亚洲社会药学

本期目录

2024年, 第19卷, 第4期　刊出日期：2024-12-21 上一期    下一期

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Application of Real-World Evidence in the Approval of Antitumor Drugs Shang Ya’nan, Huang Zhe 2024 (4):  311-318.  摘要 ( 67 )   PDF(455KB) ( 70 )   Objective To study the information of real-world evidence (RWE) that can make up the deficiency of RCT results, the unfeasibility of some trials and the possible ethical problems, and to promote the approval of RWE for anti-tumor drugs. Methods Literature analysis, policy analysis and comparative analysis were used. Results and Conclusion The studies and application of RWE in the United States, the European Union, and China were reviewed. The approval of anti-tumor drugs supported by RWE was generally used for external control groups in single arm trials, clinical efficacy and safety of adjuvant support drugs, or background analysis. The types of approvals included innovative anti-tumor drugs, supplemented indications of the approved drugs, expanding patient population, and combination medication. This study can provide reference for the approval of anti-tumor drugs using RWE in China. It is recommended to combine traditional RCT with RWE to promote the approval of anti-tumor drugs. 相关文章 | 计量指标

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Analysis of Innovations in Monitoring Adverse Drug Reaction and Application Gong Jingyu, Tian Lijuan 2024 (4):  319-326.  摘要 ( 40 )   PDF(361KB) ( 34 )   Objective To systematically study foreign adverse drug reaction monitoring technologies and applications to extract valuable experience, and provide reference for promoting its application in China. Methods Literature research, comparative research and other methods were used to investigate foreign adverse drug reaction (ADR) monitoring technologies and applications such as passive reporting systems, active monitoring systems, electronic health records and real-world data, and analyze the problems in the application of the above technologies in China. Results and Conclusion At present, China is relatively mature in the application of ADR passive reporting system, but there are some problems in the application of ADR active monitoring system, electronic health records and real-world data. In the future, we should improve the application of adverse drug reaction active monitoring system, establish close cooperation with universities, research institutes and other institutions to improve the evaluation of adverse drug reactions. Besides, we should promote the construction of the Chinese medical language processing system and strengthen the understanding of real-world data. This will improve the level of monitoring adverse drug reactions in China and promote rational drug use. 相关文章 | 计量指标

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Research on the Construction of Drug Inspection Evaluation Indicator System Hu Di, Liao Ping, Zhu Xin, Dai Yuemin, Ge Yuanyuan, Chen Yuwen 2024 (4):  327-343.  摘要 ( 61 )   PDF(457KB) ( 36 )   Objective To study a way to establish a drug inspection evaluation system in China. Methods Through literature research, behavioral event interviews, Delphi expert interviews, and other methods, the theory of “three-dimensional quality structure model” was used to extract, screen, and construct a set of evaluation indicator system for drug inspection, including 3 first-level indicators, 11 second-level indicators, and 47 third-level indicators. Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China. According to the requirements of laws, regulations, and departmental rules, combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory, some management tools are put forward to improve the quality system of drug supervision. 相关文章 | 计量指标

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Implementation of the Guidelines for Oncolytic Viruses in China Meng Qinghe, Wang Shuling, Yang Mo 2024 (4):  344-350.  摘要 ( 47 )   PDF(370KB) ( 43 )   Objective To study related guidelines such as “Guidelines for Clinical Trial Design of Oncolytic Viruses” “Technical Guidelines for Non-clinical Research and Evaluation of Gene Therapy Products” and “Technical Guidelines for Pharmacological Research and Evaluation of Oncolytic Viruses (OVs) Products” issued by the Center for Drug Evaluation (CDE) on OV and offer some suggestions for further improvement of the policies and regulations. Methods Literature comparison and questionnaire survey were used in this paper to investigate the difficulties encountered in the practical work of domestic companies that have conducted clinical trials, thus drawing some lessons to help the subsequent implementation of the guidelines. Results and Conclusion According to the characteristics of specific varieties and the published laws, regulations and guidelines, companies can adopt more suitable and scientific strategies to accelerate the development of anti-cancer drugs. In the future, as more clinical studies and product development for various cancers expand, regulatory requirements are expected to become more specialized and complex. Learning from the regulatory experience of developed countries and regions, we can improve the regulatory system by adapting it to national conditions and development status of China. Additionally, some ideas and useful inspirations can be provided after reviewing the content of the relevant guidelines and the obstacles in the practice of corporate R&D process can be addressed. These efforts will facilitate the speed of R&D and allow enterprises to work more smoothly and efficiently. 相关文章 | 计量指标

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Research on the Impact of the Centralized Drug Procurement Policy on China’s Pharmaceutical Enterprises Miao Li, Tian Lijuan 2024 (4):  351-360.  摘要 ( 86 )   PDF(1127KB) ( 70 )   Objective To analyze the impact of the centralized drug procurement policy on pharmaceutical enterprises, and put forward some suggestions for improving China’s centralized drug procurement policy. Methods Through literature analysis and comparative research, the relevant policies and implementation effects from the “4 + 7” drug procurement pilot to the seventh batch of volume procurement were sorted out, and the impact of the procurement policy on pharmaceutical enterprises was analyzed. Results and Conclusion The centralized drug procurement policy has continuously improved the enthusiasm of enterprises to participate in bidding, and the consistency evaluation work has been carried out well. However, there are also some problems, such as the reduction of enterprise profits, the difficulty of enterprise operation, the decline in the quality of winning drugs, and the insufficient innovation ability and the supply capacity of enterprises. In this regard, enterprises should reasonably control the cost of drugs to ensure the stable supply of winning drugs. Besides, enterprises should create brand effect for their timely transformation and development. While strengthening pharmaceutical innovation, they can change from low-level generic drug production to R&D innovation. The government should pay close attention to the impact of centralized procurement on the quality and efficiency of enterprise drugs. For instance, the government should improve the pricing rules for drug procurement and increase supervision of drug quality and supply. At the same time, it should give certain policy and financial support to enterprises’ technological innovation and talent introduction. 相关文章 | 计量指标

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Research on the Influence of Government R&D Funding and Enterprise R&D Investment on the Innovation Efficiency of Pharmaceutical Industry Zhang Xuefeng, Jia Zheng, Fu Shuyong, Zhang Dawei, Xing Hua 2024 (4):  361-370.  摘要 ( 34 )   PDF(453KB) ( 67 )   Objective To study the effect of government R&D funding and enterprise R&D input on innovation efficiency of China’s pharmaceutical industry. Methods Based on the inter-provincial panel data of China’s pharmaceutical industry from 2009 to 2019, the stochastic frontier analysis method was used to study the influence of government R&D funding and enterprise R&D input on the innovation efficiency. Results and Conclusion With 1% increase in government R&D funding, the innovation efficiency of enterprises will increase by 0.122%. When R&D investment increases by 1%, innovation efficiency will increase by 0.169%. Both government R&D funding and enterprise R&D investment promote the innovation efficiency of pharmaceutical enterprises, but the increase of enterprise R&D investment contributes more to the improvement of pharmaceutical innovation efficiency. 相关文章 | 计量指标

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Analysis of Patents Related to COVID-19 - Based on Patent Clustering Model in Specific Fields Fu Nan, Li Qian, Yuan Hongmei 2024 (4):  371-382.  摘要 ( 52 )   PDF(3328KB) ( 34 )   Objective To improve the efficiency of patent clustering related to COVID-19 through the topic extraction algorithm and BERT model, and to help researchers understand the patent applications for novel corona virus. Methods The weights of topic vector and BERT model vector were adjusted by cross-entropy loss algorithm to obtain joint vector. Then, k-means++ algorithm was used for patent clustering after dimension reduction. Results and Conclusion The model was applied to patents for corona virus drugs, and five clustering topics were generated. Through comparison, it is proved that the clustering results of this model are more centralized and the differentiation between clusters is significant. The five clusters generated are visually analyzed to reveal the development status of patents for corona virus drugs. 相关文章 | 计量指标

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Analysis of the Incidence and Risk Factors of Postoperative Infection in Patients with Class I Incisions Based on Literature Research Wang Jinping, Sheng Qi, Zhao Jie, Wu Zhiang 2024 (4):  383-389.  摘要 ( 63 )   PDF(469KB) ( 26 )   Objective To investigate the risk factors and variations in postoperative infection rates among different Class I surgical incisions, and to identify potential evaluation indicators that can impact the preoperative use of antimicrobial prophylaxis in Class I incisions. Methods Literature review was employed to establish inclusion and exclusion criteria, resulting in the initial examination of 4 098 articles. Then, 3 149 articles were screened out, and after thorough reading of full texts, 55 articles were studied carefully. Results and Conclusion Findings revealed that the incidence rate of surgical site infection (SSI) in Class I incisions ranged from 0.52% to 2.34%, with main risk factors including operation duration, underlying diseases, preoperative infections, antibiotic usage, length of hospital stay, and intraoperative bleeding. Risks of SSI varied significantly across different types of Class I incision surgeries. The key influencing factors in neurosurgery included emergency procedures, (national-nosocomial-infection-surveillance) NNIS score, age, and postoperative drainage tubes. In orthopedics, surgery type was closely associated with infection risk. In addition, emergency surgeries, special surgery types, and low serum albumin levels were considered as risk factors for the increase of postoperative infections, but age showed little correlation. Although prophylactic use of antibiotics in thyroid, breast, and inguinal hernia surgeries was not recommended, research suggested that they should be considered based on varying surgical levels. Patient’s preoperative condition had to be thoroughly assessed to prevent postoperative infections. In clinical practice, combining the highrisk factors of postoperative infection in different Class I incisions, we should consider the evaluation indicators of preventive use of antibiotics before different surgeries, and decide the rational use of antibacterial drugs for Class I incisions. 相关文章 | 计量指标

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Visual Analysis of the Treatment for Soft Tissue Injury with TCM Based on CiteSpace Su Haining, Duan Xiaoxiang, Wang Shuling 2024 (4):  390-400.  摘要 ( 35 )   PDF(3371KB) ( 25 )   Objective To explore the research hotspots and main content of the treatment of soft tissue injury with traditional Chinese medicine (TCM) in CNIK in the past 20 years, and to provide reference for the formulation of relevant policies and further research. Methods Based on CNKI, relevant literature was retrieved through subject terms. CiteSpace software was used for visualization analysis of authors, institutions and keywords. Finally, correlation analysis was carried out based on specific content. Results and Conclusion The cooperation networks between authors and research institutions were scattered, and most of them were independent studies. The establishment of cooperation network of research institutions is obviously limited by region. Based on keywords collinear, cluster and emergent analysis, during the sample statistical period, the research content of the treatment for soft tissue injury with TCM focused on clinical trials, especially the clinical therapeutic effects of different treatment schemes. The keywords cluster map mainly forms 10 clusters which are effective and can be analyzed. The treatment for soft tissue injury with TCM focuses more on the external application. 相关文章 | 计量指标

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The Impact of Multimorbidity on Healthcare Utilization and Expenditure: Evidence from China Ding Liman 2024 (4):  401-408.  摘要 ( 52 )   PDF(371KB) ( 42 )   Objective To investigate the impact of multimorbidity on China’s healthcare utilization and expenditure. Methods A two-part model was used to analyze the outpatient cares based on the data from CHARLS 2015 wave. Results and Conclusion As the prevalence of multimorbidity was 36.6% among 15 523 middle-aged and elderly respondents in China, the multimorbidity increased the likelihood of outpatient service, while the total outpatient expenditure did not increase significantly as well as the OOP expenditure. Secondly, although there was a similar probability of outpatient visit, the patients with multimorbidity excluding diabetes and (or) hypertension, had not been concerned by China’s Chronic Condition Management Programs (CCCMP) yet. Thirdly, the patients with multimorbidity increased the outpatient visits to different types of hospitals. Under CCCMP intervention, the patients did not switch from the county/city hospital to primary healthcare centers and township hospital. A costeffective strategy for providing services to patients with multimorbid conditions is needed, the focus of CCCMP should be switched from the single chronic disease to the multimorbidity. 相关文章 | 计量指标