1.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
2.Simultaneous determination and toxicokinetic study of six compounds from Zhachong Shisanwei Pills in plasma of chronic cerebral ischemia rats by LC-MS/MS.
Teng-Fei CHEN ; He HUANG ; Yun-Hang GAO ; Ling SONG ; Han LI ; Bo PENG ; Hong-Ping HOU ; Wei-Ya CHEN ; Jun-Miao CHEN ; Zu-Guang YE ; Guang-Ping ZHANG
China Journal of Chinese Materia Medica 2024;49(21):5932-5943
A liquid chromatography-tandem mass spectrometry method was established and validated for determining the concentrations of costunolide(CO), piperine(PI), agarotetrol(AG), glycyrrhizic acid(GL), vanillic acid(VA), and glycyrrhetinic acid(GA) in rat plasma. This method was then applied to the toxicokinetic study of these six compounds in rats with chronic cerebral ischemia(CCI) following multiple oral doses of Zhachong Shisanwei Pills. Finally, the effects of continuous multiple-dose administration of Zhachong Shisanwei Pills on the liver of CCI rats were investigated. The results showed that after oral administration of different doses of Zhachong Shisanwei Pills, the in vivo exposure of AG, VA, and GA was relatively high, with AUC_(0-∞) values ranging from 604.0-2 494.2, 1 305.4-4 634.5, and 2 177.5-4 045.7 h·ng·mL~(-1), respectively, while the exposure of CO, PI, and GL was relatively low, with AUC_(0-∞) values ranging from 37.8-238.2, 2.4-17.0, and 146.9-408.5 h·ng·mL~(-1), respectively. The C_(max) and AUC_(0-∞) of the six compounds were positively correlated with the administered dose. The T_(max) of PI and AG ranged from 0.3 to 2.0 h, their T_(1/2) ranged from 0.8 to 2.9 h, and their mean residence time(MRT) ranged from 1.0 to 3.7 h. The T_(max) of GL and VA was shorter(0.4-1.9 h), while their T_(1/2)(2.6-5.9 h) and MRT(2.5-8.5 h) were longer. Both CO and GA exhibited a bimodal phenomenon, with T_(max) ranging from 1.6 to 6.6 h, T_(1/2) ranging from 2.8 to 7.7 h, and MRT ranging from 4.1 to 12.9 h. Liver histopathology after 28 days of continuous multiple-dose administration of Zhachong Shisanwei Pills showed that the liver tissue remained normal at a low dose(crude drug 0.8 g·kg~(-1), approximately 5 times the clinical equivalent dose). However, as the dose increased(crude drug 1.1-3.0 g·kg~(-1), 6.9-18.8 times the clinical equivalent dose), varying degrees of liver damage were observed. Blood biochemical tests revealed no significant changes in the serum levels of alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP), and total bile acid(TBA) in CCI rats from administration groups 1 to 3(crude drug 0.8, 1.1, 1.5 g·kg~(-1)). However, ALT, AST, ALP, and TBA levels in groups 4 and 5(crude drug 2.1, 3.0 g·kg~(-1)) showed significant increases. This study preliminarily elucidated the toxicokinetic characteristics of the six compounds in Zhachong Shisanwei Pills and their effects on liver tissue in CCI rats, providing data as a reference for clinical use.
Animals
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Tandem Mass Spectrometry/methods*
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Rats
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Drugs, Chinese Herbal/toxicity*
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Male
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Rats, Sprague-Dawley
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Brain Ischemia/blood*
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Chromatography, Liquid/methods*
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Polyunsaturated Alkamides/blood*
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Piperidines/toxicity*
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Benzodioxoles/toxicity*
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Alkaloids/blood*
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Liquid Chromatography-Mass Spectrometry
3.Developing a development index system of Shanghai district-level disease prevention and control institutions using the Delphi method
Xinyu LI ; Haiyan SHAO ; Ping ZU ; Ye LU ; Lei WANG ; Yexin JIN ; Fangmin LIU ; Feilong HE ; Chunfeng WU ; Yong CHEN
Shanghai Journal of Preventive Medicine 2023;35(7):695-703
ObjectiveTo construct an evaluation index system for the development of district-level disease prevention and control centers according to the requirements of the modernization of Shanghai’s disease control system and public health work practices, and to comprehensively assess the construction and development of district-level disease prevention and control institutions. MethodsAccording to the national and municipal requirements for the development of disease prevention and control institutions, an index framework was proposed through literature search and expert interviews. 39 representative experts in the field of public health at the national, provincial, and municipal (district) levels were selected to participate in the consultation and construction of the index system. The authority coefficient, the coefficient of variation, etc. were used to carry out quality control and determination of each index on the Delphi method. ResultsThe questionnaire response rate was 100%, the expert authority coefficient was 0.86,the degree of familiarity was 0.79, and the judgment basis was 0.92. The coefficients of variation of the necessary indicators in the index system were all <0.25 in the dimension of importance, and there were statistical differences in the statistical test of Kendall’s W coordination coefficients at all levels and dimensions (all P<0.001). After multiple rounds of consultation, experts reached a consensus, forming a development evaluation index system of district-level CDCs with 6 first-level indicators, 24 second-level indicators, and 105 third-level indicators (including 63 necessary indicators and 42 recommended indicators). ConclusionThe evaluation index system of Shanghai district-level CDCs based on the Delphi method has good authority, reliability, sensitivity and operability. This indicator system can effectively support the development of Shanghai district-level CDCs, and can be used for evaluation at multiple levels and in an all-round way in the future. The evaluation results can provide an evidence-based basis for the modernization of the disease prevention and control system and the continuous and dynamic updating of the development goals in the future.
4.Chemical constituents in Dolomiaea plants and their pharmacological activities: a review.
Yan-Hui LYU ; Wei CHEN ; Yan-Ping WEI ; Xin-Tong WEI ; Jie WANG ; Qian-Qian DING ; Zhan-Hong LI ; Ji-Xiang HE ; Xian-Peng ZU
China Journal of Chinese Materia Medica 2023;48(6):1463-1482
Dolomiaea plants are perennial herbs in the Asteraceae family with a long medicinal history. They are rich in chemical constituents, mainly including sesquiterpenes, phenylpropanoids, triterpenes, and steroids. The extracts and chemical constituents of Dolomiaea plants have various pharmacological effects, such as anti-inflammatory, antibacterial, antitumor, anti-gastric ulcer, hepatoprotective and choleretic effects. However, there are few reports on Dolomiaea plants. This study systematically reviewed the research progress on the chemical constituents and pharmacological effects of Dolomiaea plants to provide references for the further development and research of Dolomiaea plants.
Plant Extracts/pharmacology*
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Asteraceae
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Triterpenes
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Sesquiterpenes/pharmacology*
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Anti-Inflammatory Agents
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Phytochemicals/pharmacology*
5.Application of metabonomics in study of traditional Chinese medicine syndrome:a review.
Yan-Hui LYU ; Lei XIE ; Wei CHEN ; Jie WANG ; Xin-Tong WEI ; Yan-Ping WEI ; Xian-Peng ZU ; Ji-Xiang HE
China Journal of Chinese Materia Medica 2022;47(2):367-375
Syndrome is a nonlinear "internal-excess external-deficiency", "dynamic spatial-temporal" and "multi-dimensional" complex system and thus only by using a versatile method can the connotation be expounded. Metabonomics, which is dynamic, holistic, and systematic, is consistent with the overall mode of traditional Chinese medicine(TCM)(holistic view and syndrome differentiation and treatment). Therefore, metabonomics is very important for the research on the differentiation, material basis, and metabolic pathways of syndromes, and efficacy on syndromes. This study reviewed the application of metabonomics in the study of TCM syndromes in recent years, which is expected to objectify the research on TCM syndromes.
Drugs, Chinese Herbal
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Humans
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Medicine, Chinese Traditional
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Metabolomics
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Syndrome
6.Patient Blood Management: Single Center Evidence and Practice at Fuwai Hospital.
Yun-Tai YAO ; Xin YUAN ; Li-Xian HE ; Yi-Ping YU ; Yu DU ; Gang LIU ; Li-Juan TIAN ; Zu-Xuan MA ; Yong-Bao ZHANG ; Jie MA
Chinese Medical Sciences Journal 2022;37(3):246-260
Blood loss and blood transfusion requirement are important quality control indicators of cardiovascular surgery and cardiovascular anesthesia. Patient blood management (PBM) is an evidence-based, multidisciplinary approach to optimizing the care of patients who may need transfusion, which encompasses anemia management, hemodilution, cell salvage, hemostatic treatment, and other approaches to reducing bleeding and minimizing blood transfusion. PBM in cardiovascular surgery is a "team sport" that involves cardiac and vascular surgeons, anesthesiologists, perfusionist, intensivists, and other health care providers. The current work provides an overview of evidence and practice of PBM at Fuwai Hospital. Implementation of PBM should also take local resource availability and cost-effectiveness of different devices, drugs, technologies, and techniques into consideration.
Humans
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Blood Transfusion/methods*
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Anemia/therapy*
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Hemorrhage
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Hospitals
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Blood Loss, Surgical
7.Construction and strategies of disease prevention and control system in the new era in Shanghai
Chun-feng WU ; Ping ZU ; Yong CHEN ; Fei-long HE ; Ye LU ; Jian CHEN ; Xiao-yan HUANG ; Chen FU
Shanghai Journal of Preventive Medicine 2021;33(2):97-
After the epidemic of novel Coronavirus Disease 2019(COVID-19), construction of disease prevention and control has become a top priority. As a pioneer in the recovery of global economy and society, Shanghai should play a fundamental role in building a comprehensive system of public health and advanced disease prevention and control in the new era. In this article, we systematically categorize the requirements for the construction of disease prevention and control system in the new era, identify the weakness and challenges during and after the epidemic, and then make suggestions. It is proposed that we should utilize the important window period of the"14th Five-Year Plan", with the"Healthy China"strategy and municipal"20 Tasks for Public Health Construction"as the starting point, to make substantial contribution to the functional orientation, investment of resources, capacity building, operational mechanism and team building, which may provide scientific evidence for the reform and development of disease prevention and control system.
8. Effect of Different Administration Methods with Bleomycin on Pulmonary Fibrosis in Rats
He WANG ; Guang-ping ZHANG ; Hong-ping HOU ; Yun-hang GAO ; Shuang-rong GAO ; Meng MA ; Hai-jing ZHANG ; Zhong-xiu ZHANG ; Teng-fei CHEN ; Ping SU ; Ling SONG ; Yi-fei YANG ; Jiang LI ; Zu-guang YE
Chinese Journal of Experimental Traditional Medical Formulae 2019;25(11):73-79
Objective:Compare the effects of 3 administration methods (tracheal perfusion, tail vein injection and aerosol inhalation) with bleomycin (BLM) in inducing pulmonary fibrosis in rats, in order to find out the optimal administration methods. Method:Eighty sprague-dawley (SD) male rats with SPF were randomly divided into aerosol inhalation blank group, single tracheal perfusion group(10 mg·kg-1), multiple tracheal perfusion group(5 mg·kg-1), single intravenous injection group(150 mg·kg-1), multiple intravenous injection group(50 mg·kg-1), single aerosol inhalation group (30 min)and multiple aerosol inhalation group(30 min). The mortality and body weight of rats in each group were observed at 7 d, 14 d and 28 d after the administration. And 28 days later after the administration, the lung coefficients of rats in each group were observed, paraffin sections were prepared, hematoxylin-eosin staining (HE) and Masson staining were performed, and the contents of hydroxyproline (HYP) and plasminogen activator inhibitor-1 (PAI-1) in lung tissues were detected by enzyme-linked immunosorbent assay (ELISA), so as to evaluate the alveoli inflammation and pulmonary fibrosis of rats in each group. Result:Compared with the aerosol inhalation blank group, the rats in the trachea perfusion group had the highest mortality among the drug treatment groups. The pulmonary coefficients of rats in the multiple intravenous injection group and the multiple inhalation group were significantly higher than those in the blank group(P<0.05,P<0.01). The multiple inhalation group was higher than the other model group and the single atomization model group. The results of HE and Masson staining showed thickening of pulmonary septum and higher degree of pulmonary interstitial fibrosis in tracheal perfusion group, intravenous injection group and multiple inhalation group. The degree of pulmonary fibrosis in the multiple inhalation group was more obvious than that in other groups. The results of ELISA showed that the levels of HYP and PAI-1 in lung tissues of rats in aerosol inhalation group and tracheal perfusion group were significantly higher than those in control group(P<0.05). The multiple inhalation group and the single atomization inhalation group were significantly higher than other modules. Conclusion:Bleomycin was inhaled repeatedly to establish pulmonary fibrosis model. The pathological injury and physiological indexes of the model rats were relatively stable, which conforms with the evolution process of pulmonary fibrosis.
9.Quality Control of Realgar in Compound Huanglian Ointment
Zu-Ping ZENG ; Yu LI ; Zheng TAN ; Xu-Yang HAN ; Bing PENG ; Hong WANG ; Wei HE
Chinese Journal of Information on Traditional Chinese Medicine 2018;25(3):68-71
Objective To control the quality of realgar in compound Huanglian Ointment.Methods As2O3which is the toxic component of realgar was carried limit test by Gutzeit's test; Potassium sulfate, ammonium sulfate and sulfuric acid were used to digest, and then titration method was used to determine the content of As2S2in compound Huanglian Ointment. Results The content of the soluble As in compound Huanglian Ointment was no higher than 15.6 μg/g. The content of As2S2in compound Huanglian Ointment was no less than 2.21 mg/g. Conclusion The method is simple and easy,which can be applied as the quantity control method of compound Huanglian Ointment.
10.Isolation, culture, and identification of human spermatogonial stem cells.
Jun-long WANG ; Shi YANG ; Ru-hui TIAN ; Zi-jue ZHU ; Ying GUO ; Qing-qing YUAN ; Zu-ping HE ; Zheng LI
National Journal of Andrology 2015;21(3):208-213
OBJECTIVETo isolate, identify and culture human spermatogonial stem cells (SSC) and then obtain purified and enriched human SSCs for research and application.
METHODSWe detected the expression of CD90 in the human testis using the immunofluorescence technique and isolated human testicular spermatogenic cells by two-step enzymatic digestion, followed by differential plating and magnetic-activated cell sorting (MACS) with CD90 as an SSC marker. Then we identified the isolated CD90-positive spermatogenic cells by RT-PCR and immunocytochemistry, and meanwhile cocultured them with Sertoli cells in SG medium in vitro.
RESULTSThe isolated CD90-positive cells showed a relatively homogeneous characteristic in size and morphology and expressed the genes specific for human SSCs, with high expressions (90.5%) of GFRA1, GPR125, and UCHL1. After coculture with Sertoli cells in the SG medium for 2 weeks, the isolated CD90-positive cells maintained a good activity.
CONCLUSIONCD90 can be regarded as a speci- fic marker for human SSCs and used to obtain highly enriched human SSCs by differential plating and MACS. Furthermore, the isolated human SSCs can be cultured in SG medium in vitro.
Adult Stem Cells ; cytology ; Biomarkers ; metabolism ; Cell Separation ; methods ; Cell Shape ; Cell Size ; Coculture Techniques ; Glial Cell Line-Derived Neurotrophic Factor Receptors ; metabolism ; Humans ; Immunohistochemistry ; Male ; Receptors, G-Protein-Coupled ; metabolism ; Sertoli Cells ; Spermatogonia ; cytology ; Testis ; metabolism ; Thy-1 Antigens ; isolation & purification ; metabolism ; Ubiquitin Thiolesterase ; metabolism

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