1.Research Tackling Paradigm and Technological Layout Strategies Based on Erectile Dysfunction, A Clinical Dominant Disease of Traditional Chinese Medicine
Qi ZHAO ; Yun CHEN ; Baoxing LIU ; Xuejun SHANG ; Fei SUN ; Xiaozhi ZHAO ; Zhigang WU ; Chao SUN ; Peihai ZHANG ; Wanjun CHENG ; Xing ZHOU ; Zhan QIN ; Yufeng PAN ; Weiwei TAO ; Jianhuai CHEN ; Mei MO ; Xiaoxiao ZHANG ; Xing ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):291-299
To thoroughly implement the strategic deployment outlined in the Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine regarding research on dominant diseases of traditional Chinese medicine and to uphold the development philosophy of equal emphasis on traditional Chinese medicine and western medicine,the China Association of Chinese Medicine has fully played a leading academic role by systematically organizing and conducting a series of academic youth salons on clinical dominant diseases of traditional Chinese medicine. On September 13,2024,the 36th Youth Salon on Clinical Dominant Diseases was successfully held in Nanjing,focusing on the advantages of traditional Chinese medicine and the integrative traditional Chinese medicine and western medicine in the diagnosis and treatment of erectile dysfunction (ED). The conference brought together leading experts from traditional Chinese medicine,western medicine,and interdisciplinary fields,facilitating in-depth multidisciplinary discussions that led to key consensus on optimizing traditional Chinese medicine treatment protocols for ED,researching and developing new drugs of traditional Chinese medicine,and advancing interdisciplinary development in traditional Chinese medicine. This salon systematically sorted out the clinical strengths and distinctive features of traditional Chinese medicine in the diagnosis and treatment of ED. Based on current research foundations and clinical needs,it identified key directions for future scientific layout and scientific research tackling: (1) Standardization of syndrome differentiation system of traditional Chinese medicine for ED. (2) Optimization and standardization of intervention methods of integrated traditional Chinese medicine and western medicine. (3) High-quality clinical research guided by evidence-based medicine. (4) In-depth analysis of the pharmacological mechanisms of traditional Chinese medicine in the treatment of ED. (5) Clinical translation and application promotion of new drugs of traditional Chinese medicine. (6) Interdisciplinary integration and innovation in traditional Chinese medicine. For each research direction,key focus areas,expected objectives,and clinical value were further refined,along with the establishment of a scientifically sound priority funding level evaluation system. Therefore,building on the series of salons on the ED-focused dominant diseases of traditional Chinese medicine,this paper provides standardized guidance for clinical practice of traditional Chinese medicine in ED management,effectively contributing to the high-quality development of traditional Chinese medicine. It serves as a valuable reference for national scientific and technological strategic layout, research and development decision-making in new drugs of traditional Chinese medicine,research topic planning,and clinical guideline formulation.
2.Analysis of Influential Factors on Chronic Disease Patients' Willingness to Participate in Home Pharmaceutical Care Based on Null Importance
Ke ZHAO ; Hongxin YANG ; Mingfen WU ; Hao GUO ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1347-1351
Objective To investigate the key factors influencing the willingness of chronic disease patients to participate in home pharmaceutical services.Methods The study adopted the data from inner Mongolia and northeast China set of the drug aging system research for China.The Null Importance method was employed to identify key factors influencing the willingness of chronic disease patients to participate in home pharmaceutical services.The logistic regression model was constructed and evaluated the impact of feature selection through 5 fold cross-validation and accuracy and AUC values.Results 10 key factors were selected by the Null Importance method and the performance of the logistic regression model was improved after feature selection.The factors which significantly affected patients' willingness to accept home pharmaceutical services included the number of accessible information sources(OR=1.261,95%CI=1.182~1.345),medication therapeutic indication cognition(OR=1.342,95%CI=1.124~1.603),the presence the drug packaging or not(OR=1.218,95%CI=1.015~1.462),medication adherence(OR=0.881,95%CI=0.839~0.925),medication literacy(OR=0.631,95%CI=0.488~0.817),the degree of know of medication guidance services(OR=1.211,95%CI=1.017~1.442).Conclusion The logistic model refined by the Null Importance feature selection method demonstrated good performance and was conducive to analyzing the factors influencing the willingness of chronic disease patients to participate in home pharmaceutical care.
3.Historical Evolution,Contradiction Analysis and Policy Recommendations of China's Laws and Regulations on Blood Products Import
Luofei ZHANG ; Zishun TIAN ; Ziyi WANG ; Wei ZHANG ; Jiping HUO ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1242-1246
The legal and regulatory system for the import of blood products in China has undergone a three-stage evolution of"safety first,demand-driven and standard upgrading",ultimately forming a dual control framework that centers on infectious disease prevention and control as well as quality approval.While the current policy effectively ensures biosafety,it also faces several deep-seated contradictions.These include the worsening imbalance between supply and demand,limited access to clinically needed blood products,and insufficient alignment with international standards.Moreover,strict regulation has also constrained technological innovation and market diversification.To address these challenges,it is suggested to establish a synergy mechanism that integrates a"clinical urgent need list,"hierarchical supervision,and mutual recognition of Good Manufacturing Practice(GMP).By implementing dynamic access,risk classification management,and international certification mutual recognition,it is possible to achieve compatible development between the safety baseline and medical accessibility.
4.Regulatory Barriers and Optimization Strategies for the Import of Blood Products in China
Zishun TIAN ; Luofei ZHANG ; Wei ZHANG ; Jiping HUO ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1247-1250
Blood products play a pivotal role in modern medical treatment and healthcare system,and the clinical demand in China continues to grow.However,there is a significant supply gap for raw plasma domestically,with over 60%of human albumin relying on imports.The regulatory framework for imported blood products in China has undergone multiple rounds of adjustments,establishing a comprehensive lifecycle oversight system centered around the《Law of the People's Republic of China on the Administration of Drugs》and the《Measures for the Administration of Batch Release of Biological Products》.While ensuring safety,this framework has also led to issues such as insufficient clinical supply and elevated corporate costs because of stringent market access requirements,complex approval procedures,and tariff barriers.Specifically,import market access barriers have imposed a'dual-certification'burden,and tariff barriers have increased the costs of some products,exacerbating the financial burden on patients.In response to these challenges,it is recommended to establish an interdepartmental information-sharing platform,promote mutual recognition of international quality standards,form a rapid approval team for urgently needed medications,and reduce or exempt tariffs for clinically critical products.
5.Comparison of Domestic and International Regulations on Blood Products and Insights
Hongbo PAN ; Yingying LIU ; Pei MAO ; Michael WENDT ; Wei ZHANG ; Zhihua YUE ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1250-1256
The blood products industry in China,the United States,the European Union and Japan are at different stages of development,with very different laws,regulations and regulatory systems.This paper uses methods such as literature review,policy comparison,and case study.By analyzing and comparing the blood product regulatory policies in various countries,it is found that compared with the United States,the European Union and Japan,China has differences in several areas,including plasma quarantine period,plasma fractionation processes and intermediate products,segmented production of blood products,and import management policies.It is suggested that we should learn from foreign regulatory experiences,and explore the establishment of blood product regulatory policies suitable for China's national conditions.Recommendations include optimizing China's source plasma quarantine period and blood product production process management policies,promoting multiple sites and segmented production of blood products,and establishing flexible blood product import and export management systems.These measures aim to provide references for promoting the development of the blood product industry and improving the accessibility of medications for the public.
6.Similarities and Differences of Source Plasma Collection and Quality Control In China and Abroad
Demei DONG ; Yang GAO ; Yumeng SU ; Yan ZHANG ; Chuanbo ZHAO ; Yonghao XU ; Wei ZHANG ; Jiping HUO ; Rong ZHOU ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1257-1265
In this study,the similarities and differences of plasma collection and quality control in China and abroad were analyzed by comparing the related regulations,standards,guidelines and literatures.Rational and constructive suggestions were proposed,aiming to optimize domestic plasma management and promote the improvement of plasma-related standards.There was little difference on facilities and safety control process of plasma between China and the developed countries(United States,EU and Japan),However,significant differences existed on plasma station setting,donor screening standards,collection interval,volume limits,plasma testing modes and tests,plasma quarantine standard and utilization of recovered plasma.The United States sets the industry benchmark and is worthy of reference for our country both in plasma collection and quality control.
7.Differences in Domestic and International Supervision of Blood Products Virus Safety and Related Recommendations
Peng WU ; Denis KLOCHKOV ; Jens REHBEIN ; Christoph ZUERCHER ; Connie BROUMIS ; Eleonora WIDMER ; Wei ZHANG ; Zhihua YUE ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1265-1271
Blood products are biological products derived from human plasma for use in clinical treatment.As such,they inherently carry the risk of blood-bome viral contamination,which has garnered significant attention from regulatory agencies worldwide regarding the viral safety of these products.This article compares and discusses the differences in domestic and international regulations on viral safety for blood products,focusing on aspects such as raw material selection and viral testing.Additionally,the article explores further impactful measures for viral safety control,namely,viral reduction during the manufacturing process and strategies to prevent cross-contamination.Moreover,we propose corresponding recommendations for China's regulatory framework to further enhance the viral safety of blood products in the country.
8.Research and Deveplopment Landscape and Industry Trends of Blood Product Enterprises in China and Abroad
Yanan XU ; Jiping HUO ; Qiang WU ; Ding YU ; Hong LIANG ; Rui FU ; Wenli MA ; Wei ZHANG ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1272-1280
The blood products industry,both domestically and internationally,exhibits distinct features in product research,development,and technological innovation.International companies possess extensive expertise in developing immunoglobulins,coagulation factors,and recombinant plasma protein products,demonstrating continuous advancements-particularly in specific immunoglobulin development,long-acting formulation optimization,and manufacturing process improvements.In recent years,Chinese enterprises have also achieved notable progress in related fields,especially in immunoglobulin process refinement and the development of novel recombinant coagulation factor products.However,there remains significant scope for improvement in areas such as the application of recombinant protein technologies,efficient utilization of plasma resources,and the adoption of advanced manufacturing techniques.Additional challenges include the accumulation of patented technologies,the supply of critical raw materials,and access to comprehensive epidemiological data.Driven by ongoing advances in gene recombination technologies,innovations in drug delivery systems,digital transformation,and the rise of personalized medicine,the blood products industry is poised for broader development prospects.To foster sustained and stable domestic industry growth and enhance global competitiveness,Chinese blood product enterprises should intensify their technological accumulation,upgrade manufacturing processes,and optimize plasma resource utilization.
9.Analysis of Influential Factors on Chronic Disease Patients' Willingness to Participate in Home Pharmaceutical Care Based on Null Importance
Ke ZHAO ; Hongxin YANG ; Mingfen WU ; Hao GUO ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1347-1351
Objective To investigate the key factors influencing the willingness of chronic disease patients to participate in home pharmaceutical services.Methods The study adopted the data from inner Mongolia and northeast China set of the drug aging system research for China.The Null Importance method was employed to identify key factors influencing the willingness of chronic disease patients to participate in home pharmaceutical services.The logistic regression model was constructed and evaluated the impact of feature selection through 5 fold cross-validation and accuracy and AUC values.Results 10 key factors were selected by the Null Importance method and the performance of the logistic regression model was improved after feature selection.The factors which significantly affected patients' willingness to accept home pharmaceutical services included the number of accessible information sources(OR=1.261,95%CI=1.182~1.345),medication therapeutic indication cognition(OR=1.342,95%CI=1.124~1.603),the presence the drug packaging or not(OR=1.218,95%CI=1.015~1.462),medication adherence(OR=0.881,95%CI=0.839~0.925),medication literacy(OR=0.631,95%CI=0.488~0.817),the degree of know of medication guidance services(OR=1.211,95%CI=1.017~1.442).Conclusion The logistic model refined by the Null Importance feature selection method demonstrated good performance and was conducive to analyzing the factors influencing the willingness of chronic disease patients to participate in home pharmaceutical care.
10.Historical Evolution,Contradiction Analysis and Policy Recommendations of China's Laws and Regulations on Blood Products Import
Luofei ZHANG ; Zishun TIAN ; Ziyi WANG ; Wei ZHANG ; Jiping HUO ; Zhigang ZHAO
Herald of Medicine 2025;44(8):1242-1246
The legal and regulatory system for the import of blood products in China has undergone a three-stage evolution of"safety first,demand-driven and standard upgrading",ultimately forming a dual control framework that centers on infectious disease prevention and control as well as quality approval.While the current policy effectively ensures biosafety,it also faces several deep-seated contradictions.These include the worsening imbalance between supply and demand,limited access to clinically needed blood products,and insufficient alignment with international standards.Moreover,strict regulation has also constrained technological innovation and market diversification.To address these challenges,it is suggested to establish a synergy mechanism that integrates a"clinical urgent need list,"hierarchical supervision,and mutual recognition of Good Manufacturing Practice(GMP).By implementing dynamic access,risk classification management,and international certification mutual recognition,it is possible to achieve compatible development between the safety baseline and medical accessibility.

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