The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

Objective:To develop and validate clinical predictive models for identifying poor short-term response to recombinant human growth hormone(rhGH) treatment in children with short stature.Methods:A retrospective analysis was conducted on 118 children diagnosed with growth hormone deficiency or idiopathic short stature who were treated at the First Affiliated Hospital of Zhengzhou University and two other hospitals between January 1, 2020, and January 1, 2024. A poor response to rhGH was defined as a height increase of less than 0.2 standard deviation score(SDS) after 6 months of rhGH treatment. LASSO regression was used to identify predictive variables from baseline and follow-up data. Two logistic regression models were conducted: Model A(incorporating baseline variables only) and model B(incorporating both baseline and follow-up variables), and nomograms were created for visualization. External data and internal resampling were used for dual validation of the models, and their performance was compared.Results:A total of 118 children with short stature were included. Six baseline predictive variables(diagnosis, initial height SDS, bone age, bone age-chronological age difference, rhGH dose, and gender) and one follow-up variable(height SDS after 3 months of rhGH treatment) were identified. Area under the curve values for Model A and Model B were 0.753(95% CI 0.696-0.811) and 0.930(95% CI 0.891-0.975), respectively. Calibration curves, decision curve analysis, and other evaluation metrics demonstrated good discrimination and clinical utility for both models. Model B, incorporating the 3-month follow-up variable, showed superior predictive performance compared to Model A. Conclusions:The clinical prediction models developed in this study(Model A and Model B) are practical and reliable tools for quantitatively, conveniently, and intuitively identifying children with short stature at risk of poor response to rhGH treatment.

Objective:To develop and validate clinical predictive models for identifying poor short-term response to recombinant human growth hormone(rhGH) treatment in children with short stature.Methods:A retrospective analysis was conducted on 118 children diagnosed with growth hormone deficiency or idiopathic short stature who were treated at the First Affiliated Hospital of Zhengzhou University and two other hospitals between January 1, 2020, and January 1, 2024. A poor response to rhGH was defined as a height increase of less than 0.2 standard deviation score(SDS) after 6 months of rhGH treatment. LASSO regression was used to identify predictive variables from baseline and follow-up data. Two logistic regression models were conducted: Model A(incorporating baseline variables only) and model B(incorporating both baseline and follow-up variables), and nomograms were created for visualization. External data and internal resampling were used for dual validation of the models, and their performance was compared.Results:A total of 118 children with short stature were included. Six baseline predictive variables(diagnosis, initial height SDS, bone age, bone age-chronological age difference, rhGH dose, and gender) and one follow-up variable(height SDS after 3 months of rhGH treatment) were identified. Area under the curve values for Model A and Model B were 0.753(95% CI 0.696-0.811) and 0.930(95% CI 0.891-0.975), respectively. Calibration curves, decision curve analysis, and other evaluation metrics demonstrated good discrimination and clinical utility for both models. Model B, incorporating the 3-month follow-up variable, showed superior predictive performance compared to Model A. Conclusions:The clinical prediction models developed in this study(Model A and Model B) are practical and reliable tools for quantitatively, conveniently, and intuitively identifying children with short stature at risk of poor response to rhGH treatment.

It is proposed that the disease mechanism evolution of systemic lupus erythematosus can be summarized into four stages： initial invasion and latency， the pathogenesis remains concealing； latent toxin accumulation， the disease gradually becomes apparent； active toxin begins damaging， the disease manifests aggressively； damage resulting to deficiency， the disease course prolonged. Based on the stages of latent toxin evolution， the syndrome differentiation and treatment of systemic lupus erythematosus can be summarized as follows： during the initial latent stage， characterized by latent dampness and heat stagnation， modified Sanren Decoction （三仁汤） should be used； in the toxin outbreak stage， marked by intense heat toxin， modified Xijiao Dihuang Decoction （犀角地黄汤） combined with modified Qingwen Baidu Decoction （清瘟败毒饮） should be used； during the toxin damage stage， which presents as latent toxin damaging zang-fu organs， modified Qinghao Biejia Decoction （青蒿鳖甲汤） should be used； in the healthy qi deficiency stage， characterized by deficiencies of qi， blood， yin， and yang， modified Xieli Shiquan Ointment （燮理十全膏） should be used.

“Deficiency cause， cold accumulation， and qi stagnation” originates from Essentials from the Golden Cabinet （《金匮要略》）， which is a guiding principle for the pathogenesis of women's diseases， pioneering the differentiation and treatment of women's diseases based on patterns， and having a profound influence on future generations. Following the classical principles and simplifying the complexities， this paper explored the pathogenesis and mechanism of polycystic ovary syndrome （PCOS） from the perspective of “deficiency cause， cold accumulation， and qi stagnation”， and believed that depletion of essence and blood， long-term accumulation of internal cold， and qi constraint and blood stasis are the causes of PCOS， with depletion of essence and blood， and lack of nourishment of zang-fu （脏腑） organs as the root， and cold pathogen invasion， qi constraint and blood stasis as the branch. The main treatment principle is “treating deficiency with supplementation”， and dispelling pathogen while reinforcing healthy qi， along with “treatment of cold by warming” and “treatment of stagnation by dispersing”. This is of great significance for the treatment of polycystic ovary syndrome. Clinically， these methods can be used flexibly to guide treatment and formula selection for PCOS， with the goal of harmonizing qi and blood and regulating menstruation.

Objective To understand the disease acceptance status and related factors in human immunodeficiency virus(HIV)-infected/acquired immunodeficiency syndrom(AIDS)patients,so as to guide the clinical development of intervention measures,and to provide empirical evidence for improving clinical outcomes.Methods Convenience sampling method was used to select 555 HIV-infected/AIDS patients who received treatment in the designated AIDS treatment clinic of a hospital.General data,disease acceptance,disease self-management efficacy and clinical out-comes(such as quality of life,CD4+T lymphocyte count and HIV viral load)of the studied subjects were collected.Results The average disease acceptance of HIV-infected/AIDS patients was(26.08±5.34)points.Multiple linear regression analysis showed that religious belief and self-management efficacy were related factors affecting the di-sease acceptance of patients(both P＜0.05),which could explain the 30.4％variation in disease acceptance of HIV-infected/AIDS patients,and the disease acceptance of patients was closely related to their quality of life(P＜0.001).Conclusion HIV-infected/AIDS patients have a moderate level of disease acceptance.Medical staff should fully consider patients'religious beliefs and self-management efficacy,so as to formulate targeted intervention mea-sures to improve patients'acceptance of disease,and further promote patients'quality of life.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

This study aims to characterize the cell atlas of the epididymis derived from a 46,XY disorders of sex development (DSD) patient with a novel heterozygous mutation of the nuclear receptor subfamily 5 group A member 1 (NR5A1) gene. Next-generation sequencing found a heterozygous c.124C>G mutation in NR5A1 that resulted in a p.Q42E missense mutation in the conserved DNA-binding domain of NR5A1. The patient demonstrated feminization of external genitalia and Tanner stage 1 breast development. The surgical procedure revealed a morphologically normal epididymis and vas deferens but a dysplastic testis. Microfluidic-based single-cell RNA sequencing (scRNA-seq) analysis found that the fibroblast cells were significantly increased (approximately 46.5%), whereas the number of main epididymal epithelial cells (approximately 9.2%), such as principal cells and basal cells, was dramatically decreased. Bioinformatics analysis of cell-cell communications and gene regulatory networks at the single-cell level inferred that epididymal epithelial cell loss and fibroblast occupation are associated with the epithelial-to-mesenchymal transition (EMT) process. The present study provides a cell atlas of the epididymis of a patient with 46,XY DSD and serves as an important resource for understanding the pathophysiology of DSD.
Male ; Humans ; Epididymis ; Disorder of Sex Development, 46,XY/genetics* ; Disorders of Sex Development ; Mutation ; Mutation, Missense ; Steroidogenic Factor 1/genetics*

ObjectiveTo explore the relapse status based on the positive and negative syndrome scale （PANSS Scale） and related factors of schizophrenics in Shanghai communities， and to analyze the association between socio demographic characteristics， lifestyles， clinical characteristics and relapse. MethodsA dynamic cohort prospective study design was used in this study. From March 2018 to February 2019， a total of 189 schizophrenics in Xuhui， Hongkou， Changning， Jiading， Songjiang and Baoshan districts were enrolled successively. Baseline questionnaires were conducted through face-to-face interviews at baseline， which contained social demographic information， lifestyle information and clinical information. A follow-up was conducted every 2 weeks for a measurement of PANSS Scale for a total of 6 months. Relapse was assessed by a PANSS score increase of ≥25% from baseline （or an increase of 10 points or more if the baseline score was ≤40 points）. Univariate and multivariate Cox regression models were used to analyze the associations between relapse status （assessed by PANSS Scale） and socio demographic characteristics， lifestyles， and clinical characteristics， respectively. ResultsA total of 165 community schizophrenics completed baseline and follow-up surveys， with a loss to follow-up rate of about 12.7%. After exclusion of sociodemographic and clinical information deficits， 132 patients were included in the analysis totally， with an average age of 48.18±12.67 years， among whom 41.67% were male. Totally 33 patients relapsed during the 6-month follow-up period， with a relapse rate of 25.0%. After adjusting for gender， family history， age， employment， education， marital status， smoking， drinking， exercise frequency， medication compliance， insight， social function， violence history， stress recent events， adverse drug reactions and baseline scores of PANSS Scale， risk factors of relapse included the following four factors： age below 40 years （HR=4.47， 95%CI： 1.15-17.40）， primary school or below （HR=7.11， 95%CI： 1.54-32.83）， unemployed （HR=8.34， 95%CI： 1.78-38.98）， and adverse drug reactions （HR=5.02， 95%CI： 1.75-14.37）. ConclusionWe should pay attention to the risk factors such as age， education， employment and adverse drug reactions， in order to identify high-risk patients and to conduct timely interventions during the relapse management of schizophrenics in Shanghai community.

Long chain non coding RNA (LncRNA) is widely involved in various biological processes such as intracellular chromatin modification, transcriptional regulation, nuclear transport, and protein function regulation, and is closely related to various key physiological functions such as immunity and metabolism in the body. NEAT1 (nuclear parapackle assembly transcript 1) is a newly discovered LncRNA, which is an important component of the nuclear substructural paraplaques. It has been proven to regulate downstream protein expression by binding to various miRNAs, thereby regulating the expression of inflammatory factors, epithelial mesenchymal transition, autophagy, apoptosis, proliferation, migration, and other biological processes, Its abnormal expression plays an important role in the pathogenesis of lung diseases such as asthma, chronic obstructive pulmonary disease, pneumonia, pulmonary fibrosis, and lung cancer, and is closely related to the prognosis of non-small cell lung cancer and the sensitivity of anti-tumor drugs. It is expected to become a new biological marker and therapeutic intervention target. This article mainly reviews the latest research progress on the role of NEAT1 in lung diseases.