亚洲社会药学

本期目录

2023年, 第18卷, 第1期　刊出日期：2023-03-25 上一期   

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Research and Enlightenment of Accelerated Approval Pathway in China Li He, Huang Zhe 2023 (1):  1-7.  摘要 ( 374 )   PDF(323KB) ( 210 )   Objective To provide suggestions to improve the system of accelerated review and approval in China and to speed up the development and marketing of innovative drugs. Methods A comparative analysis was made to study the accelerated review, conditional approval and breakthrough therapy between China and the United States. Combined with the implementation of accelerated pathway in China, some suggestions were put forward. Results and Conclusion The implementation of accelerated drug review and approval system can significantly speed up the process of new drug development, which will improve the accessibility of innovative drugs. However, there are some problems in the review procedures and the implementation of supportive documents in China. In view of the above problems and combined with the experiences of US FDA, we should strengthen the construction of institutional system and reviewer team, and improve the efficiency of drug research and development. 相关文章 | 计量指标

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Analysis of Adverse Reactions in the Treatment of COVID-19 with Three Chinese Patent Medicines and Three Herbal Formulas Li Qiao, Wang Aili, Wu Di, Chen Yuwen 2023 (1):  8-16.  摘要 ( 152 )   PDF(398KB) ( 129 )   Objective To explore the rules and characteristics of the adverse drug reactions (ADRs) of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19, and to provide a reference for clinical safe medication. Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed, Web of Science, Springer Link, CNKI, Wanfang and VIP database were retrieved from December 2019 to May 2021. Then we extracted and analyzed the effective information included in the literature. Results and Conclusion According to the pre-developed retrieval plan, a total of 136 documents were obtained, and a total of 6 documents met the inclusion criteria finally. 553 patients used three Chinese patent medicines and three herbal formulas, and there were 133 cases of adverse reactions. The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine, and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine. 相关文章 | 计量指标

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Present Situation and Enlightenment of Post-Approval Change Management of Drugs in China, USA and EU Lv Xiaowen, Huang Zhe 2023 (1):  17-23.  摘要 ( 309 )   PDF(358KB) ( 249 )   Objective To provide suggestions for further improvement of China’s drug post-approval change management system. Methods The current legal and regulatory requirements of post-approval change management systems of drugs in USA, EU and China were compared and analyzed. Results and Conclusion The post-approval change management of drugs is an important part of the whole life-cycle management of drugs. However, there are still some problems in China’s current post-approval change management systems. According to the model and requirements of the post-approval change management systems of the USA and EU, this paper proposes the following suggestions for the improvement of China’s post-approval change management system. Firstly, electronic files for licensed products should be created. Then, regulatory standards at the national level must be unified. Lastly, the concept of product life cycle management should be implemented. 相关文章 | 计量指标

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Study on Emergency Use Authorization and Risk Control of Pfizer-BioNTech Vaccine Wang Yiran, Yang Yue 2023 (1):  24-29.  摘要 ( 218 )   PDF(408KB) ( 155 )   Objective To analyze the methods and policies for emergency use authorization (EUA) and risk control of COVID-19 vaccines. Methods The legal basis, safety, and effectiveness evaluation criteria for Pfizer-BioNTech vaccine under EUA, as well as the continuation of phase III clinical trials and pharmacovigilance plans were sorted out. And attention was paid to the safety surveillance actions and risk control measures of vaccines under EUA. Results and Conclusion The methods and policies for EUA and risk control of Pfizer-BioNTech vaccine were made clear and we could provide a reference for the pharmacovigilance action after the COVID-19 vaccines were put on the market in China. In the case of EUA, it is necessary to analyze the existing clinical safety data. Based on this, the risk control process should be confirmed at the time of formal marketing approval and after listing. Finally, the risk control should be adjusted at any time. 相关文章 | 计量指标

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Research on Patent Situation of Medical Devices in China Wu Chenxia, Yuan Hongmei 2023 (1):  30-39.  摘要 ( 143 )   PDF(899KB) ( 129 )   Objective To study the patent situation of medical device industry in China based on patent data. Methods The analysis function of the patent search software incoPat was used to analyze the patent situation from two perspectives: The overall situation and the technical level. Results and Conclusion At present, China’s medical device industry is developing rapidly under the leadership of enterprises as the main body of innovation, but only 16% of patents are authorized. In addition, the technology distribution of medical device industry is mainly related to diagnostic, surgical and identification medical devices and implantable devices, accounting for 59% of the main technology distribution, and their technical effects are mainly related to improving convenience, reducing complexity, and improving safety. The quality of patents related to medical device industry in China is low, the technology distribution is not rich enough, and the level of technical efficacy is low. 相关文章 | 计量指标

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Analysis on the Revenue Status of the “Fourth Terminal” Industry of Ali Health Sun Xiaohua, Gao Jingyi, Wang Shuling 2023 (1):  40-48.  摘要 ( 131 )   PDF(383KB) ( 106 )   Objective To analyze the revenue status of the “fourth terminal” industry of Ali Health, and to explore the opportunities of the “internet and medical health” model and provide some suggestions for China’s medical e-commerce industry. Methods Through literature research and network collection methods, a large number of literature and network materials were studied in detail, and the revenue status of the “fourth terminal” of Ali Health in different fiscal years was compared and analyzed. Results and Conclusion According to the revenue of different fiscal years, the “fourth terminal” industry of Ali Health has developed rapidly, and the revenue gap between different business is large, so the “fourth terminal” industry should be improved. 相关文章 | 计量指标

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Research on Technology Development of Traditional Chinese Medicine Extraction Based on Patent Information Liu Yue, Fu Nan, Shen Manzhu, Yuan Hongmei 2023 (1):  49-56.  摘要 ( 154 )   PDF(2025KB) ( 98 )   Objective To understand the development status of traditional Chinese medicine extraction technology, so as to provide a reference for enterprises and scientific research institutions to determine the direction of technological innovation. Besides, the government can formulate scientific and technological innovation strategies. Methods Based on patent information, statistical methods were applied to analyze the development of traditional Chinese medicine extraction technology. Then, the core technology was identified by constructing a patent citation network. Finally, the main path analysis method was applied to discover the technological evolution path. Results and Conclusion The extraction technology of traditional Chinese medicine is still in the growth stage. At present, its R&D is based on enterprises, supplemented by scientific research institutions. The core technologies are ultrasonic extraction and enzymatic extraction. The main path represented by enzymatic extraction technology reveals the evolution process of traditional Chinese medicine extraction technology. Based on this, relevant suggestions are put forward. Firstly, technological innovation cooperation should be strengthened to explore new models of achievement transformation and cooperation. Secondly, key enterprises of technology clusters should be cultivated to accelerate breakthroughs in core technologies. Thirdly, combined technologies can achieve high-efficiency enzyme-assisted extraction and open up new ways of extracting traditional Chinese medicine. Fourthly, traditional techniques should be improved to develop innovative modern techniques. 相关文章 | 计量指标

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Economic Evaluation of Cervical Cancer Prevention Strategies in China Chen Chuhan, Sun Lihua 2023 (1):  57-63.  摘要 ( 242 )   PDF(1964KB) ( 89 )   Objective To evaluate the economy of domestic bivalent human papilloma virus (HPV) vaccine, imported 9-valent HPV vaccine and 5 cervical cancer screening programs, and to provide a reference for relevant decision-making. Methods A Markov model of the natural disease development of cervical cancer was constructed to simulate the cumulative long-term cost and quality-adjusted life years (QALYs) of one hundred thousand healthy women after they received different interventions for cost-effectiveness analysis. Results and Conclusion Compared with the non-intervention group, the cost of per QALY obtained by two HPV vaccines and 5 screening programs ranged from 1 117.56 yuan to 71 660.48 yuan. Taking China’s GDP per capita in 2020 as the threshold, two HPV vaccines and 5 screening programs are cost-effective. Domestic bivalent vaccine is cost-effective and it should be introduced to the national immunization program in the future. Different screening programs are all cost-effective, too. Among them, careHPV test once every 5 years has the lowest ICER value and it can be used as the first choice for cervical cancer screening in rural areas or resource-limited areas in China. 相关文章 | 计量指标

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The Problems and Countermeasures of Four Community Pharmacies on Drug Quality Management in Kangping County Zhang Jie, Tian lijuan 2023 (1):  64-70.  摘要 ( 92 )   PDF(394KB) ( 120 )   Objective To study the drug quality management of four community pharmacies and provide countermeasures and suggestions for improving the drug management level in Kangping County. Methods Literature research and investigation research were adopted in this paper to analyze the current situation and problems of drug management in four community pharmacies in a town of Kangping County. Results and Conclusion The problems of four community pharmacies in a town of Kangping County are low level of drug quality management, insufficient quality and capability of the practitioners and physician’s illegal act such as some licensed pharmacists paid from the linked pharmacies. There are also problems in facilities and equipment, drug display and storage, and document management, which reflects the lack of local drug supervision. Based on the above problems, some countermeasures and suggestions are put forward to strengthen the drug quality management of four community pharmacies in Kangping County. 相关文章 | 计量指标

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Countermeasures to Improve the Competitiveness of Medicine Circulation Enterprises in China under the New Situation Chen Huasheng, Dong Li 2023 (1):  71-77.  摘要 ( 89 )   PDF(440KB) ( 91 )   Objective To analyze the current situation of medicine circulation enterprises and summarize the influence of frequently introduced industry policies on the pharmaceutical field, so as to provide suggestions on improving the competitiveness and maintaining sustainable development of medicine circulation enterprises in China. Methods Industry policy analysis, literature inquiry, expert interview and questionnaire survey were used to study the challenges that medicine circulation faced under the new situation. Then, the key indexes were found out to improve its competitiveness. Results and Conclusion Through the analysis of the current situation of the industry, policy orientation and market demand, some suggestions are put forward for related enterprises to improve their competitiveness. 相关文章 | 计量指标

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Thoughts on the Innovative Design of the Integrated Service Mode of Pharmacies and Elderly Care Centers Yu Lina, Xing Miaomiao, Wang Shuling 2023 (1):  78-86.  摘要 ( 159 )   PDF(380KB) ( 127 )   Objective To evaluate the service model that integrates medical treatment and elderly care to provide a reference for the development of pharmacies and elderly care centers. Methods Through the literature investigation and case analysis, the domestic integrated medical treatment and elderly care service model was analyzed, and new ideas for the integration of pharmacies and elderly care centers were provided. Results and Conclusion The integrated service model of pharmacies and elderly care centers is designed and the integration mode of pharmacies, hospitals and elderly care centers is proposed by analyzing their advantages. The “pharmacy + elderly care” mode and the “pharmacy + medical treatment + elderly care” mode that integrates pharmacies, hospitals, and elderly care centers are put forward to predict its new development opportunities in the future. 相关文章 | 计量指标