1.Interpretation of the Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine:weighting of evaluation indicators
Haili ZHANG ; Bin LIU ; Weili WANG ; Wenjie CAO ; Yijiu YANG ; Ziteng HU ; Yaxin CHEN ; Ning LIANG ; Huizhen LI ; Qianzi CHE ; Xingyu ZONG ; Zhao CHEN ; Yanping WANG ; Nannan SHI
China Pharmacy 2024;35(7):773-777
OBJECTIVE To provide a detailed report and interpretation of the method and results for determining the weights of the technical indicators from the “multi-dimensional and multi-criteria comprehensive evaluation index system (first edition)” stated in Guideline for Multi-dimensional and Multi-criteria Comprehensive Evaluation of Chinese Patent Medicine. METHODS Normalization calculations were performed on the comprehensive weight values calculated by the analytic hierarchy process and expert weighting method to obtain the objective weights of the indicators. RESULTS The weight results of the six primary dimensions in the current comprehensive evaluation indicator system of Chinese patent medicine showed effectiveness dimension> safety dimension>standard dimension>application dimension>scientific dimension>economic dimension, with weight values of 0.281 0, 0.268 5, 0.195 8, 0.107 3, 0.096 1 and 0.051 3 respectively, consistent with the results of most researches currently. CONCLUSIONS The process of weight determination in this indicator system is scientifically reasonable, with clear methods and clear interpretations, and is worthy of further optimization and widespread application.
2.Research Progress of Traditional Chinese Medicine Intervention in Nrf2/HO-1 Signaling Pathway for Acute Pancreatitis: A Review
Wanling XIN ; Ning WANG ; Cenyi LIANG ; Yue ZU ; Sijia LI ; Minchao FENG ; Guozhong CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):265-271
Acute pancreatitis (AP) is a common clinical acute abdominal disease, which is characterized by acute onset, rapid development, severe disease, many complications, and high mortality rate. It can progress to severe AP (SAP) if not treated promptly in the early stage. The pathogenesis of AP is complex and involves multiple cellular and molecular levels. It is now clear that oxidative stress and reactive oxygen species (ROS) production are involved in the physiopathological process of AP, which is associated with a low quantity and activity of antioxidant enzymes in pancreatic cells. Nuclear factor E2-related factor 2 (Nrf2) serves as the ''golden key'' to maintain redox homeostasis in tissue cells and constitutes an important signaling pathway for antioxidant response and inflammation in vivo by collaborating with downstream antioxidant enzymes such as heme oxygenase-1 (HO-1). Traditional Chinese medicine has unique efficacy in treating diseases due to its multi-component, multi-target, multi-drug delivery, and multi-formulation characteristics. Based on the concept of synergy between traditional Chinese and Western medicine, traditional Chinese medicine is becoming a new craze in the treatment of AP. The level of oxidative stress and Nrf2/HO-1 signaling pathway in AP pancreatic tissue are in a dynamic change process, and the intervention of traditional Chinese medicine can clean ROS production, affect the inflammatory pathway, and reduce oxidative stress damage, so as to protect against pancreatic injury. This suggests that this pathway plays an important role in AP. This article reviews the recent literature on the regulation of the Nrf2/HO-1 signaling pathway by traditional Chinese medicine for AP and summarizes that the monomers of traditional Chinese medicine targeting this pathway are mainly heat-clearing and detoxifying, blood-activating and blood-stasis-removing, and Qi benefiting and middle warming, and the compounds of traditional Chinese medicine include Yinchenhao Decoction and QingYi Ⅱ, so as to provide a new direction for the prevention and treatment of AP and further drug development.
3.Superior vena cava syndrome and pulmonary artery stenosis in a patient with lung metastases of bladder cancer
Jian-Ke LI ; Ya-Nan GU ; Jun-Hao LI ; Liang-Wen WANG ; Ning-Zi TIAN ; Wei CHEN ; Xiao-Lin WANG ; Yi CHEN
Fudan University Journal of Medical Sciences 2024;51(2):277-279,284
Superior vena cava syndrome(SVCS)is a group of clinical syndromes caused by obstruction of the superior vena cava and its major branches from various causes.Pulmonary artery stenosis(PS)is a complication of lung cancer or mediastinal tumours.SVCS combined with PS due to pulmonary metastases from bladder cancer is extremely rare and has not been reported in the literature.Here we reported an old male patient with pulmonary metastases from bladder cancer presenting with swelling of the head,neck and both upper limbs.SVCS combined with PS was clarified by pulmonary artery computed tomography angiography(CTA)and digital subtraction angiography(DSA).Endovascular stenting was used to treat SVCS.Angiography also showed that PS had not caused pulmonary hypertension and did not need to be treated.The swelling of the patient's head,neck and upper limbs was gradually reduced after the procedure.
4.Protective Effects of Danmu Extract Syrup on Acute Lung Injury Induced by Lipopolysaccharide in Mice through Endothelial Barrier Repair.
Han XU ; Si-Cong XU ; Li-Yan LI ; Yu-Huang WU ; Yin-Feng TAN ; Long CHEN ; Pei LIU ; Chang-Fu LIANG ; Xiao-Ning HE ; Yong-Hui LI
Chinese journal of integrative medicine 2024;30(3):243-250
OBJECTIVE:
To investigate the effects of Danmu Extract Syrup (DMS) on lipopolysaccharide (LPS)-induced acute lung injury (ALI) in mice and explore the mechanism.
METHODS:
Seventy-two male Balb/C mice were randomly divided into 6 groups according to a random number table (n=12), including control (normal saline), LPS (5 mg/kg), LPS+DMS 2.5 mL/kg, LPS+DMS 5 mL/kg, LPS+DMS 10 mL/kg, and LPS+Dexamethasone (DXM, 5 mg/kg) groups. After pretreatment with DMS and DXM, the ALI mice model was induced by LPS, and the bronchoalveolar lavage fluid (BALF) were collected to determine protein concentration, cell counts and inflammatory cytokines. The lung tissues of mice were stained with hematoxylin-eosin, and the wet/dry weight ratio (W/D) of lung tissue was calculated. The levels of tumor necrosis factor-α (TNF-α), interleukin (IL)-6 and IL-1 β in BALF of mice were detected by enzyme linked immunosorbent assay. The expression levels of Claudin-5, vascular endothelial (VE)-cadherin, vascular endothelial growth factor (VEGF), phospho-protein kinase B (p-Akt) and Akt were detected by Western blot analysis.
RESULTS:
DMS pre-treatment significantly ameliorated lung histopathological changes. Compared with the LPS group, the W/D ratio and protein contents in BALF were obviously reduced after DMS pretreatment (P<0.05 or P<0.01). The number of cells in BALF and myeloperoxidase (MPO) activity decreased significantly after DMS pretreatment (P<0.05 or P<0.01). DMS pre-treatment decreased the levels of TNF-α, IL-6 and IL-1 β (P<0.01). Meanwhile, DMS activated the phosphoinositide 3-kinase/protein kinase B (PI3K/Akt) pathway and reversed the expressions of Claudin-5, VE-cadherin and VEGF (P<0.01).
CONCLUSIONS
DMS attenuated LPS-induced ALI in mice through repairing endothelial barrier. It might be a potential therapeutic drug for LPS-induced lung injury.
Mice
;
Male
;
Animals
;
Proto-Oncogene Proteins c-akt/metabolism*
;
Lipopolysaccharides
;
Phosphatidylinositol 3-Kinases/metabolism*
;
Interleukin-1beta/metabolism*
;
Vascular Endothelial Growth Factor A/metabolism*
;
Tumor Necrosis Factor-alpha/metabolism*
;
Claudin-5/metabolism*
;
Acute Lung Injury/chemically induced*
;
Lung/pathology*
;
Interleukin-6/metabolism*
;
Drugs, Chinese Herbal
5.Methodology for the Development of Clinical Practice Guideline for Chinese Patent Medicine(Part 1): Development Status and Characteristics
Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Fuqiang ZHANG ; Ziteng HU ; Yaxin CHEN ; Huizhen LI ; Haili ZHANG ; Zhao CHEN ; Yin JIANG ; Bin LIU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):44-49
The irrational use of Chinese patent medicines (CPM) is becoming more and more prominent, which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines, and promote its development, this paper introduced the concept of CPM guidelines, summarized the characteristics of the two development modes, namely “taking CPM as the key” and “taking disease/syndrome as the key”, and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems, three suggestions have been put forward to optimize the quality of CPM guidelines, which were clarifying the target users and scope of CPM guidelines, establishing an open and transparent mechanism of the personnel involvement and process steps, and formulating implementable and operable recommendations for the use of CPM.
6.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine: 2.Establishment of Guideline Working Group and Management of Conflict of Interests
Yaxin CHEN ; Ning LIANG ; Lijiao YAN ; Ziteng HU ; Yujing ZHANG ; Fuqiang ZHANG ; Haili ZHANG ; Huizhen LI ; Yijiu YANG ; Jing GUO ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):50-54
This paper summarized the key points and methods in terms of the establishment of the guideline working group and the management of conflict of interests, trying to provide reference for the development of clinical practice guidelines for Chinese patent medicine (CPM). The establishment of the working group is the first important step for developing CPM guidelines. Considering the characteristics of the clinical practice guidelines for CPM, this study suggests that the three key elements of ‘multidisciplinarity’, ‘clinical relevance’ and ‘geographical representativeness’ should be put focus on when forming the working group. The guideline advisory committee, clinical expert group, evidence systematic evaluation group, secretary group and the external review group should be established. All group members should clarify the conflict of interest, and the process and management method of the conflict of interest should be clearly reported.
7.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 4): Evidence Retrieval and Evaluation
Fuqiang ZHANG ; Lijiao YAN ; Ziteng HU ; Yujing ZHANG ; Yaxin CHEN ; Xingyu ZONG ; Zhao CHEN ; Weili WANG ; He LI ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):60-65
The retrieval and evaluation of evidence is the basis for the development of clinical practice guidelines for Chinese patent medicine. As traditional Chinese medicine has a different development trajectory and utilization characteristics from modern medicine, there is certain differences in terms of evidence composition, retrieval and integration.This paper discussed multi-source body of evidence on Chinese patent medicine based on modern evidence-based medicine and ancient medical literature, and summarized the retrieval strategy as well as the possible problems and solving methods. For different types of evidence on Chinese patent medicine, the corresponding evaluation tools have been recommended, and the order to integrate the evidence based on the quality of the evidence from high to low is suggested. Finally, a multi-source based evidence retrieval-evaluation-integration scheme for Chinese patent medicine has been formed, which will provide a methodological reference for practitioners in the development of clinical practice guidelines for Chinese patent medicine.
8.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 5): Retrieval and Synthesis of Key Information on Rational Drug Use
Ziteng HU ; Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Fuqiang ZHANG ; Yaxin CHEN ; Bin LIU ; Qianzi CHE ; Yixiang LI ; Jing GUO ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):167-171
Recommendations for Chinese patent medicine (CPM) based on key information on rational drug use are one of the important conditions for enhancing guideline enforceability as well as facilitating guideline implementation. In this study, we discussed in detail of the key information on the rational use of CPM in five aspects, which are dosage, drug discontinuation, drug-drug and drug-food interactions, safety and economy. Following the process of multi-source search, synthesis and prioritization, it is suggested to collect key information on the rational use of CPM from a multi-source search of drug instructions, policy documents, literature, and clinical experts' experiences. Then the searched information should be summarized and prioritized with the principle that taking drug instructions as the basis and other-sources information for check and supplementation. Finally, methodological recommendations for the retrieval and synthesis of key information on rational drug use in guideline recommendations has been formed.
9.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 7): Introduction and Interpretation of the Guideline Reporting Checklist
Yujing ZHANG ; Fuqiang ZHANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Haili ZHANG ; Huizhen LI ; Qianzi CHE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):178-184
The systematic and comprehensive introduction and interpretation of the Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 is conducive to the presentation of high-quality clinical practice guidelines for Chinese patent medicines (CPMs), thus improving their dissemination and use. The Reporting Checklist of Clinical Practice Guidelines for Chinese Patent Medicines V1.0 specifies the requirements for clear, complete and transparent reporting of the whole process of developing CPMs guidelines, containing 4 domains, 17 topics and 43 items, and involving the basic information, recommendations and methods of guideline development. Especially, it details the items related to the rules and regulations of the use of CPMs in the recommendations, which is helpful for improving the completeness, scientificity and practicality of the reporting of CPMs guideline.
10.Exploration of Value Variable Selection and Measurement for Chinese Patent Medicine Based on Hedonic Price Theory
Yijiu YANG ; Haili ZHANG ; He ZHU ; Wei LI ; Zhao CHEN ; Bin LIU ; Ning LIANG ; Huizhen LI ; Tian SONG ; Wenjie CAO ; Weili WANG ; Ziteng HU ; Yanping WANG ; Sheng HAN ; Nannan SHI
Chinese Health Economics 2024;43(5):68-71,78
To reduce the subjectivity and uncertainty present in the current international methods of drug value pricing when converting value into monetary prices,based on the hedonic pricing theory,it considers the post-negotiation price between manufacturers and payers as a reasonable price reference in the value pricing of Chinese patent medicine.By constructing an indicator system for the characteristics of Chinese patent medicine,it selects and measures the value characteristic variables that affect the price of Chinese patent medicine.It serves as the theoretical foundation and research basis for establishing a Hedonic price model between characteristic price variables and negotiation prices,thereby promoting the enhancement of rationality and objectivity in value-guided pricing of Chinese patent medicine.

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