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.

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.

Objective To analyze the incidence of biliary complications in patients with cholecystolithiasis and calculus of common bile duct after laparoscopic common bile duct exploration(LCBDE)with one-stage suture,and explore the high-risk factors of its occurrence,and then put forward targeted prevention strategies.Methods The clinical data of 201 patients with cholecystolithiasis and calculus of common bile duct after LCBDE with one-stage suture in our hospital from January 2020 to April 2024 were retrospectively analyzed.After 3 months of follow-up,the incidence of postoperative biliary complications was observed,and the clinical data of patients in the biliary complications group and the non-biliary complications group were analyzed.The factors with statistically significant differences were included in the multivariate Logistic regression model to analyze the independent risk factors affecting the occurrence of patients with cholecystolithiasis and calculus of common bile duct after LCBDE with one-stage suture.Results Among the 201 patients,12 had biliary tract infection,5 had common bile duct stenosis,and 13 had bile leakage.The total incidence of biliary complications was 14.93%(30/201).Multivariate Logistic regression analysis showed that diabetes mellitus((OR)=1.092,95%CI:1.040～1.147),common bile duct diameter<1 cm((OR)=1.097,95%CI:1.053～1.144),stone incarceration at the lower end of common bile duct((OR)=1.120,95%CI:1.062～1.180),Calot triangle adhesion((OR)=1.099,95%CI:1.042～1.158),bile turbidity((OR)=1.082,95%CI:1.043～1.123)and operation time≥2 h((OR)=1.090,95%CI:1.044～1.138)were independent risk factors for patients with cholecystolithiasis and calculus of common bile duct after LCBDE with one-stage suture(P<0.05).Conclusion The risk of patients with cholecystolithiasis and calculus of common bile duct after LCBDE with one-stage suture is high.The occurrence of complications is related to diabetes mellitus,common bile duct diameter<1 cm,stone incarceration at the lower end of the common bile duct,Calot triangle adhesion,bile turbidity and operation time≥2 h.Targeted prevention strategies can be formulated clinically to prevent the occurrence of biliary complications.

Objective To analyze the incidence of biliary complications in patients with cholecystolithiasis and calculus of common bile duct after laparoscopic common bile duct exploration(LCBDE)with one-stage suture,and explore the high-risk factors of its occurrence,and then put forward targeted prevention strategies.Methods The clinical data of 201 patients with cholecystolithiasis and calculus of common bile duct after LCBDE with one-stage suture in our hospital from January 2020 to April 2024 were retrospectively analyzed.After 3 months of follow-up,the incidence of postoperative biliary complications was observed,and the clinical data of patients in the biliary complications group and the non-biliary complications group were analyzed.The factors with statistically significant differences were included in the multivariate Logistic regression model to analyze the independent risk factors affecting the occurrence of patients with cholecystolithiasis and calculus of common bile duct after LCBDE with one-stage suture.Results Among the 201 patients,12 had biliary tract infection,5 had common bile duct stenosis,and 13 had bile leakage.The total incidence of biliary complications was 14.93%(30/201).Multivariate Logistic regression analysis showed that diabetes mellitus((OR)=1.092,95%CI:1.040～1.147),common bile duct diameter<1 cm((OR)=1.097,95%CI:1.053～1.144),stone incarceration at the lower end of common bile duct((OR)=1.120,95%CI:1.062～1.180),Calot triangle adhesion((OR)=1.099,95%CI:1.042～1.158),bile turbidity((OR)=1.082,95%CI:1.043～1.123)and operation time≥2 h((OR)=1.090,95%CI:1.044～1.138)were independent risk factors for patients with cholecystolithiasis and calculus of common bile duct after LCBDE with one-stage suture(P<0.05).Conclusion The risk of patients with cholecystolithiasis and calculus of common bile duct after LCBDE with one-stage suture is high.The occurrence of complications is related to diabetes mellitus,common bile duct diameter<1 cm,stone incarceration at the lower end of the common bile duct,Calot triangle adhesion,bile turbidity and operation time≥2 h.Targeted prevention strategies can be formulated clinically to prevent the occurrence of biliary complications.

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.

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.

Objective To evaluate the impact and clinical significance of NOD-like receptor pyrin domain-containing protein 3(NLRP3)in the activation of lipopolysaccharide(LPS)-induced BV2 microglia cells.Methods shRNA plasmids were devised for BV2 microglia transfection,and the most effective transfection segment was identified via RT-PCR and Western blot assays.NLRP3 expression in the cell line was detected by Western blotting,while light microscopy was used to observe morpho-logical alterations in BV2 cells transfected with NLRP3-shRNA.Furthermore,enzyme-linked immunosorbent assay(ELISA)was used to quantify levels of inflammatory cytokines IL-18,IL-1β,TNF-α and NO in cell supernatants.Immunofluorescence staining was used to observe the expression and localization of microglial activation markers iNOS,Arg-1,Iba1,and NLRP3.Results NLRP3 was highly expressed in LPS-induced BV2 cells.The Western blot result showed that the mRNA expression level was the lowest and transfection was the least effective in NLRP3-mus-727 group.Microscopic examination revealed a round or short spindle-shaped morphology in BV2 cells transfected with shNLRP3,which was akin to resting state cells in the blank control group.ELISA showed that pro-inflammatory mediators IL-18,IL-1β,TNF-α and NO levels were decreased in BV2 cells trans-fected with shNLRP3(all P＜0.05).Immunofluorescence staining indicated a relative decrease in iNOS and Iba1 expression,with an upregulation of Arg-1 in BV2 cells transfected with shNLRP3.Conclusion NLRP3 is highly expressed in LPS-induced BV2 cells.Inhibition of NLRP3 expression can suppress the inflammatory response of BV2 cells induced by LPS,promoting their polarization towards the M2 phenotype.

Objective:To investigate the current status and longitudinal development trajectory of postoperative cognitive dysfunction (POCD) in elderly patients undergoing hip replacement surgery and analyze the relationship between POCD and postoperative hip joint function recovery.Methods:Using the convenient sampling method, elderly patients who underwent hip replacement surgery in Department of Orthopedics in the First Affiliated Hospital of Zhengzhou University from January 2021 to March 2022 were selected as the research objects. The cognitive function at 1 week, 1 month, 2 months and 3 months after surgery was assessed using Mini-Mental State Examination (MMSE), and the longitudinal development trajectory of postoperative POCD was fitted using latent class growth model (LCGM). The differences between cognitive function categories and Oxford Hip Score (OHS) score at 3 months after surgery were compared by ANOVA.Results:A total of 307 elderly patients with hip replacement completed full follow-up and data collection. The incidence of POCD (MMSE<8 points) in patients at four postoperative time points was 30.29% (93/307), 29.97% (92/307), 28.66% (88/307) and 21.17% (65/307), respectively. The MMSE score was lowest at 1 week after surgery. Three potential categories of cognitive function longitudinal development tracks were identified by LCGM, including 208 cases (67.75%) with no cognitive dysfunction, 32 cases (10.42%) with improved cognitive dysfunction, and 67 cases (21.82%) with continuous cognitive dysfunction. Three months after surgery, patients with no cognitive impairment had the lowest OHS score, while patients with persistent cognitive impairment had the highest OHS score. There were statistically significant differences in OHS scores among patients with three longitudinal potential categories of cognitive function ( P<0.05) . Conclusions:The incidence of POCD in elderly patients with hip replacement varies at different postoperative times, with the most significant difference occurring at 1 week after surgery. Medical staff must dynamically evaluate the postoperative cognitive function of elderly patients and adopt targeted nursing strategies for different types of cognitive impairments, to promote the patient's recovery of hip function.

Objective To investigate the influencing factors and imaging characteristics of medial meniscus posterior horn root tear with displacement caused by military training.Methods The clinical data and magnetic resonance imaging(MRI)characteristics of 102 patients with root tears of the posterior horn of the medial meniscus confirmed by arthroscopy in Hebei Provincial Armed Police Corps Hospital from July 2020 to June 2022 were retrospectively analyzed.There were 84 males and 18 females with a mean age of(33.06±5.72)years(21-45 years).According to the displacement after tear,the patients were divided into displacement group(n=35)and non-displacement group(n=67).The clinical data and imaging characteristics were compared between groups.Multivariate regression analysis was used to analyze the risk factors of medial meniscus posterior horn root tear combined with displacement caused by military training.The diagnostic efficacy of MRI for the root tear of medial meniscus posterior horn with displacement was evaluated.Results The absolute amount of meniscus prolapse,the relative rate of meniscus prolapse and the proportion of patients with grade Ⅲ/Ⅳ cartilage degeneration of medial tibial plateau in the displacement group were significantly higher than those in the non-displacement group(P<0.05).Multivariate regression analysis showed that the absolute amount of meniscus prolapse(OR=2.971,95%CI:1.142-8.733),the relative rate of meniscus prolapse(OR=3.177,95%CI:1.227-9.261),and grade Ⅲ/Ⅳ cartilage degeneration of the medial tibial plateau(OR=2.930,95%CI:1.125-7.632)were related to medial meniscus posterior horn root tear with displacement caused by military training(P<0.05).Receiver operating characteristic curve analysis showed that the sensitivity,specificity and area of the curve(AUC)of MRI in the diagnosis of medial meniscus posterior horn root tear with displacement were 85.71%(95%CI:68.96%-94.62%),91.04%(95%CI:80.88%-96.31%)and 0.884(95%CI:0.805-0.939),respectively.Conclusion Medial meniscus posterior horn root tear with displacement caused by military training is related to MRI imaging parameters such as absolute amount of meniscus prolapse,relative of meniscus prolapse rate,and cartilage degeneration of medial tibial plateau.MRI has a high diagnostic efficiency for medial meniscus posterior horn root tear with displacement.