1.Market Access Policy for New Antimicrobial Drugs:International Experience and Inspiration
Baolong DING ; Qiang LIU ; Jingxuan WEI ; Yuyang SUN ; Wenmin DU ; Xin LI
Herald of Medicine 2025;44(3):416-421
Objective By reviewing the access policies for new antimicrobial drugs internationally,this study provides a reference for the development of China's antimicrobial drug access policy.Methods The Chinese and English databases,offi-cial websites of health agencies,and health technology assessment agencies of various countries(CNKI,PubMed,NICE in the UK,HAS in France,etc.)were searched to collect and sort out the access policies of new antibacterial drugs.Taking the antibacte-rial drug ceftazidime-avibactam and the antifungal drug esaconazole sulfate as examples,the key evidence points for the evaluation of antibacterial drugs in the market access process of medical insurance were analyzed.Finally,the author put forward suggestions for China's antibacterial drug access policy based on the opinions of experts in related fields of antibacterial drugs in China.Re-sults Access policies for antimicrobial drugs had already established in the UK,US,EU,Sweden Switzerland,and Republic of Korea.These policies included a series of measures such as evaluation approval rewards,patent extensions,additional reimburse-ment,decoupling sales revenue from sales volume,etc.,with the ultimate goal being to encourage research and development of new antibiotics while reducing resistance rates.The review found that besides evaluating the safety,economy,and cost-effectiveness,some evaluation agencies also consider the actual clinical value and social value of drugs when reviewing the evidence of two types of new antibacterial drugs in the medical insurance access link.Conclusion China can draw upon international framework principles while considering unique demands such as national antibiotic management policy or national healthcare negotiation re-quirements to provide certain policy support throughout the market access process for new antimicrobials due to their unique val-ues so that it can encourage research & development while curbing antibiotic resistance.
2.Market Access Policy for New Antimicrobial Drugs:International Experience and Inspiration
Baolong DING ; Qiang LIU ; Jingxuan WEI ; Yuyang SUN ; Wenmin DU ; Xin LI
Herald of Medicine 2025;44(3):416-421
Objective By reviewing the access policies for new antimicrobial drugs internationally,this study provides a reference for the development of China's antimicrobial drug access policy.Methods The Chinese and English databases,offi-cial websites of health agencies,and health technology assessment agencies of various countries(CNKI,PubMed,NICE in the UK,HAS in France,etc.)were searched to collect and sort out the access policies of new antibacterial drugs.Taking the antibacte-rial drug ceftazidime-avibactam and the antifungal drug esaconazole sulfate as examples,the key evidence points for the evaluation of antibacterial drugs in the market access process of medical insurance were analyzed.Finally,the author put forward suggestions for China's antibacterial drug access policy based on the opinions of experts in related fields of antibacterial drugs in China.Re-sults Access policies for antimicrobial drugs had already established in the UK,US,EU,Sweden Switzerland,and Republic of Korea.These policies included a series of measures such as evaluation approval rewards,patent extensions,additional reimburse-ment,decoupling sales revenue from sales volume,etc.,with the ultimate goal being to encourage research and development of new antibiotics while reducing resistance rates.The review found that besides evaluating the safety,economy,and cost-effectiveness,some evaluation agencies also consider the actual clinical value and social value of drugs when reviewing the evidence of two types of new antibacterial drugs in the medical insurance access link.Conclusion China can draw upon international framework principles while considering unique demands such as national antibiotic management policy or national healthcare negotiation re-quirements to provide certain policy support throughout the market access process for new antimicrobials due to their unique val-ues so that it can encourage research & development while curbing antibiotic resistance.
3.Evaluating the risk assessment method of occupational stress in workplaces
Aohe LIU ; Huining WANG ; Tenglong YAN ; Xiaowen DING ; Baolong LIU ; Jue LI ; Jisheng NIE
China Occupational Medicine 2023;50(6):626-631
{L-End}Objective To study and develop a suitable scale to identify and assess risks of occupational stress in workplaces of enterprises, and to explore the establishment of a workplace occupational stress risk assessment method aimed at guiding enterprises to improve working conditions based on the electronics industry in Beijing City. {L-End}Methods The initial version of the Workplace Occupational Stress Risk Assessment Scale (WOSRAS) was constructed based on literature review and expert evaluation. A total of 1 284 employees from four electronics enterprises in Beijing City were selected as the research subjects using a convenient sampling method. Item analysis and exploratory factor analysis were used to determine the final items of the scale and test its reliability and validity. The method of percentile norms was used to establish risk assessment method for the electronics industry workplace and its stress sources, and the cut-off values of low, medium, high risk was graded by the 50th and 80th percentiles of the total score and the score of each dimension of the risk assessment scale. {L-End}Results i) Based on item analysis and exploratory factor analysis, a WOSRAS consisting of six dimensions and 23 items was constructed, which could explain 63.2% of the total variation of occupational stress. The results of confirmatory factor analysis showed that the root mean square error of approximation and standardized root mean square residual were both <0.080, and the comparative fit index and Tucker-Lewis index were both >0.900. The total criterion validity of the scale was 0.816. The total Cronbach's α coefficient of the scale was 0.835, and the Spearman-Brown coefficient was 0.802. ii) The cut-off values of WOSRAS scores for high, medium and low risk in electronics industry were <53.0, 53.0-60.0 and >60.0,respectively. According to the result, the workplace stress risk levels of the production, research and development, and logistics departments of the electronics industry in Beijing were medium risk, while the management department was low risk. {L-End}Conclusion The WOSRAS constructed in this study has good reliability and validity. The proposed risk assessment method can reflect the actual risk status of enterprises in the electronic industry and is convenient for widespread application.
4.Study on the methods of individual occupational stress examination and assessment for workers in electronic industry
Yanping ZHANG ; Tenglong YAN ; Baolong LIU ; Qingsong CHEN ; Xiaowen DING ; Mingli BI ; Huining WANG ; Jue LI
China Occupational Medicine 2023;50(6):632-639
{L-End}Objective To explore the suitable methods for individual occupational stress examination and evaluation for workers in China based on the electronics industry. {L-End}Methods A total of 1 164 workers from four electronics enterprises in Beijing City were selected as the research subjects using a convenient sampling method. The Occupational Stress Measurement Scale, which was developed based on the Japanese Brief Job Stress Questionnaire, was used to assess the occupational stress of the research subjects, and test the reliability and validity of the scale. Percentile norms and T-score norms were established, and the T-scores of the three dimensions of stress reaction (psychological reaction and physical symptoms), stress factors, and social support were divided into five stages using the normal distribution method with
5.Analysis on occupational stress status of employees and its influencing factors in pharmaceutical enterprises in Beijing City
Jiaojiao SHA ; Huining WANG ; Baolong LIU ; Tenglong YAN ; Xiaowen DING ; Jue LI
China Occupational Medicine 2023;50(6):640-644
{L-End}Objective To analyze the current status of occupational stress and its influencing factors among workers in pharmaceutical enterprises in Beijing City. {L-End}Methods A total of 860 employees from six pharmaceutical enterprises in Beijing City were selected as the research subjects using convenience sampling method. The Chinese version of the New Brief Job Stress Questionnaire was used to evaluate the occupational stress, and multiple linear regression analysis was used to analyze the influencing factors of occupational stress. {L-End}Results The detection rate of high occupational stress was 1.40% (12/860). The results of multiple linear regression analysis showed that the workers with higher education level and longer length of service had a higher risk of high occupational stress (all P<0.01). Workers who were satisfied with their jobs had a lower risk of high occupational stress than those who were unsatisfied with their jobs (P<0.01). Workers who were satisfied with life had a significantly lower risk of high occupational stress than those who were unsatisfied with life (P<0.01). {L-End}Conclusion The detection rate of high occupational stress in workers of pharmaceutical enterprises is relatively low. Occupational stress is mainly affected by individual factors such as education level and length of service, and work and life satisfaction. Improving job and life satisfaction is helpful to reduce occupational stress level.
6.Effects of self-assembled IKVAV peptide nanofibers on olfactory ensheathing cells.
Huifa XU ; Zengwu SHAO ; Yongchao WU ; Chao DENG ; Xudong YU ; Fan DING ; Baolong ZHANG ; Weiwei XU
Chinese Journal of Biotechnology 2009;25(2):292-298
We observed the effects of IKVAV self-assembling peptide nanofiber scaffold (SAPNS) on olfactory ensheathing cells (OECs). The IKVAV molecules were triggered to self-assemble to interconnected nanofibers hydrogel by adjusting pH of solution and adding of DMEM/F12 culture medium. Atomic Force Microscopy (AFM) showed that self-assembly hydrogel was consisted of the interconnected nanofibers, which varied from three nm to five nm in diameter and hundreds nanometer in length. The primary OECs were isolated from rat olfactory bulb and purified by differential adhesion twice. At days 12, the purity of OECs was 85% according to immunostaining of P75 NGFR antibody. OECs were cultured with IKVAV peptide. The adhesion, viability and proliferation of OECs were observed with inverted microscope, Calcein-AM/PI staining and Cell Counting Kit-8. OECs cultured on IKVAV SAPNS grew well and the viable cell count was 95%. IKVAV SAPNS can promote the adhesion of OECs and did no hinder the proliferation of OECs. IKVAV SAPNS nanofiber gel has good biocompatibility and bioactivity for OECs. It can serve as a good nerve tissue engineering scaffold.
Animals
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Biocompatible Materials
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chemistry
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Humans
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Hydrogels
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chemistry
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Laminin
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chemistry
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Materials Testing
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Nanofibers
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chemistry
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Olfactory Bulb
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cytology
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drug effects
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Olfactory Nerve
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cytology
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drug effects
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Peptide Fragments
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chemistry
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Rats
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Rats, Sprague-Dawley
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Tissue Engineering
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methods
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Tissue Scaffolds
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chemistry

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