ABSTRACT
Objective:To introduce the construction of Henan Cerebral Palsy Register and Rehabilitation Management System (HCPRRMS) and to explore the construction project of regional register and surveillance of cerebral palsy. Methods:The construction process, registration content and preliminary results of HCPRRMS were systematically introduced. Results:HCPRRMS was independent developed in 2014. Since March, 2015, the system has been used to register information of patients with cerebral palsy in the Third Affiliated Hospital of Zhengzhou University. Until September, 2019, a total of 23 child rehabilitation institutions had used the registration management system. There were 1357 patients with cerebral palsy registered in this system, in which 936 cases (68.98%) were male, 501 cases (36.92%) were with gestational weeks < 37, 443 cases (32.65%) were with birth weight < 2500 g, and 430 cases (31.69%) were born with hypoxic-ischemic encephalopathy. Among them, the spastic cerebral palsy patients (1117 cases, 86.74%) accounted for the highest proportion. There was significant difference among types of cerebral palsy and the classification of GMFCS. A total of 1117 patients with cerebral palsy showed MRI-identified brain abnormalities, in which, periventricular leukomalacia accounted for the most (480 cases). For the complications, epilepsy accounted for 14.44% (196 cases), vision impairment accounted for 8.03% (109 cases), hearing impairment accounted for 11.64% (158 cases). Among 769 cases aged more than two years, language-speech dysfunction accounted for 52.66% (424 cases); and among 216 cases aged more than four years, mental retardation accounted for 37.96% (82 cases). Conclusion:HCPRRMS could help to understand the risk factors, clinical characteristics, and complications of cerebral palsy.
ABSTRACT
Chinese medicine preparations in medical institutions are an important reservoir for new traditional Chinese medicines. The management basis for the registration and filing of Chinese medicine preparations in medical institutions are sorted out, and the general situation is analyzed, and the current filing information and technical requirements of Chinese medicine preparations in medical institutions and new traditional Chinese medicine compound preparations are compared. The purpose is to understand the variety of Chinese medicine preparations in medical institutions and the potential issues in the application materials, and to provide reference for better application of human experience and exemption from the application materials of new traditional Chinese medicines derived from Chinese medicine preparations in medical institutions.
ABSTRACT
OBJECTIVE:To provide reference for improving registration regulation of medical institution preparation and pro-moting the development of it. METHODS:According to sorting out and summarizing the Medical Institution Preparation Registra-tion Management Approach(trail)contents,for its shortcomings in terms of medical institution preparation definitions,related im-provement suggestions were put forward. RESULTS & CONCLUSIONS:The Medical Institution Preparation Registration Manage-ment Approach(trail)has promulgated for 12 years from 2005 till now,existing shortcomings were that the definition of medical institution preparations was too wide,requirement on data of application and registration was less rigorous,regulation of clinical re-search was vague,clinical application re-evaluation was inadequate,disapproved case was lacked. In view of the above shortcom-ings,it is suggested to narrow the definition of medical institution preparations,modify the requirement on data of application and registration specify the regulation of clinical research,add monitoring period for the new preparation and update the disapproved case,so as to improve the registration regulation of medical institution preparations and promote the development of preparations in medical institutions.
ABSTRACT
There are part of similarities between kampo extract product in Japan and classical representative famous prescription in China.This paper analyzes and explains the characteristics of kampo extract product in Japan and the registration management background,suggests the relevant departments to fully consider the mistakes in the process of kampo extract product development and the re-evaluation and standardization work Japanese drug regulatory authorities have done when formulate the detailed catalogue of classical representative famous prescriptions in China.
ABSTRACT
Chinese prescription medicine in Japan derives from China's traditional Chinese medicine. Yet during the long histroy of development, the management system of production, quality standard, and registration have been gradually establised in Japan. Research and development pattern and quality control management system for Chinese prescription medicine are formed and are different from those in China. Many of them are different with our current situation, especially in the aspect of quality management. Thus their experience is worth learning and using for reference.
ABSTRACT
OBJECTIVE: To provide the basis of improving drug importation registration management system of our country by studying domestic and foreign drug importation management system adequately. METHODS: Checked out and studied the laws associated with import drug of our country and United States with literature research and comparative analysis methods. RESULTS: To reform the drug importation registration management system of our country, related problems should be analyzed. Also the recommendations should be put forward, including the registration of foreign drug establishment, unified registration procedures and adopted DMF system. CONCLUSION: Based on national conditions, we must draw on the advantages of United States system selectively, to improve our system, ensure the quality of import drug lifecycle and protect public health.
ABSTRACT
@#In Europe Registration Management for Cerebral Palsy (CP) has been widely carried out, which collects various related information and systematically manages the rehabilitation of children with CP by uniform database. Chinese Registration Management for Cerebral Palsy fitted with Chinese situations should be established as soon as possible which will benefit the following: to provide more samples for scientific research on cerebral palsy; to promote social awareness and attention for CP children by multiple side participation; to help policymaker to plan more suitable policies for CP children and their families. The main problems needed to resolve are unification of the diagnosis, clinical types and function classification of cerebral palsy.