ABSTRACT
Traditional Chinese medicine (TCM) has a long history in treating infectious diseases, and the form of intervention varies with different medical conditions and disease types. "The battle field of Chinese doctor for anti-epidemic" was formed in fighting against severe acute respiratory syndrome (SARS) epidemics in China, and from the battle, valuable experiences of using TCM for prevention and treatment had been obtained. During responding to coronavirus disease 2019 (COVID-19) epidemics, we followed the principle of keeping summary and perfection while treament. And a whole process of TCM pattern or a model was organized, including early prevention in communities, cluster intervention in isolated places, comprehensive intervention in mobile cabin hospitals, centralized treatment in designated hospitals and rehabilitation support in rehabilitation posts. Thus, the innovation of whole process of TCM intervention was involved in the "trench warfare" strategy and platform system for prevention and treatment of new infectious COVID-19 epidemics. At different stages or conditions, different TCMs were used to play advantageous roles to solve various problems and elevate the effects of prevention and treatment of the disease. The construction of TCM mobile cabin hospitals was an innovation of organization form that might offset the constraints in technology and scale of simple community isolation or simple hospital treatment, exploring a new way for TCM to cope with public health emergencies.
ABSTRACT
Chinese medicinal materials occupy an important position in China's health industry. However, its overall quality needs to be improved and it is in urgent need of regulation. Exploring the formation of effective organizational mechanisms and industry models has become an urgent need of the industry. In this context, the alliance of coconstruction and sharing Chinese herbal medicine base came into being. The alliance is based on the pursuit of the quality of Chinese herbal medicines and continues to promote the construction of Chinese herbal medicines. The Alliance provides a platform for economic and scientific cooperation in the industry. Its purpose is to guide the promotion of the standardization of local varieties and the construction of modern Chinese medicine agricultural enterprises based on the development needs of Chinese herbal medicine resources and the common interests of all members. As an important content, we will strive to expand the new pattern of coordinated development of traditional Chinese medicine agriculture and industry, explore the establishment of a new organizational system for modern Chinese medicine agricultural production with controllable quality, output and price under the link of production and demand. For the sustainable, stable and healthy development of the Chinese medicine industry, it will serve 1.3 billion people and serve humanity, provide high-quality sustainable Chinese herbal medicine resources. Since its establishment six years ago, the alliance has carried out work on key aspects such as standardized production of Chinese herbal medicines, plant protection, decoction processing, supply and demand docking, medicinal materials standards, poverty alleviation, breeding, and provided technical support to enterprises. During this period, the alliance also proposed the concept of"three-no and one- all"requires the members to take the lead in achieving the standards of"sulfur- free processing, no aflatoxin pollution, pollution-free, traceable throughout the whole", setting a benchmark for the industry.
ABSTRACT
The safety of TCM injection triggered attentions and hotspots in recent years in China.The centralized monitoring of TCM injection provided important evidence for analyzing the safety risk of TCM injections,recognizing adverse reactions and contraindications and perfecting the instructions.This study aimed at exploring the ethical problems on centralized monitoring.In this paper,we retrieved and screened the ethical issues of TCM injections over hospital centralized monitoring in China National Knowledge Infrastructure (CNKI,1979-Ju1.,2016).Issues over it were put forward and addressed.It is found that the current ethical issues related to hospital centralized monitoring lacks sufficient attentions,corresponding norms and requirements.Based on the ethical issues reflected from the literatures,suggestions should be pressed ahead with the ethical review of centralized surveillance,signing of informed consents,registration of research programs,data statistics and reporting stages,for the better protection of the rights and interests of subjects and improvement of research quality.
ABSTRACT
Safety hospital centralized monitoring is one of the important methods for evaluating the medication safety of TCM injections in clinic.It is critical to warrant research quality by reasonable statistical analysis.However,universally accepted standards and guidelines for the statistical analysis of hospital centralized monitoring of TCM injections have not been issued so far,which would probably reduce the research quality of safety hospital centralized monitoring of TCM injections since the unreasonable use of statistical analysis methods.Combined with previous practical experience and understanding,we put forward the problems of statistical analysis of hospital centralized monitoring of TCM injections with the provision of some advice in this paper based on the analysis of the preceding studies,laying a foundation for the same kind of researches.
ABSTRACT
At present,the various levels of safety evaluations of traditional Chinese medical (TCM) injections were in force in post-marketing clinical researches,while the process quality is guaranteed with difficulty.Therefore,it is requisite to call for technical guidance.By drawing lessons from the international experience of drug marketing safety evaluation and the related methods,we proposed the key techniques of quality control for clinical safety evaluation of TCM injections from the three aspects:preparation,implementation and summarization of researches,combining with the characteristics of TCM injections.The key techniques contained some scientific problems,ethics,publicity,data management,statistical analysis,specification report,etc.This paper comprehensively introduced the requisite technologies and methods over research quality,laying a foundation for the studies of post-marketing clinical safety evaluation of TCM injections.
ABSTRACT
The implementation process management plays a important role for the quality of centralized safety monitoring study of post-marketing Chinese medical injections.One of the critical link is hospital.Currently,there is no principle or specification for hospital choosing,number of monitoring points,data collection responsible part and forms of data collection as well.These issues caused uneven quality,huge differences in results and questioned conclusion.Based on the previous research experience,this paper focused on discussing the link of hospital where research data may be influenced,and proposed some suggestions.
ABSTRACT
Safety is a critical link restricting the development of TCM injections.Hospital centralized monitoring is of importance in the safety evaluation of TCM injections.However,the results of centralized monitoring studies usually deviated from the actual situation because of problems in design and process quality.Our research team have completed several projects over centralized monitoring in recent years.Based on the previous research experience,this paper mainly discussed the current statuation,the significance and methods for standard process of hospital centralized monitoring in regard to TCM injections,in order to improve the quality of centralized monitoring studies and provide technique support for recognizing the safety of TCM injections.
ABSTRACT
According to the related requirements of safety reevaluation of TCM injections,hospital centralized monitoring of the safety of TCM injection was consecutively pressed ahead.Centralized security monitoring was a large-scale real world research involving numerous data acquisition,transmission,verification and analysis.The quality of data acquisition and data verification directly affected the authenticity and reliability of research data and results.Therefore,data management played a significant role in the safety monitoring of TCM injections.Based on the analysis of previous researches,this paper discussed the implementation content,links and the frequent problems and corresponding solutions of data management during the safety monitoring of TCM injections,combining with the experience in the implementation of projects.
ABSTRACT
The launch of the clinical trial registry is a milestone event in the field of clinical research in the 21st century that has played an important role in safeguarding the openness,transparency,ethics,data sharing and process control of clinical research.The current clinical research registry is mainly aimed at clinical trial research with lack of professional registration system for security and other real events of observational study.In order to improve the level of clinical safety research,promote transparency and process quality control,we proactively proposed and established a registration platform for clinical safety research of traditional Chinese medicine.This paper made a brief introduction hereof.