Liver Involvement in Acute Respiratory Infections in Children and Adolescents – Results of a Non-interventional Study

Kamin, Wolfgang; Adams, Ortwin; Kardos, Péter; Matthys, H; Meister, Norbert; Strassburg, Christian P.

doi:10.3389/fped.2022.840008

Cited by 6 publications

(8 citation statements)

References 23 publications

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“…To verify the association of this trajectory with altered AST, ALT, GGT expression levels, we further grouped all patients based on liver enzyme reference ranges ( Methods, Table 1 ). By Kaplan-Meier survival analysis, cases with peaks of GGT (P ≤ 1.4e-02), ALT (P ≤ 2.9e-02), and AST (P ≤ 4.8e-04) in “outside the norm” were found to correlate with lower survival in all groups ( Figure 4C, Supplementary Figure 4 ), in line with previous studies 62,63 .…”

Section: Resultssupporting

confidence: 90%

Exploratory electronic health record analysis with ehrapy

Heumos,

Ehmele,

Treis

et al. 2023

Preprint

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With progressive digitalization of healthcare systems worldwide, large-scale collection of electronic health records (EHRs) has become commonplace. However, an extensible framework for comprehensive exploratory analysis that accounts for data heterogeneity is missing. Here, we introduce ehrapy, a modular open-source Python framework designed for exploratory end-to-end analysis of heterogeneous epidemiology and electronic health record data. Ehrapy incorporates a series of analytical steps, from data extraction and quality control to the generation of low-dimensional representations. Complemented by rich statistical modules, ehrapy facilitates associating patients with disease states, differential comparison between patient clusters, survival analysis, trajectory inference, causal inference, and more. Leveraging ontologies, ehrapy further enables data sharing and training EHR deep learning models paving the way for foundational models in biomedical research. We demonstrated ehrapy’s features in five distinct examples: We first applied ehrapy to stratify patients affected by unspecified pneumonia into finer-grained phenotypes. Furthermore, we revealed biomarkers for significant differences in survival among these groups. Additionally, we quantify medication-class effects of pneumonia medications on length of stay. We further leveraged ehrapy to analyze cardiovascular risks across different data modalities. Finally, we reconstructed disease state trajectories in SARS-CoV-2 patients based on imaging data. Ehrapy thus provides a framework that we envision will standardize analysis pipelines on EHR data and serve as a cornerstone for the community.

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Section: Resultssupporting

confidence: 90%

Exploratory electronic health record analysis with ehrapy

Heumos,

Ehmele,

Treis

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…The present post-authorization study in compliance with an obligation of the German Drug Regulatory Authority investigated the safety and tolerability of the EPs 7630 syrup in comparison to the EPs 7630 solution, which has been marketed for many years, in 1- to 5-year-old children suffering from AB. As viral ARTIs in children may cause an elevation of hepatic enzymes according to literature reports ( 3 , 34 – 37 ), a monitoring of hepatic enzyme activities was carried out. Expectedly, the results of our study indicate that the syrup has an equally beneficial safety profile as the long-established solution; no indication of more severe or previously unknown types of reactions was seen.…”

Section: Discussionmentioning

confidence: 99%

“…The effects of viral infections on hepatic enzymes (AST, ALT, γ GT) were recently investigated in 1,010 children and adolescents aged 1 to 17 years suffering from ARTIs ( 3 ). An elevation of at least one hepatic enzyme was observed in 11.1% (95%CI: 9.2%, 13.3%) of subjects at the time of study entry.…”

Section: Discussionmentioning

confidence: 99%

“…Acute bronchitis (AB) is one of the most common infections reported in children under 5 years of age and a leading cause of hospitalization ( 1 ). It is predominantly attributable to a viral infection ( 2 ); the most commonly identified viruses are rhinovirus, enterovirus, influenza A and B, parainfluenza virus, coronavirus, human metapneumovirus, and respiratory syncytial virus ( 2 , 3 ).…”

Section: Introductionmentioning

confidence: 99%

“…No difference was expected regarding patient safety since the active substance and the excipients of both dosage forms possess well-established tolerability. Hepatic enzyme activities were of special interest in the context of hepatic involvement described in children and adolescents suffering from ARTIs ( 3 ).…”

Section: Introductionmentioning

confidence: 99%

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Safety of Pelargonium extract EPs 7630 in young children with acute bronchitis

Kamin

Behre²,

Helm³

et al. 2023

Front. Pediatr.

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BackgroundThe efficacy and tolerability of Pelargonium sidoides DC. root extract EPs 7630 in children with acute bronchitis (AB) have been widely demonstrated. We investigated the safety and tolerability of a syrup formulation and an oral solution in pre-school children.MethodsIn an open-label, randomized clinical trial (EudraCT number 2011-002652-14), children aged 1–5 years suffering from AB received EPs 7630 syrup or solution for 7 days. Safety was assessed by frequency, severity, and nature of adverse events (AE), vital signs, and laboratory values. Outcome measures for evaluating the health status were the intensity of coughing, pulmonary rales, and dyspnea, measured by the short version of the Bronchitis Severity Scale (BSS-ped), further symptoms of the respiratory infection, general health status according to the Integrative Medicine Outcomes Scale (IMOS), and satisfaction with treatment according to the Integrative Medicine Patient Satisfaction Scale (IMPSS).Results591 children were randomized and treated with syrup (n = 403) or solution (n = 188) for 7 days. In both treatment groups, the number of adverse events was similarly low and revealed no safety concerns. The most frequently observed events were infections (syrup: 7.2%; solution: 7.4%) or gastrointestinal disorders (syrup: 2.7%; solution: 3.2%). After one week's treatment, more than 90% of the children experienced an improvement or remission of the symptoms of the BSS-ped. Further respiratory symptoms decreased similarly in both groups. At Day 7, more than 80% of the whole study population had completely recovered or showed a major improvement as assessed by the investigator and the proxy, respectively. Parents were “very satisfied” or “satisfied” with the treatment in 86.1% of patients in the combined syrup and solution group.ConclusionBoth pharmaceutical forms, EPs 7630 syrup and oral solution, were shown to be equally safe and well tolerated in pre-school children suffering from AB. Improvement of health status and of complaints were similar in both groups.

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