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.
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.
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 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.
Objective To evaluate the effectiveness and safety of Chinese medicine treatment of cholelithiasis. Methods We searched electronic databases including MEDLINE (1966 to Feb. 2009), EMbase (1974 to Feb. 2009), The Cochrane Library (Issue 4, 2008), Chinese Biomedical Literature Database (CBM, 1978 to Feb. 2009), CJFD (CNKI, 1994 to Feb. 2009), the Chinese Scientific and Technical Journals database (VIP, 1989 to Feb. 2009), and a database of Chinese biomedical journals (CMCC, 1994 to Feb. 2009). At the same time, we searched references of the included studies. Metaanalysis was performed using RevMan 5 if there was no significant heterogeneity. We described the date which could not be combined. Results A total of 18 randomized controlled trials involving 2 276 patients were included. According to measurement indicators and interventions, subgroup analysis was performed. Efficacy was reported in 10 studies, which showed that part of proprietary Chinese medicines had a higher efficiency for cholelithiasis. Gallbladder emptying index and the trend of bile into the stone were compared in 5 studies, suggesting that the bile of proprietary Chinese medicines reduced the stone index, which eased the bile tendency to rock. Three studies reported the rate of cholecystokinin. Metaanalysis results suggested that the difference was significant. Two studies reported adverse drug reactions (ADRs), such as epigastric discomfort and diarrhea. Most ADRs were slight, and could be self relieved. Conclusion Results suggest that Chinese medicines produce effects on clinical symptoms of cholelithiasis, gallbladder function and reduce the trend of bile into stones. However, the therapeutic effects for long-term are rarely reported. The conclusion needs further verification due to low methodological quality and apparent heterogeneity.
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.
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.
Comprehensive evaluation research of Chinese patent medicine (CPM) is performed to demonstrate the comprehensive value of CPM from multiple dimensions and to clarify the clinical value and positioning, so as to provide references for decision-making in health or drug policies. Therefore, to standardize and promote comprehensive evaluation studies on CPM, the current guideline introduced the specific requirements on the applicable subject, basic principles, and major evaluation content, thereby providing guidance for researchers in the future.
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.
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.