Sistematični pregled in metaanaliza vpliva zdravil na kakovost življenja bolnikov s kronično vnetno črevesno boleznijo

Jesenšek, Petra (author), Vovk, Tomaž (mentor), Drobne, David (co-mentor)

Ozadje: Kronična vnetna črevesna bolezen (KVČB) je doživljenjska bolezen, za katero so značilni akutni zagoni in obdobja remisije. Delimo jo na ulcerozni kolitis (UK) in Crohnovo bolezen (CB), v kolikor pa ne moremo potrditi ene izmed oblik, stanje opredelimo kot indeterminiran ali neklasificiran kolitis. Dolgotrajno vnetje prebavil lahko povzroči trajne okvare organov in zaplete, zato je pomembno zgodnje odkrivanje in zdravljenje bolezni. KVČB zdravimo z zdravili, kirurškimi posegi in dietno prehrano, cilj zdravljenja je vzpostavitev globoke remisije. Kakovost življenja KVČB bolnikov, predvsem tistih z akutno obliko bolezni, je močno okrnjena, saj jih bolezen prizadene tako na fizični kot duševni ravni. Namen: Namen magistrske naloge je sistematično pregledati literaturo in s pomočjo metaanalize preučiti vpliv zdravil na kakovost življenja odraslih bolnikov z zmerno do hudo obliko KVČB. Rezultate metaanalize bomo primerjali glede na tip bolezni, zdravilo, trajanje terapije ter način aplikacije. Metode: Za namene metaanalize in sistematičnega pregleda smo preiskali bazo PubMed, da bi našli instrument za merjenje kakovosti življenja, ki se pri bolnikih s KVČB uporablja najpogosteje. Nato smo v 4 podatkovnih bazah iskali randomizirane, s placebom kontrolirane raziskave, v katerih so z izbranim instrumentom merili kakovost življenja odraslih bolnikov na terapiji z biološkimi ali nebiološkimi zdravili. Metaanalizo smo izvedli s pomočjo programske opreme Review Manager 5.4.1., rezultate pa smo predstavili v obliki drevesnega diagrama. Nazadnje smo ocenili pristranost vključenih raziskav in izvedli občutljivostno analizo. Rezultati: Po pregledu instrumentov smo ugotovili, da se za določanje kakovosti življenja odraslih bolnikov s KVČB najpogosteje uporablja vprašalnik IBDQ (Inflammatory Bowel Disease Questionnaire). V metaanalizo smo vključili 27 raziskav, ki so ustrezale našim vključitvenim in izključitvenim kriterijem. Ugotovili smo, da se na začetni in vzdrževalni terapiji, tako z biološkimi kot nebiološkimi zdravili, kakovost življenja bolnikov s KVČB statistično značilno izboljša glede na placebo. V začetni terapiji UK in CB ter vzdrževalni terapiji CB imajo večji vpliv na boljšo kakovost življenja nebiološka zdravila. Pri vzdrževalni terapiji UK smo zaradi nezadostnega števila raziskav v metaanalizo vključili le dve z biološkimi zdravili in ta so se izkazala za učinkovita pri izboljšanju kakovosti življenja UK bolnikov na vzdrževalni terapiji v primerjavi s placebom. V metaanalizi vpliva načina aplikacije zdravila na kakovost življenja pa smo pri začetni in vzdrževalni terapiji dognali, da se največje izboljšanje pojavi v podskupini s peroralno (PO) aplikacijo zdravila, sledi ji intravenska (IV) in nazadnje še subkutana (SC) aplikacija zdravila. Sklepi: Biološka in nebiološka zdravila izboljšajo kakovost življenja bolnikov z zmerno do hudo obliko KVČB. PO aplicirana zdravila izboljšajo kakovost življenja bolnikov v največji meri, sledijo jim zdravila, aplicirana IV in SC. Teža bolezni pomembno vpliva na izbor zdravila in posledično tudi na način aplikacije. Navadno se bolnike najprej zdravi s PO zdravili, v kolikor so ta neučinkovita pa nastopi tudi SC in IV zdravljenje. Pri lažji obliki bolezni bodo imela torej zdravila večji učinek na kakovost življenja.

• Language: Slovenian
• Keywords: KVČB, metaanaliza, kakovost življenja, IBDQ
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-137135
• Publication date in RUL: 02.06.2022

Secondary language

• Language: English
• Title: Systematic review and meta-analysis of the medical interventions impact on quality of life in patients with inflammatory bowel disease

Abstract

Background: Inflammatory Bowel Disease (IBD) causes chronic inflammation of gastrointestinal tract and is characterised by periods of relapse and remission. Main types of IBD are ulcerative colitis (UC) and Crohn's disease (CD). When IBD type cannot be classified, disease is defined as unclassified or indeterminate colitis. Long term gastrointestinal inflammation can cause permanent organ damage and other complications, therefore early detection and treatment of IBD is highly important. Treatment target in IBD is deep remission that can be achieved with medication, surgery and diet. IBD also affects quality of life, which is decreased due to physical and mental burden of the disease. Aim: The aim of this study was to systematically review the literature and conduct a meta-analysis of the medical interventions' impact on quality of life in adult patients with moderate to severe IBD. The results of meta-analysis will be compared based on disease type, drug type, treatment duration and administration route. Methods: We performed a search in PubMed to find a heath related quality of life instrument that is most widely used in IBD patients. Then a systematic literature search was performed in 4 databases to find randomised, placebo controlled clinical studies where impact of medical intervention on quality of life was measured in adult IBD patients. Meta-analysis was conducted with Review Manager 5.4.1. software and results were presented as forest plots. Finally, we assessed risk of bias and conducted a sensitivity analysis. Results: The most frequently used quality of life instrument in IBD patients is IBDQ (Inflammatory Bowel Disease Questionnaire). 27 studies met inclusion criteria and were included in meta-analysis. We concluded that induction and maintenance therapy with both biologic and nonbiologic drugs improves quality of life in IBD patients. Nonbiologics have a bigger impact on improving quality of life in UC patients receiving induction therapy and also in CD patients receiving induction and maintenance therapy. We also compared the results according to drug application and we established that oral drugs achieve the biggest improvement of quality of life. Oral drugs are followed by intravenous and subcutaneous drugs. Conclusions: Biologic and nonbiologic drugs statistically significantly improve quality of life in patients with moderate to severe IBD. Considering route of administration, oral drugs improve quality of life the most. The severity of the disease affects the choice of a drug and consequently its administration. Patients are usually first treated with oral drugs and if those are ineffective, intravenous and subcutaneous drugs are used. In the case of a milder disease, drugs will therefore have a greater impact on quality of life.

• Keywords: IBD, meta-analysis, quality of life, IBDQ