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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.
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International Regulatory Cooperation for Herbal Medicines (IRCH) was established in 2006, and became an official agency of WHO in 2017. The development history after IRCH founded, organization framework, term of reference, workflow and requirements for joining IRCH, and current priorities of IRCH were systematically introduced. At the same time, combining to the work priorities of IRCH, China should actively participate in the relevant works of IRCH from the following aspects, such as the establishment of international herbal medicine standards, compilation of WHO herbal pharmacopoeia, evidence-based research on herbal medicine, and data information collection of herbal drugs. The participation on IRCH work could contribute to the development of traditional Chinese medicine in the global market.
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We determined a component-target-disease network for Carthamus tinctorius L. and the key compounds, identified by topological analysis, were related to vasculitis, coronary heart and cerebrovascular disease. Based on these compounds, the chromatographic fingerprint of Carthamus tinctorius L. was established. Firstly, 132 compounds were obtained from TCMID and TCMSP databases. Their targets were predicted in the PharmMapp and HemMapper databases. CardioGenBase, Therapeutic Target Database and DisGeNET databases were used to collect targets of vasculitis, coronary heart disease and cerebrovascular disease. The corresponding relationships between component and target protein were established by mapping. Finally, the "component-target-disease" network was built with Cytoscape software. The core network and key nodes were analyzed with the Cytohubba plug-in. The results showed that the 24 key compounds were alpha-tocopherol, adenosine, quinone chalcone pigments such as hydroxysafflor yellow A, safflower yellow, quercetin, kaempferol and other flavonoids, organic acids such as stearic acid, linolenic acid, coumaric acid and cinnamic acid. This resulting chromatographic fingerprint of Carthamus tinctorius L. showed good consistency, and the core chemical compounds obtained by topological analysis of the network of "component-target-disease", could be used as quality control markers. Our research provides a new approach for the identification of quality control indicators in Chinese medicinal materials.
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OBJECTIVE@#To investigate the expression of autophagy-related protein Beclin-1 and microtubule-associated protein 2 light chain 3 (LC3Ⅱ) in periodontal ligament cells in orthodontic tooth pressure areas.@*METHODS@#Sixty male SD rats were randomly divided into a blank control group and nine experimental groups. In the experimental groups, 0.392 N orthodontic force was used to move the first right upper molars for 15 min, 30 min, 1 h, 2 h, 4 h, 12 h, 1 d, 3 d, or 7 d. The blank control group did not receive any treatment. The rats were euthanized. Changes in the morphology of the periodontal membrane in the pressure areas were observed through hematoxylin and eosin (HE) staining. The expression levels of Beclin-1 and LC3Ⅱ were detected by immunohistochemical staining, and tartrate-resistant acid phosphatase (TRAP) staining was performed for the counting of osteoclasts.@*RESULTS@#The HE stains showed that the hyalinization of the periodontal ligament appeared in the pressure areas after 1 day of exertion and was gradually aggravated. The immunohistochemical stains showed that the expression levels of Beclin-1 and LC3Ⅱ in the experimental groups gradually increased, peaked after 1 h, and then gradually decreased. The expression levels peaked again after 1 d, then decreased to baseline levels at 7 d of exertion. Beclin-1 and LC3Ⅱ were expressed in the osteoclasts. The TRAP stains indicated that the number of osteoclasts started to increase after 1 day.@*CONCLUSIONS@#Autophagy may participate in the process of periodontal ligament reconstruction in orthodontic tooth pressure areas by mediating the hyalinization of periodontal ligament and affecting the biological effects of osteoclasts.
Subject(s)
Animals , Male , Rats , Autophagy , Beclin-1 , Metabolism , Microtubule-Associated Proteins , Metabolism , Osteoclasts , Periodontal Ligament , Metabolism , Random Allocation , Rats, Sprague-Dawley , Tooth Movement TechniquesABSTRACT
BACKGROUND: Estrogen can promote the osteogenic differentiation of human periodontal ligament stem cells (hPDLSCs), but the molecular mechanism is unclear. OBJECTIVE:To study the regulatory effect of estrogen on the osteogenic differentiation of hPDLSCs via Wnt/β-catenin signaling pathway. METHODS: The hPDLSCs were isolated and purified by digestion method combined with limited dilution clone method. Three experimental groups were set as follows: osteogenic induction only (control group); 1×10-7mol/L estrogen with osteogenic induction (estrogen group); and 100 μg/L Wnt3a protein with osteogenic induction (Wnt3a group). Alkaline phosphatase activity was detected at 1, 3, 5, 7 days of osteogenic induction. Western blot was used to detect the expression of Wnt/β-catenin signaling pathway related proteins β-catenin, P-GSK-3β, GSK-3β, CyclinD1 and osteoblast-related proteins Runx2 and OCN after 7 days of osteogenic induction. RESULTS AND CONCLUSION: The activity of ALP in all groups increased with time. The expression level of ALP in the estrogen group and Wnt3a group was higher than that in the control group at 1, 3, 5 and 7 days of induction (P < 0.05), while there was no significant difference between the former two groups (P > 0.05). The western blot results showed that the expression levels of β-catenin, P-GSK-3β, CyclinD1, Runx2 and OCN in the estrogen group and Wnt3a group were higher than those in the control group (P < 0.05), while the expression of GSK-3β was lower than that in the control group (P < 0.05). But there were no differences in the expression of Wnt/β-catenin signaling pathway related proteins and mid-late osteogenic markers between estrogen group and Wnt3a group (P > 0.05). To conclude, estrogen can enhance the osteogenic differentiation of hPDLSCs, and the underlying mechanism is likely to activate the Wnt/β-catenin signaling pathway in activated hPDLSCs exposed to estrogen.
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Objective To provide new ideas for establishment of prevention and control strategy for non-communicable chronic disease (NCD) that are suitable for Chinese people. Methods Sampling survey of patients with chronic disease from 14 provinces combined with literature study and researches on national statistical data were conducted to investigate the application situation and problems of traditional Chinese medicine in the prevention and control of NCD. Results Status of utilization and satisfaction of traditional Chinese medicine in the prevention and control of NCD has developed well. The main problems in the promotion and application of TCM lie in insufficient investment, lagging behind of construction of prevention and control system, insufficient professionals and ineffective heritance of practical technique. Conclusion In order to tackle these problems, relevant laws and regulations should be implemented;information management system with TCM features should be improved;construction of diversified technological innovation system should be reinforced, practical and strong technology should be promoted;construction of TCM prevention and control system for chronic diseases should be perfected.