1.Ethical Enlightenment of Foreign Rare Disease Treatment Guarantee System to China
Zezhao WANG ; Xiaolin SONG ; Jinzi ZHANG ; Mei YIN ; Ping WANG
Chinese Medical Ethics 2022;35(10):1088-1093
By summarizing the policies and regulations of foreign countries on rare disease research and drug research and development, referring to the relevant policy support of treatment guarantee system in the development of rare diseases abroad, and combining with China’s national conditions, this paper analyzed the feasible points that China can learn from, and then put forward some suggestions on the ethical problems existing in the current rare disease research, so as to provide reference suggestions for the relevant policy formulation of rare disease treatment guarantee in China: adjusting regional differences based on the principle of fairness, and establishing a national rare disease information collection center; improving the ethical quality of scientific research in pharmaceutical companies, and strengthening ethical supervision; and the government and society fulfill their obligations to protect the rights and interests of patients with rare diseases.
2.Ethical Enlightenment of Foreign Incentive Mechanism for Orphan Drugs Research and Development to China
Jinzi ZHANG ; Xiaolin SONG ; Zezhao WANG ; Ping WANG ; Mei YIN
Chinese Medical Ethics 2022;35(9):971-977
There are a large number of patients with rare diseases in China, and most of them are faced with problems such as no medicine to cure, and have drugs outside of China but not inside. This paper combed the incentive policies of orphan drugs in the United States and the European Union, including orphan drugs legislation and setting up special management institutions, orphan drugs qualification certification, government funding, tax reduction and agreement assistance in the research and development process, providing accelerated listing channels in the examination and approval process, giving market monopoly period in the circulation stage, and giving priority to review. On this basis, it also explored the incentive measures of non-profit organizations in the research and development of orphan drugs, including providing financial support, clinical research and so on. From the perspective of guaranteeing the right to life and health of patients with rare diseases, the fairness and accessibility of medication, and the subjects’ right to know and privacy in clinical trials, this paper provides reference for perfecting the incentive mechanism of orphan drugs research and development in China.
3.A method for abnormal detection of fetal monitor data in hospitals based on Euclidean distance
Jianfeng LIU ; Kuo LIAO ; Zezhao YAN ; Shaodong HUANG ; Xiu WANG ; Pengxiang ZHENG
China Medical Equipment 2024;21(11):163-166
In order to meet the accuracy requirements of hospitals for abnormal detection of fetal monitor data,a hospital fetal monitor data anomaly detection method based on Euclidean distance was proposed.In this method,according to the abnormal detection method of fetal monitor data in hospitals,the ultrasound Doppler detector was used to collect fetal heart rate signal data,and the fetal heart rate signal denoising method based on adaptive filtering was used to remove the noise components of the collected fetal heart rate signal.The denoised fetal heart rate signal was used as the identification sample of the abnormal fetal heart rate signal identification method based on Euclidean distance method.The Euclidean distance Euclidean distance between the denoised fetal heart rate signal and the normal fetal heart rate signal was analyzed by combining the Euclidean distance method and the strong classifier to analyze whether the virtual sinusoidal distance between the denoised fetal heart rate signal and the normal fetal heart rate signal was greater than the tuned Euclidean distance threshold.Fetal heart rate signal samples greater than the threshold were classified and diagnosed as abnormal monitoring data.The fetal heart rate information collected by the fetal monitor in the hospital was accurate,and the abnormal detection results were valid and reliable.