1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
3.Investigation on the Role of Medical Recombinant Human-Derived Collagen Functional Dressings in Wound Healing.
Xiaoxiao GAI ; Xiaoxia SUN ; Wenqian MA ; Zhenhua LIN ; Xinyuan LI ; Chenghu LIU
Chinese Journal of Medical Instrumentation 2025;49(4):415-422
OBJECTIVE:
To investigate the biological effect of medical recombinant human-derived collagen functional dressings in wound healing.
METHODS:
MTT assay and RTCA assay were used to detect cell toxicity and proliferation. Scratch assay and Transwell cell migration assay were used to detect cell motility and migration ability. Enzyme-linked immunosorbent assay was used to detect the contents of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-endothelial cell adhesion molecule (CD31) in the supernatant of four types of cells. After animal surgery, the surgical wound was taken at 1 week, 4 weeks and 13 weeks, respectively, for hematoxylin eosin (HE) staining and immunohistochemistry to observe the inflammatory response and CD31 expression of the wound.
RESULTS:
Medical recombinant human-derived collagen functional dressing promotes cell proliferation and migration, enhances wound angiogenesis by upregulating the expression of VEGF, FGF, and CD31 in human dermal vascular endothelial cells (HDVEC) and human vascular endothelial cells (HVEC), thereby improving local blood supply to the wound, regulating the inflammatory response of the wound, and accelerating wound healing.
CONCLUSION
Recombinant type Ⅲ humanized collagen plays an important role in wound healing.
Humans
;
Wound Healing/drug effects*
;
Recombinant Proteins/pharmacology*
;
Animals
;
Cell Proliferation
;
Cell Movement
;
Collagen/pharmacology*
;
Vascular Endothelial Growth Factor A/metabolism*
;
Bandages
;
Platelet Endothelial Cell Adhesion Molecule-1/metabolism*
;
Endothelial Cells
;
Fibroblast Growth Factors/metabolism*
4.Field-driven medical micro-robots:application prospect of continuously optimizing material preparation process
Wenqian XIAO ; Hongjuan HAN ; Haocheng YANG ; Bo LI ; Binyan HE
Chinese Journal of Tissue Engineering Research 2025;29(10):2097-2104
BACKGROUND:Micro-robots have the characteristics of small size,flexibility,and strong targeting,and can complete complex tasks in a single or clustered manner in a narrow environment.With the continuous optimization of materials,preparation processes,and driving approaches,they have shown increasingly important application value in the field of biomedicine. OBJECTIVE:To analyze the application of field-driven micro-robots in medical field and to look forward to their application prospect. METHODS:Using"microrobots,nanorobots,drivers,biomedical,medical"as Chinese keywords and"microrobots,micro-robots,nanorobots,micromachine,microswimmer,medical"as English keywords,WanFang Data and PubMed databases were searched,respectively.The search time range was from January 2010 to January 2024,and a small number of long-term articles were included.Through reading the titles and preliminarily screening the abstracts,the repetitive studies,low-quality journals,and irrelevant literature were excluded.After reading the entire text,66 papers were finally included for review. RESULTS AND CONCLUSION:Field-driven medical micro-robots mainly include magnetic,optical,thermal,ultrasonic,and multi-mixed factor-driven robots.Field-driven robots have been used in intestinal diagnosis,drug targeting therapy,and stem cell therapy.Medical micro-robots are currently only used in a small number of clinical applications,but most of which are still in the theoretical and experimental stages.Medical micro-robots will face many challenges in future,such as large-scale preparation,precise control of micro-robots,recycling or degradation in vivo,whether the materials used will cause adverse reactions to the human body,and the related minimally invasive medical procedures.
5.Association of urinary serine protease Corin with clinical staging in early diabetic kidney disease
Wenqian TIAN ; Jingyi LU ; Danyang CHEN ; Sa LI ; Shiyu LIU ; Xiaoying ZHANG ; Wanjun PANG ; Yahui HU
Chinese Journal of Endocrinology and Metabolism 2025;41(2):120-128
Objective:To investigate the level of urinary serine protease(Corin) in early diabetic kidney disease(DKD) and its correlation with clinical stage.Methods:One hundred and seventy-three patients with type 2 diabetes mellitus(DM) from two tertiary A hospitals in Henan, diagnosed between April 2023 and December 2023 were selected as the research group, and 120 healthy subjects were selected as the control group. Basic clinical information and laboratory data were collected, and urinary Corin level was detected. DM patients were classified into G1-G5 stages based on estimated glomerular filtration rate(eGFR), and those in the early DKD stages(G1-G3) were further divided into A1-A3 subgroups based on urinary albumin/creatinine ratio(ACR). Spearman correlation analysis was performed to assess relationships between urinary Corin and other indicators, linear regression analysis identified factors influencing urinary Corin in early DKD patients, logistic regression analysis evaluated the risk factors for early DKD, and receiver operating characteristic(ROC) curve analysis determined the diagnostic value of urinary Corin in early DKD. Results:Urinary Corin levels were significantly higher in early DKD patients compared to healthy controls, with levels increasing as ACR rose( P<0.05). Urinary Corin was positively associated with serum creatinine( r=0.570), urea( r=0.458), cystatin C( r=0.693), ACR( r=0.616), urinary transferrin( r=0.448), urinary α1 microglobulin( r=0.507), urinary n-acetyl-β-D-glucosaminase( r=0.388) and A subgroup( r=0.692) while was negatively correlated with eGFR( r=-0.647), albumin( r=-0.312)(all P<0.05). eGFR was the only independent factor affecting urinary Corin. After adjusting for confounding factors in logistic regression analysis, urinary Corin was still an independent influencing factor for early DKD. ROC curve analysis indicated that urinary Corin had a diagnostic AUC of 0.842(95% CI 0.791-0.892, P<0.001), with a cut-off value of 2 226.04 pg/mL, sensitivity of 0.712, and specificity of 0.858 for early DKD diagnosis. Conclusions:Urinary Corin was elevated in early DKD patients and correlated with clinical stage. Urinary Corin is an independent factor of early DKD, and a reliable predictor of early DKD diagnosis.
6.Approach to the patient with myxedema coma
Jianxia SHI ; Qiuyu FANG ; Wenqian REN ; Yunqin MA ; Qin ZHEN ; Li ZHAO ; Yufan WANG ; Yongde PENG ; Fang LIU
Chinese Journal of Endocrinology and Metabolism 2025;41(3):233-236
Myxedema coma is a rare condition, typically arising from long-standing, untreated hypothyroidism and triggered by factors such as infection, hypothermia, or severe illness. This report details a successfully treated case of myxedema coma with cardiac attest, accompanied by a literature review, to enhance clinical awareness and improve the diagnosis and management of this critical condition.
7.Research progress of novel three-dimensional echocardiographic rendering tools in structural heart disease
Alimu TEZHI ; Yuman LI ; Lin HE ; He LI ; Wenqian WU ; Yun YANG ; Huan WANG ; Mingxing XIE ; Lingyun FANG
Chinese Journal of Ultrasonography 2025;34(2):173-179
Recently developed three-dimensional echocardiography rendering technology,which includes transillumination imaging and tissue transparency imaging,is based on powerful artificial intelligence algorithm and employs unique visualization methods. This novel technology enables intuitive and realistic visualization of the heart's three-dimensional structure and blood flow images,providing richer and more accurate imaging information for evaluating cardiac anatomy and function. They demonstrate unique value in the diagnosis and treatment of structural heart diseases. This article reviews the applications and prospects of three-dimensional echocardiographic rendering techniques in structural heart disease.
8.Application of third-generation sequencing technology for identifying the AB weak subtype through family analysis
Wenqian SONG ; Shihang ZHOU ; Ning LI ; Xiaohua LIANG
Chinese Journal of Laboratory Medicine 2025;48(5):623-627
Objective:To identify the ABO blood group in a family with ABO forward/reverse typing discrepancies using serological methods and third-generation sequencing technology.Methods:In January 2024, samples with ABO blood group forward/reverse typing discrepancies were referred to Dalian Blood Center for blood group identification. Standard serological techniques were used to identify the ABO blood group. For the samples of the proband with a serological phenotype of AB weak and his father, full-length haplotype sequencing of the ABO gene was performed using third-generation sequencing. The impact of amino acid mutations on protein structure was also predicted. Results:Sequencing revealed that, compared to the reference sequence ABO*B.01, both the proband and his father had a haplotype with a mutation c.278C>T in Exon 7, resulting in p.Pro93Leu. This is consistent with the ABO*BW.12 genotype. The spatial structure of the ABO*BW.12 protein was altered, leading to reduced stability and impaired function of the B glycosyltransferase (GTB).Conclusion:For the identification of AB weak blood group, the combination of serological methods and third-generation sequencing technology enables accurate and efficient detection of haplotype mutations and identification of ABO subtypes, thus ensuring clinical transfusion safety.
9.Clinical efficacy of sulbactam-durlobactam in treating patients with carbapenem-resistant Acinetobacter baumannii pulmonary infection and drug concentration surveillance
Yue CHEN ; Lin QIAO ; Zhongyao XIE ; Wenqian CHEN ; Dongjie GUO ; Pengmei LI
Chinese Journal of Nosocomiology 2025;35(20):3105-3109
OBJECTIVE To evaluate the efficacy of sulbactam-durlobactam combined with meropenem in treating carbapenem-resistant Acinetobacter baumannii(CRAB)pulmonary infection.METHODS A total of 16 patients treated at China-Japan Friendship Hospital from Jan.1,2025 to Jun.1,2025 were included.Retrospective analy-sis was conducted on patients'basic situation,preliminary treatment regimens,infection-related diagnoses,etiolo-gy and clinical outcomes.Therapeutic drug monitoring(TDM)for sulbactam was also performed.RESULTS By the end of the treatment course,13 patients achieved etiological eradication of CRAB and clinical improvement,while 1 patient experienced CRAB recurrence within one month.Three patients showed treatment failure.TDM for sulbactam was performed in 13 patients.Except for one slightly lower,all achieved trough plasma concentra-tions above the minimum inhibitory concentration(MIC)(100%T>MIC,MIC=4 mg/L based on clinical breakpoints).Dosage adjustments based on plasma concentrations were made for 4 patients,with 3 receiving re-duced doses and 1 receiving an increased dose.CONCLUSIONS Sulbactam-durlobactam combined with meropenem demonstrates superior efficacy in treating CRAB compared to other regimens.Under the recommended dosage,all patients can achieve the PK/PD target for sulbactam.
10.A qualitative study on needle-related distress of arteriovenous fistula experiences in hemodialysis patients
Wenqian WANG ; Hongyan NIU ; Qingzhi LI ; Lulu HU
Chinese Journal of Nursing 2025;60(19):2328-2333
Objective To explore the authentic experiences of needle-related distress during arteriovenous fistula cannulation in hemodialysis patients and provide a basis for developing targeted assessment tools and intervention plans in clinical practice.Methods This study adopted a descriptive phenomenological research method.Using purposive sampling,13 hemodialysis patients with arteriovenous fistula from the blood purification center of a tertiary hospital in Changzhou were recruited for semi-structured interviews between November 2024 and January 2025.Data were analyzed using Colaizzi's 7-step method.Results Totally 4 themes and 10 sub-themes were extracted,namely dynamic evolution of distressing experiences(cognitive gaps and unfamiliar environments triggering distress,familiarity with procedures and self-management alleviating distress,sudden medical events reawakening distress),embodied cognition of distressing experiences(somatic distress,cognitive distress,mind-body dualistic interaction),subjective interaction in distress perception(subjective perceptions of differences in puncture skills,positive regulation through good communication attitudes),coping strategies for distressing experiences(empowerment-based coping,adaptive compromise).Conclusion The needle-related distress associated with arteriovenous fistula puncture in hemodialysis patients is not a single physical feeling,but a complex experience involving physical and mental interaction,nurse-patient interaction and coping strategies.Clinically,a dynamic assessment and precise intervention system should be constructed to improve patients' puncture experience and quality of life.

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