Jornal de pediatriaPub Date : 2025-11-01Epub Date: 2025-12-04DOI: 10.1016/j.jped.2025.101481
Renato Soibelmann Procianoy
{"title":"Jornal de Pediatria at a turning point: four years of growth and the road ahead in the age of AI","authors":"Renato Soibelmann Procianoy","doi":"10.1016/j.jped.2025.101481","DOIUrl":"10.1016/j.jped.2025.101481","url":null,"abstract":"","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 6","pages":"Article 101481"},"PeriodicalIF":2.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145680985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Analysis of the main characteristics of children's skin moisturizers in the Brazilian market","authors":"Bruna Rocha Reolon Branchi , Ana Elisa Kiszewski , Renan Rangel Bonamigo","doi":"10.1016/j.jped.2025.101438","DOIUrl":"10.1016/j.jped.2025.101438","url":null,"abstract":"<div><h3>Objective</h3><div>One of the possible causes of skin microbiome imbalance is the use of dermocosmetics with inadequate pH. This study aims to critically evaluate several children's moisturizers regarding their characteristics so that we can verify the tendency of the products available on the market and whether they are slightly acidic. The importance of dermocosmetics formulated without ingredients with allergenic potential is also discussed in this work.</div></div><div><h3>Method</h3><div>Observational, analytical, cross-sectional and quantitative study. Several brands of children's moisturizers were selected and divided into two groups: group 1 (G1), with moisturizers focused on the care of children with normal skin; and group 2 (G2), with moisturizers with a therapeutic focus on atopic children. We analyzed the pH of each one of the moisturizers, as well as cost, presence of potentially allergenic components and other data contained in the packaging.</div></div><div><h3>Results</h3><div>The members of G1 had an average pH of 5.81 ± 0.35, while the members of G2 had an average pH of 5.42 ± 0.28, with this difference being considered statistically significant (<em>p</em> ≤ 0.001). G1 differed in terms of cost, which was more affordable for the user, when compared to G2 (<em>p</em> ≤ 0.001), but with a predominance of potential allergens in its composition (<em>p</em> = 0.018).</div></div><div><h3>Conclusion</h3><div>This study demonstrates that all moisturizers analyzed in this study respected the acidic pH; however, the group of moisturizers with a therapeutic focus on atopic children had an even lower pH and lower allergenic potential in their composition compared to the group of moisturizers focused on care of children with normal skin.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 6","pages":"Article 101438"},"PeriodicalIF":2.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145006196","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jornal de pediatriaPub Date : 2025-11-01Epub Date: 2025-09-19DOI: 10.1016/j.jped.2025.101429
Thais Milioni Luciano, Mônica Freire Stechinni, Sonir Roberto Rauber Antonini
{"title":"Boys with constitutional delay of growth and puberty developed spontaneous puberty and reached standard adult height without pharmacological therapy","authors":"Thais Milioni Luciano, Mônica Freire Stechinni, Sonir Roberto Rauber Antonini","doi":"10.1016/j.jped.2025.101429","DOIUrl":"10.1016/j.jped.2025.101429","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate the patterns of pubertal development, growth, and adult height in untreated male patients with CDGP.</div></div><div><h3>Methods</h3><div>A retrospective study was conducted at a tertiary care center from 1984 to 2019. Medical records of 46 boys diagnosed with CDGP (after excluding those with hypogonadism) were included for further analysis.</div></div><div><h3>Results</h3><div>Most patients were born at term (78%) and appropriate for gestational age (85%). A family history of delayed puberty was noted in 50%. The median age at initial evaluation was 14.3 years (range: 4.8–16.2 years). Short stature before puberty was the main reason for seeking medical attention (48%). Short stature was common at the first evaluation (93%) but improved over time; at the final assessment, only 17% of the patients remained short. For those who reached adult height, the height Z-scores were comparable to target height. Predictions using the Bayley-Pinneau method often overestimated adult height. Delayed bone age was present in 82% of patients at initial evaluation. The median age of spontaneous pubertal onset was 15 years, with a median duration of 2.1 years (range: 1.2–4.8 years, n = 33). None of the patients received pharmacological treatment. The median age at Tanner stage G5 was 17.1 years.</div></div><div><h3>Conclusions</h3><div>In boys with CDGP, transient short stature improved spontaneously during puberty. Most achieved their target height without growth-promoting therapy. However, adult height predictions based on the Bayley-Pinneau method were often overestimated. Spontaneous puberty initiation and completion occurred at approximately 15 and 17 years of age, respectively.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 6","pages":"Article 101429"},"PeriodicalIF":2.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144816706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jornal de pediatriaPub Date : 2025-11-01Epub Date: 2025-11-02DOI: 10.1016/j.jped.2025.101466
Hua-Lin Li , Hong-Yun Lian , Wen-Yu Gong , Shuo Tian , Wei-Jing Li , Qing Zhang , Chan-Juan Wang , Hong-Hao Ma , Dong Wang , Yun-Ze Zhao , Zi-Jing Zhao , Jia-Jia Dong , Zhi-Gang Li , Rui Zhang , Lei Cui
{"title":"Peripheral immune indicators and their predictive value in disease progression or relapse of pediatric Langerhans cell histiocytosis","authors":"Hua-Lin Li , Hong-Yun Lian , Wen-Yu Gong , Shuo Tian , Wei-Jing Li , Qing Zhang , Chan-Juan Wang , Hong-Hao Ma , Dong Wang , Yun-Ze Zhao , Zi-Jing Zhao , Jia-Jia Dong , Zhi-Gang Li , Rui Zhang , Lei Cui","doi":"10.1016/j.jped.2025.101466","DOIUrl":"10.1016/j.jped.2025.101466","url":null,"abstract":"<div><h3>Objective</h3><div>Langerhans cell histiocytosis (LCH) is a rare inflammatory myeloid neoplasm in which the inflammatory microenvironment plays a crucial role in the development and progression of disease. The prognostic value of circulating lymphocyte subsets and cytokines remains uncertain.</div></div><div><h3>Methods</h3><div>The authors retrospectively analyzed baseline peripheral lymphocyte subsets and serum cytokines in 330 consecutive pediatric patients. Immune profiles were compared across disease extent, clinical events, and biological features. Prognostic associations with progression-free survival (PFS) were tested using univariable and multivariable models.</div></div><div><h3>Results</h3><div>Peripheral immune profiles varied with disease extent. Patients with multisystem risk-organ involvement (MS RO<sup>+</sup>) had fewer total T and Th1 cells, more CD4⁺ T and B cells, and higher IL-6, IL-10, and IFN-γ. Patients who progressed or relapsed showed a similar pattern, and non-survivors had particularly high IL-10. In the first-line cohort, the proportions of T, B, CD4⁺ T, CD8⁺ T, and Th1 cells, ratios of CD4/CD8 and Th1/Th2, and levels of IL-6, IL-10 predicted progression/relapse, and Youden-derived cut-offs dichotomized with distinct PFS. On multivariable Cox, IL-6, IL-10, Th1/Th2 ratio, RO status, and week-6 responses were independent predictors, and a nomogram model with good predictive capability was formed. IL-10 remained independently prognostic in multisystem LCH; the immune indices were not prognostic in single-system LCH. External validation in 103 patients confirmed risk stratification and model performance with well-calibrated PFS estimates.</div></div><div><h3>Conclusion</h3><div>Baseline peripheral lymphocyte subsets and cytokines carried prognostic information in pediatric LCH. The IL-6, IL-10, and Th1/Th2 profile supported risk stratification and may inform treatment planning.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 6","pages":"Article 101466"},"PeriodicalIF":2.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145426867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jornal de pediatriaPub Date : 2025-11-01Epub Date: 2025-09-11DOI: 10.1016/j.jped.2025.101442
Lizandro de Andrade Teles, Francisco Plácido Nogueira Arcanjo, Kailane Martins Cardoso, Jeferson de Sousa Justino
{"title":"Impact of skin-to-skin contact on acute procedural pain in newborns: a systematic review and meta-analysis","authors":"Lizandro de Andrade Teles, Francisco Plácido Nogueira Arcanjo, Kailane Martins Cardoso, Jeferson de Sousa Justino","doi":"10.1016/j.jped.2025.101442","DOIUrl":"10.1016/j.jped.2025.101442","url":null,"abstract":"<div><h3>Objective</h3><div>To systematically evaluate the effectiveness of Skin-to-Skin Contact (SSC) in reducing procedural pain in neonates, compared to standard care and other non-pharmacological interventions.</div></div><div><h3>Data Sources</h3><div>A comprehensive search was conducted in major electronic databases and gray literature up to July 2025. The review followed PRISMA and MECIR guidelines and included randomized controlled trials (RCTs) that used validated neonatal pain scales. Risk of bias was assessed using RoB 2.0, and the certainty of evidence was rated using the GRADE approach.</div></div><div><h3>Summary of Findings</h3><div>Twenty-nine RCTs involving 2995 neonates were included. SSC significantly reduced procedural pain compared to standard care (SMD = −1.13; 95 % CI: −1.54 to −0.72; <em>p</em> < 0.00001), although heterogeneity was high (I² = 93 %). Subgroup analyses suggested that heterogeneity was partially due to differences in pain assessment timing and study design. Compared to other interventions, SSC showed similar efficacy to carbohydrate solutions (SMD = 0.05; 95 % CI: −0.34 to 0.23), superior efficacy to swaddling (SMD = −0.86; 95 % CI: −1.38 to −0.34), and inferior efficacy to breastfeeding (SMD = 0.44; 95 % CI: 0.21 to 0.66).</div></div><div><h3>Conclusion</h3><div>SSC is an effective intervention for reducing procedural pain in neonates, particularly when compared to standard care and swaddling. However, its equivalence to carbohydrate solutions and inferiority to breastfeeding should be interpreted with caution due to methodological limitations and variability across studies. Further high-quality, large-scale RCTs are needed to improve the certainty of the evidence and guide clinical practice.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 6","pages":"Article 101442"},"PeriodicalIF":2.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144954894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jornal de pediatriaPub Date : 2025-11-01Epub Date: 2025-11-12DOI: 10.1016/j.jped.2025.101460
Ana Clara D. Massarollo , Guilherme W. Wendt , Lirane E.D. Ferreto , Ana P. Vieira , Gisele Arruda , Joseane R. da S. Nobre , Marina D. Massarollo , Débora M. Mazzo , Elizamara E.P. Segala , Claudicéia R. Pascotto , Franciele A.C. Follador
{"title":"Translation and cross-cultural adaptation of the Dubowitz Neurological Examination for premature infants in a high-risk outpatient clinic in Brazil","authors":"Ana Clara D. Massarollo , Guilherme W. Wendt , Lirane E.D. Ferreto , Ana P. Vieira , Gisele Arruda , Joseane R. da S. Nobre , Marina D. Massarollo , Débora M. Mazzo , Elizamara E.P. Segala , Claudicéia R. Pascotto , Franciele A.C. Follador","doi":"10.1016/j.jped.2025.101460","DOIUrl":"10.1016/j.jped.2025.101460","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to translate and cross-culturally adapt the Dubowitz Neurological Examination (DNE) instrument into Brazilian Portuguese for the neurological assessment of preterm newborns (PTNBs), as well as to evaluate its psychometric properties.</div></div><div><h3>Method</h3><div>This is a methodological study of translation and cross-cultural adaptation. The methodological process consisted of two forward translations from the original to the target language, a synthesis of the translations, two back-translations, an evaluation by an expert committee, pre-testing, and the development and application of the final version in 40 PTNBs followed at a high-risk outpatient clinic.</div></div><div><h3>Results</h3><div>Concordance among experts was 98.03 %, the intraclass correlation was 0.81, the content validity index (CVI) was 0.96 and the Kappa coefficient value was 0.76, indicating substantial agreement. Furthermore, the internal consistency indices were considered acceptable (α = 0.75). The comprehension of the 34 instrument items during the pre-test phase ranged from 82 % to 100 %.</div></div><div><h3>Conclusions</h3><div>DNE was adequately translated and adapted for Brazilian culture, showing evidence of semantic, idiomatic, and conceptual equivalence. The results demonstrate satisfactory internal consistency and high inter-rater agreement.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 6","pages":"Article 101460"},"PeriodicalIF":2.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145409315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jornal de pediatriaPub Date : 2025-11-01Epub Date: 2025-11-12DOI: 10.1016/j.jped.2025.101468
Carolina de Araújo Affonseca , Luís Fernando Andrade de Carvalho , Lêni Márcia Anchieta
{"title":"Palliative extubation in pediatrics: a scoping review","authors":"Carolina de Araújo Affonseca , Luís Fernando Andrade de Carvalho , Lêni Márcia Anchieta","doi":"10.1016/j.jped.2025.101468","DOIUrl":"10.1016/j.jped.2025.101468","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate evidence in the literature on palliative extubation in pediatrics in the context of palliative care, in any healthcare setting, to synthesize knowledge, identify gaps, and highlight future research opportunities.</div></div><div><h3>Data sources</h3><div>The PRISMA-ScR recommendations and the JBI Collaboration method were used. Searches were conducted in: Virtual Health Library, PubMed, Scopus, Embase, Cochrane Library and Web of Science. The following strategy was used: Population - children and adolescents (0 to 18 years) undergoing invasive mechanical ventilation; Concept - practices, experiences, or approaches related to palliative extubation; Context - palliative care in a hospital, hospice or home setting. Original articles published up to April 2025 were included; those that didn’t define age or were over 18 years, opinion pieces, editorials, and conference proceedings were excluded. Two independent reviewers extracted the data; discrepancies were resolved by consensus or with a third reviewer. The quality of the studies was assessed using the critical appraisal tools recommended by the JBI.</div></div><div><h3>Data synthesis</h3><div>Twelve articles were selected: eight case reports and four cross-sectional studies, totaling 129 patients; 128 were analyzed. In 78.1% of cases, palliative extubation was performed in a hospital setting, mainly in the ICU (72.6%); 93% used an endotracheal tube; 95.3% received analgesia/sedation around the time of extubation; 90.6% died after support withdrawn.</div></div><div><h3>Conclusions</h3><div>Knowledge of practices, experiences, and challenges related to palliative extubation in pediatrics is essential to support clinical decision-making and ensure that it is performed in a timely, responsible, and technically appropriate manner, following the principles of palliative care.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 6","pages":"Article 101468"},"PeriodicalIF":2.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145431384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pediatric Stevens–Johnson syndrome and toxic epidermal necrolysis: age-stratified insights from the FAERS database","authors":"Dilara Bayram-Ozgur , Onur Colak , Onur Gultekin , Narin Akici , Zehra Esra Onal , Ahmet Akici","doi":"10.1016/j.jped.2025.101455","DOIUrl":"10.1016/j.jped.2025.101455","url":null,"abstract":"<div><h3>Objective</h3><div>Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are rare but severe cutaneous adverse drug reactions, particularly concerning in pediatric populations due to their unique etiologies, clinical outcomes, and long-term complications. This study aims to examine pediatric cases of SJS/TEN reported in the U.S. FDA’s FAERS database, focusing on age-stratified patterns and drug associations.</div></div><div><h3>Method</h3><div>A retrospective cross-sectional analysis was conducted using FAERS reports submitted until the end of 2024. Pediatric cases (0–17 years) with a diagnosis of SJS or TEN and a single suspected drug were included. Reports were analyzed by age group (0–11 and 12–17 years), gender, and drug classification using ATC codes. Statistical analyses assessed associations between demographic groups and implicated medications.</div></div><div><h3>Results</h3><div>Out of 2673 pediatric reports, 67.4 % involved SJS and 32.6 % TEN. The majority (62.3 %) were in the 0–11 age group. Nervous system agents—especially antiepileptics—were predominantly associated with older children, while systemic antiinfectives such as amoxicillin, azithromycin, and cefaclor were more frequent in younger children. Lamotrigine showed both age groups and female predominance. Conversely, paracetamol and ibuprofen were significantly associated with the TEN phenotypes in younger males.</div></div><div><h3>Conclusions</h3><div>The study reveals clear age- and drug-specific patterns in pediatric SJS/TEN. Findings emphasize the importance of age-stratified pharmacovigilance issues and cautious prescribing of high-risk drugs such as lamotrigine and antibiotics. Better awareness of potential biases, such as protopathic misattribution, is crucial for accurate signal detection in pediatric pharmacovigilance.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 6","pages":"Article 101455"},"PeriodicalIF":2.5,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jornal de pediatriaPub Date : 2025-09-01Epub Date: 2025-08-18DOI: 10.1016/j.jped.2025.101436
Chao Zhang , Guoshun Mao , Guosheng Hu
{"title":"Prognostic nutritional index as a biomarker for identifying coronary artery lesions in Kawasaki disease","authors":"Chao Zhang , Guoshun Mao , Guosheng Hu","doi":"10.1016/j.jped.2025.101436","DOIUrl":"10.1016/j.jped.2025.101436","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the Prognostic Nutritional Index as a biomarker for identifying coronary artery lesions in Kawasaki disease.</div></div><div><h3>Methods</h3><div>The clinicopathological and laboratory characteristics of 241 patients with Kawasaki disease were collected from patients who were hospitalized in Fuyang People's Hospital from January 2018 to December 2024. Logistic regression analysis was conducted to evaluate the relationship between Prognostic Nutritional Index and coronary artery lesions. The critical levels of hematological parameters were determined by receiver operating characteristic analysis.</div></div><div><h3>Results</h3><div>The incidence of coronary artery lesions was 10.3 %. The optimal cut-off point for the Prognostic Nutritional Index was defined as 46.575. Prognostic Nutritional Index was negatively correlated with coronary artery diameter (<em>r</em> = −0.260, <em>p</em> < 0.001). Patients with low Prognostic Nutritional Index levels (Prognostic Nutritional Index < 46.575) were 4.25 times more likely to have coronary artery lesions compared to those with high Prognostic Nutritional Index levels (Prognostic Nutritional Index ≥ 46.575) (OR = 4.25, 95 % CI: 1.688 - 10.697, <em>p</em> < 0.001). The area under the receiver operating characteristic curve for Prognostic Nutritional Index in predicting coronary artery lesions was 0.702 (95 % CI: 0.584 - 0.821, <em>p</em> = 0.001), indicating moderate diagnostic efficacy.</div></div><div><h3>Conclusion</h3><div>Prognostic Nutritional Index may be a biomarker for children with Kawasaki disease complicated with coronary artery lesions, and it may help identify high-risk patients of coronary artery lesions among children with Kawasaki disease.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 5","pages":"Article 101436"},"PeriodicalIF":2.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144855293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jornal de pediatriaPub Date : 2025-09-01Epub Date: 2025-06-06DOI: 10.1016/j.jped.2025.04.009
Swelen Aparecida dos Santos , Mariane Yoshie Sato , Pedro Henrique Gunha Basilio , Meire Ellen Pereira , Rafaela Climaco Julião , Nielson da Cunha Arruda , Davi Paula da Silva , Cláudia Sirlene Oliveira , Victor Horacio de Souza Costa-Junior , Izonete Cristina Guiloski
{"title":"Comparison between the safety of the HPV vaccine versus placebo: a systematic review and meta-analysis of randomized clinical trials","authors":"Swelen Aparecida dos Santos , Mariane Yoshie Sato , Pedro Henrique Gunha Basilio , Meire Ellen Pereira , Rafaela Climaco Julião , Nielson da Cunha Arruda , Davi Paula da Silva , Cláudia Sirlene Oliveira , Victor Horacio de Souza Costa-Junior , Izonete Cristina Guiloski","doi":"10.1016/j.jped.2025.04.009","DOIUrl":"10.1016/j.jped.2025.04.009","url":null,"abstract":"<div><h3>Objective</h3><div>Human Papillomavirus (HPV) is a virus that targets epithelial tissues. Virtually all cases of cervical cancer are related to HPV, emphasizing the importance of vaccines in prevention. Although >200 million doses have been administered worldwide, concerns persist about adverse reactions. This study evaluated the safety of the HPV vaccine and the main adverse effects.</div></div><div><h3>Data sources</h3><div>The study was registered in the PROSPERO database (CRD42023365692). The systematic searches were conducted in the PubMed, Scopus, Embase, Cochrane, Science Direct, and Web of Science databases using the search strategy \"HPV\" AND \"vaccine\" AND \"safety\" NOT \"COVID\" from 01/01/2007 to 31/12/2022. Inclusion criteria were based on the PICOT strategy, focusing on studies with humans, vaccinated populations comprising children, adolescents, and adults, and Phase II/III randomized clinical trials. The PEDro scale was used to assess the quality of the studies.</div></div><div><h3>Summary of findings</h3><div>Eleven articles were qualified for qualitative synthesis and meta-analysis. The results indicated that HPV vaccination was associated with increased local reactions, fatigue, and myalgia compared to the placebo. However, there were no significant differences in serious adverse events, gastrointestinal reactions, cutaneous effects, headache, or fever between the vaccine and placebo groups.</div></div><div><h3>Conclusion</h3><div>Local reactions, fatigue, and myalgia were more prevalent in the HPV vaccine group; the overall safety profile of the vaccine was favorable. The HPV vaccine was deemed safe, mirroring the profile of adverse reactions seen with other vaccines. With its potential to prevent cancer, the benefits of HPV vaccination far outweigh the minimal risks.</div></div>","PeriodicalId":14867,"journal":{"name":"Jornal de pediatria","volume":"101 5","pages":"Article 101411"},"PeriodicalIF":2.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144159110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}