The western medicine are main drugs in treatment of infectious diseases, but the combination of Traditional Chinese and western medicine are used in China. In recent years, proportion of proprietary Chinese medicine increased significantly in this field. However, the classification of proprietary Chinese medicine and matching with the counterparts of western medicine were difficult, and the package inserts were less scientific and normative. By searching the terms of "Qing kai ling" and "Infection", the paper found the quality of post-marketing clinical researches was low. The use proportion of Qing kai ling combined with other drugs was more than 50%, 70% of which was western medicine. The further studies are needed to explore some proprietary Chinese medicine with obvious competitive advantage and improve the quality of methodology and reporting, in order to standardize and guide the rational use of proprietary Chinese medicine in infectious diseases.
Objective The modification of Chinese patent medicines (CPM) instructions is currently the focus of national drug regulation, with policies and regulations being established. Nevertheless, the policies pertaining to CPM instructions have not been thoroughly investigated. This study analyzes the direction and current issues with existing policy items to give a reference for future optimization and adjustment of policies linked to CPM instructions. Methods The official website of the National Medical Products Administration (NMPA) and National Health Commission (NHC) were searched to collect policy documents related to the CPM instructions issued at the national level in China from January 1st 2000 to June 1st 2024. Based on the classification of policy tools (supply-based policy tools, demand-based policy tools, environment-based policy tools) and the dimension of policy development (policy planning, policy implementation, policy supervision, and policy evaluation ), a two-dimensional analytical framework of "policy tools and policy process" was constructed by using the content analysis method and the quantitative analysis method, and policy documents were analyzed. Results The 27 policy texts included in the analysis generated 104 policy entries in total, wherein, environment-based policy tools (74.04%) were used the most in the dimension of policy tools, followed by demand-based policy tools (24.04%) and supply-based policy tools (1.92%). In the dimension of policy development, policy planning tools, policy implementation tools, policy supervision tools, and policy evaluation tools accounted for 24.04%, 52.88%, 17.31%, and 5.77%, respectively. An in-depth analysis of the content of the policy entries discovered that the existing policy took into account the specification of the content of the instruction and the standardization of the expression of writing, the instruction application guidance, etc, and more and more attention was being paid to the content of the characteristics of TCM in the instruction. Conclusion Currently, there is an insufficient amount of policy documents on CPM standards, which are overly focused on environment-based policy tools and the policy implementation process. To achieve the policy goal of regulating and applying CPM specifications, it is recommended to create a balanced and coordinated structure of policy instruments, emphasise the direct promotion and pulling effect of supply and demand, increase the weight of policy evaluation and supervision, and develop a standard system for evaluating CPM specifications.
It is very important to develop and revise expert panel consensus on Chinese patent medical clinical application. The contents of the expert panel consensus include determination of the subject, clarity of the application scope, indications, dosage and administration, and safety of Chinese patent medicine. In the process, clinical researchers establish project team, formulate clinical management questions, select the outcome index, retrieve and make the evidence, and develop expert consensus with consensus methods strictly according to the requirements of methodology.
Our team proposed and constructed an Expert-knowledge and Data-driven Comprehensive Evaluation Model of Chinese Patent Medicine (EDCEM-CPM) using the machine learning algorithm. This model could improve the system of the comprehensive evaluation of the Chinese patent medicine in technology and provide measurement tools for Chinese patent medicine according to its characteristics. The model evaluates the multi-dimensional value of Chinese patent medicine by data pre-treatment, clustering algorithms, and data training steps, such as automatic learning weighting. This evaluation model is already in practice. In this paper, we introduced the establishment of the model with the calculation process for reference.
The preferred reporting items for comprehensive evaluation of Chinese patent medicine (PRICE-CPM) were developed, and comprised six domains, 21 items and 72 sub-items. The EQUATOR collaboration network for the formulation and revision of reporting specifications was referred to and the final report list items were established by adopting the literature analysis method, the expert committee discussion and the Delphi method, and considering the characteristics of CPM evaluation.
ObjectiveTo systematically review the studies on the clinical comprehensive evaluation system of drugs at home and abroad. MethodsThe PubMed, EMbase, Cochrane Library, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect the literature and policy documents of the clinical comprehensive evaluation system of drugs from inception to October 31, 2022. The evaluation organization, evaluation perspective, application scope, domains and criteria were sorted out, and the evaluation of different types of drugs was analyzed in detail. ResultsA total of 101 clinical comprehensive evaluation systems of drugs were included. The publishing time was from 2009 to 2022, and the number of published articles increased. The first author mainly came from 26 countries, including China (n=34), Canada (n=11), the United States (n=10), and Spain (n=10). Forty-seven articles reported the evaluation perspective. All evaluation systems could be used for drug evaluation, of which 43 could be used as universal evaluation tools, and 58 could be used for the evaluation of specific drugs, mainly including anti-tumor drugs (n=15), orphan drugs (n=10) and traditional Chinese medicine (n=7). The number of evaluation domains varied from 2 to 22, and the number of criteria varied from 4 to 56. Among them, economics (n=73), effectiveness (n=72), safety (n=54), disease demand/burden (n=34), and innovation (n=24) were the most frequent evaluation domains. ConclusionThe research on clinical comprehensive evaluation of drugs at home and abroad has grown up. During the implementation of clinical comprehensive evaluation of Chinese patent medicine, it is necessary to clarify the evaluation perspective, define the evaluation scope, and determine the evaluation domains.
Traditional Chinese medicine (TCM) has a long history. In the process of fighting against diseases, TCM has formed a unique theoretical system and the way to think and diagnose. The holistic thinking, and the treatment according to syndrome differentiation are the most prominent characteristics of TCM, which matches with advanced medical concept and direction. The clinical efficacy has always been the basis for the advancement of TCM. However, issues such as the lagging behind of modern research on the evaluation of TCM curative effect, as well as lacking high-quality scientific research evidence, impede the development and promotion of the TCM toward the world. To address the above problems, recent progress in real-word study (RWS) has provided the opportunity for TCM researches, especially for the post-marketing evaluation of Chinese patent medicine (CPM). The formulation of this technical guidance for RWS of CPM is helpful to researchers in carrying out standardized, reasonable and scientific researches, to improve the quality of production and use of real-word evidence, and to promote the advancement of the TCM industry.
ObjectiveTo analyse the quality of implementation in clinical application guidelines of the Chinese patent medicines for the treatment of common diseases. MethodsWe retrieved clinical application guidelines of the Chinese patent medicines for the treatment of common diseases published from February, 2019 to August, 2022 in databases. The clinical practice guideline (CPG) implementation evaluation tool was used to evaluate the implementation of the included guidelines. ResultsA total of 29 guidelines were included. The implementation quality of included guidelines was moderate. Thirteen (44.8%) were high quality and 16 (55.2%) were moderate quality. ConclusionThe quality of implementation of clinical application guidelines of the Chinese patent medicines for the treatment of common diseases is higher than that of other traditional Chinese medicine CPG. The CPG implementation evaluation tool can be used in traditional Chinese medicine CPGs and particularity of TCM should also be considered.
ObjectiveTo construct the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, to determine the weight of indicators, and to provide references for the comprehensive evaluation of the efficacy, safety, and economy of Chinese patent medicines.MethodsTwo rounds of expert consultation by Delphi method were applied to establish the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke, and the weight of each indicator was determined by the analytic hierarchy process method.ResultsQuestionnaire recovery rates of 2 rounds were 92.59% and 96.00%, the expert authority coefficient was greater than 0.7, and the coordination coefficients of experts in the total index were 0.224 and 0.370 (P<0.001). A three-level comprehensive evaluation indicator system for Chinese patent medicines for ischemic stroke was established and the three first-level indicators included efficacy, safety, and economy. And there were 15 second-level indicators, and 33 third-level indicators. Through the analytic hierarchy process method, the weights of each first-level indicator were 0.626 4, 0.301 2, and 0.072 4, respectively.ConclusionThe comprehensive evaluation indicator system contains efficacy, safety and economy, and provides a basis for a comprehensive evaluation of Chinese patent medicines for ischemic stroke. The indicator system is of great significance for the design of outcomes for clinical trials of ischemic stroke, the conduction of systematic reviews, and the development of clinical practice guidelines for ischemic stroke patients when selecting study outcomes.