Objective To study the relationship between the expression of p53，bcl-2 and nm23 and clinicopathology in the patients with gastric cancer and to probe the correlation among the expression of three kinds of oncogene.Methods Eighty cases of different differentiated gastric cancer, 37 cases of peri-tumor atypical mucosa hyperplasia and 20 cases of normal gastric mucosa were stained by immunohistochemistry (SP method).The expression of p53,bcl-2 and nm23 was analyzed with their relation to histologic type，differentiation，lymph node metastasis and prognosis of gastric carcinoma.Results The positive rates of bcl-2 protein expression in mild,middle and severe peritumor atypical hyperplasia were 7.1%, 18.1% and 25.0%. There was no obvious difference among 3 groups (Pgt;0.05). The bcl-2 positive rates of welldifferentiated and poordifferentiated gastric cancer were 78.2% and 48.5% respectively, the difference was obvious (P＜0.05). The positive expression rate of p53 protein in welldifferentiated gastric cancer was 72.5%, obviously lower than that of poordifferentiated gastric cancer (86.2%,P＜0.05). The positive rate of nm23 in welldifferentiated gastric cancer was 84.3%, obviously higher than that of poordifferentiated (17.2%),and the expression rate of nonlymph node metastasis group was higher than that of lymph node metastasis group (P＜0.05). The expression rate of nm23 protein was closely correlated to tumor differentiation and lymph node metastasis (P＜0.05). There was a negative correlation between p53 and bcl-2 expression. Conclusion bcl-2 and p53 can be important indices for tumor differentiation and prognosis. nm23 protein plays an important inhibiting role in the process of gastric cancer metastasis and may be a molecular biological basis for the evaluation of patients prognosis in gastric cancer.
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 understand the feasibility of application of objective performance criteria single arm trial in clinical efficacy evaluation of traditional Chinese medicine, and put forward theoretical countermeasures for the difficulties in application, so as to provide references for promoting the application of objective performance criteria single arm trial in clinical efficacy evaluation of traditional Chinese medicine in the future. Methods Semi-structured qualitative interviews were conducted among clinical experts and methodologists who were involved in objective performance criteria single arm trials using purposive sampling combined with snowball sampling and a preset interview outline. To explore the application situations, influencing factors and difficulties in the application process of objective performance criteria single arm trial in the clinical efficacy evaluation of traditional Chinese medicine, and put forward theoretical countermeasures. Results A total of 12 respondents were interviewed, including 7 clinical experts and 5 methodologists. The interview content was summarized and formed into 216 codes. After category analysis, 5 categories were formed, including the applicable situations, advantages, limitations, difficulties in the application process and theoretical countermeasures. The respondents believed that objective performance criteria single arm trial could be used as an alternative plan when controlled trials could not be carried out, or as a preliminary exploration or evidence supplement. It had the advantages of reducing sample size, good patient compliance, saving resource input, and relatively rigorous design. However, its application was limited due to low awareness and unclear level of evidence. The application difficulties included the setting of objective performance criteria, sample size calculation, quality control and statistical analysis. It was suggested to form a standard to promote its application in the efficacy evaluation of traditional Chinese medicine. Conclusion The design of objective performance criteria single arm trial is consistent with the characteristics of clinical research of traditional Chinese medicine. However, because there is no control group, the validity of objective performance criteria single arm trial is challenged, which hinders its further application in the clinical efficacy evaluation of traditional Chinese medicine. By standardizing the selection of objective performance criteria, calculation of sample size, statistical analysis methods and research implementation steps, the strength of its demonstration and the recognition can be improved to a certain extent, but attention should be paid to avoid its misuse. In the future, the objective performance criteria single arm trial may be used as a basis to further explore the new direction of scientific research methods for clinical efficacy evaluation of traditional Chinese medicine.
In the formulation of the clinical question of traditional Chinese medicine clinical practice guidelines, even if the intervention elements (intervention or control) have an appropriate scope, guideline developers are still faced with a variety of interventions. By analyzing the difficulty and necessity of priority selection of intervention interventions, we propose the approach of extending expert evidence to the process of priority selection of intervention interventions, and further provide the methodology of expert evidence data collection table design, application, data presentation and expert decision-making method to provide references and guidance for guideline developers.
Clinical practice guidelines will be incorporated in different evidence sources and evidence types, the research and exploration of multiple sources of evidence at China and foreign, this paper advocates the construction of both characteristics of multi-source evidence of traditional Chinese medicine, by combing 70 guide manuals, analyze the necessity and advantages of multi-source evidence construction, and further from the multi-source evidence source and evidence logic theory interpretation and application, in order to provide methodological references for the formulation of evidence-based clinical practice guidelines of traditional Chinese medicine.
Currently, the recommendations of the clinical practice guidelines related to acupuncture in China and abroad are opaque to the source of the acupuncture prescription, there is a lack of comprehensive evaluation of the rationality of the acupuncture prescription, and the standards for the selection of the acupuncture prescription are opaque and nonstandard, and the writing and reporting details are insufficient, thus affecting the clinical applicability of the guidelines. To a certain extent, the utilization rate of the recommendations of the guidelines is low. This paper discusses the origin, rationality comprehensive evaluation, priority selection, writing and reporting of acupuncture prescriptions, and puts forward detailed methodological suggestions, to provide guidance makers of methodological optimization thoughts and suggestions for the evaluation, selection and writing of acupuncture prescriptions in the recommendations.
When prioritizing clinical questions in the development of the clinical practice guidelines, clinical questions with high recognition and low variability, or high score and less disagreement among experts were often prioritized, while questions with high recognition but high variability were excluded. By this approach, clinical questions with practical value but also showed high variability due to different causes were not accepted as priorities. There were some methodological and clinical limitations by doing so. By summarizing the causes and connotations of expert opinion variability in terms of clinical experience, expertise and values, this paper analyzed the advantages of the variability quantification application, and proposed corresponding methodological recommendations, so as to provide references for guideline developers in the priority selection of clinical questions.
Objective To form the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single arm trial, and initially construct a methodological guiding tool for the selection and evaluation of target value, so as far to provide a research basis for improving the system of single-arm trial quality evaluation by objective performance criteria method. Methods Combining the bias risk assessment method of observational study, interventional trails, domestic and foreign policy documents, and systematically collecting the common bias and evaluation key points, preliminarily proposing the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial, via two rounds of expert consensus voting using nominal group method, finally formulating the list based on the voting results and expert opinions. Results Through two rounds of discussion, sorting, comprehensive expert opinions, we improved the corresponding items in the list and finally formed the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial, which included four areas: authority, traceability, comparability, and reliability, including 10 items. The entries in each field considered both design and implementation throughout the clinical trial. Conclusion The methodology list developed in this study provides methodological guidance for the selection of objective performance criteria and quality evaluation, and provides a solid theoretical basis for the establishment of a complete methodological system of quality evaluation for objective performance criteria single arm trails.
In the process of formation of recommendations of clinical practice guidelines, experts have many difficult problems of lack of transparency and high subjectivity in making final decisions, such as incomplete comprehensive consideration of dimensions and great heterogeneity in the evaluation of importance between dimensions, etc. As a decision-making tool, multi-criterion decision analysis improves the decision-making level of recommendation by adding the combination of qualitative and quantitative methods. By analyzing the challenges facing the formation of recommendations, this paper introduces the decision assistance of multi-criterion decision, and analyzes and summarizes the advantages and methods of the application of multi-criterion decision, so as to provide reference and guidance for guide makers to solve the difficulties in the formation of recommendations.
In the process of formulation, traditional Chinese medicine clinical practice guidelines are often faced with the dilemma of lack of evidence. Guidelines development groups tend to make final decisions based on expert experience or expert opinion, but the limitations of cognitive bias reduce the credibility and transparency of the guidelines. By clarifying the difference between the expert experience and expert opinion and expert evidence, the expert evidence of traditional Chinese medicine discipline advantages and necessity, providing the recommendation form link using expert evidence methodology design and implementation details, retaining the empirical characteristics of traditional Chinese medicine and improving the lack of evidence, has certain practical application value.