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.

A retrospective analysis was performed for the clinical data of a patient with GFAP astrocytopathy that was initially misdiagnosed as viral encephalitis， and the diagnostic and therapeutic experience of this disease was summarized through a literature review.The female patient， aged 39 years， presented with headache and fever after diarrhea for 1 day， with the main manifestations of distending pain in the brain， nausea， vomiting， low‑grade fever， and right‑sided ataxia. Physical examination showed papilledema in both eyes and neck stiffness； contrast-enhanced cranial MRI showed extensive leptomeningeal enhancement； cerebrospinal fluid （CSF） analysis showed a significant increase in opening pressure and lymphocytic‑predominant pleocytosis. The patient was tested negative for common infectious pathogens and autoimmune encephalitis antibodies， and therefore， she was once misdiagnosed with viral encephalitis. After unsuccessful antiviral and antibiotic therapies， CSF and serum samples were tested positive for GFAP‑IgG antibodies， and the patient was finally diagnosed with GFAP astrocytopathy. The patient symptoms were rapidly relieved after pulse therapy with methylprednisolone （1 g/day）， and imaging reexamination showed the disappearance of leptomeningeal enhancement， with significant improvements in both intracranial pressure and CSF parameters. The patient remained asymptomatic till the last follow‑up in July 2025， and negative conversion was observed for CSF GFAP antibodies.GFAP astrocytopathy lacks specific clinical manifestations， with leptomeningeal enhancement and lymphocytic predominance in CSF as crucial clues for early diagnosis， and detection of GFAP IgG antibodies in CSF and serum is the key to a confirmed diagnosis. This disease is highly sensitive to glucocorticoid therapy， and early identification followed by standardized treatment can help to achieve a good prognosis. This disease should be differentiated from common central nervous system infections such as viral encephalitis in clinical practice to avoid treatment delay due to missed diagnosis or misdiagnosis.

BACKGROUND: While emotional distress, encompassing anxiety and depression, has been associated with negative clinical outcomes, its impact across various clinical departments and general hospitals has been less explored. Previous studies with limited sample sizes have examined the effectiveness of specific treatments (e.g., antidepressants) rather than a systemic management strategy for outcome improvement in non-psychiatric inpatients. To enhance the understanding of the importance of addressing mental health care needs among non-psychiatric patients in general hospitals, this study retrospectively investigated the impacts of emotional distress and the effects of early detection and management of depression and anxiety on hospital length of stay (LOS) and rate of long LOS (LLOS, i.e., LOS >30 days) in a large sample of non-psychiatric inpatients. METHODS: This retrospective cohort study included 487,871 inpatients from 20 non-psychiatric departments of a general hospital. They were divided, according to whether they underwent a novel strategy to manage emotional distress which deployed the Huaxi Emotional Distress Index (HEI) for brief screening with grading psychological services (BS-GPS), into BS-GPS ( n = 178,883) and non-BS-GPS ( n = 308,988) cohorts. The LOS and rate of LLOS between the BS-GPS and non-BS-GPS cohorts and between subcohorts with and without clinically significant anxiety and/or depression (CSAD, i.e., HEI score ≥11 on admission to the hospital) in the BS-GPS cohort were compared using univariable analyses, multilevel analyses, and/or propensity score-matched analyses, respectively. RESULTS: The detection rate of CSAD in the BS-GPS cohort varied from 2.64% (95% confidence interval [CI]: 2.49%-2.81%) to 20.50% (95% CI: 19.43%-21.62%) across the 20 departments, with a average rate of 5.36%. Significant differences were observed in both the LOS and LLOS rates between the subcohorts with CSAD (12.7 days, 535/9590) and without CSAD (9.5 days, 3800/169,293) and between the BS-GPS (9.6 days, 4335/178,883) and non-BS-GPS (10.8 days, 11,483/308,988) cohorts. These differences remained significant after controlling for confounders using propensity score-matched comparisons. A multilevel analysis indicated that BS-GPS was negatively associated with both LOS and LLOS after controlling for sociodemographics and the departments of patient discharge and remained negatively associated with LLOS after controlling additionally for the year of patient discharge. CONCLUSION Emotional distress significantly prolonged the LOS and increased the LLOS of non-psychiatric inpatients across most departments and general hospitals. These impacts were moderated by the implementation of BS-GPS. Thus, BS-GPS has the potential as an effective, resource-saving strategy for enhancing mental health care and optimizing medical resources in general hospitals.
Humans ; Retrospective Studies ; Male ; Length of Stay/statistics & numerical data* ; Female ; Middle Aged ; Adult ; Psychological Distress ; Inpatients/psychology* ; Aged ; Anxiety/diagnosis* ; Depression/diagnosis*

INTRODUCTION: Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD. METHODS: In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging. RESULTS: A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline. CONCLUSIONS: Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies. REGISTRATION ClinicalTrials.gov , NCT07034222.
Humans ; Alzheimer Disease/drug therapy* ; Male ; Female ; Aged ; Middle Aged ; Cognitive Dysfunction/drug therapy* ; Aged, 80 and over ; Amyloid beta-Peptides/metabolism* ; Biomarkers ; East Asian People

Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C₀), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug‍-‍drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage* ; Drug Monitoring/methods* ; Humans ; Organ Transplantation ; Immunosuppressive Agents/administration & dosage* ; Delphi Technique

Alzheimer's disease (AD) is the most prevalent neurodegenerative disorder worldwide, causing dementia and affecting millions of individuals. One prominent characteristic in the brains of AD patients is glucose hypometabolism. In the context of galactose metabolism, intracellular glucose levels are heightened. Galactose mutarotase (GALM) plays a crucial role in maintaining normal galactose metabolism by catalyzing the conversion of β-D-galactose into α-D-galactose (α-D-G). The latter is then converted into glucose-6-phosphate, improving glucose metabolism levels. However, the involvement of GALM in AD progression is still unclear. In the present study, we found that the expression of GALM was significantly increased in AD patients and model mice. Genetic knockdown of GALM using adeno-associated virus did not change the expression of amyloid precursor protein (APP) and APP-cleaving enzymes including a disintegrin and metalloprotease 10 (ADAM10), β-site APP-cleaving enzyme 1 (BACE1), and presenilin-1 (PS1). Interestingly, genetic overexpression of GALM reduced APP and Aβ deposition by increasing the maturation of ADAM10, although it did not alter the expression of BACE1 and PS1. Further electrophysiological and behavioral experiments showed that GALM overexpression significantly ameliorated the deficits in hippocampal CA1 long-term potentiation (LTP) and spatial learning and memory in AD model mice. Importantly, direct α-D-G (20 mg/kg, i.p.) also inhibited Aβ deposition by increasing the maturation of ADAM10, thereby improving hippocampal CA1 LTP and spatial learning and memory in AD model mice. Taken together, our results indicate that GALM shifts APP processing towards α-cleavage, preventing Aβ generation by increasing the level of mature ADAM10. These findings indicate that GALM may be a potential therapeutic target for AD, and α-D-G has the potential to be used as a dietary supplement for the prevention and treatment of AD.
Animals ; ADAM10 Protein/metabolism* ; Alzheimer Disease/pathology* ; Amyloid Precursor Protein Secretases/metabolism* ; Disease Models, Animal ; Humans ; Mice ; Amyloid beta-Peptides/metabolism* ; Male ; Mice, Transgenic ; Membrane Proteins/metabolism* ; Cognitive Dysfunction/pathology* ; Mice, Inbred C57BL ; Amyloid beta-Protein Precursor/metabolism* ; Female ; Hippocampus/metabolism* ; Long-Term Potentiation/physiology*

OBJECTIVE To explore the construction path and effectiveness of dynamic zoning management model during dengue fever pandemic,and to provide evidence for optimizing hospital-acquired infection control strategies.METHODS Retrospective analysis method was conducted,the practical data of dengue fever epidemic prevention and control in a tertiary general hospital in 2024 as the sample,to evaluate the application effect of the"zoned treatment-dynamic allocation-environmental coordination"trinity prevention and control model.Based on the optimized infection prevention and control strategies implemented during the epidemic,such as the"core ward-specialist collaboration"dynamic zoning,flexible ward expansion,hierarchical disinfection,real-time dynamic re-source allocation mechanism,and precise environmental intervention,a comprehensive evaluation of prevention and control efficiency was conducted across key dimensions including infection control,resource utilization,pre-vention and control costs and patient outcomes.RESULTS Through the construction of flexible wards,the number of expanded isolation beds accounted for 44.13％(331/750)of the total beds,including 144 beds(19.20％)in core wards and 187 beds(24.93％)in specialist collaborative wards.The expansion of specialist collaborative wards increased the isolation admission capacity by 129.86％.The two types of wards admitted 57.27％of single-disease dengue patients and 42.73％of isolated patients with combined diagnosis and treatment needs from inter-nal medicine,surgery,obstetrics,gynecology,and pediatrics.The minimum ratio of flexible buffer isolation beds was 6.34％(21/331),with a maximum daily treatment capacity of 310 patients.Data showed:hospital infec-tion incidence rate was 0,peak adult mosquito density was 0.13 mosquitoes/trap·night,prevention and control cost was 95.22 yuan per case,and patient satisfaction increased by 1.98％(95.09 vs.93.24,P=0.014).CONCLUSIONS The"dynamic zoning"model achieves rapid spatial elastic reconstruction of inpatient wards for"peace-epidemic conversion"through the coordination of three links.Based on effectively blocking in-hospital transmission,it ensures the needs of multi-specialty treatment,enabling the hospital to strike a balance between the bottom line of prevention and control safety and the fulfillment of diversified medical service requirements dur-ing the epidemic outbreak period.It can provide standardized prevention and control solutions for medical institu-tions to respond to public health emergencies of vector-borne infectious diseases,and achieve the goal of zero cross infection of hospital-acquired Dengue.

Volatile organic compounds (VOCs) are a type of organic compounds that exist in the form of vapor in the air at room temperature, and are common pollutants in industrial production and living environments. The health hazards caused by exposure to VOCs are gradually gaining recognition and social attention. At present, the research on the harm of VOCs to human health mainly involves the respiratory system, cardiovascular system and nervous system. However, in recent years, people have realized that VOCs can induce glucose metabolism disorder through insulin resistance, oxidative stress and oxidative damage, inflammatory reaction and liver damage, leading to increased blood sugar and increased potential risk of diabetes, and even increased the risk of complications of diabetes. This review summarizes the epidemiology and related mechanisms of VOCs, diabetes and its complications, providing a reference for effective prevention and control of VOC induced diabetes.

Objective:To investigate the number of medical institutions and staff involved in 131I diagnosis and therapy in China, and to ascertain the level of 131I activity incorporated in thyroid of medical staff performing the 131I treatment. Methods:Questionnaires were used to investigate the basic information on nuclear medicine practices in all the non-military hospitals in China. Portable gamma spectrometers were used to determine and analyze the 131I activity in thyroid of the medical staff in some radioiodine treatment workplaces. The result were reported through National Radiological Health Information Platform. Results:Until December 2022, there had been 959 hospitals performing clinical nuclear medicine practices in China, with a total of 10 820 medical staff. In China, there have been 623 hospitals performing 131I therapeutical procedures, accounting for 65.0% of all nuclear medicine hospitals, and 333 hospitals performing 131I treatment of thyroid cancer, accounting for 34.7%. The hospitals equipped with automated radiopharmaceutical dispenser accounted for 61.3% of the 623 hospitals. A total of 2 210 nuclear medicine staff were monitored for internal exposure in 20 provinces in 2022, with 249 (11.3%) having activities above 100 Bq and the maximum value of 2.9 × 10 4 Bq. A total of 426 nuclear medicine staff in four provinces were detected using HPGe detectors, with 101 (23.7%) detected to have 131I in their thyroid glands. A total of 1 748 in 17 provinces were detected using NaI or LaBr detectors, with 379 (21.2%) detected to have 131I in their thyroid glands. The detection rate of 131I in the staff was found to increase with the increased amount of 131I purchased by hospitals. The detection rate of 131I in the hosptitals having purchased the amount of 131I≥3.70 × 10 6 MBq in 2021 was 32.1%. This value was notably higher than in the other three groups whose purchased amount <3.70 × 10 6 MBq, with a statistically significant difference( χ2=15.46, P < 0.001). Conclusions:There were great differences in the number of both hospitals and staff performing 131I treatment between different provinces in China. About one fifth of the staff in the 131I treatment workplaces could be detected to have incorporated 131I in their thyroid glands.