1.Research advances in the mechanism of osteoarthritis caused by the mechanical instability
Anqi JI ; Guoying DENG ; Qiugen WANG ; Qian WANG
Journal of Shanghai Jiaotong University(Medical Science) 2017;37(4):561-565
Osteoarthritis is a common articular cartilage degenerative disease and the main cause is mechanical instability. The mechanical instability can reduce the number of chondrocytes and destroy extracellular matrix through direct injury, inducing cell apoptosis, and stimulating the production of inflammatory factors, leading to decrease of matrix typeⅡ collagen and proteoglycan and degeneration of cartilage. Long-term cartilage degeneration can result in osteoarthritis. Therefore, understanding how mechanical instability leads to the incidence of osteoarthritis can better improve the course of osteoarthritis from the perspective of mechanics.
2.Expedited program and utilization for anticancer drug approval in China and the United States
Qi ZHU ; Huiyao HUANG ; Anqi YU ; Xinyu MENG ; Ye LENG ; Hong FANG ; Ziwei LI ; Yu TANG ; Ji LI ; Ning LI
Chinese Journal of Oncology 2024;46(9):904-910
Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P<0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.
3.Expedited program and utilization for anticancer drug approval in China and the United States
Qi ZHU ; Huiyao HUANG ; Anqi YU ; Xinyu MENG ; Ye LENG ; Hong FANG ; Ziwei LI ; Yu TANG ; Ji LI ; Ning LI
Chinese Journal of Oncology 2024;46(9):904-910
Objective:To systematically summarize and comparatively analyze the development, establishment and usage of oncology drugs speedy review approaches in China and in the United States between 2012 and 2021.Methods:Based on National Medical Products Administration (NMPA) and Food and Drug Administration (FDA) websites, the development and current status of the speedy review approaches were consulted and summarized. Approved oncology drugs in China and in the United States (87 in China, 118 in the United States) over the past decade were analyzed using chi-square test for group comparison.Results:Five speedy approaches have been established in China and in the United States, three of which are the same, priority review, conditional approval or accelerated approval and breakthrough therapy. The rest two are special review and approval, special examination and approval in China, and fast track and real-time oncology review in the United States. Compared to the United States, speedy review approaches in China set up late (1992 vs. 2005). The overall utilization rates of the oncology drugs speedy review approaches were similar between the China and United States (90.8% vs. 92.4%, P=0.800) in the previous 10 years, and priority review have highest utilization rates in both China and the United States without significant group difference (77.0% vs. 82.2%, P=0.381); relatively low utilization rates of conditional approval (31.0% vs. 44.9%, P=0.041) and breakthrough therapy (2.3% vs. 50.0%, P<0.001) were seen in China. 52.9% of new drugs applied for special examination and approval in China and 40.7% of new drugs applied for fast track in the United States. Overall, the priority review both in China and the United States are stable, with a similar average annual utilization rate (84.8% vs. 83.7%); accelerated approval and breakthrough therapies in the United States fluctuate wildly, but the situation is tending towards stability in the last 3 years. Conclusions:Both China and the United States have established a relatively complete accelerated review system, with an overall utilization rate over 90%; China's accelerated review started late, although the overall utilization rate is close to that of the United States. The utilization rates of conditional approval and breakthrough therapy are still relatively low. Flexible usage of speedy review approaches, gaining regulatory recognition to use alternative endpoints, achieving real-time review and guidance are keys to accelerate new drug development in China.
4.Establishment of a county-level trauma treatment system based on the multidisciplinary treatment team model of emergency green channel
Anqi PANG ; Liehua DENG ; Tong TAN ; Huashu LIANG ; Guoxi CHEN ; Feng SHEN ; Weixin QUAN ; Fenghua LI ; Kangrong JI ; Jianing PANG ; Ruojia SU
Modern Hospital 2024;24(8):1231-1234
Objective To establish a county-level trauma treatment model,designed to prioritize efficiency and guided by a multidisciplinary approach for emergency green channels.Methods Adhering to the Consensus of Experts on the Construc-tion and Management of Trauma Centers in Municipal Comprehensive Hospitals(2020),and using the trauma center creation plan from Guangdong Province as a reference,we established a county-level trauma center,leveraging its strengths and unique at-tributes,with the emergency department as its core.Results The application of information technology facilitated the establish-ment of a two-way referral information platform and a three-tiered diagnosis and treatment system for county medical communities,thereby enhancing the efficiency and quality of healthcare.The implementation of the emergency green channel multidisciplinary treatment team model significantly improved the admission rates for complex and critical cases and increased the utilization of new technologies.Conclusion The development of a county-level emergency treatment system,spearheaded by the establishment of a provincial-level trauma center and a multidisciplinary team model for emergency green channels,can expedite trauma patient care,augment diagnostic efficiency and treatment efficacy,and catalyze advancements in medical technology within county hospitals.