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.Expert Consensus on Clinical Application of Ruyi Zhenbaowan
Ming CHEN ; Jingling CHANG ; Shangquan WANG ; Gejia ZHONG ; Qiang DENG ; Hongxia CHEN ; Qien LI ; Yaming LIN ; Zujian XU ; Changkuan FU ; Yuer HU ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):173-183
Osteoarthritis (OA) and stroke are common clinical diseases that reduce patients' quality of life and place a burden on families and society. Ruyi Zhenbaowan, a classic prescription in Tibetan medicine, have the functions of clearing heat, awakening the brain and opening orifices, relaxing tendons and promoting meridian circulation, and eliminating yellow water. Clinically, they are used to treat osteoarthritis, post-stroke sequelae, neuropathic pain, and other related conditions. Modern pharmacological studies have demonstrated their anti-inflammatory, analgesic, and nerve-repairing effects. However, current research remains insufficient regarding the appropriate indications, timing, and efficacy of this medicine in treating relevant diseases. To enhance clinicians' understanding of this medicine and promote its standardized and rational clinical use, a panel of national experts, including clinical specialists, Tibetan medicine practitioners, pharmacologists, and methodologists, formulated this consensus based on clinical experience and evidence-based practice. The Cochrane systematic review framework, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system, and the nominal group method were employed to generate seven graded recommendations and 19 consensus-based suggestions. These recommendations clearly define the key points in the clinical application of Ruyi Zhenbaowan, including therapeutic indications, dosage and administration, treatment duration, and medication safety. The consensus specifically addresses the clinical efficacy, appropriate timing of administration, dosage strategies, treatment cycles, and combination medication strategies for treating osteoarthritis and stroke and provides an overview of safety considerations. The aim is to provide standardized guidance for hospitals and healthcare institutions nationwide to ensure the rational application of Ruyi Zhenbaowan in the treatment of osteoarthritis and stroke, reduce medication-related risks, and further leverage its clinical advantages. This consensus has been approved and issued by the China Association of Chinese Medicine, with the standard number GS/CACM 369-2024.
4.ALKBH3-regulated m1A of ALDOA potentiates glycolysis and doxorubicin resistance of triple negative breast cancer cells.
Yuhua DENG ; Zhiyan CHEN ; Peixian CHEN ; Yaming XIONG ; Chuling ZHANG ; Qiuyuan WU ; Huiqi HUANG ; Shuqing YANG ; Kun ZHANG ; Tiancheng HE ; Wei LI ; Guolin YE ; Wei LUO ; Hongsheng WANG ; Dan ZHOU
Acta Pharmaceutica Sinica B 2025;15(6):3092-3106
Chemotherapy is currently the mainstay of systemic management for triple-negative breast cancer (TNBC), but chemoresistance significantly impacts patient outcomes. Our research indicates that Doxorubicin (Dox)-resistant TNBC cells exhibit increased glycolysis and ATP generation compared to their parental cells, with this metabolic shift contributing to chemoresistance. We discovered that ALKBH3, an m1A demethylase enzyme, is crucial in regulating the enhanced glycolysis in Dox-resistant TNBC cells. Knocking down ALKBH3 reduced ATP generation, glucose consumption, and lactate production, implicating its involvement in mediating glycolysis. Further investigation revealed that aldolase A (ALDOA), a key enzyme in glycolysis, is a downstream target of ALKBH3. ALKBH3 regulates ALDOA mRNA stability through m1A demethylation at the 3'-untranslated region (3'UTR). This methylation negatively affects ALDOA mRNA stability by recruiting the YTHDF2/PAN2-PAN3 complex, leading to mRNA degradation. The ALKBH3/ALDOA axis promotes Dox resistance both in vitro and in vivo. Clinical analysis demonstrated that ALKBH3 and ALDOA are upregulated in breast cancer tissues, and higher expression of these proteins is associated with reduced overall survival in TNBC patients. Our study highlights the role of the ALKBH3/ALDOA axis in contributing to Dox resistance in TNBC cells through regulation of ALDOA mRNA stability and glycolysis.
5.Effects of Herbal Compatibility on Chemical Composition and Neuroinflammatory Activity of Banxia Houpo Decoction
Yuanning ZENG ; Yaming CHEN ; Huilin SU ; Qiuhong WANG ; Qian WANG
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(9):2305-2313
Objective To investigate the influence of herbal compatibility on the chemical composition of Banxia Houpo Decoction(BHD)using ultra-performance liquid chromatography-tandem mass spectrometry(UPLC-MS)coupled with multivariate statistical analysis,and to evaluate the neuroprotective effects of key differential components against neuroinflammation and neuronal injury using cellular models.Methods(1)UPLC-MS analysis of chemical constituents in co-decoction and separated decoction(individual herbs decocted separately then combined)of Banxia Houpo Decoction,followed by orthogonal partial least squares-discriminant analysis(OPLS-DA)to identify differential components before and after herbal compatibility(2)BV2 microglia were stimulated with lipopolysaccharide(LPS)to establish a neuroinflammation model.Cell viability was assessed using the Cell Counting Kit 8(CCK-8)assay.Nitric oxide(NO)levels were measured by the Griess method,while TNF-α and IL-1β concentrations were quantified via enzyme-linked immunosorbent assay(ELISA).(3)SH-SY5Y neuronal cells were co-cultured with conditioned medium from LPS-stimulated BV2 cells(LPS-CM)to model neuronal injury.Cell viability was evaluated using the CCK-8 assay.Results UPLC-MS/OPLS-DA identified 11 differential components between compatibility methods,with honokiol and magnolol showing significant post-compatibility increases.In the neuroinflammation model,LPS stimulation elevated NO,TNF-α and IL-1 β levels in BV2 cells,which were suppressed by 5,10 μg/mL honokiol or magnolol.In the neuronal injury model,LPS-CM induced SH-SY5Y apoptosis,while 5,10 μg/mL honokiol or magnolol attenuated this damage.Conclusion Herbal compatibility significantly enhances honokiol and magnolol content in BHD.These components inhibit microglial inflammatory responses and neuronal apoptosis,suggesting their role as primary active constituents mediating BHD's neuroprotective effects.
6.Expert consensus on the workflow of digital aesthetic design in prosthodontics
Zhonghao LIU ; Feng LIU ; Jiang CHEN ; Cui HUANG ; Xianglong HAN ; Wenjie HU ; Chun XU ; Weicai LIU ; Lina NIU ; Chufan MA ; Yijiao ZHAO ; Ke ZHAO ; Ming ZHENG ; Yaming CHEN ; Qingfeng HUANG ; Yi MAN ; Mingming XU ; Xuliang DENG ; Ti ZHOU ; Xiaorui SHI
Journal of Practical Stomatology 2024;40(2):156-163
In the field of dental aesthetics,digital aesthetic design plays a crucial role in helping dentists to predict treatment outcomes vis-ually,as well as in enhancing the consistency of knowledge and understanding of aesthetic goals between dentists and patients.It serves as the foundation for achieving ideal aesthetic effects.However,there is no clear standard for this digital process currently in China and abroad.Many dentists lack of systematic understanding of how to carry out digital aesthetic design for treatment.To establish standardized processes for dental aesthetic design and to improve the homogeneity of treatment outcomes,Chinese Society of Digital Dental Industry(CSD-DI)convened domestic experts in related field to compile this consensus.This article elaborates on the key aspects of digital aesthetic data collection,integration steps,and the digital aesthetic design process.It also formulates a decision tree for dental aesthetics at macro level and outlines corresponding workflows for various clinical scenarios,serving as a reference for clinicians.
7.Protective effect and mechanism of Longshengzhi capsules on cerebral ischemia-reperfusion injury in rats
Huanle FANG ; Xiaoming LI ; Yaming ZHOU ; Xin ZHANG ; Xiaoxi LIU ; Yanbin CHEN
China Pharmacy 2024;35(7):813-818
OBJECTIVE To explore the protective effect and mechanism of Longshengzhi capsules on cerebral ischemia- reperfusion injury in rats. METHODS The model of middle cerebral artery occlusion (MCAO) was established by using the improved thread occlusion method. The experiment was divided into six groups: sham surgery group (only separating blood vessels without inserting thread plugs, given the same volume of normal saline), model group (modeling, given the same volume of normal saline), nimodipine group (positive control, modeling, dose of 20 mg/kg), and low-dose, medium-dose, and high-dose groups of Longshengzhi capsules (modeling, doses of 0.72, 1.44 and 2.88 g/kg, respectively), with 10 mice in each group. Each group was given corresponding medication solution/normal saline by gavage, once a day, for 7 consecutive days. One hour after the last administration, the Zea Longa scoring method was used to score the neurological deficits in each group of rats, and the ABC enzyme-linked immunosorbent assay was used to detect the serum levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) in rats; TTC staining was used to observe the volume of cerebral infarction in rats and calculate the cerebral infarction volume ratio. Hematoxylin eosin staining was used to observe the pathological changes in the brain tissue of rats. Immunohistochemical staining was used to detect the positive expression of NLRP3 protein in the brain tissue of rats. Real-time fluorescence quantitative PCR was used to detect mRNA relative expressions of Toll-like receptor 4 (TLR4) and nuclear factor-κB (NF-κB) in the brain tissue of rats. Western blot assay was adopted to detect the relative expressions of TLR4, NLRP3 and phosphorylated NF-κB (p-NF-κB) protein in the brain tissue of rats and its intracellular NF-κB protein. RESULTS Compared with the sham surgery group, the neural dysfunction score, serum levels of TNF-α and IL-6, cerebral infarction volume ratio, relative expression levels of NF-κB and TLR4 mRNA, as well as protein relative expressions of TLR4, NLRP3 and p-NF-κB in the brain tissue, and relative protein expression of intracellular NF-κB were increased significantly in the model group (P<0.01); the enlarged gap and significant edema were observed in cortical nerve cells of brain tissue in rats, with a large amount of inflammatory cell infiltration; the positive expression of NLRP3 protein in brain tissue of rats obviously increased. Compared with the model group, the levels of the above indicators in the medium-dose and high-dose groups of Longshengzhi capsules, as well as the Nimodipine group, were reversed to varying degrees, and most differences were statistically significant (P<0.05 or P<0.01); the pathological morphology observation showed a significant improvement, and the positive expression of NLRP3 protein in the brain tissue of rats was obviously reduced. CONCLUSIONS Longshengzhi capsules may inhibit TLR4/NF-κB/NLRP3 signaling pathway and neuroinflammatory response, thereby achieving a protective effect against cerebral ischemia-reperfusion injury in rats.
8.Analysis of clinical characteristics in 9 cases of empyema caused by Streptococcus anginosus
Song LIU ; Yaming LI ; Zonghai LI ; Hui CHEN ; Xin DIAO ; Shuang PAN
Chongqing Medicine 2024;53(15):2362-2365,2369
Objective To investigate the clinical characteristics of empyema caused by Streptococcus anginosus (SA).Methods The clinical data in 9 cases of SA caused empyema admitted and treated in the First Affiliated Hospital of Xi'an Medical University from January 2016 to September 2023 were analyzed ret-rospectively,summarized the clinical characteristics of empyema caused by SA.Results Among 9 patients,there were 8 males and 1 female,with a mean age of (60.8±12.8)years old.All patients had the underlying diseases,meanwhile were accompanied by fever,expectoration,chest pain and dyspnea.The onset time was (6.1±2.2)d.The hospitalization time was (19.33±7.48)d.All patients showed the increase in white blood cells (WBC),C reactive protein (CRP),procalcitonin (PCT),D-dimer (D-D) and pleural effusion lactic dehy-drogenase (LDH),and decrease in blood albumin (ALB) and pleural effusion glucose (GLU).Most of the pa-tients had elevation of adenosine deaminase (ADA) in pleural fluid.Four patients had respiratory failure.The drug sensitivity test results of pleural effusion culture suggested five patients were resistant to erythromycin and clindamycin.One patient was resistant to ceftriaxone.Nine patients were improved after symptomatic treatment such as anti-infection,closed thoracic drainage and nutritional support.Conclusion The patients with SA caused empye-ma are more common in elderly patients with underlying diseases.The incubation period is short,the hospital stay is long,the infection indexes are high,malnutrition exists,and the resistance rate to erythromycin and clindamycin is high.
9.Expert consensus on clinical application of 177Lu-prostate specific membrane antigen radio-ligand therapy in prostate cancer
Guobing LIU ; Weihai ZHUO ; Yushen GU ; Zhi YANG ; Yue CHEN ; Wei FAN ; Jianming GUO ; Jian TAN ; Xiaohua ZHU ; Li HUO ; Xiaoli LAN ; Biao LI ; Weibing MIAO ; Shaoli SONG ; Hao XU ; Rong TIAN ; Quanyong LUO ; Feng WANG ; Xuemei WANG ; Aimin YANG ; Dong DAI ; Zhiyong DENG ; Jinhua ZHAO ; Xiaoliang CHEN ; Yan FAN ; Zairong GAO ; Xingmin HAN ; Ningyi JIANG ; Anren KUANG ; Yansong LIN ; Fugeng LIU ; Cen LOU ; Xinhui SU ; Lijun TANG ; Hui WANG ; Xinlu WANG ; Fuzhou YANG ; Hui YANG ; Xinming ZHAO ; Bo YANG ; Xiaodong HUANG ; Jiliang CHEN ; Sijin LI ; Jing WANG ; Yaming LI ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2024;31(5):844-850,封3
177Lu-prostate specific membrane antigen(PSMA)radio-ligand therapy has been approved abroad for advanced prostate cancer and has been in several clinical trials in China.Based on domestic clinical practice and experimental data and referred to international experience and viewpoints,the expert group forms a consensus on the clinical application of 177Lu-PSMA radio-ligand therapy in prostate cancer to guide clinical practice.
10.Arthroscopic ligament reconstruction in the treatment of chronic PalmerⅠD type triangular fibrochondral complex injury
Shun YANG ; Yabo CHENG ; Wang XIANG ; Jing ZHANG ; Keyi CHEN ; Yaming YU
Chinese Journal of Sports Medicine 2024;43(7):512-517
Objective To explore the clinical effect of reconstructing distal radioulnar ligament with al-lograft tendon under wrist arthroscopy in the treatment of chronic PalmerⅠD type triangular fibrocarti-lage complex injury complicated with distal radioulnar joint instability.Methods Clinical data of 15 pa-tients with chronic PalmerⅠD type triangular fibrocartilage complex injury and admitted to our hospital between January 2017 to January 2020 were retrospectively analyzed.All of them were treated with wrist arthroscopic allograft tendon reconstruction of distal radioulnar ligament.During the postoperative follow-up,the wrist range of motion and grip strength were evaluated,while the wrist pain and wrist function were assessed using the visual analogue scale(VAS)and modified Mayo score.Results All pa-tients were followed up twelve to twenty-four months,with an average of(18.15±2.20)months.The postoperative VAS score was(2.56±0.69),significantly better than the preoperative one(6.78±1.24)(P<0.05).Moreover,the postoperative ratio of grip strength between the affected and the healthy hand was(76.18±9.72)%,significantly better than that of(50.18±6.79)%(P<0.05),with increased grip strength.Meanwhile,the postoperative rotational motion of wrist joint[(151.09±12.38)°]improved significantly compared with that before operation[(142.87±10.19)°](P<0.05).According to the modi-fied Mayo score,8 cases were excellent,6 cases were good,and 1 case was fair,reaching an excel-lent and good rate of 93.33%.Conclusion Wrist arthroscopic reconstruction of distal radioulnar liga-ment with allograft tendon is effective in the treatment of chronic PalmerⅠD type triangular fibrocarti-lage complex injury with lower radioulnar joint instability,relieving pain and promoting grip strength and rotational motion.

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