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Sclerosi sistemica e vaccinazioni: studio di coorte basato su un registro della durata di tre anni riguardo il tasso di vaccinazione nei pazienti afferenti al Centro di Riferimento Ligure, Nord-Ovest Italia.
No full textTitolo della tesi: Sclerosi sistemica e vaccinazioni: studio di coorte basato su un registro della durata di tre anni riguardo il tasso di vaccinazione nei pazienti afferenti al Centro di Riferimento Ligure.
Introduzione
La Sclerosi Sistemica è una rara malattia infiammatoria cronica caratterizzata da una prevalenza compresa tra 7 e 700 casi per milione di persone con una importante differenza tra i vari Paesi e regioni del mondo.
Dal punto di vista patogenetico, la fibrosi tissutale tipica della malattia è sostenuta da un continuo protrarsi di infiammazione, in cui rivestono un ruolo chiave i radicali libero dell’ossigeno, le citochine pro-infiammatorie e il fibroblasto. I siti principalmente colpiti sono la cute, con danno prevalentemente vascolare, i reni, il cuore e il tratto gastrointestinale. Dal punto di vista clinico si possono distinguere due sottotipi di Sclerosi Sistemica: una variante limitata ed una variante diffusa. I pazienti con diagnosi di Sclerosi Sistemica, specialmente nella variante diffusa, presentano un rischio aumentato di complicazioni respiratorie severe che portano ad una maggiore frequenza di ricovero in terapia intensiva. In particolare, valutazioni epidemiologiche hanno mostrato che il periodo medio che intercorre tra la diagnosi ed il primo ricovero presso un’unità di terapia intensiva è di circa 78 mesi; la prima causa di ricovero in questi pazienti è rappresentata dall’insufficienza respiratoria acuta. Le principali cause di morte sono rappresentate da: malattia interstiziale polmonare, ipertensione arteriosa polmonare, cause cardiache ed infezioni.
Focalizzando l’attenzione sull’infezioni, la vaccinazione rappresenta il mezzo migliore di prevenzione e cura in pazienti fragili, permettendo di ridurre la mortalità e la morbilità da infezioni e garantendo una migliore qualità di vita. Sia la vaccinazione contro l’influenza stagionale sia quella contro lo Streptococco Pneumoniae sono attualmente raccomandate dalle linee guida redatte da EULAR, al fine di prevenire polmoniti, meningiti e sepsi.
Il presente studio ha l’obiettivo di analizzare la copertura vaccinale contro S. Pneumoniae e Influenza stagionale in pazienti con diagnosi di Sclerosi Sistemica e valutare eventuali variabili demografiche o cliniche correlate all’adesione vaccinale.
Materiali e Metodi
Previa acquisizione del consenso informato da parte di ogni partecipante, tutti I pazienti seguiti presso IRCCS Ospedale Policlinico San Martino, Genova, sono stati arruolati nello studio. Per ogni paziente arruolato sono stati raccolti dati demografici e clinici. Tutti i pazienti sono inoltre stati indirizzati presso U.O. Igiene, IRCCS Ospedale Policlinico San Martino e DiSSal, Università di Genova, per ottenere informazioni riguardo le vaccinazioni anti-influenza stagionale ed anti-pneumococco. La correlazione tra la vaccinazione e i vari fattori presi in esame è stata analizzata mediante test di Fisher (considerato significativo se p<0.05) e test d chi-quadro. Il cambiamento nella copertura vaccinale tra gli anni 2017-18, 2018-19 e 2019-20 è stato valutato mediante test di Fisher e il test del chi-quadro.
Risultati
Nel primo anno sono stati inclusi 72 pazienti, nel secondo anno 91 pazienti e nel terzo anno 92 pazienti. L’età media dei pazienti inclusi era di 63,51 (SD 13.98) anni con una mediana di 64 (IQR 54-74.5). La popolazione femminile superava l’80% con un rapporto maschi : femmine di 1:4. Il 50,5% dei pazienti era classificato come forma limitata di malattia, il 29,7% presentava la forma diffusa, il 19,8% presentava una diagnosi di sindrome overlap o forma non specificata. L’85,7% dei pazienti inclusi presentava altre comorbidità: malattia polmonare interstiziale nel 61% dei casi, patologia cardiovascolare nel 53,9%, insufficienza renale cronica di grado II o maggiore nel 18,7% e patologia neoplastica nel 4,4%. Il 34,1% presentava un’anamnesi positiva per fumo di sigaretta e il 40,7% era in terapia con una terapia immunosoppressiva.
L’analisi statistica riguardo la copertura vaccinale nella coorte presa in esame ha evidenziato aumento statisticamente significativo nella copertura vaccinale dal primo all’ultimo biennio preso in analisi (23.6% vs 76,9% per Pneumococco e 58,3% vs 75,5% per influenza). Il più ampio miglioramento si è verificato tra il primo ed il secondo biennio, mentre tra il secondo ed il terzo la differenza non è risultata statisticamente significativa seppur lasciando intuire la persistenza di un trend in progressiva salita. Tra i fattori demografici e clinici, l’età maggiore di 65 anni è risultato significativamente correlato con una maggiore aderenza vaccinale.
Discussione
Lo studio mostra come un adeguata informazione e educazione dei pazienti possa migliorare l’aderenza vaccinale, specialmente in soggetti fragili come i pazienti con diagnosi di Sclerosi Sistemica, con risultati soddisfacenti al di sopra del 75%, obiettivo del Piano Nazionale di Prevenzione Vaccinale per influenza e pneumococco. È proprio tra i soggetti fragili, in cui molti studi hanno dimostrato come le infezioni da influenza e pneumococco presentino un decorso di malattia più complicato ed una prognosi peggiore, che la vaccinazione svolge un’azione di cruciale importanza. Un punto chiave del presente studio, ed in contrasto con precedenti lavori, è il ruolo sostenuto dallo Specialista Immunologo nell’informare e educare il paziente circa l’utilità ed i benefici della vaccinazione. In tale ottica, il primo passo per migliorare la copertura vaccinale anche nella popolazione generale, sarebbe quello di potenziare l’educazione vaccinale e l’importanza delle azioni preventive, anche e soprattutto attraverso il Medico specialista in Medicina Generale. È importante sottolineare come l’età, nel presente studio, sia correlata con una maggiore accettazione della vaccinazione, dato presente anche nella popolazione generale ma con un tasso di vaccinazione, però, molto più basso (circa il 50% per l’influenza stagionale, dati del Ministero della Salute aggiornati al 2019).
Una limitazione dello studio esposto è la possibile presenza di bias di selezione in quanto la coorte presa in esame risulta costituita da pazienti affetti da una patologia rara ed altamente seguiti presso un centro specialistico.
In conclusione, un’adeguata informazione ed educazione del paziente può portare ad una soddisfacente aderenza vaccinale che si mantiene stabile e tende all’incremento nel corso degli anni. L’ottenimento di risultati analoghi non solo in pazienti affetti da Sclerosi Sistemica ma anche nella popolazione generale aiuterebbe gradualmente a creare un’immunità di gregge che a sua volta aumenterebbe l’efficacia della vaccinazione nei pazienti fragili andando a proteggerli maggiormente dalle forme più aggressive di malattia.Title: Systemic sclerosis and vaccinations: a three-year register-based cohort study about vaccination rate and uptake from Liguria referral center, northwest Italy
Introduction
Systemic Sclerosis is a chronic rare inflammatory disease characterized by a prevalence ranging from 7 to 700 cases per million with a significant difference among countries of the world.
The main pathogenetic effect behind the disease is the continuous cycle of inflammation followed by tissue fibrosis, sustained by reacting oxygen species, pro-inflammatory cytokines, and fibroblasts. The main areas affected are the skin, vascular system, and organs such as lungs, kidneys, heart, and the gastrointestinal tract, Clinically, patients can be divided into two different subtypes: limited cutaneous (lSSc) and diffuse cutaneous systemic sclerosis (dSSc). Patients diagnosed with Systemic Sclerosis, especially dSSc, are characterized by a higher risk of severe respiratory complications that may lead to an higher need of intensive medical care. Specifically, epidemiology showed that mean time from diagnosis to first admission to an intensive care unit is 78 months and the most frequent reason for admission is acute respiratory failure. Most common causes of death are interstitial lung disease, pulmonary hypertension, cardiac diseases, and infections.
Focusing on infections, vaccination is the best way to prevent and treat frail patients, thus reducing mortality and morbidity and guaranteeing an higher quality of life. In order to prevent pneumonia, meningitis and sepsis, both vaccinations against seasonal flu and Streptococcus Pneumoniae are recommended by EULAR guidelines.
The aim of this study is to analyze vaccination coverage against Streptococcus Pneumoniae and seasonal Flu in patients diagnosed with Systemic Sclerosis and investigate demographic and clinical variables significantly related to vaccine acceptance.
Materials and Methods
All adult patients followed up at IRCCS Polyclinic San Martino Hospital in Genoa were recruited for the study. Informed consent was obtained by each enrolled patient. Demographic and clinical data were recorded for each patient. Each patient was then evaluated by Department of Hygiene at IRCCS Polyclinic San Martino Hospital and DiSSal, University of Genoa in order to adequate inform about seasonal flu and pneumococcal vaccinations. Correlation between vaccination and variables has been evaluated with Fisher's exact test (the result is significant if p <0.05) and the chi-square test. Changes in vaccination coverage between 2017-18 and 2018-19 seasons was examined with Fisher's exact test (the result is significant if p <0.05) and the chi-square test.
Results
In the first year 72 patients, in the second year 91 patients and in the third year 92 patients were enrolled, respectively. The average age was 63.51 (SD 13.98) years, with a median of 64 (IQR 54-74.5). The female population was just over 80% and the male to female ratio was 1: 4, in line with the epidemiology of the disease. 50% of patients was diagnosed with lcSSc, 29.7% of the cohort was diagnosed with dcSSc, 19.8% of patients was diagnosed with an overlapping or unspecified form.
Most patients were affected by comorbidities (85.7%). In order of prevalence pulmonary, interstitial lung disease was the most represented with a prevalence of 61.5%, followed by cardiovascular diseases (53.9%), chronic renal failure of grade II or higher in 18.7%, and neoplastic disease in 4.4%. 34.1% of patients had a positive history of smoking and 40.7% were currently treated with an immunosuppressive therapy.
Statistical analysis showed a statistically significant increase in vaccination coverage from first to last year examined (23.6% vs 76,9% for Streptococcus Pneumoniae and 58,3% vs 75,5% for seasonal Flu). The most marked improvement was from the first to the second year whereas, despite the presence of a clear trend, difference between second and third year was not statistically significant. Among demographic and clinical variables, age over 65 significantly correlates with an higher vaccination adherence.
Discussion
This study showed that an adequate patient information and education can improve vaccination adherence, especially in frail subjects like patients diagnosed with Systemic Sclerosis, with satisfying results over 75%, in agreement with current recommendations. Influenza and pneumococcal infections present an higher rate of complications and a worse prognosis in frail patients, and vaccination plays a key role. In our study, the frequent follow-up in a specialistic Immunology Unit was of extreme importance, in order to inform and educate patients about available vaccinations and their benefits. Indeed, education and preventions may represent the best possibilities in general population too, especially by General Practitioner and Specialists. In our study, age over 65 has been correlated with a higher vaccination adherence, as showed in general population, but with a vaccination rate much lower (50% for seasonal flu in general population, in 2019).
The study may present a selection bias because the studied cohort was made of patients diagnosed with a rare disease with an high-intensity and frequent follow-up.
In conclusion, adequate patient information and education may lead to satisfying vaccination adherence, that keep stabile and trend to increase through years. The achievement of similar result not only in Systemic Sclerosis patients but also in general population could lead to herd immunity that, in turn, could increase efficacy of vaccination in frail patient thus leading to a further protection
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