1.Clinical Manifestation and Heredity Feature in Five Pedigrees with Porokeratosis
Xueqi ZHANG ; Sen YANG ; Yong GUO ; Do LIN ; Guoshu LIN ; Chunjun YANG ; Ming LI ; Chengrang LI ; Hui LI ; Zhongying WANG ; Hongsong GE ; Xuejun ZHANG
Chinese Journal of Dermatology 2003;0(10):-
Objective To analyze the clinic features and hereditary characteristics of three subtypes of porokeratosis, namely disseminated superficial actinic porokeratosis (DSAP), porokeratosis palmaris et plantaris disseminata(PPPD) and porokeratosis of Mibelli (PM) in five pedigrees with porokeratosis. Meth-ods After clinical and pathological diagnosis, every living family member of the five pedigrees with poro-kerotosis was undergoing medical examination and genetics analysis. These five pedigrees consisted of three DSAP pedigrees (totally 266 family members including 100 patients), and one PPPD pedigree (composing of 90 members including 26 patients), one PM pedigree (cornposing of 34 members including 17 patients). Results While diagnosed as porokeratosis, the five pedigrees included three distinctive variants, each with its own clinic characteristics. The lesions was initiated on the face in DSAP subtype, on palms and the flex-ion side of fingers in PPPD subtype; or involving sun-covered areas in PM subtype. Of the three subtypes of porokeratosis, the onset age in DSAP subtype was earliest, usually about 8-20 years old, about 14-20 years old in PPPD subtype, but PM subtype about 20-30 years old. Conclusions As a group of autosomal dominant genodermatosis, porokeratosis presented various clinic variants with different genetic basis. And, different subtype could be seen in a same patient or same pedigree.
2.Research on the supply efficiency and influencing factors of provincial medical and health services in China
Kui CHEN ; Haitao ZHANG ; Jiayue LU ; Guoshu GE
Chinese Journal of Hospital Administration 2023;39(1):16-21
Objective:To analyze the supply efficiency and influencing factors of medical and health services in 31 provinces in China from 2011 to 2020, providing reference for rational allocation of medical and health resources and improving service efficiency.Methods:The data related to the input-output indicators of China′s medical and health services from 2011 to 2020 were collected from China Health Statistical Yearbook, China Statistical Yearbook and China Social Statistical Yearbook. Data envelopment analysis was used to calculate the static efficiency of China′s medical and health service supply, the Malmquist index method was used to analyze the dynamic efficiency of China′s medical and health service supply, and the Tobit model was used to analyze the factors affecting the efficiency. Results:In 2020, the comprehensive efficiency of medical and health service supply in 15 provinces (Tianjin, Shanghai, Zhejiang, etc.) was 1.000, and the scale benefit remained unchanged. The comprehensive efficiency in 16 provinces (Heilongjiang, Jilin, Inner Mongolia, etc.) was less than 1.000. Among them, 15 provinces showed a decreasing scale benefit, while 1 province showed an increasing scale benefit.From 2011 to 2020, the total factor production efficiency index of China′s healthcare service supply increased from 0.988 to 1.036. The factors affecting the efficiency included number of people with a college degree or above per 10 000 people, the utilization rate of hospital bed rate, population density, asset liability ratio, and average length of stay ( P<0.05). Conclusions:In recent years, the efficiency of healthcare service supply in China showed a growth trend featuring regional differences and multiple influencing factors. It is suggested to further narrow the regional differences of the efficiency, reasonable control the scale of medical institutions, optimize medical service technology and management levels, shorten the average transfer day and improve bed utilization to improve the overall efficiency of medical and health service supply.
3.On the"3W"principles of Party building in public hospitals
Yan JIN ; Jing SUN ; Guoshu GE
Modern Hospital 2024;24(1):23-25
With the implementation of Party building in public hospitals in the new era,and the deep integration of Party building of administration departments and healthcare services as well,the high-quality development of hospitals through high-quality Party building is realized,which is a topic that needs to be explored in Party building in public hospitals.The Party build-ing in public hospitals has its unique functional positioning.With the requirements of Party building in the new era and the de-mand for high-quality development of public hospitals,Party building in public hospitals needs to solve the problems of"What","How"and"Well"from the ideological perspective,top-level design and practical level respectively,which are called the"3W"principles.
4.Occupational risk perception and self-efficacy and their relationship in surgeons
Gaoyue XIANG ; Zhi ZENG ; Yifang DU ; Guoshu GE
Modern Hospital 2024;24(1):26-29
Objective To investigate the occupational risk perception of surgeons in a tertiary hospital in Suzhou and ex-plore the relationship between occupational risk perception and self-efficacy,and to provide suggestions for improving surgeons'mental health.Methods The occupational risk perception scale of surgeons was designed to investigate,and 194 valid question-naires were collected.Factor analysis,correlation analysis and regression analysis were used to study the data.Results Occupa-tional risk perception of surgeons has multidimensional structures,including physical function risk,economic risk,occupational exposure risk,organizational risk,time risk and psycho-social risk.Age,educational background,professional title and working time are the influencing factors of occupational risk perception,and occupational risk perception of surgeons is significantly nega-tively correlated with self-efficacy.Conclusion The scale designed has good reliability and validity,and surgeons have a high lev-el of occupational risk perception,which can reduce the negative impact of occupational risk perception by improving self-efficacy.
5.Practice and reflection on commencing united front work in public hospitals in the new situations
Jiali GU ; Yi FAN ; Fang TANG ; Yiduo DING ; Guoshu GE ; Yang XU
Modern Hospital 2024;24(11):1667-1669
In the backdrop of the new era,enhancing Party building in public hospitals,particularly the united front work,holds great significance for elevating medical service standards,fostering harmonious doctor-patient relationships,consoli-dating mechanisms of unity,and promoting the high-quality development of hospitals.In this case study with the First Affiliated Hospital of Soochow University,the authors explored how public hospitals can effectively conduct united front work in the context of strengthening Party construction and leveraging this work to promote comprehensive development in all aspects of the hospital.
6.Current Status and Regulatory Considerations of Drug-led Combination Products
GE Yuanyuan ; LIAO Ping ; JIA Guoshu ; LIANG Yan ; ZHANG Jingchen ; CHEN Guiliang ; YUAN Hongmei
Chinese Journal of Modern Applied Pharmacy 2023;40(20):2774-2785
Abstract
This paper focuses on the regulatory strategy of drug-led drug device combination products, comparing and analyzing the definition, scope and management mode of drug device combination products in the United States, the European Union, Japan, Canada and China; summarizing and analyzing the types of combination products in the Product-specific Guidances for Generic Drug Development(PSGs) of the US FDA's scientific and technical reports in the past five years, the results show that the top three PSGs newly added to the FDA were transdermal system, nasal sprays, and single-dose prefilled syringes/pens(including auto-injectors).
As of March 1, 2023, the National Medical Products Administration(NMPA) had cumulatively announced the results of 339 combination products applied for attribute definition by enterprises, of which 88 were "drug-led drug device combination products", accounting for 26%; and 78 were "device-led drug device combination products", accounting for 23%; the results of "not belonging to drug device combination products" accounted for more than half (51.0%), which indicated that there was a big difference between the industry and the regulatory understanding of the definition of drug-device combination products, and that the existing guideline and documents were unable to provide clear and predictable positioning of the combination products under research and development for the time being.
This paper also puts forward suggestions for solving the problems in the development of drug-device combination products in China, in order to improve the consistency, predictability and transparency of the classification and definition of drug-device combination products in China, and to provide references for the development and scientific supervision of this kind of products.
7.Progress and Enlightenment of FDA Regulatory Science Research on Nasal Preparations
LIAO Ping ; GE Yuanyuan ; CAO Meng ; ZHAO Lu ; JIA Guoshu ; ZHANG Jingchen ; CHEN Guiliang
Chinese Journal of Modern Applied Pharmacy 2023;40(20):2766-2773
Abstract
OBJECTIVE To introduce the scientific progress in the regulation of nasal preparations by the US Food and Drug Administration(FDA), and provide reference and inspiration for the development, manufacture, quality control and supervision of nasal preparations in China. METHODS Regulations and literature relevant to the nasal preparations were translated and collated, and research projects and latest developments of FDA regulatory science were introduced. The difficulties encountered in the development of nasal preparations and the future development direction were analyzed. RESULTS The main directions of FDA nasal regulatory science were to evaluate potential bioequivalence(BE) methods as an alternative to comparative clinical endpoint BE studies, to employ digital technology to establish computer models, to study the factors influencing nasal absorption, pharmacokinetics and pharmacodynamics characteristics, as well as pediatric drug use studies, nasal-brain delivery, and to develop new tools, new methods, and new standards. It provided a scientific basis for optimizing regulatory strategy and improving regulatory efficiency. CONCLUSION This article summarizes the latest research on the regulatory science of nasal preparation, provides a reference for the management personnel of regulatory agencies, and provides new ideas and new methods for improving the quality and efficiency of China's drug regulation and realizing international standards.