1.Establishment and application of evaluation criteria for rational use of pyrotinib
Yiyi LIAO ; Xin LI ; Yaowen XIA ; Hongmei ZHAO ; Qingqing CHEN
China Pharmacy 2025;36(6):742-747
OBJECTIVE To establish drug utilization evaluation (DUE) criteria for pyrotinib to promote its appropriate application in clinical practice. METHODS Based on the label of Pyrotinib maleate tablets, with relevant guiding principles and diagnostic and treatment guidelines as the evaluation basis, DUE criteria for pyrotinib were determined through the Delphi method. Attribute hierarchical model (AHM) and entropy weight method (EWM) were used to combine and assign weights to each indicator within the DUE criteria. Additionally, the weighted technique for order preference by similarity to an ideal solution (TOPSIS) method was applied to perform rationality evaluation of medication in archived medical records from Hainan Provincial Tumor Hospital and Hainan Western Central Hospital regarding the use of pyrotinib from November 2019 to November 2023. RESULTS The established DUE criteria for pyrotinib included 4 primary indicators (prescription authority, indications for use, medication process, and medication outcomes) and 11 secondary indicators. The secondary indicators with higher weights were the route of administration and dosage (0.257) and indications in the label (0.241). Among the 88 archived cases included, there were 28 cases of inappropriate medication (31.82%), 43 cases of generally appropriate medication (48.86%), and 17 cases of appropriate medication (19.32%). The main issues related to inappropriate medication involved off-label use (42.05%) and inappropriate routes of administration and dosage (43.18%). CONCLUSIONS DUE criteria for pyrotinib established using the AHM-EWM-weighted TOPSIS method is highly operational and results in quantifiable evaluation outcomes. The overall rationality of the use of pyrotinib in the above hospitals remains to be improved, and there are some issues, like the off-label use,and inappropriate routes of administration and dosage being liaoyylyy@163.com unreasonable.
2.Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
Xiaohua TANG ; Qingqing JIANG ; Haiwei ZHANG ; Weiran MAO ; Yuanyuan YIN ; Jiangdong SUI ; Jun LI ; Xia CHEN
China Pharmacy 2025;36(20):2489-2494
OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution, providing a basis for optimizing the training system for committee members, improving the quality of ethical review, and fully safeguarding the safety and rights of subjects. METHODS Using methods such as literature research and expert consultation, a preliminary core competency evaluation index system was constructed. The Delphi method was employed to revise and validate it, ultimately forming an evaluation index system for the core competencies of ethics committee members. Based on this system, a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide, comparing their importance rating and self-assessment scores of the core competency indexes. RESULTS The evaluation system constructed included 4 primary indicators (ethics and professional knowledge, ethics review ability, communication and expression ability, moral integrity and work style) and 39 secondary indicators (familiarity with the content of clinical trial-related laws and regulations, ability to complete project ethics review and identify ethical defects in research protocols within a short period of time, ability to judge the scientific value of clinical research, etc.). The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge, ethical norms, review efficiency, risk judgment, and problem analysis. The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38. CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members. It can provide a scientific framework for committee member training, qualification certification, and standardized management of ethics committees.
3.Research progress in hypoxia-induced endothelial-to-mesenchymal transition induced pulmonary vascular remodeling and drug interventions
Hongmai WANG ; Qingqing XIA ; Xiangyun GAI ; Jinyu WANG ; Yuefu ZHAO
Chinese Journal of Pharmacology and Toxicology 2024;38(3):232-240
Pulmonary hypertension(PH)is the pulmonary vascular remodeling caused by endothe-lial dysfunction and other factors,which leads to the increase of pulmonary artery pressure and finally right heart failure and patient death.Medications can significantly improve the symptoms of patients with pulmonary hypertension,but drugs can't cure vascular remodeling and right heart failure once for all,so it is urgent to find new treatments.Endothelial cells can obtain mesenchymal phenotypes after hypoxia stimulation,that is,endothelial-to-mesenchymal transition(EndMT).Increasing studies have shown that EndMT plays an important role in pulmonary vascular remodeling of PH.In this review,three signaling pathways related to induction of endothelial-to-mesenchymal transition under hypoxic conditions and research progress in related drugs are elaborated:① Transforming growth factor-β/bone morphogenetic protein(TGF-β/BMP)signaling pathway.The TGF-β/BMP pathway is mediated by Smad,and hypoxia regulates the expressions of EndMT-related genes by inhibiting or inducing the phosphorylation level of Smad in the downstream medium.② Notch signaling pathway.Hypoxia can enhance Jagged/Notch signaling pathway and promote the EndMT process.③Wnt/β-catenin signaling pathway.Hypoxia increases the expression of β-catenin,activates the Wnt signaling pathway,and regulates the expressions of EndMT regulatory genes.The significance of hypoxia-induced EndMT as an impor-tant pathogenic factor in PH is clarified in order to provide new ideas for the improvement of pulmonary vascular remodeling and recommend new effective strategies for the prevention and treatment of PH.
4.Visual Analysis on Research Hotspots and Trends of Wuzhuyu Decoction
Qingqing XIA ; Ouying CHEN ; Yong ZENG ; Jinxing WANG ; Yanhong KANG ; Fang FANG ; Yan CHEN ; Dongya LI ; Haili ZHU
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(2):84-89
Objective To understand the research status,hotspots and trends of Wuzhuyu Decoction;To provide reference for relevant research.Methods The literature related to Wuzhuyu Decoction was retrieved from CNKI,VIP,Wanfang Data and CBM databases from the establishment to February 28,2023.NoteExpress 3.6 was used to merge and deduplicate,and the author,organization and keywords were mapped and interpreted by CiteSpace 6.1.R6 software.Results A total of 822 articles were included,and the number of publications showed a wave upward trend;the top journals were New Chinese Medicine,Henan Traditional Chinese Medicine and Sichuan Traditional Chinese Medicine;the main research institutions were Beijing University of Chinese Medicine,China Academy of Chinese Medical Sciences and Shandong University of Traditional Chinese Medicine;a total of 566 authors were involved,and the authors with more publications included Wang Zhimin(12),Gong Muxin(9)and Bi Kaishun(5);high-frequency keywords included"headache","Shang Han Lun","TCM therapy"and so on.Conclusion Wuzhuyu Decoction is effective in treating chronic gastritis,hypertension and other primary diseases,which is a research hotspot in this field.It is a research trend in this field to explore its active components by high performance liquid chromatography and explain its action mechanism and target at the molecular level.
5.Visualization Analysis on Research Hotspots and Trends of Animal Medicinal Materials from 2000 to 2003
Qingqing XIA ; Ouying CHEN ; Yong ZENG ; Jinxing WANG ; Yanhong KANG ; Fang FANG ; Yan CHEN ; Dongya LI ; Haili ZHU
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(4):72-78
Objective To understand the research status,hotspots and trends of animal medicinal materials;To provide reference for future research.Methods The literature related to animal medicinal materials was retrieved from CNKI,VIP,Wanfang Data and CBM from January 1,2000 to April 30,2023.NoteExpress 3.6 was used to merge and deduplicate,and the author,institution and keywords were mapped and interpreted by CiteSpace 6.1.R6 software.Results A total of 1 169 articles were included,and the overall publication quantity in this field showed a stable fluctuation trend;the top journals were Lishizhen Medicine and Materia Medica Research,China Journal of Chinese Materia Medica and Modern Chinese Medicine;the main research institutions were China Academy of Chinese Medical Sciences,Changchun University of Chinese Medicine and Chinese Academy of Medical Sciences;a total of 676 authors were involved,and the authors with more publications included Zhang Hui(22),Liu Rui(15),Lin Zhe and Ma Shuangcheng(14);high-frequency keywords included"identification","TCM resources","clinical application"and so on.Conclusion Resource survey of animal medicinal materials,standardized breeding of medicinal animals,development of alternatives to rare medicinal animal resources,and construction of quality standard system for animal medicinal materials are the research hotspots in this field.The basic research of pharmacodynamic substances of animal medicinal materials based on the integrated analysis strategies of proteomics,peptideomics and transcriptomics,and the revelation of the signaling pathways and targets of animal medicinal materials from the molecular biology level are the research trends in this field.
6.Related factors of psychotic symptoms in adolescent patients with depressive disorder
Mingru HAO ; Lewei LIU ; Xin ZHAO ; Qingqing SHEN ; Haojie FAN ; Lei XIA ; Feng GENG ; Daming MO ; Huanzhong LIU
Sichuan Mental Health 2024;37(6):507-514
BackgroundPatients demonstrating depressive disorder with psychotic symptoms often have increased risk of death and poor prognosis. A large amount of research has explored the factors influencing psychotic symptoms in adult patients with depressive disorder, but few has focused on adolescent patients. ObjectiveTo explore the influencing factors of psychotic symptoms in adolescent patients with depressive disorder, so as to provide references for early screening and intervention in clinic. MethodsA total of 96 adolescent patients who met the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) for depressive disorder and were seen in the psychiatry departments of Chaohu Hospital of Anhui Medical University and The Fourth People's Hospital of Hefei from September 2022 to January 2023 were included. Another 56 healthy individuals from the health examination center of Chaohu Hospital of Anhui Medical University were concurrently recruited as control group. Patients were assigned into psychotic group (n=32) and non-psychotic group (n=64) according to the presence or absence of psychotic symptoms. Hamilton Depression Scale-24 item (HAMD-24), Positive and Negative Syndrome Scale (PANSS), Positive and Negative Suicide Ideation (PANSI) and Childhood Trauma Questionnaire-Short Form (CTQ-SF) were used for evaluation. Plasma brain-derived neurotrophic factor (BDNF) concentration was obtained using Meso Scale Discovery electrochemiluminescence assay. Pearson and Spearman correlation analysis were adopted to determine the correlation of PANSS positive symptom subscale score with plasma BDNF concentration and clinical characteristics of adolescent depression patients with psychotic symptoms. Binary Logistic regression analysis was used to identify the factors influencing the presence of psychotic symptoms in adolescent patients with depressive disorder, and multiple linear regression analysis was utilized to screen the factors affecting the severity of psychotic symptoms. ResultsThe plasma BDNF concentration of adolescent patients with depressive disorder was lower than that of control group (t=-3.080, P<0.01).The plasma BDNF concentration of psychotic group was lower than that of non-psychotic group (t=2.418, P<0.05), while the body mass index (BMI) PANSI scores, CTQ-SF scores and HAMD-24 total scores were all higher than those of non-psychotic group (t=-2.024, -2.530, -2.187, -4.977, P<0.05 or 0.01). Correlation analysis showed that PANSS positive symptom subscale scores were negatively correlated with anxiety/somatization factor score and weight factor score in HAMD-24 of psychotic group (r=-0.438, -0.498, P<0.05 or 0.01). Binary Logistic regression showed that BMI, plasma BDNF concentration, HAMD-24 total scores and cognitive dysfunction factor score were the influencing factors of psychotic symptoms in adolescent patients with depressive disorder. Multiple linear regression analysis demonstrated that weight factor scores (β=-0.349, P<0.05) and anxiety/somatization factor score (β=-0.433, P<0.05) in HAMD-24 were the factors influencing the severity of psychotic symptoms. ConclusionHigh BMI, low plasma BDNF concentration, severe depressive symptoms and cognitive dysfunction may be the risk factors of psychotic symptoms in adolescent patients with depressive disorder, furthermore, BMI and anxiety symptoms are found to be associated with the severity of psychotic symptoms. [Funded by Scientific Research Fund Project of Anhui Institute of Translational Medicine (number, 2022zhyx-B01); Central Finance Supported Provincial Key Clinical Specialty Construction Project of Anhui Province in 2019]
7.Co-word cluster analysis of research hotspots on hospice care education for nursing staff at home and abroad
Qingqing XIA ; Yanhong KANG ; Fang FANG ; Xiumei LIU ; Shiyi LIAO ; Ouying CHEN
Chinese Journal of Practical Nursing 2024;40(28):2227-2234
Objective:To understand the current status, hotspots and trends of hospice care education for nursing staff at home and abroad, so as to provide the reference for follow-up research.Methods:Literatures related to hospice care education for nursing staff were retrieved from China National Knowledge Infrastructure and Web of Science database from January 1, 2000 to October 8, 2023. EndNote21 was used for bibliometric analysis. CiteSpace6.2.R2 software was used to draw and interpret the knowledge map of keywords.Results:A total of 445 and 3 637 articles were included in China National Knowledge Infrastructure and Web of Science database. The number of publications was on the rise. A total of 11 clusters and 12 emerging keywords were obtained from China National Knowledge Infrastructure database. A total of 11 clusters and 25 emerging keywords were obtained from Web of Science database.Conclusions:The construction of standardized and homogeneous curriculum system and feedback evaluation system of hospice care education has been a research hotspot at home and abroad in recent years. For nurses with multi-level education, the use of multidisciplinary, multi-center, in-depth intervention research and evidence-based research to explore the hospice care education model in line with China′s national conditions is the development trend in the future.
8.Visualization analysis on research literature about Tianma Gouteng Decoction based on CiteSpace
Fang FANG ; Jinxing WANG ; Yanhong KANG ; Qingqing XIA ; Ouying CHEN ; Yong ZENG
International Journal of Traditional Chinese Medicine 2024;46(7):913-919
Objective:To analyze the development status, research hotspots and development trend of Tianma Gouteng Decoction.Methods:Research literature on Tianma Gouteng Decoction in the medical field from January 1, 2002 to December 31, 2022 was retrieved from CNKI, WanFang, VIP, and SinoMed. The NoteExpress 3.7.0 software was used to merge and remove the duplicates. CiteSpace 6.1.R6 software was used to visually analyze the information such as the publication trend, authors, institutions and keywords of the included literature, and to display the cooperation network of authors and institutions, as well as the co-occurrence, clustering and burst map of keywords.Results:Totally 2 137 articles were finally included, with an overall increasing trend of annual publication. The distribution of journals was mainly in TCM, among which the Journal of Practical Traditional Chinese Internal Medicine had the most publications. Xian Shaoxiang (First Affiliated Hospital of Guangzhou University of Chinese Medicine) was the author with the most publications (17 articles). The institution with the most publications was Tianjin University of Traditional Chinese Medicine (23 articles), and the cooperation between research institutions was mainly in Chinese medicine colleges and their affiliated hospitals. The results of keyword analysis showed that the high-frequency keywords were hypertension, vertigo, hyperactivity of liver yang, clinical efficacy, migraine, etc. The keywords formed 10 clusters. The keywords with a long time span were syndrome differentiation and treatment, hypertension, experience of famous doctors, and clinical observation. In recent years, the emergent keywords were adverse reactions, blood pressure levels, vertigo, addition and subtraction treatment, and medication laws. Conclusions:The current research field of Tianma Gouteng Decoction is in a rising stage of development, and it is still necessary to strengthen academic exchanges and cooperation across regions and teams. Relevant research mainly focuses on the clinical application of cardiovascular and cerebrovascular diseases. The commonly used treatment is comprehensive therapy of TCM, focusing on blood pressure changes, adverse reactions and so on. The application of Tianma Gouteng Decoction in the treatment of vertigo, the study of adverse drug reactions and the discussion of medication rules have gradually become research hotspots.
9.Visualization Analysis on Research Literature about Prunellae Spica from 2002 to 2023
Fang FANG ; Jinxing WANG ; Yanhong KANG ; Qingqing XIA ; Ouying CHEN ; Yong ZENG
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(7):57-62
Objective To understand the current status and development trend of the research on Prunellae Spica;To provide reference for the subsequent research.Methods The research literature related to Prunellae Spica was searched in China Knowledge Resources Database(CNKI),Chinese Science and Technology Journal Database(VIP),Chinese Academic Journal Database(Wanfang Data),and Chinese Biomedical Literature Database(CBM)from January 1,2002 to March 23,2023.After merging and removing duplicates using NoteExpress 3.7.0.9258 software,CiteSpace 6.2.R1 software was used to visualize and analyze authors,institutions and keywords.Results Totally 3 136 articles were included,and the annual number of publications showed a fluctuating upward trend.Shaanxi Journal of Traditional Chinese Medicine had the most publications(93).The core authors included Lin Limei(34),Guo Qiaosheng(27),and Zhang Mingzhi(20),and core research institutions included Shandong University of Traditional Chinese Medicine(37),Tianjin University of Traditional Chinese Medicine(30),and Nanjing University of Chinese Medicine(28),with less cooperation among authors and institutions.The analysis of keywords showed that the research on the treatment of diseases were mainly"hypertension","breast cancer","hyperplasia of mammary glands","vertigo","insomnia".The chemical composition studies were mainly on"rosmarinic acid"and"ursolic acid".The type of literature was mainly"experience of famous doctors"and"clinical observation".Conclusion The research field of Prunellae Spica is in the rising stage of development,and the research content mainly focuses on clinical application and chemical composition research,etc.Summarizing the law of medication,exploring its mechanism of action and action target through data mining and molecular docking technology are the research trends.
10.Visualization Analysis on Research Literature about Scrophulariae Radix from 2000 to 2023
Fang FANG ; Jinxing WANG ; Yanhong KANG ; Qingqing XIA ; Ouying CHEN ; Yong ZENG
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(8):64-69
Objective To understand the research hotspots and trend of Scrophulariae Radix from 2000 to 2023;To provide reference for related research.Methods The relevant literature of Scrophulariae Radix were retrieved from CNKI,VIP,Wanfang Data and CBM from January 1,2000 to June 1,2023.NoteExpress 3.7.0.9296 software was used to manage files and weight,and CiteSpace 6.2.R4 software was used for visualization analysis of authors,institutions and keywords.Results A total of 2 240 articles were included,and the annual number of publications showed a dynamic upward trend.The source journals with more publications included Shaanxi Journal of Traditional Chinese Medicine,Journal of Traditional Chinese Medicine,Shizhen Journal of Traditional Chinese Medicine Research and so on.The core authors were Zhang Ning,Liu Shumin,Liu Bin,etc;the main research institutions included Beijing University of Chinese Medicine,Nanjing University of Chinese Medicine,Guangzhou University of Chinese Medicine,etc.;high-frequency keywords were"harpagoside","quality standard","clinical observation"and so on.Conclusion The research of Scrophulariae Radix mainly focuses on chemical composition,disease treatment and compatibility application.It is a research trend in recent years to explore the medication law and mechanism of Scrophulariae Radix by using data mining,network pharmacology and molecular docking.

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