-covid-19","tag-saglik-calisanlari","tag-yan-etkiler"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/26369","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/comments?post=26369"}],"version-history":[{"count":4,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/26369\/revisions"}],"predecessor-version":[{"id":26839,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/posts\/26369\/revisions\/26839"}],"wp:attachment":[{"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/media?parent=26369"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/categories?post=26369"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.klimikdergisi.org\/tr\/wp-json\/wp\/v2\/tags?post=26369"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}