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Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Assuntos
Medicina Tradicional Chinesa , Medicamentos sem Prescrição , Consenso , China , Padrões de Referência , Medicamentos de Ervas ChinesasRESUMO
Evidence and value：impact on DEcisionMaking （EVIDEM） framework was developed by EVIDEM collaboration. Its core is the combination of multiple criteria decision analysis （MCDA） model and standardized health technology assessment （HTA） report， which aims to evaluate the overall value of medical interventions. It has been tested and implemented in the real-world evaluation environments. After more than 10 years of development， EVIDEM framework has been updated to version 10， and the relevant operation manuals have been published. More than 40 countries have joined the collaboration and more than 20 countries have carried out relevant studies. The framework is constructed with patients， population and sustainability as the overall goals， combing the evidence and value， forming a relatively complete decision-making framework system composed of 2 levels， 7 dimensions and 20 criteria. The two levels include normative universal criteria and contextual criteria. The normative universal criteria， namely EVIDEM core model， is the quantitative evaluation， consisting of 5 dimensions and 13 criteria. Contextual criteria， namely contextual tools， are qualitative evaluation， consisting of 2 dimensions and 7 criteria. The specific operation steps of EVIDEM framework include selecting and constructing criteria， assigning weights， integrating and evaluating evidence， quantitative and qualitative evaluation of value， comprehensive value estimation and ranking based on value estimation. EVIDEM framework is applicable to disease diagnosis， treatment， management and other fields. Its application scope includes medical insurance reimbursement， clinical practice decision-making， drug selection and so on， which can provide a method for more systematic， transparent and scientific healthcare decision-making. At present， the framework has been introduced into the field of traditional Chinese medicine and can provide a scientific and feasible evaluation tool and methodology system for the clinical comprehensive evaluation of Chinese patent medicine.
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@#AIM: To investigate the effect of intestinal fungal dysbiosis induced by antifungal drug on corneal wound healing in mice.<p>METHODS: Male C57BL/6J mice(free of eye disease)were divided into two groups randomly: control(Ctrl)group and amphotericin B treated(Amph)group, The Ctrl group was given a normal diet, and the Amph group was supplemented with amphotericin B to induce intestinal fungal dysbiosis. After 4wk intervention, corneal epithelial trauma was implemented in both groups. Corneal fluorescein staining was used to evaluate the corneal wound area dynamically. Immunofluorescence staining was applied to observe the changes of corneal epithelial cells and inflammatory cells. HE staining was used to assess the change of corneal thickness.<p>RESULTS: Compared with Ctrl group, Amph group had delayed re-epithelialization rate and wound repair, less inflammatory cells and thinner corneal.<p>CONCLUSION: Intestinal fungal dysbiosis delays the corneal wound healing, leading to a weak inflammatory response.
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The SOD and POD enzyme activities were detected, ginseng saponin content and protein concentration at 4 ℃ preservation on fresh ginseng by different substrates were determined. The results showed that the appearance of the ginseng and the survival ability were good after six months by perlite preservation. It has lower SOD, POD enzyme activity and higher saponins and protein contention. It is the best fresh storing conditions for ginseng by using perlite at 4 ℃ preservation.
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Due to the weak foundation of clinical trials, the pre-market data of pediatric medicine is insufficient. Therefore, a comprehensive evaluation system of pediatric clinical medicine is urgently needed to safeguard the children’s medication safety. This article provides the method and builds path to establish the comprehensive evaluation system from the aspects of biulding organizational structure, operational process and evaluation methodology, respectively. Further, based on the concept of "Evidence-based or otherwise evidence-created", and following the example of "Mini-Sentinel" of the United States, the big data in medicine can be used to overcome the "Evidence-created" difficulty in the evaluation of pediatric medication. Thus more extensive comprehensive evaluation can be made through collecting the clinical data generated from the real world for the pediatric medication. In the future, the comprehensive evaluation system of pediatric clinical medicine established on the basis of big data can be linked to the "Precision Medicine" Project in our country, the evaluation bases can be the "Mini-Sentinel" to collect big medical data and biological samples, thus to bring a steady flow of power for promoting the pediatric medicine active surveillance and pediatric precision medicine, and finally to safeguard the children’s health in our country.