Objective:To evaluate the efficacy and safety of nebulized inhalation of recombinant human interferon (IFN) α1b injection in the treatment of respiratory syncytial virus (RSV) associated lower respiratory tract infections (pneumonia and bronchiolitis) in children.Methods:A randomized, double-blind, parallel, placebo-controlled add-on design was used.Children with pneumonia or bronchiolitis aged 2 months to 5 years who tested positive for RSV antigen within 72 hours of onset from 30 clinical trial sites including Beijing Children′s Hospital, Capital Medical University between February 2021 and December 2022 were included in this study and randomly divided into 2 groups at a ratio of 1∶1 based on a stratified-block method.Both groups received basic treatments such as cough control, asthma relieving, expectorant treatment, fever reduction, oxygen therapy, etc.The experimental group received additional nebulized inhalation of IFN α1b injection at a dose of 2.0 μg/(kg·time), twice a day.The control group received nebulized inhalation of placebo twice a day.Clinical efficacy was evaluated based on indicators such as the duration of clinical symptoms and signs, and the Kaplan-Meier method was used to calculate the median and 95% CI of the duration of clinical symptoms and signs.The Log-rank test was used to compared data between groups.Safety was assessed through the incidence of adverse reactions and laboratory tests, and the Chi-square test was used to analyze the difference between groups. Results:There were 123 children in the experimental group and 122 children in the control group.The median durations of all the 5 clinical symptoms and signs [including shortness of breath, wheezing, dyspnea (visible retractions), decreased transcutaneous oxygen saturation, and abnormal mental state] in the experimental group after treatment were slightly shortened than those in the control group [2.7 d(95% CI: 1.9-3.0 d)] vs.[2.9 d(95% CI: 2.6-3.6 d), P=0.027].The improvement in dyspnea (retractions) was especially pronounced in the experimental group, with a relief rate of 50.0% (0, 100%) on the first day of administration[compared with 0 (0, 50.0%) in the control group ( Z=2.002, P=0.025)].The median duration of dyspnea in the experimental group was nearly 1 day shorter than that in the control group [1.0 d(95% CI: 0.7-1.7 d) vs.1.8 d(95% CI: 1.0-2.5 d), P=0.046].There were no significant difference in hospital stay [6.0(5.0, 8.0) d vs.6.5(5.0, 8.0) d, Z=0.675, P=0.500], oxygen therapy duration [32.0(14.0, 96.3) h vs.39.0 (24.0, 83.2) h, Z=0.094, P=0.925], the recovery rate from clinical symptoms during treatment [(105/106, 99.1%) vs.(96/101, 95.0%)], and recurrence rate [(0/106, 0) vs.(2/101, 2.0%)] between the 2 groups (all P>0.05).However, the above-mentioned four indicators in the experimental group showed a trend of clinical benefits.The quantitative virus detection results showed that the RSV viral load in both groups decreased after treatment compared to before treatment.After 2 days of treatment, the decline rate of RSV viral load from the baseline was 0.90 lg copies/(mL·d) in the experimental group and 0.25 lg copies/(mL·d)in the control group, with a statistically significant difference ( P<0.05).Furthermore, there was no statistically significant difference in the incidence of adverse reactions between the 2 groups ( P>0.05).Importantly, no drug-related serious adverse reactions occurred in both groups. Conclusions:The nebulized inhalation therapy of IFN α1b demonstrates efficacy and safety in treating pediatric RSV associated lower respiratory tract infections.It particularly offers outstanding clinical therapeutic value for severe children.

Objective:To evaluate the sample preparation proficiency and storage proficiency of 11 clinical biobanks in Beijing through simulated experiments, and to establish an assessment method for the quality comparability of biological samples.Methods:An exploratory research design was adopted. In November 2023, artificial composite serum quality control materials containing six recombinant human protein markers—recombinant human alanine aminotransferase (rhALT), recombinant human aspartate aminotransferase (rhAST), recombinant human creatine kinase (rhCK), recombinant human creatine kinase-MB (rhCK-MB), recombinant human B-type natriuretic peptide (rhBNP), and recombinant human troponin I (rhTNI)—were distributed to 11 clinical biobanks in Beijing City. Sample preparation and storage followed the standardized operating procedures. Proficiency differences were assessed through statistical analysis.Results:Three-way repeated measures ANOVA revealed all six protein markers showed a declining trend over storage time in ultra-low-temperature environments ( F values 11.68-4 179.66, all P<0.01). However, neither long-term/temporary refrigerator types ( F values 0.01-1.23, all P>0.05)nor placement locations within refrigerators significantly affected the stability of these six proteins ( F valus 0.03-1.47, all P>0.05). The biases in detection results for rhALT, rhAST, rhTNI, and rhBNP at different storage time points were within the allowable bias limits for each item, supporting their use as markers for protein stability in biobank samples. All 11 institutions passed the storage proficiency assessment. In the preparation proficiency assessment, deviations were observed in post-preparation sample results, with a notably high out-of-control rate for rhCK (36.36%). Conclusion:Sample preparation proficiency can serve as a quality control metric for clinical biobanks. Future external quality assessment systems for biobanks should focus on sample preparation rather than storage processes.

Objective:To describe epidemiological characteristics and their influencing factors of diabetes and pre-diabetes among adult residents in Hainan Province and provide a theoretical basis to develop epidemic prevention and control strategies for diabetes.Methods:This study used a two-stage unequal proportion cluster sampling method, and 32 857 subjects (≥18 years old) were collected from 24 cities/counties/districts in Hainan Province. All the subjects were investigated with questionnaires, physical examination, and laboratory tests from January to June 2023. The χ2 and Mantel-Haenszel trend χ2 tests were used to analyze the data. Multivariate logistic regression was used to analyze the factors influencing diabetes and pre-diabetes. SPSS 23.0 software was used to analyze the data. Results:The crude prevalence of diabetes and pre-diabetes in adult residents of Hainan Province were 18.1% and 22.8%, while the weighted rates were 13.7% and 20.7%, respectively. The results of multivariate logistic regression analysis showed that: aging (30-39 years old: OR=2.65, 95% CI: 2.06-3.41; 40-49 years old: OR=5.64, 95% CI: 4.40-7.24; 50- 59 years old: OR=9.88, 95% CI: 7.71-12.67; 60-69 years old: OR=18.34, 95% CI: 14.28-23.55; 70-79 years old: OR=21.30, 95% CI: 16.41-27.65; 80 years old and above: OR=24.13, 95% CI: 17.94-32.46), nationality (Li minority group: OR=1.50, 95% CI: 1.38-1.63; other ethnic groups: OR=1.53, 95% CI: 1.20-1.94), urban ( OR=1.12, 95% CI: 1.04-1.21), central obesity ( OR=2.14, 95% CI: 2.01-2.29), higher frequency of alcohol consumption (5-7 day/week: OR=1.24, 95% CI: 1.11-1.38), physical inactivity ( OR=1.09, 95% CI: 1.02-1.17) were risk factors for diabetes, while aging (30-39 years old: OR=1.53, 95% CI: 1.31-1.79; 40-49 years old: OR=2.36, 95% CI: 2.01-2.76; 50-59 years old: OR=3.03, 95% CI: 2.58-3.55; 60-69 years old: OR=4.22, 95% CI: 3.58-4.97; 70-79 years old: OR=5.05, 95% CI: 4.23-6.04; 80 years old and above: OR=6.08, 95% CI: 4.86-7.61), nationality: (Li minority group: OR=1.18, 95% CI: 1.10-1.28; other ethnic groups: OR=1.40, 95% CI: 1.14-1.71), urban ( OR=1.12, 95% CI: 1.04-1.19), central obesity ( OR=1.72, 95% CI: 1.62-1.83), higher frequency of alcohol consumption (1-4 day/week: OR=1.12, 95% CI: 1.01-1.23; 5-7 day/week: OR=1.35, 95% CI: 1.22-1.49) were risk factors for pre-diabetes. Conclusions:The epidemic situation of diabetes and pre-diabetes among adult residents in Hainan Province was not optimistic. In order to control the development of abnormal blood glucose, measures and targeted health education should be carried out to strengthen the screening, treatment, and management of people with abnormal blood glucose among different populations.

Objective:To explore the impact of the two-way referral model on compliance and prognosis in patients with heart failure.Methods:This bidirectional cohort study enrolled chronic heart failure (CHF) patients treated at Qilu Hospital of Shandong University or designated primary hospitals between March 2018 and March 2022. Patients were categorized into two groups based on referral status: two-way referral group (participating in the referral model with≥1 follow-up visit at primary hospitals) and the core hospital group (receiving treatment and follow-up exclusively at Qilu Hospital). Baseline clinical characteristics were collected and compared between groups. Patients underwent followed-up, with primary endpoints including follow-up rate, drug (β-blockers, angiotension converting enzyme inhibitor (ACEI)/angiotensin Ⅱ receptor blockers (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), sodium-glucose cotransporter 2 inhibitors and mineralocorticoid receptor antagonists) utilization rate and target dose achievement rate. Secondary endpoints encompassed changes from baseline in left ventricular ejection fraction (LVEF), left ventricular end-diastolic diameter (LVEDd), and N-terminal pro-brain natriuretic peptide (NT-proBNP), plus cardiovascular mortality and heart failure rehospitalization. Generalized linear mixed models analyzed longitudinal trends in LVEF, LVEDd, and NT-proBNP levels. Kaplan-Meier curves and Cox regression evaluated LVEF recovery rates, supplemented by subgroup analyses. Multivariate logistic regression was used to identify factors influencing target dose achievement rate for β-blockers and ACEI/ARB/ARNI therapies in CHF patients.Results:A total of 357 patients were enrolled, aged 53 (41, 63) years, including 256 males (71.7%). 157 patients were in the two-way referral group and 200 patients in the core hospital-treated group. Compared with the core hospital-treated group, the two-way referral group had lower baseline LVEF (28 (22, 34)% vs. 31 (23, 36)%, P=0.021) and systolic blood pressure (116 (104, 125) mmHg vs. 121 (109, 134) mmHg (1 mmHg=0.133 kPa), P=0.010). The 12-month follow-up rate of the two-way referral group was higher than the core hospital-treated group (73.8% vs. 56.0%, P=0.004). No significant between-group differences were observed in drug utilization rate of β-blockers, ACEI/ARB/ARNI, or sodium-glucose cotransporter 2 inhibitors during follow-up (all P>0.05), while mineralocorticoid receptor antagonists use showed a declining trend in both groups. Although the core hospital-treated group had higher target dose achievement rates for β-blockers (65.4% vs. 49.3%, P=0.042) and ACEI/ARB/ARNI (79.8% vs. 65.8%, P=0.046) than the two-way referral group, multivariate logistic regression indicated that the two-way referral model was not a negative predictor for these outcomes (all P>0.05). Both groups showed improved NT-proBNP, LVEDd, and LVEF from baseline (all P<0.001) with no significant difference in trends between groups (all P>0.05). There was no significant difference in the composite incidence (7.6% vs. 6.5%, P=0.674) and cumulative incidence (log-rank P=0.684) of cardiovascular death and heart failure rehospitalization at 12 months between two groups. Conclusion:The two-way referral model demonstrates advantages in improving medication adherence, drug utilization rates, and targetdoseachievement rates among CHF patients. This model not only promotes cardiac functional recovery but also reduces risks of cardiovascular mortality and heart failure rehospitalization, achieving comparable therapeutic and management outcomes to those observed in core hospital-treated patients.

Quality control is a key link in the modernization process of traditional Chinese medicine(TCM). Studies have shown that the effects of active components in TCM depend on not only their chemical composition but also their suitable physical forms and states. The physical phase structures, such as micelles, vesicles, gels, and nanoparticles, can improve the solubility, delivery efficiency, and targeting precision of active components. These structures significantly enhance the pharmacological activity while reducing the toxicity and side effects, demonstrating functional activity surpassing that of active components and highlighting the key effects of "structures" on "functions" of active components. Taking the physical phase structure as a breakthrough point, this paper outlines the common types of TCM physical phase structures. Furthermore, this paper explores how to realize the quality upgrading of TCM through the precise regulation of physical phase structures based on the current applications and potential of TCM physical phase structures in processing to increase the efficacy and reduce the toxicity, compounding and decocting processes, drug delivery systems, and quality control, aiming to provide novel insights for the future quality control of TCM.
Quality Control ; Drugs, Chinese Herbal/standards* ; Medicine, Chinese Traditional/standards* ; Humans ; Drug Delivery Systems

Objective:To describe epidemiological characteristics and their influencing factors of diabetes and pre-diabetes among adult residents in Hainan Province and provide a theoretical basis to develop epidemic prevention and control strategies for diabetes.Methods:This study used a two-stage unequal proportion cluster sampling method, and 32 857 subjects (≥18 years old) were collected from 24 cities/counties/districts in Hainan Province. All the subjects were investigated with questionnaires, physical examination, and laboratory tests from January to June 2023. The χ2 and Mantel-Haenszel trend χ2 tests were used to analyze the data. Multivariate logistic regression was used to analyze the factors influencing diabetes and pre-diabetes. SPSS 23.0 software was used to analyze the data. Results:The crude prevalence of diabetes and pre-diabetes in adult residents of Hainan Province were 18.1% and 22.8%, while the weighted rates were 13.7% and 20.7%, respectively. The results of multivariate logistic regression analysis showed that: aging (30-39 years old: OR=2.65, 95% CI: 2.06-3.41; 40-49 years old: OR=5.64, 95% CI: 4.40-7.24; 50- 59 years old: OR=9.88, 95% CI: 7.71-12.67; 60-69 years old: OR=18.34, 95% CI: 14.28-23.55; 70-79 years old: OR=21.30, 95% CI: 16.41-27.65; 80 years old and above: OR=24.13, 95% CI: 17.94-32.46), nationality (Li minority group: OR=1.50, 95% CI: 1.38-1.63; other ethnic groups: OR=1.53, 95% CI: 1.20-1.94), urban ( OR=1.12, 95% CI: 1.04-1.21), central obesity ( OR=2.14, 95% CI: 2.01-2.29), higher frequency of alcohol consumption (5-7 day/week: OR=1.24, 95% CI: 1.11-1.38), physical inactivity ( OR=1.09, 95% CI: 1.02-1.17) were risk factors for diabetes, while aging (30-39 years old: OR=1.53, 95% CI: 1.31-1.79; 40-49 years old: OR=2.36, 95% CI: 2.01-2.76; 50-59 years old: OR=3.03, 95% CI: 2.58-3.55; 60-69 years old: OR=4.22, 95% CI: 3.58-4.97; 70-79 years old: OR=5.05, 95% CI: 4.23-6.04; 80 years old and above: OR=6.08, 95% CI: 4.86-7.61), nationality: (Li minority group: OR=1.18, 95% CI: 1.10-1.28; other ethnic groups: OR=1.40, 95% CI: 1.14-1.71), urban ( OR=1.12, 95% CI: 1.04-1.19), central obesity ( OR=1.72, 95% CI: 1.62-1.83), higher frequency of alcohol consumption (1-4 day/week: OR=1.12, 95% CI: 1.01-1.23; 5-7 day/week: OR=1.35, 95% CI: 1.22-1.49) were risk factors for pre-diabetes. Conclusions:The epidemic situation of diabetes and pre-diabetes among adult residents in Hainan Province was not optimistic. In order to control the development of abnormal blood glucose, measures and targeted health education should be carried out to strengthen the screening, treatment, and management of people with abnormal blood glucose among different populations.

Objective:To evaluate the sample preparation proficiency and storage proficiency of 11 clinical biobanks in Beijing through simulated experiments, and to establish an assessment method for the quality comparability of biological samples.Methods:An exploratory research design was adopted. In November 2023, artificial composite serum quality control materials containing six recombinant human protein markers—recombinant human alanine aminotransferase (rhALT), recombinant human aspartate aminotransferase (rhAST), recombinant human creatine kinase (rhCK), recombinant human creatine kinase-MB (rhCK-MB), recombinant human B-type natriuretic peptide (rhBNP), and recombinant human troponin I (rhTNI)—were distributed to 11 clinical biobanks in Beijing City. Sample preparation and storage followed the standardized operating procedures. Proficiency differences were assessed through statistical analysis.Results:Three-way repeated measures ANOVA revealed all six protein markers showed a declining trend over storage time in ultra-low-temperature environments ( F values 11.68-4 179.66, all P<0.01). However, neither long-term/temporary refrigerator types ( F values 0.01-1.23, all P>0.05)nor placement locations within refrigerators significantly affected the stability of these six proteins ( F valus 0.03-1.47, all P>0.05). The biases in detection results for rhALT, rhAST, rhTNI, and rhBNP at different storage time points were within the allowable bias limits for each item, supporting their use as markers for protein stability in biobank samples. All 11 institutions passed the storage proficiency assessment. In the preparation proficiency assessment, deviations were observed in post-preparation sample results, with a notably high out-of-control rate for rhCK (36.36%). Conclusion:Sample preparation proficiency can serve as a quality control metric for clinical biobanks. Future external quality assessment systems for biobanks should focus on sample preparation rather than storage processes.

Cervical spine health issues not only seriously affect patients' quality of life but also impose a heavy burden on the social healthcare system. Existing guidelines lack sufficient clinical guidance on lifestyle and work habits, such as exercise, posture, daily routine, and diet, making it difficult to meet practical needs. To address this, relying on the China Association of Chinese Medicine, Wangjing Hospital of China Academy of Chinese Medical Sciences took the lead and joined hands with more than ten institutions to form a multidisciplinary guideline development group. For the first time, the group developed the Guidelines for Cervical Spine Health Intervention based on evidence-based medicine methods, strictly following the standardized procedures outlined in the World Health Organization Handbook for Guideline Development and the Guiding Principles for the Formulation/Revision of Clinical Practice Guidelines in China (2022 Edition). This proposal systematically explains the methods and steps for developing the guideline, aiming to make the guideline development process scientific, standardized, and transparent.
Humans ; Practice Guidelines as Topic/standards* ; Cervical Vertebrae ; China

The interaction between m⁶A-methylated RNA and chromatin modification remains largely unknown. We found that targeted inhibition of bromodomain-containing protein 4 (BRD4) by siRNA or its inhibitor (JQ1) significantly decreases mRNA m⁶A levels and suppresses the malignancy of breast cancer (BC) cells via increased expression of demethylase AlkB homolog 5 (ALKBH5). Mechanistically, inhibition of BRD4 increases the mRNA stability of ALKBH5 via enhanced binding between its 3' untranslated regions (3'UTRs) with RNA-binding protein RALY. Further, BRD4 serves as a scaffold for ubiquitin enzymes tripartite motif containing-21 (TRIM21) and ALKBH5, resulting in the ubiquitination and degradation of ALKBH5 protein. JQ1-increased ALKBH5 then demethylates mRNA of extra spindle pole bodies like 1 (ESPL1) and reduces binding between ESPL1 mRNA and m⁶A reader insulin like growth factor 2 mRNA binding protein 3 (IGF2BP3), leading to decay of ESPL1 mRNA. Animal and clinical studies confirm a critical role of BRD4/ALKBH5/ESPL1 pathway in BC progression. Further, our study sheds light on the crosstalks between histone modification and RNA methylation.

[This corrects the article DOI: 10.1016/j.apsb.2018.08.009.].