1.Research on the standardization of “Indications”in package inserts for Chinese patent medicines
Meiwei ZHANG ; Keqian LI ; Keyu YAO ; Yan ZHU
China Pharmacy 2025;36(5):513-518
OBJECTIVE To promote the standardization of the “Indications” section in package inserts for Chinese patent medicines and ensure rational clinical and patient use. METHODS The “Function and Indications” information of package inserts for Chinese patent medicines was retrieved and collected from the 2020 edition of the Chinese Pharmacopoeia (Volume Ⅰ) and various national and regional standards. Identification criteria were established for syndrome, pathogenesis, disease name, and symptom terminology in the “Indications” section. Microsoft Office Access 2021 was utilized to create query tables for manual extraction of terminological elements, followed by the construction of a three-tier classification system for “Indications” descriptions. A standardized template for “Indications” was developed through quantitative analysis. RESULTS & CONCLUSIONS A total of 9 851 valid package inserts for Chinese patent medicines were included. Among these, the majority (7 991) contained symptom terminology, followed by disease names (5 867) and pathogenesis descriptions (5 167). Within disease name terminology, Western medical disease names predominated (4 446), followed by traditional Chinese medicine disease names (2 018). The “Function and Indications” content of 6 962 package inserts complied with existing requirements. Notably, the secondary classifications of “disease name”, as well as the tertiary classification of “disease name+symptoms” and “symptoms”, failed to meet established standards. Two standardized templates for “Indications” were formulated based on pathogenesis and syndrome:“pathogenesis+disease name+symptoms” and “disease name+syndrome+symptoms”. The “Indications”section should provide complete and accurate information, adhere to standardized formatting, and employ appropriate conjunctions and punctuation. For non-prescription patent medicines, package inserts should be categorized into professional and patient versions. These measures will facilitate the standardization of “Indications” descriptions and advance the overall package inserts for Chinese patent medicines documentation.
2.A Comparative Study on the Organ Representation Characteristics of Three Mainstream Anatomical Ontologies
Lu FU ; Keyu YAO ; Xiaolin YANG ; Yan ZHU
Journal of Medical Informatics 2024;45(2):59-64
Purpose/Significance To analyze the characteristics of organ representation of anatomical ontologies,and to provide ref-erences for the research and construction of ontology in other fields.Method/Process The similarities and differences of three mainstream anatomical ontologies of SNOMED CT(SCT),Uberon and the foundational model of anatomy ontology(FMA)in terms of organ classifi-cation methods and term mapping are compared.Result/Conclusion Among the three main types of anatomical ontologies,SCT and Uberon are mainly classified according to the function of organs,while FMA is mainly classified according to the anatomical morphology of organs.The concept of organs in FMA and Uberon is the same as the concept of entire organs in SCT,and the representation forms of paired organs in SCT,Uberon and FMA are similar.
3.Dilemmas in decision-making:a qualitative study of family surrogate decision-makers of severe stroke patients
Zining GUO ; Keyu LING ; Shufan CHEN ; Haihan LI ; Ting YAO ; Sining ZENG ; Ling XU ; Xiaoping ZHU
Chinese Journal of Nursing 2024;59(14):1746-1751
Objective To explore the dilemmas faced by surrogate decision-makers of severe stroke patients in treatment decision-making,and to provide a basis for developing decision support strategies.Methods From April to December 2023,through phenomenological qualitative research with 16 surrogate decision-makers with severe stroke patients from ICU of the department of neurology in a tertiary hospital in Jing'an District,Shanghai.semi-structured in-depth interviews were used to examine the perceptions of decision-making on surrogate.Data were analyzed via Braun's style of thematic analysis.Results 4 themes and 10 sub-themes were identified.Theme 1:negative emotional dilemmas(urgent decision-making leads to anxiety,fear,and unknown stroke trajectory increases the sense of uncertainty).Theme 2:supportive environment dilemmas(lack of information support delays decision-making;lack of family support increases decision-making stress;insufficient economic support increases the burden of decision-making).Theme 3:the dilemma of weighing the pros and cons(difficult trade-offs between risk and reward,tough decisions between reality and ethics,conflicting choices of life and dignity).Theme 4:preference management dilemmas(practical difficulties in adhering to patient preferences,impediments to decision-making due to unknown patient preferences).Conclusion Surrogate decision-makers of severe stroke patients face multiple decision-making dilemmas.Healthcare professionals should provide emotional support in multiple ways and comprehensive support to reduce the decision-making dilemmas experienced by surrogate decision-makers,as well as implement death education for surrogate decision-makers and promote advance care planning to reduce their decision-making stress.
4.New progress in laboratory detection of respiratory infectious diseases in children
Keyu ZHU ; Fang YUAN ; Haiou YANG
Chinese Journal of Preventive Medicine 2024;58(9):1458-1464
Respiratory infectious disease has become ahead of all the children′s diseases, with the trend of continuously increasing global incidence, antimicrobial resistance and simultaneous infection with multiple pathogens. Diagnosis of this disease is mainly based on clinical symptoms and pathogenic detection. However, there are some differences in clinical manifestations, progression and prognosis between pediatric patients and adults, which prompting clinical diagnosis mainly depending on clinical laboratory test. Therefore, fast, convenient and accurate methods are urgently needed to clarify the type of infectious pathogen and carry out differentiated treatment, and reduce the burden on families and public health-care systems in schools. This article aims to elaborate the laboratory methods of children′s respiratory infectious diseases and explore the opportunities and challenges, which can provide ideas for prevention, early screening and diagnosis, prognosis and treatment monitoring.
5.New progress in laboratory detection of respiratory infectious diseases in children
Keyu ZHU ; Fang YUAN ; Haiou YANG
Chinese Journal of Preventive Medicine 2024;58(9):1458-1464
Respiratory infectious disease has become ahead of all the children′s diseases, with the trend of continuously increasing global incidence, antimicrobial resistance and simultaneous infection with multiple pathogens. Diagnosis of this disease is mainly based on clinical symptoms and pathogenic detection. However, there are some differences in clinical manifestations, progression and prognosis between pediatric patients and adults, which prompting clinical diagnosis mainly depending on clinical laboratory test. Therefore, fast, convenient and accurate methods are urgently needed to clarify the type of infectious pathogen and carry out differentiated treatment, and reduce the burden on families and public health-care systems in schools. This article aims to elaborate the laboratory methods of children′s respiratory infectious diseases and explore the opportunities and challenges, which can provide ideas for prevention, early screening and diagnosis, prognosis and treatment monitoring.
6.Journey map of chronic constipation patients undergoing fecal microbiota transplantation
Haihan LI ; Shufan CHEN ; Keyu LING ; Shailan ZHOU ; Zining GUO ; Ling XU ; Sining ZENG ; Xiaoping ZHU
Chinese Journal of Modern Nursing 2024;30(34):4662-4669
Objective:To explore the journey map of patients with chronic constipation during fecal microbiota transplantation.Methods:This study adopted phenomenological methods. From October to December 2023, purposive sampling was used to select chronic constipation follow-up patients who underwent fecal microbiota transplantation at the Intestinal Microecology Center of Shanghai Tenth People's Hospital as respondents for semi-structured interviews. Colaizzi 7-step analysis method and NVivo 11.0 software were used for data analysis.Results:A total of 15 interviewees were interviewed. During fecal microbiota transplantation, the journey map of constipation patients included stages, mood changes, touchpoints, themes, emotional experiences and opportunities. The patient's experience and needs were summarized into three themes and ten sub-themes, including pre-transplant adaptation disorders to new environments (unfamiliarity and confusion-admission coordination disorders, anxiety and expectations-diverse complex emotions, puzzle and helplessness-asymmetric doctor and patient information), effectiveness-related psychological and social experiences in transplantation (attention and expectations-longing for positive efficacy, perception of benefits and risk avoidance, shame and inferiority-treatment stigmatization experience, questioning and despair-unrealized expectations, treatment resistance-sensitive economic burden), post-transplant transition dilemmas (inaccessible medical services-lack of continuous treatment and nursing, disease recurrence troubles) .Conclusions:This study visualizes the experiences and needs of constipation patients during microbiota transplantation through a patient journey map and identifies multidimensional issues and needs of patients. Clinical medical and nursing staff should pay attention to the needs of patients at different stages of the treatment process when formulating intervention programs to improve the quality of fecal microbiota transplantation nursing.
7.Bibliometrics and visualized analysis of research hotspots and current status in clinical management of osteoporotic fractures
Ruizhi ZHANG ; Junjie LI ; Peng JIA ; Qiaocheng ZHAI ; Aifei WANG ; Baoshan LIU ; Zihou CAO ; Keyu ZHU ; Youjia XU
Chinese Journal of Endocrinology and Metabolism 2023;39(2):130-140
Objective:Based on Web of Science database, this study aimed to explore the current status, research hotspots and development trends of countries regarding clinical management of osteoporotic fractures using bibliometrics and visualized analysis.Methods:We collected literatures in the field of clinical management of osteoporotic fractures included in Web of Science database, and applied bibliometrics to analyze the publication dates, countries, institutions, journals, authors, highly cited literatures and research hotspots. Visualization was drawn by VOSviewer software.Results:Analysis of the 2 508 articles revealed 3 types of data. (1) The analysis of basic information of the literature showed that: ①The country with the largest number of publications was the United States, which published 672 articles, followed by the United Kingdom and Canada, and China ranked fourth; ②The top three authors in the number of publications were Kanis JA, Cooper C and McCloskey EV respectively; ③The institution with the highest number of publications was the University of Sheffield, UK, followed by the University of Southampton, UK and the University of Toronto, Canada. (2) Network visualization of highly cited literatures showed that 118 highly cited literatures were mainly divided into 5 clusters, which were related to osteoporotic fracture diagnosis, treatment, medication adherence, management consensus and strategies of preventing refracture. (3) Temporal overlay visualization of research hotspots showed that early research mainly focused on traditional therapeutic drugs, and current research hotspots were mainly molecular targeted drugs, trabecular bone score and fracture liaison services.Conclusion:This study shows that the research activity of clinical management of osteoporotic fractures is increasing worldwide, and there is still a huge gap between China and Europe or the United States. Current research hotspots and development trends mainly focus on molecular targeted drugs, osteoporotic fracture treatment concepts, emerging fracture risk assessment tools, and fracture prevention and management models.
8.Chinese Medicine Intervenes in NLRP3 Inflammasome in Treatment of Bone and Joint Diseases: A Review
Tuanzhuang ZHANG ; Yuan SONG ; Zhijun HE ; Tao LIU ; Xiyan LYU ; Xiaotao WEI ; Jiaxuan SHEN ; Xudong LIANG ; Keyu ZHU ; Jing QIAO
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(22):193-203
The prevalence of osteoporosis, osteoarthritis, gouty arthritis, rheumatoid arthritis, and intervertebral disc degeneration is increasing year by year with the growing number of elderly people, and the common clinical manifestations of these diseases include severe pain in different areas, which seriously affects the daily life of the patients. Therefore, how to relieve the pain and reduce the prevalence of bone and joint diseases and improve the quality of life of the patients is a hot spot in the medical field. Studies have confirmed that NOD-like receptor family, pyrin domain-containing protein 3 (NLRP3) inflammasomes, as pattern recognition receptors, are involved in the inflammation, chondrocyte proliferation, osteoblast and osteoclast differentiation, intervertebral disc cell inflammation and scorching, extracellular matrix degradation and apoptosis, mitochondrial dysfunction, endoplasmic reticulum stress, and reactive oxygen species damage, demonstrating close link with the development of bone and joint diseases. Chinese medicine has a long history and demonstrates remarkable therapeutic effects in the treatment of bone and joint diseases. It can mitigate the pathological changes of bone and joint diseases by inhibiting NLRP3 inflammasomes to alleviate the pain, playing a role in preventing and treating these diseases. Therefore, this paper briefly describes the relationship between NLRP3 inflammasomes and the development of bone and joint diseases by reviewing the latest research progress at home and abroad. We summarize the latest studies about the active components, extracts, and compound prescriptions of Chinese medicines in the treatment of bone and joint diseases via regulating NLRP3 inflammasomes. This review is expected to offer new insights into the in-depth research on the pathogenesis and drug treatment of bone and joint diseases and provide a basis for the clinical application of Chinese medicine in the prevention and treatment of such diseases.
9.Early numerical rating scale and Oswestry disability index in postmenopausal osteoporosis treated with denosumab
Qi WEI ; Miao ZHENG ; Chengwei WENG ; Keyu ZHU ; Xingyu JIN ; Weifeng LIU ; Dong ZHANG ; Qiaocheng ZHAI ; Peng ZHANG ; Youjia XU
Chinese Journal of Orthopaedics 2022;42(12):768-775
Objective:To compare the numerical rating scales (NRS) and Oswestry disability index (ODI) of denosumab in Chinese postmenopausal osteoporosis patients after 3 months, and analyze the early adverse reactions to provide reference for clinical diagnosis and treatment.Methods:Using a prospective study method, 260 patients with postmenopausal osteoporosis who were outpatients and inpatients in the Second Affiliated Hospital of Soochow University from September 2020 to October 2021 were selected, and general information, including age, height, weight, bone mineral density, history of fragility fractures, and use of anti-osteoporosis drugs. All subjects received denosumab 60 mg subcutaneously, and were given calcium and vitamin D at the same time. Pain was scored by NRS before treatment and 3 months after treatment, and functional improvement was assessed by ODI.Results:After 3 months of denosumab treatment in postmenopausal women with osteoporosis, among patients with different age groups, different degrees of osteoporosis, history of fragility fractures, and history of use of anti-osteoporosis drugs, NRS score and ODI score were lower than those before treatment, and the difference was statistically significant ( P<0.05). In addition, in patients with a history of fragility fractures (mainly vertebral fractures), the NRS scores and the ODI score decreased more significantly, and the difference was statistically significant ( P<0.05); the NRS score and ODI score decreased more significantly in patients with severe osteoporosis than in patients with osteoporosis, and the difference was statistically significant ( P<0.05); the BMD value of lumbar spine was negatively correlated with the reduction of NRS score before and after treatment ( P=0.042). In this study, 260 patients had musculoskeletal pain in 6 (2.3%), fatigue in 5 (1.9%), rash in 4 (1.5%), urinary tract infection in 2 (0.7%), and dizziness in 2 (0.7%), 2 case of fever (0.7%), 1 case of hypocalcemia (0.4%), a total of 22 cases of adverse reactions were reported, and the overall adverse reaction rate was 8.5%. Conclusion:Denosumab can improve pain symptoms and functional disability early in the clinical application of Chinese postmenopausal women with osteoporosis, and the incidence of adverse reactions is low. Especially for postmenopausal female osteoporosis patients with severe osteoporosis, low lumbar spine bone density, and a history of fragility fractures (mainly vertebral fractures), the application effect is more significant.
10.Study on the medication rule and mechanism of treating cervical spondylosis by National TCM master Liu Bailing based on bioinformatics
Jintao LIU ; Jinfeng SHANG ; Qian LIU ; Shuliang LI ; Keyu YAO ; Huiru WANG ; Gegongming ZHU ; Shuangqing ZHAI
International Journal of Traditional Chinese Medicine 2022;44(7):786-795
Objective:To study the medication rules of treating cervical spondylosis by National TCM master Liu Bailing based on data mining and network pharmacology, and explore the potential action mechanism of its core compounds.Methods:By collecting the prescriptions of National TCM master Liu Bailing treating cervical spondylosis in the past 8 years, this paper analyses the frequency, nature, flavor, meridian, hierarchical clustering and association rules of those prescriptions by RStudio to obtain the core prescription. Then, the effective components of the core prescription were collected by using TCMSP, and the network of "medicine-component-target" was constructed by using Cytoscape 3.8.0; by searching for databases like GEO, DisGeNET, TTD HPO and Genecards were retrieved to obtain the target data set of cervical spondylosis; by using STRING 11.0 platform to construct protein interaction network; by using DAVID platform to cary out gene ontology (GO) and KEGG pathway enrichment analysis; by using Auto Dock software for molecular docking.Results:In the 844 prescriptions, there are 199 Chinese medicines and the properties are mainly warm, plain and cold; the flavors were mainly sweet, pungent and bitter; mainly belong to the liver, spleen, and kidney meridians. The Association Rule shows that the core compound is made up of Salvia miltiorrhiza, Gastrodia elata, Rhizoma corydalis, Alisma rhizoma, centipede, Astragalus membranaceus and Rhizome of Pueraria. Besides, 140 effective constituents and 247 targets of the core prescription were screened, and the main constituents were quercetin, kamanol, luteolin, tanshinone ⅡA, β-sitosterol, etc. 13 core targets among the core prescription treating cervical spondylosis were obtained, which were enriched into 30 pathways including toll-like receptor signaling pathway, TNF signaling pathway and HIF-1 signaling pathway. Conclusion:National TCM master Liu Bailing treatment of cervical spondylosis mainly focuses on expelling wind and relieving pain, dredging meridians and soothing tendons, and the mechanism of action of the core prescription may focus on inhibiting inflammatory response and relieving oxidative stress, providing guidance and reference for the clinical treatment of cervical spondylosis.

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