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本期目录

    2022年, 第17卷, 第4期 刊出日期:2022-12-26 上一期    下一期
    Research on the Development of Drug Regulatory Science in China
    Wang Guanjie, Shao Mingli
    2022 (4):  285-290. 
    摘要 ( 297 )   PDF(427KB) ( 233 )  
    Objective To study the situation of the development of China’s drug regulatory science and to provide some suggestions for its future development. Methods Based on the origin of regulatory science in China, the methods of literature research and comparison were used to make a detailed analysis of China’s drug regulatory science plan and its implementation effect, the research direction, the number of key laboratories, regulatory science exchange conferences and professional papers published, so as to put forward the development trend of China’s regulatory science. Results and Conclusion According to China’s national conditions, the government should continue to promote the development of the regulatory science system from three aspects: basic theoretical research, discipline construction and action plan. China’s drug regulatory science can not only promote the rapid development of pharmaceutical industry, but also guarantee public health.
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    Study on the Changes of FDA Finished Pharmaceuticals Warning Letters between 2011 and 2021
    Jiang Yang, Yang Yue
    2022 (4):  291-299. 
    摘要 ( 288 )   PDF(487KB) ( 253 )  
    Objective To explore the trends in the distribution of countries to which FDA warning letters for Finished Pharmaceuticals have been issued over the past 10 years, and whether there are changes in the number of GMP violations, and to study their possible causes. Methods Public data on FDA warning letters and inspections were retrieved and analyzed using statistical methods for different classifications. Results and Conclusion Asia was the continent that received the most GMP warning letters in the last 10 years. More inspections were conducted in developed countries than that in developing countries, but they received a small number of warning letters. Quality control unit responsibilities were the most variable within all violation codes. The number of warning letters issued
    by Center for Drug Evaluation and Research (CDER) for Finished Pharmaceuticals increases with the number of inspections, and the enforcement of GMP by domestic drug manufacturers is better than that of overseas drug manufacturers. In addition, drug manufacturers in developed countries are better at GMP implementation than developing countries. GMP compliance in China has become better in recent years, but it still receives more inspections and warning letters. FDA inspections of Finished Pharmaceuticals become more stringent in the last 10 years, and many quality unit issues are affected by both personnel qualifications and personnel numbers.
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    Interviews on the Cooperation between Hainan and Macao in the TCM Industry to Promote Hainan’s TCM Industry
    Liu Tianchi, Zhang Xiaopo, Wang Yitao, Zeng Yu
    2022 (4):  300-308. 
    摘要 ( 410 )   PDF(447KB) ( 403 )  
    Objective To develop the internationalization and modernization of Hainan’s TCM industry, explore the development direction and fill in the research gap. Methods Design qualitative approaches, including fieldwork, semi-structured interviews, and policy analysis, were employed to identify development challenges for the cooperation between Hainan and Macao in TCM industry. Ten interviews with key TCM industry stakeholders in Hainan and Macao were conducted in 2020. These stakeholders are from schools, hospitals, companies, and governments. Hainan Province is the only free trade port with Chinese characteristics. Macao is an international free trade port that has special economic relations with European and Portuguese-speaking countries. Therefore, this study focuses on the cooperation in the traditional Chinese medicine (TCM) industry between Hainan and Macao. Besides, it investigates the traditional Chinese medicine industry in Hainan and Macau according to the SWOT model. Results and Conclusion The study revealed strengths, weaknesses, opportunities, and threats for cooperation between Hainan and Macao in TCM industry. Cooperation between Hainan and Macao can be taken as a priority outline and a standard for the internationalization and modernization of Hainan’s TCM industry.
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    Co-integration Analysis of the Relationship between New Product Output and R&D Investment in China’s Pharmaceutical Industry
    Li Gan, Wang Su, Chen Yuwen
    2022 (4):  309-316. 
    摘要 ( 312 )   PDF(500KB) ( 159 )  
    Objective To study the possible relationship between the output of new products in China’s pharmaceutical industry and the investment in research and development (R&D), and to provide a theoretical basis for the decision-making of relevant enterprises and institutions. Methods The econometric software Stata 14 was used to perform unit root test on the relevant data. Then, a co-integration regression equation was established after stabilization, which was analyzed through co-integration test (E-G two-step method). Results and Conclusion There is a long-term equilibrium and short-term error correction relationship between the output of new products and the investment of R&D funds in China’s pharmaceutical industry. During the lagging periods from 1 to 6, R&D investment is the Granger reason for the output of new products. The investment of R&D funds has a positive effect on the output of new products and the effect is significant. Therefore, more investment should be made in R&D to enhance the output of new products.
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    A Case Analysis of the Influencing Factors of Job Satisfaction of Licensed Pharmacists in Retail Pharmacies Based on SEM - Taking R Retail Pharmacy for an Example
    Chen Jing, Cui Yuxue, Chen Jing
    2022 (4):  317-332. 
    摘要 ( 285 )   PDF(1122KB) ( 281 )  
    Objective To explore the influencing factors on job satisfaction of licensed pharmacists in R retail pharmacy, and to provide a reference for improving the job satisfaction of licensed pharmacists in China. Methods Through literature research and satisfaction questionnaire, 349 licensed pharmacists in R retail pharmacy were investigated. Then, the influencing factor equation model was constructed by factor analysis and structural equation method. Results and Conclusion The overall adaptation of the structural equation model was well established. The job satisfaction of licensed pharmacists in R retail pharmacy was closely related to interpersonal relationship, work characteristics, good management, salary and growth opportunity, and it was not significantly correlated with job environment. Therefore, work characteristics influenced most, followed by salary. Five key factors affecting the job satisfaction of licensed pharmacists in R retail pharmacy are summarized in this paper. It is suggested to adjust corresponding key factors such as work characteristics and salary, so as to improve job satisfaction of licensed pharmacists in the same industry.
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    Research on the Extraction Techniques of Ginseng Based on Patent Analysis
    Yu Huixian, Zhang Wenfeng, Yuan Hongmei
    2022 (4):  333-342. 
    摘要 ( 184 )   PDF(3385KB) ( 249 )  
    Objective To analyze the gaps between patents of ginseng extraction method in China and South Korea, and to provide research and development directions for Chinese companies. Methods By observing the changes in the amount of patent applications over time, the distribution of application countries and regions, the analysis of applicants, the extraction of technical topics, and the development and change of method, an in-depth discussion on the patent of ginseng extraction method in China and South Korea was conducted. Results and Conclusion China lacks the mastery of advanced technology and the exploration of popular fields, while South Korea is just the opposite of China. Therefore, Chinese enterprises should focus on extraction processes and actively explore new technical fields.
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    Economic Evaluation of Gastroscopy for Detecting Gastric Cancer in Chinese Natural Population
    Liu Yuhan, Sun Lihua
    2022 (4):  343-350. 
    摘要 ( 432 )   PDF(535KB) ( 135 )  
    Objective To evaluate the economy of detecting gastric cancer by electronic gastroscope in Chinese natural population of different ages and genders. Methods A Markov model was constructed for the population, including both men and women of different ages. The model cycle was one year and the simulation time was 60 years. The cost-effectiveness of electronic gastroscopy in detecting gastric cancer of general population in China was analyzed from the perspective of the whole society, and the stability of the results was verified by sensitivity analysis. Results and Conclusion For the general population, the incremental cost-effectiveness ratio (ICER) of gastric cancer screening from the age of 50 is 50 143 yuan/QALY (quality-adjusted life-year), which is less than two times of per capita gross domestic product (GDP) compared with the screening from the age of 55. For men who start gastric cancer screening at the age of 50, the ICER is 38 525 yuan/QALY, which is less than two times of per capita GDP, and it is economical. For women who start the screening from the age of 55, the ICER is 47 814 yuan/QALY, which is less than two times of per capita GDP, so it is economical. The results of sensitivity analysis are consistent with the conclusions of basic analysis, and the results of basic analysis are stable. For the general population, it is more economical to start gastric cancer screening from the age of 50, while for men and women, it is more economical to start gastric cancer screening from the age of 50 and 55, respectively.
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    A Systematic Review of Economic Evaluation of CDK4/6 Inhibitors in HR+/HER2- Advanced Breast Cancer
    Wang Fang, Zhang Fang, Li Xue, Dong Li
    2022 (4):  351-366. 
    摘要 ( 422 )   PDF(558KB) ( 143 )  
    Objective To review the domestic and foreign economic studies on CDK4/6 inhibitors in first-line or second-line treatment of HR+/HER2- advanced breast cancer, and to analyze the main methodologies and research results. Methods Systematic literature review was used to search PubMed, EMBASE, Cochrane Library, CNKI, CBM, and Wanfang database. The incremental cost-effectiveness ratio was taken as the main outcome index, and all pharmacoeconomic evaluations with CDK4/6 inhibitors as intervention measures were included, such as Palbociclib, Ribociclib, and Abemaciclib. According to the Quality of Health Economic Studies Instrument, the quality of the included articles was evaluated, and then the included literature was analyzed. Results and Conclusion A total of 16 pharmacoeconomic evaluation studies were included, mainly from the perspective of national healthcare systems or third-party payers. Only 2 studies focused on second-line treatment, and the remaining treatment levels were first-line treatment. In terms of model structure, 7 studies adopted the Markov model, 6 studies adopted the PSM model, and 3 studies adopted the DES model. The basic analysis results showed that CDK4/6 inhibitor combined with endocrine regimen was not economical compared with endocrine alone regimen when the threshold was the conventional willingness to pay (WTP) value of each country. The uncertainty analysis included deterministic sensitivity analysis and probability sensitivity analysis. The included studies are all Cost-Utility Analysis with high-quality evaluation, which can provide evidence support for health-related decision-makers in decision-making. It can also provide methodological reference for the economic evaluation of other targeted drugs.
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    Current Situation and Suggestions on the Development of Diagnosis Related Group (DRG) Policy in China
    Dong Yujiao, Wang Shuling
    2022 (4):  367-375. 
    摘要 ( 449 )   PDF(571KB) ( 313 )  
    Objective To implement the national diagnosis related group (DRG) policy smoothly, and gradually move towards value medicine and fine management, some suggestions are put forward for improving medical service efficiency, saving medical insurance fund, and reducing the burden of patients, so as to realize the win-win situation of medical insurance and patients. Methods Based on the experience of the United States, Australia, and Germany, the policy implementation background and development process in China were summarized. The advantages and disadvantages of single disease payment method, disease score payment method, and diagnosis related groups - prospective payment system (DRG-PPS) method were compared, and then the problems were found out. Results and Conclusion In view of the imperfect information system, lack of professional talents, and uneven progress of each pilot, it is proposed that relevant departments should pay more attention to the construction and improvement of coding and other information systems, cultivate professional talents, promote the reform of DRG payment technology specification and grouping technology combined with national pilot project, thus enhancing the application and in-depth development of DRG policy in China.
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    Reflections on the Participation of Social Organizations in the Prevention of COVID-19
    Liao Wenjing, Lin Xiangpeng, Liu Liang, Dou Lele, Wang Shuling
    2022 (4):  376-382. 
    摘要 ( 468 )   PDF(450KB) ( 126 )  
    Objective To study the problems of Chinese social organizations in participating in the prevention and control of the COVID-19 pandemic so that we can standardize the participation mechanism, improve the collaborative management mechanism, and promote the development of social organizations. Methods Through the analysis of CNKI, news reports, industry conferences and other data, combined with the current situation, the participation of social organizations in public health emergencies were investigated. Results and Conclusion The coordination between government and social organizations is not good. Social organizations in the field of public health are unable to stand out in a timely manner. The public do not have self-management ability. Some of the media spread rumors. Besides, most social organizations are highly dependent on the government and they are ack supervision. Social organizations should be incorporated into the emergency management system and national hub-based social organizations must be established. In addition, supervision should be strengthened to increase the credibility of social organizations. The responsibilities of community and emergency management at the grassroots level should be enhanced. The public opinion response and disposal system should be improved. Lastly, the responsibility of social organizations in the field of public health must be fulfilled.
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