1.Construction of a Competency Evaluation Model for Forensic Practitioners
Jing-Chun BAO ; Jing-Jing ZHAO ; Jiao-Yong LI ; Jing-Hua MENG ; Xiao-Long WANG ; Xiao-Ni ZHAN ; Jun YAO ; Xu WU
Journal of Forensic Medicine 2025;41(4):371-379
Objective To construct a competency evaluation model for forensic practitioners,providing a reference for their training and assessment.Methods Based on the iceberg and onion models of com-petency,and with reference to Spencer's Competency Dictionary,literature research was conducted and focus group interviews were employed to preliminarily construct core indices and measurement items for evaluating the competency of forensic practitioners.The Delphi method was applied for two rounds of expert consultation to further refine the competency evaluation index system.The analytic hierarchy process(AHP)was used to calculate the weights of the indices.Results A competency evaluation model for forensic practitioners was constructed,consisting of 7 core indices,encompassing forensic skills,identification service capabilities,and the ability to apply relevant legal knowledge and 49 mea-surement items.The weights of the core indices and measurement items were determined.Conclusion The constructed competency evaluation model for forensic practitioners is scientifically sound and inno-vative,and has unique characteristics of forensic medicine compared with other medical models.
2.Effects of porcine acellular dermal matrix combined with human epidermal stem cells on wound healing of full-thickness skin defect in nude mice.
Xiao Hong ZHAO ; Yu Cheng GUO ; Hong Hao CHEN ; Xue LI ; Ying WANG ; Wen Qiang NI ; Meng Qiu XING ; Rui ZHANG ; Shi Cang YU ; Yin Gen PAN ; Ri Xing ZHAN ; Gao Xing LUO
Chinese Journal of Burns 2022;38(1):45-56
Objective: To explore the effects of porcine acellular dermal matrix (ADM) combined with human epidermal stem cells (ESCs) on wound healing of full-thickness skin defect in nude mice. Methods: The morphology of porcine ADM was analyzed by photograph of digital camera, the cell residues in porcine ADM were observed by hematoxylin-eosin (HE) staining, the surface structure of porcine ADM was observed by scanning electron microscope, the secondary structure of porcine ADM was analyzed by infrared spectrometer, the porcine ADM particle size was analyzed by dynamic light scattering particle size analyzer, and the porcine ADM potential was analyzed by nano-particle size potentiometer. The morphology of porcine ADM was observed by inverted fluorescence microscope when it was placed in culture medium for 30 min, 1 d, and 5 d (n=2). The porcine ADM was divided into 5 min group, 10 min group, 20 min group, 30 min group, 60 min group, and 120 min group according to the random number table (the same grouping method below) in static state at normal temperature for the corresponding time to calculate the water absorption by weighing method (n=3). Swiss white mouse embryonic fibroblasts (Fbs) were divided into blank control group (culture medium only), and 50.0 g/L ADM extract group, 37.5 g/L ADM extract group, 25.0 g/L ADM extract group, 12.5 g/L ADM extract group, and 6.5 g/L ADM extract group which were added with the corresponding final concentrations of ADM extract respectively. At post culture hour (PCH) 24, 48, and 72, the cell survival rate was detected by cell counting kit 8 and the cytotoxicity was graded (n=5). The erythrocytes of a 6-week-old male Sprague-Dawley male rat were divided into normal saline group, ultra-pure water group, and 5 mg/mL ADM extract group, 10 mg/mL ADM extract group, and 15 mg/mL ADM extract group which were treated with the corresponding final concentrations of porcine ADM extract respectively. After reaction for 3 h, the absorbance value of hemoglobin was detected by microplate reader to represent the blood compatibility of porcine ADM (n=3). ESCs were isolated and cultured from the discarded prepuce of a 6-year-old healthy boy who was treated in the Department of Urology of the First Affiliated Hospital of Army Medical University (the Third Military Medical University) in July 2020, and then identified by flow cytometry. The porcine ADM particles of composite ESC (hereinafter referred to as ESC/ADM) were constructed by mixed culture. After 3 days of culture, the composite effect of ESC/ADM was observed by HE staining and laser scanning confocal microscope. Thirty-six 7-8-week-old male non-thymic nude mice were divided into phosphate buffer solution (PBS) alone group, ADM alone group, ESC alone group, and ESC/ADM group, with 9 mice in each group, and the wound model of full-thickness skin defect was established. Immediately after injury, the wounds were treated with the corresponding reagents at one time. On post injury day (PID) 1, 7, 11, and 15, the wound healing was observed and the wound healing rate was counted (n=3). On PID 7, the epithelialization of wounds was observed by HE staining and the length of un-epithelialized wound was measured (with this and the following sample numbers of 4). On PID 11, the dermal area and collagen deposition of wounds were observed by Masson staining and the dermal area of wound section was calculated, the number of cells expressing CD49f, a specific marker of ESC, was calculated with immunofluorescence staining, the mRNA expression of glyceraldehyde-3-phosphate dehydrogenase (GAPDH) in ESC after wound transplantation was detected by real-time fluorescence quantitative reverse transcription polymerase chain reaction. Data were statistically analyzed with independent sample t test, one-way analysis of variance, analysis of variance for repeated measurement, and least significant difference t test. Results: The porcine ADM was white particles and composed of reticular structure, with no cells inside, disordered structure, and rough surface. The absorption peak of porcine ADM appeared at the wave numbers of 1 659, 1 549, and 1 239 cm-1, respectively. The main particle size distribution of porcine ADM in solution was 500 to 700 nm, with negative charge on the surface. The morphology of porcine ADM in static state at 30 min and on 1 and 5 d was relatively stable. The water absorption of porcine ADM remained relatively high level in static state from 30 min to 120 min. The cytotoxicity of mouse embryonic Fbs in 6.5 g/L ADM extract group, 12.5 g/L ADM extract group, and 25.0 g/L ADM extract group was grade 1 at PCH 24, and the cytotoxicity of the other groups was 0 grade at each time point. After reaction for 3 h, the absorbance value of hemoglobin of erythrocytes in ultra-pure water group was significantly higher than the values in normal saline group and 15 mg/mL ADM extract group (with t values of 8.14 and 7.96, respectively, P<0.01). After 3 days of culture, the cells of the fourth passage showed pebble-like morphology, with low expression of CD71 and high expression of CD49f, which were identified as ESCs. There was ESC attachment and growth on porcine ADM particles. On PID 1, the wound sizes of nude mice were almost the same in PBS alone group, ADM alone group, ESC alone group, and ESC/ADM group. On PID 7, 11, and 15, the wound contraction of nude mice in each group was observed, especially in ADM alone group, ESC alone group, and ESC/ADM group. On PID 7, the wound healing rates of nude mice in ESC alone group and ESC/ADM group were significantly higher than the rate in PBS alone group (with t values of 2.83 and 4.72 respectively, P<0.05 or P<0.01). On PID 11, the wound healing rate of nude mice in ESC/ADM group was significantly higher than that in PBS alone group (t=4.86, P<0.01). On PID 15, the wound healing rates of nude mice in ADM alone group, ESC alone group, and ESC/ADM group were significantly higher than the rate in PBS alone group (with t values of 2.71, 2.90, and 3.23 respectively, P<0.05). On PID 7, the length of un-epithelialized wound of nude mice in ADM alone group, ESC alone group, and ESC/ADM group was (816±85), (635±66), and (163±32) μm, respectively, which were significantly shorter than (1 199±43) μm in PBS alone group (with t values of 5.69, 10.19, and 27.54 respectively, P<0.01). On PID 11, the dermal areas of wound section of nude mice in ADM alone group, ESC alone group, and ESC/ADM group were significantly larger than the area in PBS alone group (with t values of 27.14, 5.29, and 15.90 respectively, P<0.01); the collagen production of nude mice in ADM alone group and ESC/ADM group was more obvious than that in PBS alone group, and the collagen production of nude mice in ESC alone group and PBS alone group was similar. On PID 11, in the wounds of nude mice in ESC alone group and ESC/ADM group, the cells with positive expression of CD49f were respectively 135±7 and 185±15, and the mRNA expressions of GAPDH were positive; while there were no expressions of CD49f nor mRNA of GAPDH in the wounds of nude mice in PBS alone group and ADM alone group. Conclusions: ESC/ADM particles can promote the wound healing of full-thickness skin defects in nude mice, which may be related to the improved survival rate of ESCs after transplantation and the promotion of dermal structure rearrangement and angiogenesis by ADM.
Acellular Dermis
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Animals
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Fibroblasts
;
Humans
;
Male
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Mice
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Mice, Nude
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Rats
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Rats, Sprague-Dawley
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Stem Cells
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Swine
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Wound Healing
3.Clinical features and risk factors associated with severe COVID-19 patients in China.
Ning JIANG ; Yan-Nan LIU ; Jing BAO ; Ran LI ; Wen-Tao NI ; Xing-Yu TAN ; Yu XU ; Li-Ping PENG ; Xiao-Rong WANG ; Yi-Ming ZENG ; Dai-Shun LIU ; Qing XUE ; Jia-Shu LI ; Ke HU ; Ya-Li ZHENG ; Zhan-Cheng GAO
Chinese Medical Journal 2021;134(8):944-953
BACKGROUND:
Coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has rapidly spread throughout the world. In this study, we aimed to identify the risk factors for severe COVID-19 to improve treatment guidelines.
METHODS:
A multicenter, cross-sectional study was conducted on 313 patients hospitalized with COVID-19. Patients were classified into two groups based on disease severity (nonsevere and severe) according to initial clinical presentation. Laboratory test results and epidemiological and clinical characteristics were analyzed using descriptive statistics. Univariate and multivariate logistic regression models were used to detect potential risk factors associated with severe COVID-19.
RESULTS:
A total of 289 patients (197 nonsevere and 92 severe cases) with a median age of 45.0 (33.0, 61.0) years were included in this study, and 53.3% (154/289) were male. Fever (192/286, 67.1%) and cough (170/289, 58.8%) were commonly observed, followed by sore throat (49/289, 17.0%). Multivariate logistic regression analysis suggested that patients who were aged ≥ 65 years (OR: 2.725, 95% confidence interval [CI]: 1.317-5.636; P = 0.007), were male (OR: 1.878, 95% CI: 1.002-3.520, P = 0.049), had comorbid diabetes (OR: 3.314, 95% CI: 1.126-9.758, P = 0.030), cough (OR: 3.427, 95% CI: 1.752-6.706, P < 0.001), and/or diarrhea (OR: 2.629, 95% CI: 1.109-6.231, P = 0.028) on admission had a higher risk of severe disease. Moreover, stratification analysis indicated that male patients with diabetes were more likely to have severe COVID-19 (71.4% vs. 28.6%, χ2 = 8.183, P = 0.004).
CONCLUSIONS
The clinical characteristics of those with severe and nonsevere COVID-19 were significantly different. The elderly, male patients with COVID-19, diabetes, and presenting with cough and/or diarrhea on admission may require close monitoring to prevent deterioration.
Adult
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COVID-19/pathology*
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China/epidemiology*
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Comorbidity
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Cough
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Cross-Sectional Studies
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Diarrhea
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Female
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Humans
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Male
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Middle Aged
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Retrospective Studies
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Risk Factors
4.Efficacy and safety of Shenyankangfu Tablet, a Chinese patent medicine, for primary glomerulonephritis: A multicenter randomized controlled trial.
Jie WU ; Shu-Wei DUAN ; Hong-Tao YANG ; Yue-Yi DENG ; Wei LI ; Ya-Ni HE ; Zhao-Hui NI ; Yong-Li ZHAN ; Shan LIN ; Zhi-Yong GUO ; Jun ZHU ; Jing-Ai FANG ; Xu-Sheng LIU ; Li-Hua WANG ; Rong WANG ; Nian-Song WANG ; Xiao-Hong CHENG ; Li-Qun HE ; Ping LUO ; Shi-Ren SUN ; Ji-Feng SUN ; Ai-Ping YIN ; Geng-Ru JIANG ; Hong-Yu CHEN ; Wen-Hu LIU ; Hong-Li LIN ; Meng LIANG ; Lu MA ; Ming CHEN ; Li-Qun SONG ; Jian CHEN ; Qing ZHU ; Chang-Ying XING ; Yun LI ; Ji-Ning GAO ; Rong-Shan LI ; Ying LI ; Hao ZHANG ; Ying LU ; Qiao-Ling ZHOU ; Jun-Zhou FU ; Qiang HE ; Guang-Yan CAI ; Xiang-Mei CHEN
Journal of Integrative Medicine 2021;19(2):111-119
BACKGROUND:
Shenyankangfu Tablet (SYKFT) is a Chinese patent medicine that has been used widely to decrease proteinuria and the progression of chronic kidney disease.
OBJECTIVE:
This trial compared the efficacy and safety of SYKFT, for the control of proteinuria in primary glomerulonephritis patients, against the standard drug, losartan potassium.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTION:
This was a multicenter, double-blind, randomized, controlled clinical trial. Primary glomerulonephritis patients, aged 18-70 years, with blood pressure ≤ 140/90 mmHg, estimated glomerular filtration rate (eGFR) ≥ 45 mL/min per 1.73 m
MAIN OUTCOME MEASURES:
The primary outcome was change in the 24-hour proteinuria level, after 48 weeks of treatment.
RESULTS:
A total of 735 participants were enrolled. The percent decline of urine protein quantification in the SYKFT group after 48 weeks was 8.78% ± 2.56% (P = 0.006) more than that in the losartan 50 mg group, which was 0.51% ± 2.54% (P = 1.000) less than that in the losartan 100 mg group. Compared with the losartan potassium 50 mg group, the SYKFT plus losartan potassium 50 mg group had a 13.39% ± 2.49% (P < 0.001) greater reduction in urine protein level. Compared with the losartan potassium 100 mg group, the SYKFT plus losartan potassium 100 mg group had a 9.77% ± 2.52% (P = 0.001) greater reduction in urine protein. With a superiority threshold of 15%, neither was statistically significant. eGFR, serum creatinine and serum albumin from the baseline did not change statistically significant. The average change in TCM syndrome score between the patients who took SYKFT (-3.00 [-6.00, -2.00]) and who did not take SYKFT (-2.00 [-5.00, 0]) was statistically significant (P = 0.003). No obvious adverse reactions were observed in any group.
CONCLUSION:
SYKFT decreased the proteinuria and improved the TCM syndrome scores of primary glomerulonephritis patients, with no change in the rate of decrease in the eGFR. SYKFT plus losartan potassium therapy decreased proteinuria more than losartan potassium therapy alone.
TRIAL REGISTRATION NUMBER
NCT02063100 on ClinicalTrials.gov.
5.Physical and neuropsychological development of children with Citrin deficiency.
Ni-Si ZHANG ; Zhan-Hui ZHANG ; Wei-Xia LIN ; Meng ZHANG ; Bing-Xiao LI
Chinese Journal of Contemporary Pediatrics 2021;23(12):1262-1266
OBJECTIVES:
To study the physical and neuropsychological development of children with Citrin deficiency (CD).
METHODS:
A total of 93 children, aged 1.9-59.8 months, who were diagnosed with CD by
RESULTS:
For the 93 children with CD, the incidence rate of failure to thrive was 25% (23 children) and the proportion of small for gestational age was 47% (44 children). For the 100 cases of CD, the incidence rates of growth retardation, underweight, emaciation, overweight, and microcephalus were 23% (23 cases), 14% (14 cases), 4% (4 cases), 8% (8 cases), and 9% (9 cases), respectively. The incidence rate of neuropsychological developmental delay was 25% (25 cases), and the incidence rates of development delay in the five domains of adaptability, gross motor, fine motor, language, and social ability were 7% (7 cases), 15% (15 cases), 7% (7 cases), 9% (9 cases), and 7% (7 cases), respectively.
CONCLUSIONS
Physical and neuropsychological developmental delay can be observed in children with CD, and physical and neuropsychological development should be regularly assessed.
Child
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Citrullinemia
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Humans
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Infant
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Mitochondrial Membrane Transport Proteins
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Retrospective Studies
6.Bioinformatic Analysis of Related Genes and Therapeutic Drugs of Asthma
Xiu-fang HUANG ; Gang LIAO ; Yun-ji GAO ; Shao-feng ZHAN ; Hui-ting HUANG ; Yan-ni LAI ; Xiao-hong LIU
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(2):155-163
Objective::Bioinformatic analysis was used to compare the gene expression profile between asthma patients and healthy people, and the gene characteristics of asthma were preliminarily identified and the potential mechanism and drugs were revealed. Method::The GSE74986 gene expression profile was downloaded from the gene expression omnibus (GEO) and the differentially expressed genes (DEGs) were analyzed by GEO2R. Then the gene heat map of DEGs was made by Morpheus, and their gene ontology (GO) and Kyoto encyclopedia of genes and genomes (KEGG) analysis were performed by DAVID 6.8. Moreover, the protein-protein interaction (PPI) network and hub genes were constructed by String 10.5. Finally, the significant modules were analyzed by MCODE in Cytoscape 3.6.1, small molecule drugs related to asthma were screened through Coremine Medical. Result::A total of 510 DEGs were screened, including 29 up-regulated genes and 481 down-regulated genes. DEGs were mainly involved in these biological processes and pathways, including chromatin silencing, transcriptional regulation of RNA polymerase Ⅱ promoter, protein transport, messenger RNA (mRNA) processing, RNA splicing, ubiquitin-mediated proteolysis, protein processing in the endoplasmic reticulum, RNA transport, and myeloid differentiation factor (MyD)-dependent Toll-like receptor signaling pathway, platelet activation, nucleotide binding oligomerization domain (NOD)-like receptor signaling pathway and so on. A total of 9 hub genes were obtained, including T-complex protein 1 subunit theta (CCT8), T-complex protein 1 subunit alpha (TCP1), 26S protease regulatory subunit S10B (PSMC6), heat shock protein 90 alpha (HSP90A)A1, cell cycle protein C (CCNC), HSP90AB1, 26S proteasome non-ATPase regulatory subunit 6 (PSMD6), ubiquitin-specific protease 14 (USP14) and eukaryotic translation initiation factor 4E (EIF4E). Two important modules were obtained. The genes in two modules mainly involved these biological process, such as splice, ubiquitin-mediated proteolysis, protein modification, RNA modification and so on. Some potential molecular drugs for the treatment of asthma, such as anisomycin and genistein, have been developed. Conclusion::DEGs and hub genes can contribute to understanding the molecular mechanism of asthma and providing potential therapeutic targets and drugs for the diagnosis and treatment of asthma.
7.Effects of Niaoduqing Particles () on Delaying Progression of Renal Dysfunction: A Post-trial, Open-Label, Follow-up Study.
Ying ZHENG ; Nian-Song WANG ; Yu-Ning LIU ; Li-Qun HE ; Gui-Hua JIAN ; Xu-Sheng LIU ; Zhao-Hui NI ; Xiao-Hong CHENG ; Hong-Li LIN ; Wen-Hua ZHOU ; Ya-Ping WANG ; Jing-Ai FANG ; Ya-Ni HE ; Hong-Tao YANG ; Li-Juan ZHAO ; Han-Lu DING ; Li-Hua WANG ; Ren-Huan YU ; Wen-Ge LI ; Zhi-Ming YE ; Wang GUO ; Yong-Li ZHAN ; Hui-Juan MAO ; Zhao HU ; Chen YAO ; Guang-Yan CAI ; Xiang-Mei CHEN
Chinese journal of integrative medicine 2019;25(3):168-174
OBJECTIVE:
To follow up the participants of the randomized clinical trial "Efficacy and Safety of Niaoduqing Particles () for Delaying Moderate-to-Severe Renal Dysfunction", and assess the long-term effects of Niaoduqing Particles on delaying the progression of renal dysfunction.
METHODS:
Participants, who had previously been randomly assigned to receive Niaoduqing Particles or placebo for 24 weeks (146 cases in each group), were invited to follow-up and all were administered Niaoduqing Particles 5 g thrice daily and 10 g before bedtime for 24 weeks. The primary endpoints were changes in baseline serum creatinine (Scr) and estimated glomerular filtration rate (eGFR) after completion of the open-label treatment period.
RESULTS:
After the double-blind period, the median (interquartile range) changes in Scr were 1.1 (-13.0-24.1) and 11.7 (-2.6-42.9) μmol/L for the Niaoduqing Particle and placebo groups, respectively (P=0.008), and the median changes in eGFRs were-0.2 (-4.3-2.7) and-2.21 (-5.7-0.8) mL•min•1.73 m, respectively (P=0.016). There were significant differences in the double-blind period changes in renal function between groups. After the open-label period, the median changes in Scr were 9.0 (-10.0-41.9) and 17.5 (-6.0-50.0) μmol/L for the Niaoduqing Particle and placebo groups according to baseline grouping, respectively (P=0.214), and the median changes in eGFRs were-2.3 (-6.4-1.9) and-3.7 (-7.5-1.1) mL•min•1.73 m, respectively (P=0.134). There were no statistical differences in the open-label period changes in renal function between groups. The eGFR reduction of participants who accepted Niaoduqing Particle treatment for 48 weeks was projected to 2.5 mL•min•1.73 m per year.
CONCLUSION
Niaoduqing Particles appear to have long-term efficacy for patients with moderate-to-severe renal dysfunction. Although there was no statistical difference, the early use of Niaoduqing Paticles seems to ameliorate the worsening of renal function. (Trial registration No. ChiCTR-TRC-12002448).
Adult
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Disease Progression
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Double-Blind Method
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Drugs, Chinese Herbal
;
therapeutic use
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Female
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Follow-Up Studies
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Glomerular Filtration Rate
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drug effects
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Humans
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Kidney Diseases
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drug therapy
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physiopathology
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Male
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Middle Aged
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Outcome Assessment (Health Care)
8. Analysis on Mechanism of Shema Zhichuan Liquid in Treating Asthma Based on Network Pharmacology
Xiu-fang HUANG ; Yun-ji GAO ; Gang LIAO ; Hui-ting HUANG ; Shao-feng ZHAN ; Yan-ni LAI ; Xiao-hong LIU
Chinese Journal of Experimental Traditional Medical Formulae 2019;25(23):187-195
Objective: To explore the potential mechanism of Shema Zhichuan liquid in treatment of asthma by network pharmacology. Method: Bioinformatics analysis tool for molecular mechanism of traditional Chinese medicine (TCM), systematic pharmacological database and analysis platform of TCM were employed to find the components in Shema Zhichuan liquid and their targets, and asthma-related genes were obtained from the comparative toxicogenomics database (CTD). The data set of Shema Zhichuan liquid-gene and asthma-gene were imported into the Draw Venn Diagram for intersection analysis. The obtained data set of Shema Zhichuan liquid-asthma-gene was imported into String 11.0 for protein-protein interaction (PPI) analysis, and was visualized by Cytoscape 3.6.1, and further important modules were analyzed with MCODE. DAVID 6.8 was used to analyze pathway enrichment and biological process of Shema Zhichuan liquid-asthma-gene. Result: A total of 399 components and 2 099 potential targets were obtained from Shema Zhichuan liquid, 98 asthma-related targets were retrieved, 45 common genes and 16 hub genes were screened, including transforming growth factor-β1(TGF-β1), heme oxygenase-1 (HMOX1), interleukin-4 (IL-4), etc. Enrichment analysis showed that the common biological processes of Shema Zhichuan liquid and asthma were related to inflammation, contraction and remodeling of airway, cell proliferation and apoptosis, etc. The common biological pathways mainly included tumor necrosis factor (TNF) signaling pathway, receptor with high affinity for immunoglobulin E (Fc epsilon RI) signaling pathway, nuclear transcription factor-kappa B (NF-κB) signaling pathway, nucleotide binding oligomerization domain (NOD)-like receptor signaling pathway and so on. Conclusion: Shema Zhichuan liquid serves as a multi-target, multi-pathway treatment for asthma, which can provide a reference for the further research and clinical application of this preparation.
9.Expert consensus statement on treatment of type 2 diabetes with Xiaoke Pills in clinical practice.
Yuan-Yuan LI ; Qing NI ; Yan-Ming XIE ; Jin-Xi ZHAO ; Xiao-Hui YANG ; Jun-Ping WEI ; Guang-de ZHANG ; Yan-Bin GAO ; Si-Yan ZHAN
China Journal of Chinese Materia Medica 2019;44(24):5291-5293
Xiaoke Pills are Chinese and Western medicine compound preparations with effects of nourishing kidney and Yin,and supplementing Qi and promoting fluid. It is widely used in clinical treatment of type 2 diabetes( Qi and Yin deficiency syndrome),and continuously included in 2010,2013 and 2017 editions of Chinese prevention guide for type 2 diabetes. For the purpose of accurate positioning and rational use in clinic,it is necessary to further define the curative effect,indications,medication precautions and contraindications of Xiaoke Pills,in order to improve medication safety. This consensus was reached by reference of international clinical guidelines and expert consensus approach based on clinical evidence-based evidence,expert experience and standard specification. The evidence-based evaluation was oriented to clinical problems summarized by no less than 200 front-line clinical physicians in two rounds.GRADE system was adopted for quality classification and evaluation of the evidences,and then the nominal group method was used to form consensus recommendations or suggestions. This consensus defined the curative effect advantages,target users,dosage,administration method,contraindications and precautions of Xiaoke Pills,and provided valuable reference for the clinical use of the drug. Thisconsensus still needs to be updated and revised based on new clinical problems and evidence-based evidence in practical application in the future.
Consensus
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Diabetes Mellitus, Type 2/drug therapy*
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Drugs, Chinese Herbal/therapeutic use*
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Humans
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Medicine, Chinese Traditional
;
Yin Deficiency
10.Simultaneous determination the concentration of risperidone, paliperidone,olanzapine and quetiapine in human serum by HPLC-MS/MS
Xiao-Jia NI ; Zhan-Zhang WANG ; Hao-Yang LU ; De-Wei SHANG ; Yu-Guan WEN
The Chinese Journal of Clinical Pharmacology 2018;34(1):53-56
Objective To develop a simultaneous determination method of risperidone,paliperidone,olanzapine and quetiapine in human serum for therapeutic drug monitoring.Methods Clinical serum samples were prepared by protein precipitation and analytes were determined using HPLC-MS/MS.An Eclipse XDB C1s column (4.6 mm ×50 mm,1.8μm) was combined with mobile phase consisted of methanol,water and acetrile (37.5:12.5:50,plus 2.5 mmol · L-1 ammonium formate).The flow rate was 0.5 mL · min-1 The column temperature was 35 ℃ and the injection volume was 2 μL.MS detection was carried out using an electrospray ionization source operated in multiple reaction monitoring (MRM) mode.The ion transitions were m/z 427.3 → m/z 207.2(paliperidone),m/z 431.3--m/z 211.2 (paliperidone-D4),m/z 411→m/z 191 (risperidone),m/z 415.4→m/z195.2 (risperidone-D4),m/z 384.3→m/z 253.1 (quetiapine),m/z 392.3→m/z 258 (quetiapine-D8),m/z313→m/z 256 (olanzapine),m/z 316→m/z 256 (olanzapine-D3),respectively.Results The calibration curves of risperidone and paliperidone were y =0.67x +4.94 × 10-4 (R2 =0.999 4) and y =0.68x +0.14 × 10-2 (R2 =0.999 6),with the linear ranges of 1-100 ng · mL-1.The linear ranges were 2-200 ng · mL-1(calibration curve:y =1.33x-0.65 × 10-2,R2 =0.998 6) for olanzapine and 8-800 ng· mL-1 (calibration curve:y =1.80x-2.08 × 10-2,R2 =0.999 4) for quetiapine.The inter and intra-batch precisions of risperidone,paliperidone,olanzapine and quetiapine were all within 15 % in lower limit of quantitation (LLOQ),low,middle and high levels of quality control samples.The extraction efficiency was more than 90% for four analytes.The concentration of analytes in quality control samples were less than ± 15 % bias compared with nominal concentration after storage at room temperature for 24 h,-70 ℃ for 34 d or after freeze-thaw for 3 cycles.Conclusion The validated method was simple,fast and sensitive for the simultaneous determination of risperidone,paliperidone,olanzapine and quetiapine in human serum.The method was applied to the therapeutic drug monitoring for patients administered with the above drugs.The stability of mixed quality control samples is reliable and can be used for therapeutic drug monitoring.

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