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Article in English | WPRIM | ID: wpr-888672


Although there is guidance from different regulatory agencies, there are opportunities to bring greater consistency and stronger applicability to address the practical issues of establishing and operating a data monitoring committee (DMC) for clinical studies of Chinese medicine. We names it as a Chinese Medicine Data Monitoring Committee (CMDMC). A panel composed of clinical and statistical experts shared their experience and thoughts on the important aspects of CMDMCs. Subsequently, a community standard on CMDMCs (T/CACM 1323-2019) was issued by the China Association of Chinese Medicine on September 12, 2019. This paper summarizes the key content of this standard to help the sponsors of clinical studies establish and operate CMDMCs, which will further develop the scientific integrity and quality of clinical studies.

Article in Chinese | WPRIM | ID: wpr-279244


Based on the software of traditional Chinese medicine inheritance support system (TCMISS), this article aims to analyze the experience and composition rules for cough from the descendant of Meng He Medical School, Xu Di-hua. The cough cases treated by Xu Di-hua were collected, and recorded into TCMISS (V2.0). Data mining methods such as Apriori algorithm and complex system entropy cluster were used to analyze the medication principles of Xu Di-hua for cough from pathogenesis and therapeutie aspects, and dig out the frequency of the herbs in prescription, core medicine and new combinations. The experience of curing cough from Professor Xu Di-hua were well found in the research. He is good at choosing prescriptions accurately, and pays attention to simultaneous use of cold and moisture drugs with combination of tonification and purgation. He is skilled in adding or reducing materia medica flexibly, as well as regulating lung to relieve cough and eliminating phlegm by clearing heat.

Algorithms , Cough , Drug Therapy , Data Mining , Drug Therapy, Combination , Drugs, Chinese Herbal , Chemistry , Therapeutic Uses , Female , Humans , Male , Materia Medica , Medicine, Chinese Traditional
Article in Chinese | WPRIM | ID: wpr-294353


According to the principle of evidence-based medicine (EBM), Chinese medical literatures based descriptive statistical analysis of common Chinese medical syndrome types were performed. By data extraction, standardization, and frequency calculation of disease names and syndrome types from 286 literatures in line with the inclusion criteria, the frequencies of diseases and syndromes were obtained to analyze common syndrome types in clinical practice, to analyze the distribution features of disease related syndromes and syndrome related diseases, to analyze the distribution of basic Chinese medical syndrome types in clinical common diseases as a whole, thus providing reference for clinical and basic researches.

Evidence-Based Medicine , Humans , Medicine, Chinese Traditional
Article in Chinese | WPRIM | ID: wpr-326708


<p><b>OBJECTIVE</b>To explore the thinking and method of studying the diagnostic standard for TCM Syndrome Differentiation by means of clinical epidemiological investigation on climacteric syndrome.</p><p><b>METHODS</b>Adopting DME (design measurement evaluation), the field investigation data of 400 patients with climacteric syndrome were statistically managed and analyzed using blind method. The distribution of syndromes, including information of four-diagnosis of various syndromes as well as the laboratory findings in patients were studied using factor analysis and model of structural equation.</p><p><b>RESULTS</b>The Syndrome types of climacteric syndrome were identified as the Gan-Yang exuberance type, the Shen-Yang deficiency type, the Gan-Shen Yin-deficiency type and the Gan-stagnancy injuring Spirit type.</p><p><b>CONCLUSION</b>Thinking of the diagnostic standard study for TCM Syndrome Differentiation is to identify the supposed diagnostic standard of a disease based on retrospective study, to formulate a new hypothetical standard of Syndrome by way of field investigation, category analysis, factor analysis, and critical theory, followed with identification of Syndrome distribution in the disease, its critical syndrome, typical syndrome, complicated syndrome, and criteria for Syndrome Differentiation.</p>

Climacteric , Diagnosis, Differential , Diagnostic Techniques and Procedures , Reference Standards , Female , Humans , Medicine, Chinese Traditional , Middle Aged , Retrospective Studies , Syndrome , Yang Deficiency , Diagnosis , Yin Deficiency , Diagnosis