Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.

Objective To improve and refine the relevant regulations and guiding principles of warnings on drug instructions and labels in China.Methods This paper sorted out the drug instructions of small molecule anti-tumor drugs listed by the U.S.Food and Drug Administration(FDA)from 2005 to 2022,included the drugs mentioned in the QT interval prolongation risk,analyzed the clinical research and QT research results,and sorted out the identification and warning rules of the instructions.Results A total of 35 drugs were included,4 drugs wrote the risk of QT interval prolongation in the black box warning,21 drugs were wrote in the warning and precautions position,6 drugs were wrote in the adverse reaction section,and 2 drugs were only described under clinical pharmacology section.According to the severity of the QT interval prolongation caused by the drug and whether there were serious clinical consequences,they were displayed in the warnings(black box warnings),precautions(warnings and precautions)and adverse reactions in the instructions.Conclusion The aim of this article is to provide a reference for the writing of QT risk warning information of the instructions of domestic drug production enterprises and regulatory departments.It is recommended to clarify the severity of drug safety and the location of the instructions in clinical research,and continue to carry out safety monitoring and update the instructions in time after listing.

This study aims to comprehensively analyze the material basis of toad visceral oil(hereafter referred to as toad oil), and explore the pharmacological effect of toad oil on atopic dermatitis(AD). Ultra-high performance liquid chromatography-linear ion trap/orbitrap high-resolution mass spectrometry(UHPLC-LTQ-Orbitrap-MS) and gas chromatography-mass spectrometry(GC-MS) were employed to comprehensively identify the chemical components in toad oil. The animal model of AD was prepared by the hapten stimulation method. The modeled animals were respectively administrated with positive drug(0.1% hydrocortisone butyrate cream) and low-and high-doses(1%, 10%) of toad oil by gavage. The effect of toad oil on AD was evaluated with the AD score, ear swelling rate, spleen index, and pathological section results as indicators. A total of 99 components were identified by UHPLC-LTQ-Orbitrap-MS, including 14 bufadienolides, 7 fatty acids, 6 alkaloids, 10 ketones, 18 amides, and other compounds. After methylation of toad oil samples, a total of 20 compounds were identified by GC-MS. Compared with the model group, the low-and high-dose toad oil groups showed declined AD score, ear swelling rate, and spleen index, alleviated skin lesions, and reduced infiltrating mast cells. This study comprehensively analyzes the chemical composition and clarifies the material basis of toad oil. Meanwhile, this study proves that toad oil has a good therapeutic effect on AD and is a reserve resource of traditional Chinese medicine for external use in the treatment of AD.
Animals ; Dermatitis, Atopic/immunology* ; Disease Models, Animal ; Mice ; Male ; Gas Chromatography-Mass Spectrometry ; Humans ; Bufonidae ; Oils/administration & dosage* ; Chromatography, High Pressure Liquid ; Female ; Mice, Inbred BALB C

Basket trial, as an innovative clinical trial design concept, marks the transformation of medical research from the traditional large-scale and single-disease treatment to the precise and individualized treatment. By gradually incorporating the Bayesian method during development, the trial design becomes more scientific and reasonable and increases its efficiency. The fundamental principle of the Bayesian method is the utilization of prior knowledge in conjunction with new observational data to dynamically update the posterior probability. This flexibility enhances the basket trial's capacity to effectively adapt to variations during the research process. Consequently, it enables researchers to dynamically adjust research strategies based on accumulated data and improve the predictive accuracy regarding treatment responses. In addition, the design concept of the basket trial aligns with the traditional Chinese medicine(TCM) principle of "homotherapy for heteropathy". The principle of "homotherapy for heteropathy" emphasizes that under certain conditions, different diseases may have the same treatment. Similarly, basket trials allow using a uniform trial design across multiple diseases, offering enhanced operational and significant practical value in the realm of TCM, particularly within the context of syndrome-based disease research. By introducing basket trials, the design of TCM clinical studies will be more scientific and yield higher-quality evidence. This study systematically categorized various Bayesian methods and models utilized in basket trials, evaluated their strengths and weaknesses, and identified their appropriate application contexts, so as to offer a practical guide for designing basket trials in the realm of TCM.
Bayes Theorem ; Humans ; Medicine, Chinese Traditional/methods* ; Research Design ; Clinical Trials as Topic/methods* ; Drugs, Chinese Herbal/therapeutic use*

In-depth study of the components of polymyxins is the key to controlling the quality of this class of antibiotics.Similarities and variations of components present significant analytical challenges.A two-dimensional(2D)liquid chromatography-mass spectrometry(LC-MS)method was established for screening and comprehensive profiling of compositions of the antibiotic colistimethate sodium(CMS).A high concentration of phosphate buffer mobile phase was used in the first-dimensional LC system to get the components well separated.For efficient and high-accuracy screening of CMS,a targeted method based on a self-constructed high resolution(HR)mass spectrum database of CMS components was established.The database was built based on the commercial MassHunter Personal Compound Database and Library(PCDL)software and its accuracy of the compound matching result was verified with six known components before being applied to genuine sample screening.On this basis,the unknown peaks in the CMS chromatograms were deduced and assigned.The molecular formula,group composition,and origins of a total of 99 compounds,of which the combined area percentage accounted for more than 95％of CMS components,were deduced by this 2D-LC-MS method combined with the MassHunter PCDL.This profiling method was highly efficient and could distinguish hundreds of components within 3 h,providing reliable results for quality control of this kind of complex drugs.

In-depth study of the components of polymyxins is the key to controlling the quality of this class of antibiotics. Similarities and variations of components present significant analytical challenges. A two-dimensional (2D) liquid chromatography-mass spectrometr (LC-MS) method was established for screening and comprehensive profiling of compositions of the antibiotic colistimethate sodium (CMS). A high concentration of phosphate buffer mobile phase was used in the first-dimensional LC system to get the components well separated. For efficient and high-accuracy screening of CMS, a targeted method based on a self-constructed high resolution (HR) mass spectrum database of CMS components was established. The database was built based on the commercial MassHunter Personal Compound Database and Library (PCDL) software and its accuracy of the compound matching result was verified with six known components before being applied to genuine sample screening. On this basis, the unknown peaks in the CMS chromatograms were deduced and assigned. The molecular formula, group composition, and origins of a total of 99 compounds, of which the combined area percentage accounted for more than 95% of CMS components, were deduced by this 2D-LC-MS method combined with the MassHunter PCDL. This profiling method was highly efficient and could distinguish hundreds of components within 3 h, providing reliable results for quality control of this kind of complex drugs.

Objective:To investigate effect of comprehensive management intervention based on WeChat multimedia classroom on cardiac function and prognosis in elderly patients with acute myocardial infarction(AMI).Methods:Clinical data of 118 elderly patients diagnosed with AMI in the Second Affiliated Hospital of Chinese PLA Air Force Military Medical University between August 2021 and December 2022 were retrospectively collected.According to nursing way after operation,they were divided into control group(n=60,comprehensive management interven-tion)and intervention group(n=58,comprehensive management intervention based on WeChat multimedia class-room),both groups were intervened for 5 months.Cardiac function,exercise tolerance,compliance to rehabilita-tion management,self-efficacy and healthy behavior were compared between two groups.Kaplan-Meier survival curve was employed to compare incidence of adverse cardiovascular events during follow-up between two groups.Results:After 5-month intervention,compared with patients in control group,those in intervention group had sig-nificant higher left ventricular ejection fraction(LVEF)[(58.14±1.88)％vs.(54.48±1.34)％],6min walking distance(6MWD)[(490.41±59.59)m vs.(394.97±28.20)m],scores of compliance to rehabilitation manage-ment[(6.97±2.03)points vs.(5.03±1.40)points],General Self-Efficacy Scale(GSES)[(30.34±4.67)points vs.(23.55±4.86)points]and Health Promoting Lifestyle Profile-Ⅱ[(137.62±30.17)points vs.(115.95±22.66)points],and significant lower left ventricular end-diastolic volume(LVEDV)[(117.90±4.22)ml vs.(131.28±3.61)ml],left ventriadar end-systolic volume(LVESV)[(54.46±2.10)ml vs.(63.15±2.06)ml],serum brain natriuretic peptide(BNP)[(362.32±25.36)pg/ml vs.(567.58±21.90)pg/ml]and incidence of ad-verse cardiovascular events(6.90％vs.21.67％)(P＜0.05 or＜0.01).Conclusion:Comprehensive management intervention based on the WeChat multimedia classroom could significantly improve cardiac function,exercise toler-ance,compliance to rehabilitation,self-efficacy and healthy behavior,and reduce incidence of adverse cardiovas-cular events after operation in elderly AMI patients.

AIM To prepare the sustained-release microspheres of ginsenosides.METHODS The sustained-release microspheres were prepared by SPG membrane emulsification technology with poly(lactic-co-glycolic acid)(PLGA)as a shell carrier.With PLGA concentration,feed rate and Span 60 concentration as influencing factors,comprehensive score for appearance,drug loading and encapsulation efficiency as an evaluation indice,the preparation process was optimized by response surface method.The morphology of sustained-release microspheres was observed,after which the particle size,drug loading and encapsulation efficiency were determined,and the in vitro drug release was investigated.RESULTS The optimal conditons were determined to be 45 s for agitation time of primary emulsion,74.68 mg/mL for PLGA concentration,11％for feed rate,and 4.18 mg/mL for Span 60 concentration,the comprehensive score was 74.98.The round sustained-release microspheres demonstrated the average particle size of 4.33 μm,drug loading of(8.24±0.13)％,and encapsulation efficiency of(74.94±1.17)％,respectively.At 336 h,ginsenosides Rg1,Rb1,Rb2 displayed the accumulative release rates of 84.12％,78.04％,65.88％,respectively.CONCLUSION This reasonable and feasible method can be used for the preparation of sustained-release microspheres of ginsenosides with good appearance and high drug loading,which can provide references for the preparation of other water-soluble drug microspheres and solution of microsphere collapse problem.

AIM To prepare the sustained-release microspheres of ginsenosides.METHODS The sustained-release microspheres were prepared by SPG membrane emulsification technology with poly(lactic-co-glycolic acid)(PLGA)as a shell carrier.With PLGA concentration,feed rate and Span 60 concentration as influencing factors,comprehensive score for appearance,drug loading and encapsulation efficiency as an evaluation indice,the preparation process was optimized by response surface method.The morphology of sustained-release microspheres was observed,after which the particle size,drug loading and encapsulation efficiency were determined,and the in vitro drug release was investigated.RESULTS The optimal conditons were determined to be 45 s for agitation time of primary emulsion,74.68 mg/mL for PLGA concentration,11％for feed rate,and 4.18 mg/mL for Span 60 concentration,the comprehensive score was 74.98.The round sustained-release microspheres demonstrated the average particle size of 4.33 μm,drug loading of(8.24±0.13)％,and encapsulation efficiency of(74.94±1.17)％,respectively.At 336 h,ginsenosides Rg1,Rb1,Rb2 displayed the accumulative release rates of 84.12％,78.04％,65.88％,respectively.CONCLUSION This reasonable and feasible method can be used for the preparation of sustained-release microspheres of ginsenosides with good appearance and high drug loading,which can provide references for the preparation of other water-soluble drug microspheres and solution of microsphere collapse problem.

Objective To improve and refine the relevant regulations and guiding principles of warnings on drug instructions and labels in China.Methods This paper sorted out the drug instructions of small molecule anti-tumor drugs listed by the U.S.Food and Drug Administration(FDA)from 2005 to 2022,included the drugs mentioned in the QT interval prolongation risk,analyzed the clinical research and QT research results,and sorted out the identification and warning rules of the instructions.Results A total of 35 drugs were included,4 drugs wrote the risk of QT interval prolongation in the black box warning,21 drugs were wrote in the warning and precautions position,6 drugs were wrote in the adverse reaction section,and 2 drugs were only described under clinical pharmacology section.According to the severity of the QT interval prolongation caused by the drug and whether there were serious clinical consequences,they were displayed in the warnings(black box warnings),precautions(warnings and precautions)and adverse reactions in the instructions.Conclusion The aim of this article is to provide a reference for the writing of QT risk warning information of the instructions of domestic drug production enterprises and regulatory departments.It is recommended to clarify the severity of drug safety and the location of the instructions in clinical research,and continue to carry out safety monitoring and update the instructions in time after listing.