{"title":"[Off-label use of intravenous immunoglobulin g in a highly complex pediatric hospital in Argentina. A prospective observational study]","authors":"Roxana Rivero, Ingrid Strusberg, Silvia Joekes, Silvana Yori, Carolina Barros Herrero, Marcela Noemí Rousseau, Daniela Fontana","doi":"10.31053/1853.0605.v81.n2.42261","DOIUrl":"10.31053/1853.0605.v81.n2.42261","url":null,"abstract":"<p><strong>Introduction: </strong>The World Health Organization recommends prioritizing safe and effective drugs proven by clinical or epidemiological studies. However, in population groups with little research, a drug can be used for an indication or pharmaceutical form different from that approved by the regulatory agency (off-label), extrapolating data from studies in adults and exposing pediatric patients. to develop an Adverse Drug Reaction (ADR) due to safety considerations that have not been systematically studied. Intravenous immunoglobulin (IVIg), a high-cost drug, is used with scant evidence in some low-prevalence pathologies. This paper describes and analyzes the off-label use of IVIg at the J. P. Garrahan Pediatric Hospital.</p><p><strong>Methods: </strong>Observational, descriptive, prospective study on off-label indications of IVIg. The sampling technique was non-probabilistic and for convenience during 7 months.</p><p><strong>Results: </strong>305 IVIg infusions were studied, corresponding to 111 patients. The indication classification showed that 22% (n=67) of the infusions were off-label. In neurology there was a higher percentage of off-label indications (46%) and within them 45% corresponded to the use in neurological disorders. 81% of the doses indicated off-label were in the range 0.8-1g/kg. The off-label infusions presented 61.5% (n=8) of the ADRs. Those from the Neurology service represented 87.5%; 75% being from the \"Neurological disorders\" group.</p><p><strong>Conclusion: </strong>In some cases, IVIg was indicated in an off-label manner, finding a statistically significant relationship with the appearance of ADR. This finding motivates the proposition of new hypotheses to carry out more studies.</p>","PeriodicalId":38814,"journal":{"name":"Revista de la Facultad de Ciencias Medicas de Cordoba","volume":"81 2","pages":"254-269"},"PeriodicalIF":0.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11370868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Héctor Chiang Wong, María Del Carmen González Guzmán, Patricio González Saldaña
{"title":"[Primary immune thrombocytopenia linked to the ingestion of guinea pigs (Cavia porcellus)\u0000causality or coincidence?]","authors":"Héctor Chiang Wong, María Del Carmen González Guzmán, Patricio González Saldaña","doi":"10.31053/1853.0605.v81.n2.44592","DOIUrl":"10.31053/1853.0605.v81.n2.44592","url":null,"abstract":"<p><p>The guinea pig in Ecuador is synonymous with our ancestral gastronomy and cultural tradition, but because of the diet rich in L-canavanine (alfalfa) that they receive; could limit its consumption in patients with primary immune thrombocytopenia (ITP).\u0000\u0000Ingestion of alfalfa in humans can cause kidney failure and lupus-like syndrome. The John Hopkins Lupus Center recommends avoiding it in the diet of patients with Systemic Lupus Erythematosus (SLE), as it aggravates inflammation by stimulating immune activity (flares).\u0000\u0000We present two cases of patients with ITP linked to guinea pig ingestion. It is probable</p>","PeriodicalId":38814,"journal":{"name":"Revista de la Facultad de Ciencias Medicas de Cordoba","volume":"81 2","pages":"391-402"},"PeriodicalIF":0.0,"publicationDate":"2024-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11370874/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471318","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}