A comprehensive evaluation system of Chinese patent medicine (CPM) is considered as a critical tool to measure the value of CPM. The "guideline for multi-dimensional and multi-criteria comprehensive evaluation for Chinese patent medicine" (abbreviated as guideline) has been released, proposing a comprehensive evaluation system of CPM (1st) comprising six aspects: safety, effectiveness, economy, applicability, scientificity and standardization. This paper elaborated the development method and explained the evaluation dimensions and criteria, so as to help the researchers understand and use the comprehensive evaluation system in the future when evaluating CPM.
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.
Objective To systematically evaluate the quality of published pharmacoeconomics studies on Chinese patent medicines for neoplasms. Methods Datasets including CNKI, WanFang Data, VIP, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase were searched to collect pharmacoeconomics studies of Chinese patent medicines in neoplasms from the establishment of the database to September 30, 2022. Consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) and quality of health economics studies (QHES) were used to evaluate the reporting quality and methodological quality. Results A total of 25 studies were included, with an average CHEERS 2022 coincidence rate of 40.09% and an average QHES score of 53.2. Conclusion The quantity and quality of pharmacoeconomics studies on Chinese patent medicines in neoplasms are insufficient and flawed. It is suggested to strenthen the collaboration between scientific research institutions and hospitals and standardize the pharmacoeconomics studies on Chinese patent medicines in neoplasms to provide hygienic decision-making evidence for Chinese patent medicines in neoplasms.
Objective To summarize and analyze the characteristics, advantages and disadvantages of the current governance framework for public health emergencies in China. Methods The CNKI, VIP, WanFang Data, CBM and PubMed databases were electronically searched to collect studies on the management of major infectious disease outbreaks in China from inception to April 15, 2023. The basic information and governance elements included in the study were extracted and analyzed. Results A total of 30 studies were included, and the time of issuance was from 2020 to 2022. Most of the studies were on COVID-19, focusing on the governance framework of big data governance, holistic governance, and multi-agent collaborative governance. The governance elements were mainly concentrated in three aspects: governance subject, governance cycle and institutional guarantee. The governance entities were concentrated on multi-agent collaborative governance, with the governance cycle mainly focused on in process governance, and the basic guarantee is a multiple guarantee with information technology big data as the main body. Conclusion The governance body of China's major infectious disease epidemic management framework has transitioned from a single entity to a multi entity collaborative governance. While increasing prewarning governance, attention should also be paid to governance during the post recovery period. In terms of system, comprehensive guarantees such as epidemic public opinion control system guarantees, privacy security guarantees, and psychological counseling guarantees should be added.
ObjectiveThis study aims to conduct a systematic review and quality assessment of published domestic and foreign studies on the pharmacoeconomics of Chinese patent medicines, with the goal of identifying relevant issues and proposing improvement suggestions. MethodsThe methods used in this study involved systematic searches of the CNKI, WanFang Data, VIP, and PubMed databases for domestic and foreign studies related to the pharmacoeconomics of Chinese patent medicines, with a search deadline of May 20, 2022. The studies were evaluated systematically based on various aspects such as title, year, author, journal, research perspective, research type, disease area, research object, research design type, research method, application model, model calibration, sensitivity analysis, cost calculation, effectiveness indicators, and adverse reaction comparison. The evaluation of report quality and methodological quality was conducted using the consolidated health economic evaluation reporting standards 2022 (CHEERS 2022) and the quality of health economic studies (QHES) tools, respectively. ResultsThis study included a total of 249 articles, including 247 in Chinese and 2 in English. The first article on the pharmacoeconomics of Chinese patent medicine was published in 2000. The diseases studied covered 59.26% of the ICD-11 disease areas. Articles reporting on the research perspective accounted for 16.87% of the total number of studies, while 32.4% of studies provided an explanation of the research type. The main method used was cost-effectiveness analysis, accounting for 86.75% of the studies, and the main cost component was direct medical costs, accounting for 89.56%. The primary effectiveness indicator was the overall effective rate, accounting for 78.31% of the studies. The average compliance rate with the CHEERS 2022 standard was 43.58%, and the average QHES score was 56.7. ConclusionA considerable part of the existing research on the pharmacoeconomics of traditional Chinese medicine (TCM) suffers from problems such as the lack of research methods or non-standardized methods. Therefore, the relevant research abilities of researchers who conduct TCM pharmacoeconomic research need to be improved.
Objective To analyze the current research status, characteristics and development trend of traditional medicine-related clinical trials registration, and to provide ideas and directions for further development of traditional medicine clinical trials. Methods The International Traditional Medicine Clinical Trial Registry (ITMCTR) database was searched by computer from inception to June 30, 2024, with unlimited trial registration status, to collect all the clinical trials on traditional medicine, and analyzed in terms of the basic information of the trials, the diseases studied and the interventions. Results A total of 4 349 clinical trials related to traditional medicine were included, with the number of registrations peaking in the second half of 2020, and showing a steady upward trend after 2023. The studies conducted covered a total of 47 countries/regions, led by Beijing, Shanghai, Guangdong, Sichuan, and Zhejiang provinces, accounting for 69.72% of the total, and included 13 overseas regions. The financial support for the studies was dominated by local government funds in various provinces and cities, accounting for 29.66%. Disease types studied were mainly circulatory system diseases, musculoskeletal system or connective tissue diseases, and tumor diseases, accounting for 29.91% of the total. 3 751 (86.3%) clinical trials were interventional studies, of which randomized parallel control was predominant, and there were 213 large-sample studies with a sample size of more than 1 000 cases. A total of 20 types of interventions were involved, of which 1 114 (29.86%) clinical trials utilized oral herbal soup/granule interventions. Conclusion Clinical trial enrollment in traditional medicine has increased overall, but with significant geographic unevenness. Oral herbal soup/granule interventional studies are the mainstream hotspots. It is recommended to strengthen international cooperation, enrich the types of interventions, refine the trial design, and raise the awareness of researchers about the registration of high-quality traditional medicine clinical trials.
The preferred reporting items for comprehensive evaluation of Chinese patent medicine (PRICE-CPM) regulate the specific requirements of forming integrity, clear, and transparent reports from title to conclusion. It contains six domains with twenty-one items and seventy-two sub-items and is important to promote the integrity, scientificity, transparency, and applicability of relevant reports. Additionally, it indicates that comprehensive evaluation results reports of post-marketing Chinese patent medicine should refer to PRICE-CPM. Therefore, this article provides a detailed interpretation of the report list and references for future users.