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.

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.

As a patented characteristic medicine of Yi ethnic minority， Pingxuan capsules have the effects of nourishing the liver and kidney， pacifying the liver， and subduing Yang. With the main indications of dizziness， headache， palpitations， tinnitus， insomnia， dreaminess， waist and knee soreness caused by liver-kidney deficiency and liver Yang upward disturbance， Pingxuan capsules are widely used in the treatment of posterior circulation ischemic vertigo， vestibular migraine， benign paroxysmal positional vertigo. However， the current knowledge is limited regarding the efficacy， syndrome differentiation， and safety of this medicine. On the basis of summarizing the experience of clinicians and the existing evidence， this study invites clinical experts of traditional Chinese and Western medicine， pharmaceutical experts， and methodological experts from relevant fields across China to conduct evidence-based evaluation of Pingxuan capsules. The evaluation follows the Specifications for the Development of Clinical Expert Consensus on Chinese Patent Medicines issued by the Standardization Office of the China Association of Chinese Medicine， and reaches 5 recommendations and 16 consensus suggestions. The consensus clarifies the clinical applications， efficacy， dose， course of treatment， combination of medicines， precautions， and contraindications of Pingxuan capsules in the treatment of vertigo and explains the safety of clinical application. This consensus is applicable to clinicians （traditional Chinese medicine， Western medicine， and integrated traditional Chinese and Western medicine） and pharmacists in tertiary hospitals， secondary hospitals， and community-level medical and health institutions across China， providing a reference for the rational use of Pingxuan capsules in the treatment of vertigo. It is hoped that the promotion of this consensus can facilitate the rational use of drugs in clinical practice， reduce the risk of drug use， and give full play to the advantages of Pingxuan capsules in the treatment of vertigo diseases. This consensus has been reviewed and published by the China Association of Chinese Medicine， with the number GS/CACM330-2023.

Purpose To evaluate the value of tumors invasion in the central airway(TICA)in predicting the severe immune checkpoint inhibitor-related pneumonitis(S-CIP)in lung cancer patients using propensity score matching(PSM).Materials and Methods The intact data of 162 consecutive lung cancer patients who received treatment with immune checkpoint inhibitors in Xi'an International Medical Center Hospital from September 2019 to March 2022 were retrospectively collected.Patients were divided into S-CIP group(23 cases)and non-S-CIP group(139 cases)according to the presence of S-CIP.The demographic information of the patients,including gender,age,history of smoking,thoracic radiotherapy histology,baseline lung diseases,classification,TNM stage,tumor location as well as TICA were collected.A binary Logistic regression was used to analyze the confounding factors and independent risk factors of S-CIP and to predict the development of S-CIP.A 1:1 matching was performed by the nearest neighbor method for PSM.The PSM was used to pair the two groups,and the value of TICA in predicting S-CIP before and after PSM was compared.The receiver operating characteristic curve and the area under the curve were used for model performance based on TICA.Results Before PSM,the proportion of baseline lung diseases(78.3%vs.32.4%,OR=6.802,P=0.001),thoracic radiotherapy history(69.6%vs.30.2%,OR=5.300,P=0.002)and TICA(65.2%vs.27.3%,OR=5.882,P=0.001)in the S-CIP group was higher than those in the non-S-CIP group,and were independent risk factor for predicting S-CIP.After PSM,20 patients were included in each group.The presence of TICA was higher in S-CIP group than that in the non-S-CIP group(60.0%vs.20.0%,OR=6.000,P=0.013).The area under the curves of Logistic regression model based on TICA was 0.700(95%CI 0.534-0.866).Conclusion TICA is an independent risk factor for development of S-CIP,which has moderate degree of accuracy in predicting S-CIP,can be used for risk prediction and early intervention to reduce the poor prognosis of S-CIP patients.

Cardiovascular diseases (CVD s) remain the leading cause of death globally, constituting a serious threat to human health. As the cornerstone of primary and secondary prevention, antiplatelet therapy exhibits substantial individual variability in treatment efficacy, presenting a major challenge in clinical practice. Recent investigations have revealed that the diversity of platelet responses not only bears a close association with the risks of thrombotic/bleeding events but also serves as a pivotal breakthrough point for realizing precision medication. This paper systematically reviews the impact of genetic polymorphisms on platelet reactivity in response to three commonly used antiplatelet drugs: aspirin, P2Y12 receptor antagonists, and protease-activated receptor antagonists. It emphasizes the importance of multidimensional assessment in individualized treatment and highlights the critical role of precision antiplatelet therapy strategies.

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.

Purpose To evaluate the value of tumors invasion in the central airway(TICA)in predicting the severe immune checkpoint inhibitor-related pneumonitis(S-CIP)in lung cancer patients using propensity score matching(PSM).Materials and Methods The intact data of 162 consecutive lung cancer patients who received treatment with immune checkpoint inhibitors in Xi'an International Medical Center Hospital from September 2019 to March 2022 were retrospectively collected.Patients were divided into S-CIP group(23 cases)and non-S-CIP group(139 cases)according to the presence of S-CIP.The demographic information of the patients,including gender,age,history of smoking,thoracic radiotherapy histology,baseline lung diseases,classification,TNM stage,tumor location as well as TICA were collected.A binary Logistic regression was used to analyze the confounding factors and independent risk factors of S-CIP and to predict the development of S-CIP.A 1:1 matching was performed by the nearest neighbor method for PSM.The PSM was used to pair the two groups,and the value of TICA in predicting S-CIP before and after PSM was compared.The receiver operating characteristic curve and the area under the curve were used for model performance based on TICA.Results Before PSM,the proportion of baseline lung diseases(78.3%vs.32.4%,OR=6.802,P=0.001),thoracic radiotherapy history(69.6%vs.30.2%,OR=5.300,P=0.002)and TICA(65.2%vs.27.3%,OR=5.882,P=0.001)in the S-CIP group was higher than those in the non-S-CIP group,and were independent risk factor for predicting S-CIP.After PSM,20 patients were included in each group.The presence of TICA was higher in S-CIP group than that in the non-S-CIP group(60.0%vs.20.0%,OR=6.000,P=0.013).The area under the curves of Logistic regression model based on TICA was 0.700(95%CI 0.534-0.866).Conclusion TICA is an independent risk factor for development of S-CIP,which has moderate degree of accuracy in predicting S-CIP,can be used for risk prediction and early intervention to reduce the poor prognosis of S-CIP patients.

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.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

New threats posed by the emerging circulating variants of SARS-CoV-2 highlight the need to find conserved neutralizing epitopes for therapeutic antibodies and efficient vaccine design. Here, we identified a receptor-binding domain (RBD)-binding antibody, XG014, which potently neutralizes β-coronavirus lineage B (β-CoV-B), including SARS-CoV-2, its circulating variants, SARS-CoV and bat SARSr-CoV WIV1. Interestingly, antibody family members competing with XG014 binding show reduced levels of cross-reactivity and induce antibody-dependent SARS-CoV-2 spike (S) protein-mediated cell-cell fusion, suggesting a unique mode of recognition by XG014. Structural analyses reveal that XG014 recognizes a conserved epitope outside the ACE2 binding site and completely locks RBD in the non-functional "down" conformation, while its family member XG005 directly competes with ACE2 binding and position the RBD "up". Single administration of XG014 is effective in protection against and therapy of SARS-CoV-2 infection in vivo. Our findings suggest the potential to develop XG014 as pan-β-CoV-B therapeutics and the importance of the XG014 conserved antigenic epitope for designing broadly protective vaccines against β-CoV-B and newly emerging SARS-CoV-2 variants of concern.
Angiotensin-Converting Enzyme 2 ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 ; Epitopes ; Humans ; SARS-CoV-2/genetics* ; Spike Glycoprotein, Coronavirus/genetics*