La journée des patients atteints de narcolepsie est ponctuée ainsi d'alternances d'états de veille et d'accès de sommeil[14]. Results of the main analysis considering date of diagnosis as the index date, and of the sensitivity analyses performed regarding date of referral for MSLT or date of first symptoms onset. The aim of the sub-analysis of the Narcoflu-VF study presented here was (i) to investigate the association between pandemic H1N1 vaccination and narcolepsy-cataplexy in both children and adults compared with gender-, age- and geographic location-matched controls in France; and (ii) to compare the phenotype of cases with narcolepsy-cataplexy according to exposure to H1N1 vaccination. Des recherches sont actuellement en cours sur une possible origine de la narcolepsie et des hypersomnies liée à un défaut de production d'histamine[24]. Diagnosis of narcolepsy-cataplexy was established using the revised International Classification of Sleep Disorders (ICSD, 2005). C'est le professeur Michel Jouvet qui a découvert cet état du sommeil appelé à juste titre « sommeil paradoxal ». Adultes et personnes âgées. However, this cannot be fully certified and the occurrence of misclassification for exposure cannot be eliminated. Comparison of socio-demographic and medical history of patients with narcolepsy-cataplexy and matched control subjects. Elles peuvent être très effrayantes et les malades développent alors une véritable peur de se coucher. Lorsque cesse la cataplexie, le malade garde le souvenir de tout événement survenu au cours de son accès puisqu'il était parfaitement conscient. Among the 62 remaining eligible cases, 66.1% were males, median age was 15.3 years (range 5–51 years), and 35 (56.5%) were <18 years of age. La narcolepsie touche un peu plus d'hommes que de femmes[9]. For Permissions, please email: journals.permissions@oup.com, Aberrant striatal dopamine links topographically with cortico-thalamic dysconnectivity in schizophrenia, Diagnostic challenges in chronic inflammatory demyelinating polyradiculoneuropathy, Effects of dopamine on reinforcement learning in Parkinson’s disease depend on motor phenotype, Cross-frequency coupling between gamma oscillations and deep brain stimulation frequency in Parkinson’s disease, National Narcolepsy Study Steering Committee, 2012, http://www.ecdc.europa.eu/en/publications/Publications/Forms/ECDC_DispForm.aspx?ID=959, http://healthupdate.gov.ie/wp-content/uploads/2012/04/Final_Report_of_National_Narcolepsy_Study_Steering_Committee-latest1.pdf, http://www.thlfi/en_US/web/en/pressrelease?id=22930, Receive exclusive offers and updates from Oxford Academic, Clinical and polysomnographic course of childhood narcolepsy with cataplexy, Rapid eye movement sleep behaviour disorder in patients with narcolepsy is associated with hypocretin-1 deficiency, Correlates of sleep-onset REM periods during the Multiple Sleep Latency Test in community adults. Au cours de l'année, le patient atteint de narcolepsie peut voir apparaître des moments de répit, avec une diminution du symptôme, de sa profondeur ou de sa fréquence. Non-flu vaccinations during the past 2 years. You can change your cookie settings at any time. Sensitivity analyses taking into account either date of referral for MSLT or date of onset of first symptoms did not change the results. Dans de rares cas, le corps entier peut se paralyser et les muscles devenir raides. A ce jour, un total de 61 cas de narcolepsie (dont 47 associés à des épisodes cataplexiques) a été rapporté chez des personnes vaccinées par Pandemrix (56 cas pour 4 100 000 personnes vaccinées), Panenza (3 cas pour 1 600 000 personnes vaccinées) et un vaccin grippal A/H1N1 dont le nom de spécialité n’a pas été identifié (2 cas). All cases agreeing to participate were validated using the Brighton collaboration criteria by an expert committee to fully confirm the diagnosis of typical narcolepsy-cataplexy (Poli et al., 2012). Les 25 cas de narcolepsie observés après vaccination sont survenus chez 14 personnes de 16 ans et plus et 11 chez des adolescents âgés de 8 à 15 ans. No differences were found regarding the frequency of history of infections. Dans de nombreux cas, des siestes organisées peuvent réduire la nécessité du traitement ou améliorer son efficacité. Effets indésirables 1. This was not an industry-supported study. Gastrointestinal tract infectious episode between 1 January 2005 and index date. This ensured complete information for most patients concerning type of vaccine and date of vaccination. Dans les années 2000-2010, chaque année en France ce sont environ 900 nouveaux cas de narcolepsie qui sont déclarés, chez des adolescents ou des adultes jeunes la plupart du temps[11]. La cataplexie est une perte brusque du tonus musculaire sans altération de la conscience et survenant à un moment quelconque de la journée. Cas de narcolepsie avec cataplexie notifiés en France à la suite d’une vaccination contre le virus de la grippe A/H1N1 - Communiqué; Pandémie de grippe A (H1N1)v : bilan de pharmacovigilance des vaccins (11/05/2010) (102 ko) La narcolepsie ou « maladie de Gélineau » est un trouble du sommeil chronique ou dyssomnie rare. , seul vaccin utilisé dans ces deux pays lors de la campagne de vaccination pandémique 2009/2010. Associate Prof of Medicine, Harvard University & David Zieve, Medical Director of A.D.A.M, Inc. ANSM (Agence nationale de sécurité du médicament et des produits de santé), Eigentümliche mit Einschlafen verbundene Anfälle, Jean-Baptiste Gélineau « De la narcolepsie », Age at onset of narcolepsy in two large populations of patients in France and Quebec. Elle peut s’accompagner, à la suite d’une émotion, de pertes soudaines du tonus musculaire (cataplexie). For these reasons, patient knowledge on this specific vaccination appear reliable at least for the fact of being vaccinated and the period of vaccination, even if vaccination type and exact date were considered only when they could be certified according to information from the medical booklet or the additional H1N1 vaccination certificate. The sleep disorder canine narcolepsy is caused by a mutation in the hypocretin (orexin), The hypocretins: hypothalamus-specific peptides with neuroexcitatory activity, Le sel sodique d'un acide est une formule chimique de cet acide dans laquelle on a remplacé un atome, Dernière modification le 3 octobre 2020, à 00:31, commission départementale des permis de conduire, test itératif de latence à l'endormissement, Vaccins pandémiques grippe A (H1N1) et narcolepsie : Résultats de l’étude européenne et de l’étude cas-témoins française, https://cordis.europa.eu/news/rcn/33898_fr.html, http://www.lakemedelsverket.se/Alla-nyheter/Nyheter-2013/Registerstudie-bekraftar-okad-risk-for-narkolepsi-efter-vaccination-med-Pandemrix-hos-barn-och-ungdomar-och-visar-aven-en-riskokning-hos-unga-vuxna/. Le RCP du Xyrem, dont la version en vigueur est en permanence disponible en ligne sur le site web de l'ANSM[29], fournit aussi de nombreuses indications très détaillées sur les études préalables qui ont été faites avant son AMM, les panels de tests, les caractéristiques thérapeutiques, les propriétés pharmacodynamiques et pharmacocinétiques et les nombreux risques déjà identifiés ou restant à qualifier et quantifier encore à ce jour. Of the 177 cases with narcolepsy (all types considered) initially contacted to participate to the full Narcoflu-VF study, 127 responded and agreed to participate. To prevent the impact of professional/media attention on the rate of narcolepsy-cataplexy recognition, we analysed the results taking into account the recruitment period of date of diagnosis, date of referral for MSLT and date of onset of symptoms before and after 1 July 2010. Donc, des médicaments connus par ailleurs pour leur rôle antidépresseur (clomipramine, imipramine, ou protriptyline, venlafaxine). All patients presented excessive daytime sleepiness, typical cataplexy, at least two sleep-onset REM periods and a mean sleep latency <8 min during the MSLT. Up to four control subjects were individually matched to each case according to sex, age (year of birth ± 2 years) and geographic location during the same recruitment period. Non-flu vaccinations between 1 January 2005 and index date, Main analysis (index date: date of diagnosis), Sensitivity analysis (index date: date of referral for MSLT), Sensitivity analysis (index date: date of onset of first symptoms), Index date: date of diagnosis (65 cases, 148 controls), Index date: date of referral for MSLT (64 cases, 142 controls), Index date: date of onset of first symptoms (45 cases, 105 controls), Index date: date of diagnosis (55 cases, 117 controls), Index date: date of referral for MSLT (51 cases, 106 controls), Index date: date of onset of first symptoms (41 cases, 89 controls), Age at date of diagnosis, years, median (IQR), Delay between excessive daytime sleepiness and cataplexy onset, in months (median, IQR), Delay of diagnosis, in months (median, IQR), Daily number of cataplexy attacks, median (IQR), Night REM sleep latency, min, median (IQR). No difference was found regarding history of infections. Le sommeil arrive en moyenne après 15 minutes de repos, durée nommée « latence à l'endormissement ». Une éducation thérapeutique peut et doit être mise en place pour les patients qui le souhaitent. Narcolepsy with cataplexy is a disabling orphan disorder caused by a loss of hypothalamic hypocretin/orexin-producing neurons with the main peak of disease onset at 16 years of age (Dauvilliers et al., 2001, 2007). De plus, le malade lui-même hésite parfois très longtemps avant de consulter en raison de la nature mentale de ces symptômes, d'où le retard au diagnostic positif. Dans tous les cas, la pratique des siestes qui ne doivent pas dépasser 20 minutes ou des « sommeils flash » est recommandée. Our results indicate that H1N1 vaccination, mostly represented by Pandemrix® in our study, could have contributed to narcolepsy-cataplexy in both children and adults. A campaign of vaccination against pandemic H1N1 influenza was implemented in France using both ASO3-adjuvanted and non-adjuvanted vaccines. Associations between streptococcus infections and recent onset cases of narcolepsy-cataplexy were also reported with large frequency of high levels of serum antibodies against streptolysin O (65%) within 1 year of onset compared with age-matched controls (26%) (Aran et al., 2009). Information on the characteristics of narcolepsy-cataplexy was collected from medical records. Leur pratique n'est pas immédiate et demande un certain entraînement et une certaine persévérance pour devenir efficace. Mais pour certains malades, la pratique de ces siestes est insuffisante et la maladie reste lourdement handicapante. La narcolepsie peut être associée avec des lésions de l'amygdale cérébrale. At least one seasonal influenza vaccination between 1 January 2005 and index date. Narcobank is a study financed by a national research programme from the French Health Ministry in 2007 with aims to study biomarkers and genetic risk factors of narcolepsy and other rare central hypersomnias. De même, il existe des patients atteints de narcolepsie non porteurs de ces formes[9]. Considering only exposure to AS03-adjuvanted vaccine, we found a strong association with narcolepsy-cataplexy in both children and adults. In conclusion, in this case-control study, we found a strong association between H1N1 vaccination, mostly represented by Pandemrix®, and narcolepsy-cataplexy in both children and adults. Le mésusage bien connu de cette molécule est même la première information fournie explicitement au tout début de la notice et du RCP (Résumé des Caractéristiques du Produit). Results did not vary significantly between analyses, but were not significant for the period before July 2010 when considering diagnosis date as the index date. Published by Oxford University Press on behalf of the Guarantors of Brain. Thus, in the sensitivity analysis, cases vaccinated after first onset of symptoms were already considered as non-exposed. Control subjects were recruited from: (i) patients from the hospitals to which the participating sleep centres belonged; and (ii) healthy volunteers from a national database (Narcobank). Seule la dose administrée de la molécule active fait la différence entre ces deux utilisations, thérapeutique ou illégale. First, each case was validated independently by two experts blind to the vaccination status and who had not been involved in the case recruitment. Elles sont mal comprises ; probablement multiples, et peut-être synergiques. Full or Associate Professor, Head of the Division of Geriatrics, New Faculty Positions - Molecular Epidemiology, Endowed Chair and Head, Division of Infectious Diseases & Co-Director, Center for Infectious Diseases, Age at primary index date (i.e. MP d Ortho has received funds for speaking from Cephalon and board engagements with Bioprojet. La fréquence de ces formes varie suivant le type ethnique (DR2 - DQw1 chez les Européens) et n'implique nullement une narcolepsie active sur le plan clinique. Estimation of the association between H1N1 vaccination and the risk of narcolepsy-cataplexy. No between group differences were found for HLA DQB1*06:02 reported in 92% of vaccinated versus 85.2% in non-vaccinated cases. Polysomnography recordings revealed similar total sleep time, REM sleep latency and percentage of patients with apnea/hypopnea index >15/h between groups. A structured telephone interview was performed to collect information on medical history, past infections and vaccinations. For cases with a diagnosis date before July 2010 and matched controls, the odds ratio was estimated at 2.8 (95% CI 0.8–10.5); it was estimated at odds ratio 7.6 (95% CI 2.8–20.8) for those with a later index date. Additional analyses were performed: (i) an analysis including cases with narcolepsy-cataplexy that were excluded from the main analysis because their date of onset of symptoms was before the date of H1N1 vaccination. Second, to allow for consideration of cases who, after the exposure period, would have had a longer time to develop symptoms and be diagnosed with narcolepsy-cataplexy, we decided to consider a longer period of recruitment after the vaccination campaign than that retained in the VAESCO protocol (ECDC, 2012). No specific emphasis was put on H1N1 vaccination, to limit the possibility of a participation bias related to this specific exposure. Only confirmed cases of narcolepsy-cataplexy for whom the date of onset of symptoms—either excessive daytime sleepiness or cataplexy—was after 1 January 2005, and after the date of H1N1 vaccination for exposed cases, were included in the main analysis. En effet, deux centres de référence et une dizaine de centres de compétences sont présents sur le territoire français pour l’accueil et la prise en charge des personnes narcoleptiques (www.orpha.net Chaque année, 900 nouveaux cas de narcolepsie sont dénombrés en France. Taken together, the majority of the results from the H1N1 vaccine story reinforce the underlying autoimmune hypothesis of narcolepsy-cataplexy. The protocol was approved by the research scientific committee of the ANSM and the Bordeaux hospital ethics committee. L'année suivante, en 1881, le Dr Gélineau publie l'ouvrage suivant : « Gélineau, Jean-Baptiste Edouard. All subjects gave written informed consent to participate. En outre, il a participé, à partir de l’année 2011, au programme national de recherche sur la narcolepsie. Vaccine Adverse Event Surveillance & Communication (VAESCO) network report, Narcolepsy is strongly associated with the T-cell receptor alpha locus, Narcolepsy onset is seasonal and increased following the 2009 H1N1 pandemic in china, Decreased incidence of childhood narcolepsy two years after the 2009 pH1N1, Genome-wide association study identifies new HLA class II haplotypes strongly protective against narcolepsy, A new method for measuring daytime sleepiness: the Epworth sleepiness scale, Common variants in P2RY11 are associated with narcolepsy, Narcolepsy with hypocretin/orexin deficiency, infections and autoimmunity of the brain, Complex HLA-DR and -DQ interactions confer risk of narcolepsy-cataplexy in three ethnic groups, Risk of narcolepsy in children and young people receiving AS03 adjuvanted pandemic A/H1N1 2009 influenza vaccine: retrospective analysis, Factors associated with a delay in the diagnosis of narcolepsy, Occurrence of narcolepsy with cataplexy among children and adolescents in relation to the H1N1 pandemic and Pandemrix vaccinations—results of a case inventory study by the MPA in Sweden during 2009-2010, National Narcolepsy Study Steering Committee, Investigation of an Increase in the Incidence of Narcolepsy in Children and Adolescents in 2009 and 2010, AS03 adjuvanted AH1N1 vaccine associated with an abrupt increase in the incidence of childhood narcolepsy in Finland, Increased incidence and clinical picture of childhood narcolepsy following the 2009 H1N1 pandemic vaccination campaign in Finland, Narcolepsy as a possible adverse event following immunization: case definition and guidelines for data collection, analysis and presentation, Increased childhood incidence of narcolepsy in western Sweden after H1N1 influenza vaccination, The National Institute for Health and Welfare recommends discontinuation of Pandemrix vaccinations (THL), Finnish National Institute for Health and Welfare website, The International Classification of Sleep Disorders (ICSD), © The Author (2013).
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