1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
3.Comparison of pedicled lateral thoracic artery perforator flap and mammoplasty in oncoplastic breast-conserving surgery for early-stage breast cancer
Yixian LI ; Mingquan HUANG ; Haiyan WANG ; Bin WU ; Huaiquan ZUO ; Yi QUAN ; Guangrui PAN
Chinese Journal of General Surgery 2025;34(5):953-962
Background and Aims:Oncoplastic breast-conserving surgery(OBCS)integrates oncologic and plastic surgical techniques and includes two primary approaches:volume displacement and volume replacement.The pedicled lateral thoracic artery perforator(LTAP)flap is a commonly used technique for volume replacement.Although recent studies in China have confirmed its safety in OBCS,its patient-reported outcomes have not been systematically evaluated,and comparative data with volume displacement techniques remain lacking.Therefore,this study was performed to compare the clinical outcomes and patient satisfaction of LTAP flap versus mammoplasty(volume displacement)in OBCS,to inform surgical decision-making.Methods:A retrospective case-control study was conducted,including 106 patients with unilateral stage 0-Ⅲ breast cancer who underwent OBCS at the Affiliated Hospital of Southwest Medical University from January 2023 to June 2024.Patients were divided into the LTAP flap group(27 cases)and the mammoplasty group(79 cases)based on the surgical technique.Intraoperative variables,cosmetic outcomes,postoperative complications,and Breast-Q scores before and after surgery were compared between the two groups.Results:There were no significant differences between the two groups in clinicopathological characteristics or preoperative Breast-Q scores(all P>0.05).The LTAP group had longer operative times,larger excised tissue volumes,and greater postoperative drainage volumes(all P<0.001).Postoperative cosmetic outcomes were significantly better in the LTAP group,with a higher rate of excellent-to-good cosmetic results(88.9%vs.57.3%)and higher Breast-Q scores in breast satisfaction,psychosocial well-being,and physical well-being(all P<0.05).There were no significant differences in complication rates or local recurrence between the two groups(all P>0.05).Conclusion:In OBCS,the LTAP flap demonstrates comparable safety to mammoplasty while achieving superior cosmetic outcomes and patient satisfaction.It is particularly suitable for patients with small breast volumes requiring large tissue excision and holds promise for broader clinical application.
4.Research progress on the treatment of ischemia-reperfusion injury with human umbilical cord mesenchymal stem cells and their derivatives
Ru NIE ; Yunlong DUAN ; Mingquan PANG ; Zhixin WANG ; Haining FAN
Organ Transplantation 2025;16(4):516-525
Ischemia-reperfusion injury (IRI) can lead to organ dysfunction and tissue necrosis in the liver, kidney, myocardium and spinal cord, and there is currently a lack of effective treatment options. Human umbilical cord mesenchymal stem cell (HUC-MSC) and their derivatives have anti-inflammatory, anti-apoptotic, reactive oxygen species scavenging, mitochondrial and endothelial function improvement properties, and are ideal gene therapy carrier cells, providing new possibilities for the treatment of IRI in different organs. This article reviews the concept and mechanisms of IRI, the biological characteristics of HUC-MSC and their derivatives and their comparison with mesenchymal stem cells from other sources, and the mechanisms of HUC-MSC in treating IRI in different organs. It also summarizes and analyzes the advantages and disadvantages of HUC-MSC in protecting different organs from IRI, and prospects future research directions to explore more valuable research paths.
5.Recent advance in role of metabolism reprogramming of microglia in Alzheimer's disease
Jie WANG ; Xiaoting ZHU ; Yunqiang LI ; Xinyue ZHANG ; Fan LI ; Mingquan LI
Chinese Journal of Neuromedicine 2025;24(4):401-406
Alzheimer's disease (AD) is a neurodegenerative disease characterized by progressive cognitive impairment, memory decline and emotional loss, which is more common in middle-aged and elderly people. In recent years, studies have shown that chronic neuroinflammation is an important factor leading to AD development. As the core participant in neuroinflammation, microglia play a dual role in the pathological process of AD: on one hand, through M1 polarization, they exert a pro-inflammatory effect and exacerbate the neurotoxic response; on the other hand, through M2 polarization, they enhance the phagocytic ability of amyloid β-protein and exert a neuroprotective effect. Metabolic reprogramming is the key in determining the polarization of microglia M1/M2 type and exerting neurotoxicity/protection. Therefore, this article reviews the recent advance in role of metabolism reprogramming of microglia in AD, in order to provide new idea and direction for studing AD pathogenesis and treatment in the future.
6.Comparison of pedicled lateral thoracic artery perforator flap and mammoplasty in oncoplastic breast-conserving surgery for early-stage breast cancer
Yixian LI ; Mingquan HUANG ; Haiyan WANG ; Bin WU ; Huaiquan ZUO ; Yi QUAN ; Guangrui PAN
Chinese Journal of General Surgery 2025;34(5):953-962
Background and Aims:Oncoplastic breast-conserving surgery(OBCS)integrates oncologic and plastic surgical techniques and includes two primary approaches:volume displacement and volume replacement.The pedicled lateral thoracic artery perforator(LTAP)flap is a commonly used technique for volume replacement.Although recent studies in China have confirmed its safety in OBCS,its patient-reported outcomes have not been systematically evaluated,and comparative data with volume displacement techniques remain lacking.Therefore,this study was performed to compare the clinical outcomes and patient satisfaction of LTAP flap versus mammoplasty(volume displacement)in OBCS,to inform surgical decision-making.Methods:A retrospective case-control study was conducted,including 106 patients with unilateral stage 0-Ⅲ breast cancer who underwent OBCS at the Affiliated Hospital of Southwest Medical University from January 2023 to June 2024.Patients were divided into the LTAP flap group(27 cases)and the mammoplasty group(79 cases)based on the surgical technique.Intraoperative variables,cosmetic outcomes,postoperative complications,and Breast-Q scores before and after surgery were compared between the two groups.Results:There were no significant differences between the two groups in clinicopathological characteristics or preoperative Breast-Q scores(all P>0.05).The LTAP group had longer operative times,larger excised tissue volumes,and greater postoperative drainage volumes(all P<0.001).Postoperative cosmetic outcomes were significantly better in the LTAP group,with a higher rate of excellent-to-good cosmetic results(88.9%vs.57.3%)and higher Breast-Q scores in breast satisfaction,psychosocial well-being,and physical well-being(all P<0.05).There were no significant differences in complication rates or local recurrence between the two groups(all P>0.05).Conclusion:In OBCS,the LTAP flap demonstrates comparable safety to mammoplasty while achieving superior cosmetic outcomes and patient satisfaction.It is particularly suitable for patients with small breast volumes requiring large tissue excision and holds promise for broader clinical application.
7.Recent advance in role of metabolism reprogramming of microglia in Alzheimer's disease
Jie WANG ; Xiaoting ZHU ; Yunqiang LI ; Xinyue ZHANG ; Fan LI ; Mingquan LI
Chinese Journal of Neuromedicine 2025;24(4):401-406
Alzheimer's disease (AD) is a neurodegenerative disease characterized by progressive cognitive impairment, memory decline and emotional loss, which is more common in middle-aged and elderly people. In recent years, studies have shown that chronic neuroinflammation is an important factor leading to AD development. As the core participant in neuroinflammation, microglia play a dual role in the pathological process of AD: on one hand, through M1 polarization, they exert a pro-inflammatory effect and exacerbate the neurotoxic response; on the other hand, through M2 polarization, they enhance the phagocytic ability of amyloid β-protein and exert a neuroprotective effect. Metabolic reprogramming is the key in determining the polarization of microglia M1/M2 type and exerting neurotoxicity/protection. Therefore, this article reviews the recent advance in role of metabolism reprogramming of microglia in AD, in order to provide new idea and direction for studing AD pathogenesis and treatment in the future.
8.Lung nodule segmentation algorithm based on full-scale channel feature aggregation coding and decoding network
Shaopeng XIE ; Mingquan WANG ; Yujie GENG ; Xinyue HUANG ; Ran SHANG
Chinese Journal of Medical Physics 2024;41(12):1501-1508
To address the difficulty in accurately detecting pulmonary nodules of different properties,a full-scale channel feature aggregation encoding and decoding network(FCFA-Net)is employed to assist experienced physicians in diagnosis.The network which consists of SMC,full-scale feature aggregator,autocorrelation feature enhancer,channel feature hierarchy extraction decoder and binomial constraint loss function can fully extract shallow and deep features from CT images for realizing the segmentation of pulmonary nodules of different sizes and shapes.Compared with UNet,UNet++and TransUnet,FCFA-Net increases the accuracy by 9.96%,7.84%and 3.75%,recall rate by 5.50%,2.96%and 1.37%,mean intersection over union by 11.35%,7.16%and 4.18%,F1 score by 8.07%,5.87%and 3.10%,respectively.Additionally,ablation experiment results demonstrate that each structure is effective and can achieve the best result within the acceptable parameter range.
9.Clinical application of multi-marker combined detection model in diagnosing type 4a myocardial infarction
Yujie WU ; Bo DENG ; Mingquan GUO ; Jue WANG ; Ye HE ; Haoyu MENG ; Liansheng WANG
Chinese Journal of Clinical Laboratory Science 2024;42(8):574-579
Objective To compare the diagnostic performance of a multi-marker panel(copeptin,cardiac troponin T[cTnT],and heart-type fatty acid-binding protein[HFABP])with the single marker cTnT in the diagnosis of type 4a acute myocardial infarction(AMI),and explore the application value of combined detectionmodel with the multiple markers.Methods The enrolled non-AMI pa-tients underwent elective percutaneous coronary intervention(PCI)at Nanjing Medical University First Affiliated Hospital during the period from March to December 2022 and were assessed as postoperative elevation of cTnT above the 99th percentile upper reference limit(URL).According to the Fourth Universal Definition of Myocardial Infarction,the patients were divided into non-type 4a AMI group and type 4a AMI group based on whether type 4a AMI occurred after surgery.The concentrations of AMI biomarkers were meas-ured using a chemiluminescent immuno-gold nanoassembly immunosensor array(chemiluminescent immuno-Gold,ciGold).Receiver operating characteristic(ROC)curves were used to analyze the performance of the diagnostic models with single and combined cardiac biomarkers.The sensitivity and specificity were also obtained from the ROC curves,and the area under the ROC curve(AUCROC)was calculated to evaluate respective diagnostic value.Kappa analysis was used to assess the consistency between the results combined de-tection model of multiple biomarkers and the diagnosis based on the Fourth Universal Definition of Myocardial Infarction.Results In this study,a total of 65 patients were included in whom females accounted for 23.1%.The ROC curve indicated that the combined de-tection model of multiple cardiac biomarkers showed specificity of 96.5%,sensitivity of 92.3%,agreement rate of 94.6%,positive pre-dictive value of 92.3%,negative predictive value of 96.2%,and AUCROC of 0.979.The single cTnT diagnostic model showed specificity of 94.2%,sensitivity of 100%,agreement rate of 95.7%,positive predictive value of 100%,negative predictive value of 94.9%,and AUCROC of 0.987.Although the combined detection model of multiple biomarkers had lower sensitivity(P=0.011),it showed higher specificity(P=0.016).The analysis of AUCROC differences between the two diagnostic models showed P>0.05,indicating no signifi-cantly statistical difference for the diagnostic accuracy.Kappa analysis demonstrated a strong consistency between the combined detec-tion model of multiple cardiac biomarkers and the diagnosis of type 4a AMI based on the Fourth Universal Definition of Myocardial In-farction with a Cohen's Kappa coefficient of 0.818.Conclusion The multi-marker combined detection model showed similar perform-ance of cTnT in diagnos of type 4a AMI with strong diagnostic consistency.However,the combined detection model exhibited an advan-tage of higher specificity.
10.The predictive value of serum uric acid levels for the occurrence of sarcopenia after hepatectomy in patients with primary liver cancer
Mingquan WANG ; Huizhe WANG ; Shuangdong LU ; Qian WANG ; Zengqiang CAI
Journal of Clinical Surgery 2024;32(9):937-941
Objective To explore the predictive value of serum uric acid levels for the occurrence of sarcopenia after hepatectomy in patients with primary liver cancer(PLC).Method A convenience sampling method was used to prospectively include 161 PLC patients who underwent liver resection surgery at Baoding NO.2 Central Hospital of Hebei Province from January 2019 to December 2021.They were divided into occurrence group and non occurrence group based on whether they had muscle deficiency.The clinical data,serum uric acid and other blood biochemical examination results were compared between the two groups,and the predictive value and influence of serum uric acid level on sarcopenia after hepatectomy in PLC patients were analyzed.Results Among the 158 PLC patients who underwent hepatectomy in the final inclusion of this study,34 patients developed postoperative sarcopenia,with an incidence rate of approximately 21.52%.The serum uric acid level(311.79±35.32)μmol/L in the occurrence group was higher than that in the non-occurrence group(280.52±31.15)μmol/L,the ALB level(31.59±5.73)g/L was lower than that in the non-occurrence group(35.63±5.13)g/L,and the proportion of postoperative adjuvant hepatic arterial infusion chemotherapy(HAIC)(38.24%)was higher than that in the non-occurrence group(20.16%),with statistical significant differences(P<0.05).Multiple Logistic regression analysis showed that serum uric acid、ALB、postoperative adjuvant HAIC were associated with sarcopenia after hepatectomy in PLC patients(OR=0.853,1.035,11.189,95%CI:0.770-0.945,1.018-1.052,3.533-35.433,P<0.05).The receiver operating characteristic curve(ROC)showed that the area under the curve(AUC)of serum uric acid in predicting sarcopenia after hepatectomy in PLC patients was 0.754(95%CI:0.657-0.850),which had certain predictive value.The nomogram showed that the C-index of the prediction model constructed by serum uric acid assisted other major clinical indicators to predict the occurrence of sarcopenia after hepatectomy in PLC patients was 0.847(95%CI:0.782-0.913),suggesting that the model had certain predictive value.The results of the decision curve showed that when the threshold was in the range of 0.00-1.00,the actual clinical net benefit rate of the model was always greater than 0,and the maximum net benefit rate was 0.215,suggesting that the model had good clinical application value.Conclusion The increase of serum uric acid level in PLC patients is a risk factor for postoperative sarcopenia.The detection of serum uric acid level is helpful to assist in the early prediction of the risk of sarcopenia.

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