Kunling Shen

Influenza is a seasonal viral respiratory disease associated with high morbidity, mortality and substantial economic burden globally (Iuliano et al. 2018). Children, particularly those under 5 year...

The process of asthma, after its onset, is featured by periods of persistence, relapse and remission. This follow-up study is aim to investigate the landscape of asthma management and personal factors associated with persistence and remission in children aged 0-18 years at Beijing Children's Hospital. This was a retrospective cohort study. Children hospitalized in Beijing Children's Hospital from 2019 to 2021 due to acute asthma attacks were included as study participants. A questionnaire was used to collect information on both asthma management and the occurrence of any asthma attacks following discharge. We defined asthma remission as the absence of asthma symptoms for one year, in contrast to persistent asthma. Logistic regression analyses were performed to identify factors associated with asthma remission and persistence. A total of 210 children with asthma were enrolled in this study. Of these, 152 (72.4%) completed the follow-up and were included in the final analysis. The median follow-up time was 2.76 years (interquartile range (IQR), 2.18-3.95). Among these patients, the frequency of asthma attacks after discharge varied with different follow-up duration. 31.6% of children with asthma had regular follow-up visits, 36.8% had regular use of inhaled corticosteroids (ICS) for 3 months or more, and 42.8% used ICS only for asthma symptoms. There were 75 children with remission of asthma and 77 children with persistence. Multivariate logistic regression analysis identified three factors associated with asthma persistence: allergic rhinitis (odds ratio (OR) = 3.88, 95% confidence interval (CI): 1.54-9.75), ≥ 3 exacerbations in Early Period (OR = 12.34, 95% CI: 4.74-32.14) and unplanned healthcare attendances in Early Period (OR = 8.61, 95% CI: 2.51-29.51). After discharge, some children had acute asthma attacks. About 30% were engaged in regular follow-up and anti-asthma treatment. 50.7% of the children with asthma have experienced persistent asthma symptoms in the past year. Allergic rhinitis, ≥ 3 acute asthma attacks in Early Period, and unplanned healthcare attendances in Early Period were associated with asthma persistence.

Background: Mycoplasma pneumoniae (MP) is a major cause of community‐acquired pneumonia in children, with increasing macrolide resistance complicating treatment. Traditional Chinese Medicine (TCM) provides unique benefits for pediatric respiratory infections. Purpose: To evaluate the safety and efficacy of Lianhua Qingke (LHQK) tablets as adjunctive therapy in children with M. pneumoniae pneumonia (MPP). Study Design: This prospective, multicenter, randomized, double‐blind, placebo‐controlled trial adhered to the Declaration of Helsinki and was registered in the Chinese Clinical Trial Registry (ChiCTR2300078209). Methods: A total of 160 children aged 4–14 years with mild MPP were randomized 1:1 to receive conventional therapy plus LHQK or conventional therapy plus placebo for 7 days across 13 hospitals over 4 months. Efficacy analysis included 128 participants with centrally confirmed MP infection; safety analysis included all 160. Baseline characteristics were comparable (all p > 0.05), with 98.8% medication compliance in both groups ( p > 0.05). The primary outcome was the major symptom resolution rate by Day 7. Results: The LHQK group showed a significantly higher major symptom resolution rate (85.9% vs. 65.6%, p < 0.05), with a numerically shorter median time to resolution (4.5 vs. 5.0 days, p = 0.072). LHQK also significantly improved cough and expectoration relief rates (all p < 0.05). No differences were found in laboratory parameters. Adverse event incidence was lower with LHQK (2.5% vs. 8.8%, p > 0.05), with no serious events reported. Conclusion: LHQK is a safe and effective adjunctive TCM therapy for mild MPP in children, offering significant benefits in respiratory symptom alleviation and a favorable safety profile, with a trend toward shorter recovery time, providing a valuable treatment option amid rising antibiotic resistance.

Importance: The ketogenic diet (KD) is effective in managing epilepsy, particularly West syndrome (WS); however, the role of gut microbiome (GM) and metabolome in its efficacy remains unclear. Understanding these mechanisms could optimize the KD for WS treatment. Objective: To identify microbiome‐metabolome signatures associated with KD efficacy in WS by analyzing changes in GM composition and metabolic pathways. Methods: Fecal samples were collected from WS patients ( n = 16) and healthy children ( n = 24). Metagenome and metabolome analyses were performed to assess GM composition and metabolic profiles. Results: WS patients showed GM imbalances compared to healthy children. Disease status contributed sufficiently to the GM. The abundance of Bacteroides , Parabacteroides , and Faecalibacterium was lower in WS (3.30% vs. 39.86%, P ‐adj = 0.140; 0.14% vs. 0.73%, P ‐adj = 0.023; 0.04% vs. 1.35%, P ‐adj = 0.018), whereas Bifidobacterium and Escherichia were higher (6.08% vs. 2.23%, P ‐adj = 0.140; 7.57% vs. 0.15%, P ‐adj < 0.001). After KD, Parabacteroides (particularly P. distasonis ) and Bacteroides (particularly B. fragilis ) increased (0.14% vs. 0.35%, P ‐adj = 0.034; 3.30% vs. 21.18%, P ‐adj = 0.380); Bifidobacterium (particularly B. breve ) and Escherichia (particularly E. coli ) decreased from 6.08% and 7.57% to 1.24% and 2.52%, respectively. Kyoto Encyclopedia of Genes and Genomes pathway analysis demonstrated that ATP‐binding cassette (ABC) transporters, fatty acid biosynthesis, tyrosine metabolism, and other pathways were significantly altered in patients with WS, and these alterations were reversed following ketogenic diet (KD) consumption. The KD also altered intestinal metabolites. Integrative analysis of microbial features, gene functions, and metabolites revealed that Bacteroides species and P. distasonis were significantly associated with ABC transporters, alanine aspartate and glutamate metabolism, and negatively correlated with 3‐sulfinoalanine, suggesting potential regulatory roles in metabolic pathways. Interpretation: KD induces significant shifts in GM composition and metabolic pathways, which may contribute to its therapeutic efficacy in WS. The restoration of Bacteroides and Parabacteroides dominance, alongside alterations in gene functions and neurotransmitter‐related metabolites, suggests a potential mechanism for the antiepileptic effects of KD.

Objective: To evaluate the efficacy and safety of inhaled ambroxol solution in improving sputum of lower respiratory tract infections (LRTIs) in children. Study Design: This study was a randomized, double-blind, parallel-group, placebo-controlled, multicenter trial. The patients were administered inhaled ambroxol or a placebo twice a day for 7 days. And researchers collected efficacy and (or) safety indicators every day during the course. Results: A total of 236 children were randomly assigned to receive ambroxol or placebo (1:1). At all visit points after the medication, the mean difference of cough score with the baseline between the two groups was statistically significant (P < 0.05). Compared with the baseline, the phlegm-sound scores in the throat of the experimental group decreased more on the 1st, 2nd, and 3rd days after administration (P < 0.05). But there was no difference in pulmonary rale scores. The occurrence of adverse events in the experimental group was lower (21.37% vs. 35.59%, P = 0.021), and the incidence of adverse reactions was similar between the two groups (2.56% vs. 5.08%, P = 0.499). Conclusion: Inhaled ambroxol solution could improve the sticky sputum symptoms in children with LRTIs and is safe in clinical application. Further research is needed to confirm these findings. Trial registration: The study was retrospectively registered on June 14, 2023, at https://www.chictr.org.cn/ under the number ChiCTR2300072466.

Importance: Although macrolides combined with glucocorticoid therapy have demonstrated efficacy in preventing long‐term pulmonary lesions of severe Mycoplasma pneumoniae pneumonia (MPP), evidence regarding glucocorticoid dose is lacking.Objective: To evaluate the effects of low‐ and high‐dose methylprednisolone on the risk of long‐term pulmonary lesions for children with severe MPP when combined with azithromycin.Methods: This randomized, parallel‐controlled, multicenter clinical trial was conducted in mainland China and enrolled pediatric patients hospitalized with severe MPP. A total of 424 enrolled patients were randomized (allocation ratio of 1:1) to azithromycin combined with either a low‐dose [2 mg/(kg·d)] or a high‐dose [10 mg/(kg·d)] methylprednisolone treatment for 3 d followed by tapering over 12 d. The primary outcome was the incidence of composite adverse outcomes, including atelectasis, bronchiectasis, or bronchiolitis obliterans 6 months after treatment.Results: A total of 118 (27.8%) developed adverse pulmonary lesions at 6 months after treatment; 66 of 211 (31.3%) in the high‐dose methylprednisolone group and 52 of 213 (24.4%) in the low‐dose group, respectively. The risk ratio of long‐term pulmonary lesions in a high‐dose group to those in a low‐dose group was 1.28 (95% confidence interval [95% CI]: 0.94–1.75). In addition, the risk of hypertension in the high‐dose group (8.1%, 17 of 211) was higher than that in the low‐dose group (1.4%, three of 213), with a risk ratio of 5.72 (95% CI: 1.70–19.23)Interpretation: Azithromycin combined with low‐dose methylprednisolone demonstrates non‐inferior efficacy in reducing pulmonary lesions at 6‐month follow‐up compared to combined with high‐dose methylprednisolone while exhibiting a more favorable safety profile.

Background: Xiao’er Fengre Qing Oral Liquid (XFQOL) is developed based on the classical traditional Chinese medicinal formula Yinqiao Powder. Compared to the original formulation, XFQOL exhibits enhanced heat-clearing, detoxification, and fever reduction, which can effectively address the common complications associated with influenza in children and is well-suited for pediatric use. However, there is currently a lack of high-quality evidence from clinical trials to support its efficacy and safety in clinical applications.Objective: This study aimed to investigate the efficacy and safety of XFQOL compared with Oseltamivir in pediatric influenza.Methods: A multicenter, block-randomized, double-blind, double-dummy, positive-drug-controlled, non-Inferiority clinical trial design was conducted. The study plans to enroll 420 pediatric participants, with 210 in each group. The experimental group will receive XFQOL with an Oseltamivir granules placebo, and the control group will receive Oseltamivir granules with a XFQOL placebo for 5 days, followed by a 2-day post-treatment observation. The primary endpoint was clinical recovery time, while secondary endpoints included complete fever resolution time, the area under the curve (AUC) of Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom dimension Score over time, Traditional Chinese Medicine (TCM) syndrome efficacy, disappearance rates for individual symptoms, incidences of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate. Safety evaluation focused on adverse events (AE) and adverse drug reactions (ADR).Results: A total of 418 participants were included in the Full Analysis Set, with 208 in the experimental group and 210 in the control group. Baseline characteristics were comparable between the groups. The median time to clinical recovery was 3 days for both groups, with a hazard ratio and its 95% confidence interval (experimental group/control group) of 1.115 (95% CI: 0.912–1.363). Non-inferiority testing demonstrated that the experimental group was not inferior to the control group. Subgroup analyses (positive for RT-PCR influenza, positive for RT-PCR influenza A, positive for RT-PCR influenza B) yielded results consistent with the primary endpoint. The median time to complete fever resolution was 32 h in both groups, with no statistically significant difference (P = 0.407). There were no statistically significant differences in the AUC of CARIFS symptom scores over time between the groups (P = 0.211). No significant differences were observed between the groups in the efficacy rates of TCM syndromes of Wind-Heat Invading the Defense Syndrome (P = 0.076) and Fright-complicated Syndrome (P = 0.168); however, significant differences were found in Phlegm-complicated Syndrome (P = 0.008) and Food-stagnation-complicated Syndrome (P = 0.024). The disappearance rates for individual symptoms, such as red and swollen pharynx, cough, copious sputum or audible phlegm sounds in the throat, and lack of appetite, showed statistically significant differences between the groups (P < 0.05), while no significant differences were observed for other symptoms. No statistically significant differences were observed between the experimental and control groups in the incidence of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate (P > 0.05). The incidence rates of AE (P = 0.885) and ADR (P = 0.685) were comparable between the two groups, with no statistically significant differences observed.Conclusion: The efficacy of XFQOL in treating pediatric influenza (Wind-Heat Invading the Defense Syndrome) is non-inferior to Oseltamivir with respect to clinical recovery time. Additionally, its effectiveness in terms of fever reduction, symptom alleviation, incidences of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate is comparable to that of Oseltamivir. Furthermore, it demonstrates good safety, suggesting its potential for clinical application.Clinical Trial Registration: clinicaltrials.gov, identifier ChiCTR2300076191.