Based on the traditional Chinese medicine theories of "correspondence between man and nature" and "latent pathogens"， this paper explores the etiology， pathogenesis， and prevention strategies of thunderstorm asthma. The etiology of thunderstorm asthma is often due to deficiency of the lungs， spleen and kidneys in the body， with "latent phlegm and long-standing root causes" internally. The external pathogenic factors of thunderstorms trigger the internal pathogens， leading to the onset of the disease. The core pathogenesis involves "external wind triggers the internally latent phlegm， which blocks the lung qi and impairs the lungs′ function of dispersion and descent". In the acute stage， there is deficiency in the root and excess in the symptoms. During the attack， excessive symptoms are predominant； while in the remission stage， there is deficiency of the lungs， spleen and kidneys， and latent phlegm-fluid retention. The treatment follows the principle of "treating the symptoms in an emergency and treating the root cause in a non-emergency situation". In the acute attack stage， the treatment aims to open the orifices and relieve asthma， while in the remission stage， it focuses on regulating constitution and reducing recurrence. Traditional Chinese medicine has the advantages of overall regulation and stage-based treatment in preventing and treating thunderstorm asthma. Relying on the concept of "preventing disease before they occur" to condition the allergic constitution and following the principle of "preventing disease progression after they occur" to control symptoms， it provides theoretical and clinical ideas for dealing with sudden group-based respiratory events.

Based on Liu Wansu's "xuanfu theory"， this paper innovatively proposes that "stagnation due to deficiency and blockage of the xuanfu" is the core pathogenesis of allergic rhinitis （AR）. The onset of AR is fundamentally rooted in the deficiency of healthy qi in the lung， spleen， and kidney， which leads to impaired circulation of qi and fluids in the xuanfu of the nasal orifices and dysfunction of their gatekeeping mechanism， ultimately manifesting as the branch manifestation of blocked microscopic orifices. This paper systematically elaborates on the connotation of this pathogenic theory and constructs a corresponding differentiation and treatment system with the general principle of "simultaneous unblocking and tonifying， restoring their opening and closing". This system emphasizes dispersing and unblocking the xuanfu to relieve stagnation during the acute stage， while focusing on tonifying the zang-fu organs to replenish deficiency during the remission stage， with particular attention paid to utilizing wind-dispersing medicinals to facilitate the free flow of qi. This framework not only provides new theoretical guidance for the TCM clinical diagnosis and treatment of AR but also promotes the precise and rational use of Chinese medicines in clinical practice through its integrated approach combining "holistic and local perspectives" and "simultaneous unblocking and tonifying". This is especially evident in the clearer criteria for the selection， combination， and application of wind-dispersing medicinals， blood-activating medicinals， and tonifying medicinals， contributing to improving therapeutic efficacy and reducing misuse of medications.

Idiopathic pulmonary fibrosis （IPF） is a progressive and debilitating interstitial lung disease of unknown etiology and pathogenesis， for which no effective treatment is currently available. Pirfenidone and nintedanib are the only approved anti-fibrotic agents for IPF by June 2025. However， neither can reverse disease progression， and their use is often limited by adverse drug reactions. Therefore， there is an urgent need to develop novel and more effective therapeutic strategies for IPF. In this review， we searched for investigational drugs for IPF in recent years based on the ClinicalTrials.gov and Chinese Clinical Trial Registry （ChiCTR） platform， and summarized their mechanisms of action， efficacy， and safety profiles， aiming to provide new insights for the development of innovative treatments for IPF.

This article reports a case of acute asthma attack induced by thunderstorm weather in a patient with allergic rhinitis. This 25-year-old female patient with a history of seasonal allergic rhinitis experienced sudden chest tightness， difficulty breathing， and other acute asthma symptoms during a thunderstorm at night. This article analyzed the association between thunderstorm weather and acute asthma attacks in patients with allergic rhinitis， explored the pathogenesis and risk factors of thunderstorm asthma， and proposed corresponding adjustments to medication treatment plans and preventive measures. After active treatment， the patients' symptoms disappeared and they were discharged from the hospital. The article aims to remind patients with allergic rhinitis to enhance protection and drug intervention during the thunderstorm season， in order to reduce the risk of thunderstorm asthma.

Ascites is a common complication of decompensated liver cirrhosis. Long-term use of conventional diuretics is often limited by diuretic resistance and renal impairment. Tolvaptan， a selective arginine vasopressin V2 receptor antagonist， offers a novel therapeutic option； however， its optimal timing and combination strategy with conventional diuretics are still debated. This article compares the differences in the initial timing of tolvaptan and the combination dosing with conventional diuretics between the Japanese Evidence-based Clinical Practice Guidelines for Liver Cirrhosis 2020 and the Chinese Guidelines on the Management of ascites in Cirrhosis （2023 version）， and systematically reviews the evidence from the following perspectives： mechanism of action， clinical application， combination strategies and differences between Chinese and Japanese populations. This article aims to provide evidence-based references for optimizing clinical therapeutic strategies of tolvaptan and calls for high-quality prospective studies in the Chinese population.

Stem cell-derived pancreatic islet cell medicinal products have gained increasing attention as offering new options for the treatment of diabetes mellitus in recent years. Unlike other cell therapy medicinal products， stem cell-derived pancreatic islet cell medicinal products have unique characteristics in terms of active ingredients， structure and production technology， and their quality and clinical performance are more closely related to their manufacturing processes. This makes manufacturing design and process control crucial for the quality controllability， clinical safety and efficacy of these products. The manufacturing and regulation of stem cell-derived pancreatic islet cell medicinal products constitute a considerable challenge. Critical issues include the process robustness across scale production， the heterogeneity of product quality， the potential risks of tumorigenicity， the immune rejection problem， and the limited applicability of existing regulatory guidelines， complicating the quality control and regulatory decision-making on these products. This article briefly reviews the research progress of stem cell-derived pancreatic islet cell medicinal products， and discusses upstream design and construction， manufacturing process development and control， and pharmaceutical evaluation considerations for these products， by integrating current scientific understanding with practical experience from industrial practice and regulatory evaluation of similar products. It provides a reference for research and regulation， with the aim of facilitating the clinical application and commercialization of such products.

Human epidermal growth factor receptor 2 （HER2） is a core target for tumor therapy. The innovation of antibody-drug conjugate （ADC） technology has promoted the coverage of HER2-targeted therapy to tumors with low HER2 expression. JSKN003 is a novel HER2-targeted bispecific epitope ADC independently developed by Jiangsu Alphamab Oncology Co.， Ltd. It achieves dual binding to domains Ⅱ and Ⅳ of the HER2 receptor through the bispecific antibody scaffold KN026， combined with site-specific glycosylation conjugation technology， which ensures antitumor activity while broadening the therapeutic window. Clinical data have shown that this drug has demonstrated excellent efficacy in tumor types such as HER2-positive and low-expression breast cancer， as well as gastric cancer/gastroesophageal junction cancer， and has been granted breakthrough therapy designation by China's National Medical Products Administration. The incidence of grade 3 or higher treatment-related adverse events is low， and the incidence and severity of interstitial lung disease are also low. This article systematically elaborates on the basic information， mechanism of action， preclinical and clinical research data of JSKN003， and reviews its future prospects.

Remibrutinib is an oral Bruton's tyrosine kinase （BTK） inhibitor developed by Novartis and is primarily used for the treatment of chronic spontaneous urticaria （CSU） in adults with inadequate response to H₁-antihistamines. The drug was approved by the U.S. FDA on September 30， 2025. This article elaborates on the research and development progress of remibrutinib， including its basic information， mechanism of action， pharmacokinetic profile， clinical efficacy， safety， dosage and administration， and drug interactions， with the aim of providing a reference for its rational clinical use.

Objective To analyze the characteristics of adverse drug reaction （ADRs） in cancer patients， and to provide a reference for safe use of anti-tumor drugs in clinical practice. Methods A retrospective study was conducted to collect the reports of tumor-related ADRs submitted by Shaanxi Cancer Hospital from July 2022 to July 2025. Data were analyzed regarding patient demographics， drug categories， affected systems and organs， severity， and clinical outcomes. Results A total of 1960 ADR records were collected， and after screening and exclusion， 1851 tumor-related ADR events were ultimately included. The majority of ADRs were of moderate severity （85.47%）， and high-risk groups included females （57.21%） and patients aged 50-69 years （64.40%）. The Department of Integrated Traditional Chinese and Western Medicine reported the highest number of cases （1212 cases， 65.48%）. The most frequently implicated drug categories were platinum-based agents （365 cases， 19.72%）， taxanes （281 cases， 15.18%）， and Chinese patent medicines （226 cases， 12.21%）. ADRs most commonly involved systemic symptoms （697 cases， 23.40%）， digestive system （665 cases， 22.33%）， and hematologic system （530 cases， 17.80%）. Severe ADRs mainly involved respiratory systems （90 cases） and cardiovascular （83 cases）. The ADR correlation analysis showed that different drug categories had characteristic adverse reaction profiles. Median resolution time was 3-7 days， but significantly longer （7-10 days） for newer drugs like DNA polymerase inhibitors. Conclusion The occurrence of ADRs in cancer patients demonstrated distinct characteristics in terms of population， drug categories， and organ systems. Clinical attention should target high-risk groups （females， elderly population） and frequently implicated drugs （platinum agents， taxanes， parenteral nutrition）. Extra vigilance is needed for severe cardiovascular and respiratory ADRs， and individualized pharmaceutical care should be given based on drug-specific profiles and resolution times.

Objective To investigate the clinical efficacy and safety of zhuangyaojianshen pills in the treatment of patients with lumbar disc herniation （LDH） of kidney deficiency and blood stasis type. Methods A multi-center， prospective cohort study was conducted in patients with LDH of kidney deficiency and blood stasis type admitted to 7 hospitals including Yuquan Hospital of Tsinghua University from March to September 2023. Subjects were divided into the control group （non-exposed group） and the experimental group （exposed group） based on the exposure factor of taking zhuangyaojianshen pills. Both groups received continuous treatment for 4 weeks， and the therapeutic efficacy and safety were evaluated. Results A total of 469 patients were enrolled， including 360 cases in the experimental group and 109 cases in the control group. At the 4th weeks after treatment， the numeric rating scale （NRS） scores for low back pain/leg pain， Japanese Orthopaedic Association （JOA） scores for lumbar spine and Oswestry disability index （ODI） scores in the experimental group were significantly improved （P<0.05） compared with those in the control group， and the total effective rates of traditional Chinese medicine （TCM） syndromes in the experimental group was significantly higher than that in the control group （P<0.01）. Interaction analysis showed that there were significant interaction effects between group and follow-up time point in all indicators （P<0.01）. Trend test confirmed that the improvement degree of the above indicators had a significant linear correlation with treatment time （P<0.05）. The total effective rates of TCM syndrome in the experimental group at the 2nd and 4th weeks after treatment and the marked effective rate at the 4th week were significantly higher than those in the control group （P<0.01）. Overall clinical efficacy of the experimental group was also significantly superior to that of the control group （P<0.01）. Only one mild adverse reaction related to zhuangyaojianshen pills occurred during the entire study， which caused no serious adverse effects on the patient. Conclusion Zhuangyaojianshen pills have a definite curative effect and good safety in the treatment of LDH of kidney deficiency and blood stasis type， which can significantly improve patients' low back and leg pain， lumbar spine function and related TCM syndromes of kidney deficiency and blood stasis， and its efficacy can gradually enhance as the treatment time prolongs.

Objective To investigate the occurrence and clinical features of liver injury caused by glucagon-like peptide-1 receptor agonists （GLP-1RAs）， so as to provide reference for safe clinical medication. Methods The case reports of liver injury induced by GLP-1RAs were retrieved from the China Academic Journal Network Publishing Database， VIP， Wanfang Data Knowledge Service Platform， Web of Science， and PubMed databases from the inception of these databases to September 2025. The relevant data were collected and analyzed by descriptive statistical methods. Results A total of 11 cases from 11 articles were obtained， including 4 males and 7 females， with an average age of （56.9±19.6） years. Liraglutide was used in 6 cases （54.6%）， semaglutide in 3 cases （27.3%）， and dulaglutide in 2 cases （18.2%）. The time of liver injury ranged from 12 d to 16 months， and 9 cases （81.8%） occurred within 6 months. The clinical manifestations mainly included abdominal discomfort， nausea， and vomiting. All patients had a good outcome after treatments such as drug withdrawal， symptomatic treatments and artificial liver support. Conclusion Different GLP-1RAs can cause liver injury. For female patients， especially those who are taking other medications with liver injury risk， liver function monitoring should be strengthened. Once liver injury occurs， GLP-1RAs should be discontinued immediately and symptomatic treatment should be started.

Objective To establish an evaluation index system that fits within China's current legal and regulatory framework which can be used by marketing authorization holder （MAH） based on expert experience in order to assess the current status of their pharmacovigilance practices. Methods Based on laws and regulations sorting and literature analysis， indicators were selected to build a primary index system for evaluating the current situation of MAH pharmacovigilance. Delphi expert consultation method was used to establish the index system， and the auxiliary software of YAAHP， was used to generate the weight value of the evaluation dimension. Finally， the MAH pharmacovigilance evaluation index system was constructed. Results The evaluation index system of MAH pharmacovigilance was established， including 2 first-class indicators， 7 second-class indicators and 25 third-class indicators. Conclusion The MAH pharmacovigilance evaluation index system established in this study is highly consistent with the national requirements for MAH pharmacovigilance.

Objective To explore the adverse event （AE） signals of enzyme replacement therapy （ERT） for mucopolysaccharidosis and to provide a reference for rational drug monitoring based on the U.S. FDA adverse event reporting system （FAERS） database. Methods AE reports of two ERTs （laronidase and idursulfase） already marketed in China， from the first quarter of 2004 to the third quarter of 2024， were extracted from the FAERS database. Data mining was performed using reporting odds ratio and information component methods. Results A total of 3685 and 3675 AE reports related to laronidase and idursulfase as the primary suspected drugs were extracted respectively. Laronidase-related AEs showed a nearly equal proportion between males and females （37.04% vs 36.96%）， while idursulfase-related AEs occurred predominantly in males （84.49%）. Both ERTs were primarily used in pediatric patients. A total of 331 positive signals for laronidase were detected， involving 22 system organ classes （SOCs）， while 390 positive signals for idursulfase involved 23 SOCs. New AE signals were identified， including nasopharyngitis， ear infections， device-related infection and sepsis for laronidase， and pneumonia and respiratory tract infection for idursulfase. Conclusion Mining and analyzing AEs signals for ERT in mucopolysaccharidoses can complement real-world safety data for rare disease treatments and support rational drug use in clinical practice.

Objective To mine the risk signals related to drug-induced cholelithiasis based on the FDA adverse event reporting system （FAERS） database， so as to provide data support for clinically identifying high-risk drugs. Methods The FAERS database was searched from July 2013 to December 2024. After classification and cleaning by R software and the Medical Dictionary for Regularly Activities， adverse event （AE） reports with drug-induced cholelithiasis as the primary suspected drug were extracted. The reporting odds ratio method， the comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency， and the information component method were adopted for signal mining and analysis. Results A total of 21 029 AE reports with drug-induced cholelithiasis as the primary suspected drug were included， involving 2778 drugs. Patients were mainly distributed in the 45-64 years old （middle-aged， 26.53%） and ≥65 years old （elderly， 25.78%） groups， and the risk of onset in females was 1.7 times that of males. A total of 991 drugs related to positive cholelithiasis signals were screened by the three algorithms. The analysis focuses on the top 30 drugs， among which adalimumab had the highest number of reports （1416 cases）， followed by drospirenone and ethinylestradiol tablets （526 cases）， octreotide acetate long-acting sustained-release injection （457 cases）， etanercept （402 cases）， etc.， involving 8 system organ classes， mainly immune system diseases （17 drugs）. Only 11 drugs had clear labels of cholelithiasis as an adverse reaction in their package inserts， and 19 drugs had no labels related to cholelithiasis adverse reactions. Conclusion The occurrence risk of drug-induced cholelithiasis is seriously underestimated in the clinical setting. Therefore， clinical monitoring should be strengthened， with a focus on middle-aged and elderly females and the use of 30 high-risk drugs.

Objective To understand the incidence of hospital-acquired pneumonia （HAP）， the distribution of pathogens and drug resistance in elderly hospitalized patients （≥60 years） and to provide evidence for clinical rational use of antibacterial agents. Methods Retrospective analysis was conducted on the data of elderly patients hospitalized in the internal medicine department of Wenzhou Central Hospital from May 2023 to May 2024. The incidence of HAP was counted. Antimicrobial susceptibility results of the pathogen specimens were analyzed. Results Among the 11 073 patients， 396 cases had HAP， and the infection rate was 3.58%. The department with the highest infection rate was the Department of Hematology （8.95%） and the lowest was the Department of Gastroenterology （1.49%）. There was a significant difference in the infection rate of HAP among the departments （P<0.05）. A total of 170 strains of pathogenic bacteria were isolated from HAP patients， including 157 strains of Gram-negative bacteria， accounting for 92.35%， 8 strains of Gram-positive bacteria， accounting for 4.71%， and 5 strains of fungi， accounting for 2.94%. The top 5 Gram-negative bacteria in terms of pathogen detection rate were Klebsiella pneumoniae， Pseudomonas aeruginosa， Escherichia coli， Acinetobacter baumannii， and Stenotrophomonas maltophilia in order. The top 3 antimicrobial agents with the highest antibacterial activity against these 5 Gram-negative bacteria were cefoperazone sodium and sulbactam sodium， meropenem， and ceftazidime， with resistance rates of 13.04%， 24.35%， and 26.09%， respectively. Conclusion The incidence of HAP in elderly patients is high. The pathogens are mainly Gram-negative bacteria. Cefoperazone sodium and sulbactam sodium， meropenem and ceftazidime have the strongest antibacterial activity， which can be used as empirical drugs for HAP in the elderly. Drug sensitivity test should be carried out as much as possible， and antibacterial agents should be used reasonably.

Objective To discuss the efficacy of tislelizumab combined with whole-brain radiotherapy （WBRT） in the treatment of non-small cell lung cancer （NSCLC） with brain metastases （BM）. Methods From January to November 2024， 111 NSCLC-BM patients admitted to Hebei First Veterans' and Preferential Treatment Hospital were assigned into the control group of 55 cases （WBRT） and the experimental group of 56 cases （tislelizumab+WBRT） randomly. The efficacy， immune function， tumor marker levels， adverse reactions， and mortality rate of the two groups were compared. Results After treatment， the disease control rate of the experimental group was higher than that of the control group （94.64% vs 80.00%） with statistically significant difference （P<0.05）. The experimental group had higher CD3⁺［（61.09%±7.12%） vs （55.41%±6.29%）］， CD4⁺［（41.77%±5.88%） vs （37.68%±5.25%）］， and NK cell ratio ［（17.21%±2.97%） vs （14.93%±2.85%）］， and lower CD8⁺ ratio， ferritin， neuron-specific enolase， squamous cell carcinoma antigen， and carcinoembryonic antigen than those in the control group ［（23.66%±2.97%） vs （25.05%±3.12%）， （205.44±27.42） μg/L vs （232.59±33.85） μg/L， （16.27±2.31） ng/mL vs （19.13±2.78） ng/mL， （9.46±1.87） μg/L vs （13.54±2.53） μg/L， （29.15±3.27） μg/L vs （34.56±4.72） μg/L］， the differences were statistically significant （P<0.05）. The experimental group had a lower mortality rate than that of the control group （10.71% vs 30.91%） with statistically significant difference （P<0.05）. Conclusion Tislelizumab combined with WBRT can improve the disease control rate of patients with NSCLC-BM， systematically activate the anti-tumor immune response， inhibit the concentration of serum tumor markers， and reduce the mortality of patients without increasing the incidence of adverse reactions.

A 40-year-old female patient with Stage ⅣB cervical carcinoma received anti-tumor therapy with cadonilimab. After one cycle of cadonilimab combined with albumin-bound paclitaxel plus cisplatin， the patient's liver enzyme levels increased significantly， and Grade 4 immune-related liver injury occurred. This adverse reaction was considered to be induced by cadonilimab. Following discontinuation of cadonilimab and symptomatic treatment， all liver enzyme indicators of the patient improved. This case suggests that attention should be paid to related adverse reactions during the clinical application of cadonilimab to ensure the safety of clinical medication.