Reslizumab u odnosu na placebo za neadekvatno kontrolisanu, tešku eozinofilnu astmu: meta-analiza

  • Miloš N. Milosavljević University of Kragujevac, Faculty of Medical Sciences, Kragujevac, Serbia
  • Slobodan M. Jankovic University of Kragujevac, Faculty of Medical Sciences, Kragujevac, Serbia
  • Ana V. Pejčić University of Kragujevac, Faculty of Medical Sciences, Kragujevac, Serbia
  • Jasmina R. Milovanović University of Kragujevac, Faculty of Medical Sciences, Kragujevac, Serbia
  • Valentina D. Opančina University of Kragujevac, Faculty of Medical Sciences, Kragujevac, Serbia
  • Marina J. Kostić University of Kragujevac, Faculty of Medical Sciences, Kragujevac, Serbia
DOI: https://doi.org/10.2298/VSP161124013M
Ključne reči: astma;, eozinofilija;, antiastmatici;, reslizumab;, lečenje, ishod;, meta-analiza.

Sažetak


Uvod/Cilj. Reslizumab je humanizovano monoklonsko antitelo, stvoreno rekombinantnom DNK tehnologijom, ko­je se vezuje za cirkulišući interleukin 5 (IL-5) i dovodi do nishodne regulacije signalnog puta koji pokreće ovaj interleukin. Reslizumab je indikovan kao dodatna terapija održa­vanja kod bolesnika starijih od 18 godina sa teškim oblikom eozinofilne astme, čiji simptomi nisu dovoljno kontrolisani inhalacionim kortikosteroidima. Cilj ove meta-analize je bio da proceni efikasnost i bezbednost reslizumaba u poređenju sa placebom kod bolesnika sa neadekvatno kontrolisanom, umerenom do teškom astmom, i sa povišenim brojem eozinofila u krvi. Metode.  Naša meta-analiza je zasnovana na sistematskom pretraživanju literature i selekciji dokaza visokog kvaliteta prema prethodno postavljenim kriterijumima za uključivanje i isključivanje. Efekti reslizumaba i placebo su sumirani pomoću programa Review Menager (RevMan) 5.3.5, a hetereogenost studija je procenjena Kohranovim Q testom i vrednošću I². Ispitano je nekoliko tipova sklonosti (bias), pri čemu je i sklonost za izostavljanje publikacija analizirana pomoću Funnel grafika i Egerove regresije. Rezultati. Meta-analiza je uključila pet randomiziranih, placebo-kontrolisanih kliničkih studija. Reslizumab 3.0 mg/kg je doveo do značajnog poboljšanja forsiranog ekspiratornog volumena u 1. sekundi (FEV 1) (srednja razlika 0,15 [0,10, 0,21]) i forsiranog vitalnog kapaciteta (FVC-a) (srednja razlika 0,21 [0,09, 0,32]) posle perioda lečenja od 15 do 16 nedelja, značajnog smanjenja u odnosu na placebo Ashtma Control Questionnaire (ACQ) zbira (srednja razlika -0,28 [-0,41, -0,16]) i značajnog povećanja u odnosu na placebo od os­novne vrednosti Asthma Quality of Life Questionnaire (AQLQ) ukupnog zbira (srednja razlika 0,24 [0,06, 0,43]). Takođe, reslizumab 3,0 mg/kg je izazvao manje neželjenih dejstava u odnosu na placebo (OR 0,67 [0,51, 0,88]), posebno kada je u pitanju pogoršanje astme(OR 0,53 [0,36, 0,77]) ili bronhitis (OR 0,42 [0,24, 0,74]). Zaključak. Na osnovu publikovanih kliničkih studija reslizumab se može smatrati efikasnom i bezbednom terapijskom opcijom kod bolesnika sa teškom, neadekvatno kontrolisanom eozinofilnom astmom.

Reference

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Objavljeno
2020/12/08
Broj časopisa
Vol. 75 Br. 9 (2018): September Vol. 75 (No. 9)
Rubrika
Metaanaliza