1.Risk analysis for coil adverse events based on FDA MAUDE database
Jian-wei YANG ; Lin HUANG ; Yu-juan ZHAO ; Yi XUAN ; Jian-jun CAO ; Chang-qing LIU ; Hui-fang NIU ; Xia LI
Chinese Medical Equipment Journal 2025;46(6):83-87
The coil adverse events in the U.S.Food and Drug Administration Manufacturer and User Facility Device Experience(MAUDE)database from January 2021 to June 2024 were analyzed retrospectively.The risks of coils during the clinical application and their causes were explored with hospital survey and expert demonstration in Shandong Province.Some improving measures were put forward for the safe use of coils,including implementing the main responsibility of the registrant,enhancing the professional skills of the using institutions and strengthening the supervision of the supervisory authorities.[Chinese Medical Equipment Journal,2025,46(6):83-87]
2.Recommendations for the clinical use of anti-amyloid-β monoclonal antibody for Alzheimer's disease(2025)
Nan ZHI ; Jinwen XIAO ; Rujing REN ; Binyin LI ; Jintao WANG ; Jieli GENG ; Wenwei CAO ; Yaying SONG ; Hualong WANG ; Shuguang CHU ; Guoping PENG ; Jun LIU ; Xiaoyun LIU ; Fang YUAN ; Wen WANG ; Ronghua DOU ; Xia LI ; Ling YUE ; Wenshi WEI ; Xiaoling PAN ; Xiangyang ZHU ; Dian HE ; Weinü FAN ; Jingping SHI ; Nan ZHANG ; Hui ZHAO ; Qin CHEN ; Cuibai WEI ; Xiaochun CHEN ; Gang WANG
Journal of Chongqing Medical University 2025;50(9):1133-1140
In recent years,significant breakthroughs have been achieved in the immunotherapy for Alzheimer's disease.In line with global advancements,two anti-amyloid-β monoclonal antibodies have been approved and successfully launched in China for clinical use.Lecanemab and Donanemab were officially used in June 2024 and April 2025 in China,respectively.In order to standardize the rational and safe application of anti-amyloid-β monoclonal antibodies for Alzheimer's disease in China,this article integrates recom-mendations from the clinical trials and real-world experience from the author's team and domestic peers to further update the recom-mendations for the clinical use of anti-amyloid-β monoclonal antibody based on the 2024 version.It includes indications for therapy,pre-treatment evaluation and preparation,administration protocols and safety measures during treatment,and post-treatment monitor-ing strategies.
3.Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults (version 2025)
Bobin MI ; Faqi CAO ; Weixian HU ; Wu ZHOU ; Chenchen YAN ; Hui LI ; Yun SUN ; Yuan XIONG ; Jinmi ZHAO ; Qikai HUA ; Xinbao WU ; Xieyuan JIANG ; Dianying ZHANG ; Zhongguo FU ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Tengbo YU ; Jinhai TAN ; Xi CHEN ; Fengfei LIN ; Zhangyuan LIN ; Dongfa LIAO ; Aiguo WANG ; Shiwu DONG ; Gaoxing LUO ; Zhao XIE ; Dong SUN ; Dehao FU ; Yunfeng CHEN ; Changqing ZHANG ; Kun LIU ; Deye SONG ; Yongjun RUI ; Fei WU ; Ximing LIU ; Junwen WANG ; Meng ZHAO ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Xiao CHEN ; Guandong DAI ; Shiyuan FANG ; Wenchao SONG ; Ming CHEN ; Guanghua GUO ; Yongqing XU ; Lei YANG ; Wenqian ZHANG ; Kun ZHANG ; Xin TANG ; Hua CHEN ; Weiguo XU ; Shuquan GUO ; Yong LIU ; Xiaodong GUO ; Zhewei YE ; Liming XIONG ; Tian XIA ; Hongbin WU ; Qisheng ZHOU ; Mengfei LIU ; Yiqiang HU ; Yanjiu HAN ; Hang XUE ; Kangkang ZHA ; Wei CHEN ; Zhiyong HOU ; Bin YU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Guohui LIU
Chinese Journal of Trauma 2025;41(5):421-432
Postoperative infection of internal fixation of closed fractures the lower limbs in adults represents a devastating complication, characterized by diagnostic challenges, prolonged treatment duration and high disability rates. Current management of these infections faces multiple challenges, such as difficulties in early accurate diagnosis, and various controversies about the treatment plan, leading to poor overall diagnosis and treatment results. To address these issues, based on evidence-based medicine and principles with emphasis on scientific rigor, clinical applicability and innovation, the Trauma Branch of the Chinese Medical Association, Orthopedic Branch of the Chinese Medical Doctor Association, Orthopedics Branch of the Chinese Medical Association, and Trauma Orthopedics and Polytrauma Group of the Resuscitation and Emergency Committee of the Chinese Medical Doctor Association have collaboratively organized a panel of relevant experts to develop the Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults ( version 2025). The guideline proposed 10 recommendations, aiming to provide a foundation for standardized diagnosis and treatment of postoperative infection in adults with closed lower limb fractures.
4.Efficacy and safety of vericiguat added to GDMT regimen in the treatment of heart failure with reduced ejection fraction
Xingyuan ZHAO ; Xiangyan CHEN ; Nan HU ; Liying WANG ; Hui XUE ; Zongling XIA
China Pharmacy 2025;36(17):2165-2169
OBJECTIVE To evaluate the efficacy and safety of guideline-directed medical therapy (GDMT) combined with vericiguat in treating heart failure with reduced ejection fraction (HFrEF). METHODS A retrospective study was conducted on 346 patients with HFrEF who received standardized diagnosis and treatment at the First People’s Hospital of Changzhou from January 2023 to May 2024. They were divided into standard treatment group (n=215) and vericiguat group (n=131). Patients in the standard treatment group received GDMT, while patients in the vericiguat group received GDMT combined with vericiguat. Propensity score matching (PSM) was used to balance confounding factors between two groups, and the effectiveness (including outcome and prognostic indicators) and safety (occurrence of adverse events) of both groups were evaluated. Kaplan-Meier survival curves for primary and secondary outcome events were drawn, and the influential factors of primary outcome events were screened through univariate and multivariate Cox regression analysis. RESULTS After PSM, there were 100 patients in the standard treatment group and 100 patients in the vericiguat group, and there was no statistically significant differences in baseline data between two groups (P>0.05). During a 1-year follow-up, there were statistically significant differences in the cumulative incidence of major outcome events between the standard treatment group and the vericiguat group, cumulative incidence of hospitalization events due to heart failure, changes in N-terminal pro-B-type natriuretic peptide levels before and after treatment between the standard treatment group and the vericiguat group (P<0.05). There was no statistically significant difference in the incidence of adverse events between the two groups (P>0.05). Multivariate Cox regression analysis results showed that left ventricular ejection fraction ≤35% was a risk factor for the occurrence of major outcome events within 1 year [hazard ratio (HR)= 2.090, 95% confidence interval (CI): 1.175-3.718, P=0.012], while the use of vericiguat was a protective factor for the occurrence of major outcome events within 1 year (HR=0.505, 95%CI: 0.284-0.899, P=0.020). CONCLUSIONS Compared with GDMT, GDMT combined with vericiguat can improve the clinical symptoms and prognosis of HFrEF patients, and has good safety.
5.Analyzing the heart-oriented view of the treatment of mental illness in Synopsis of Golden Chamber based on the theory of five-spirit-viscera
ZOU Peng ; Kai CHENG ; Minlong XIA ; Menghan LI ; Shuxian WANG ; Hui KONG ; Yan ZHAO ; Changming ZHAI ; Fang LU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):495-500
Mental state is an important part of the normal life activities of the human body, and it is also the most external expression and the most easily obtained information of the physical condition. The normal activities of the mind depend on the normal operation of the viscera, qi, and blood, and are a unified whole that prospers together and suffers together. The theory of the five-spirit-viscera in the Yellow Emperor’s Inner Classic revealed that the normal mental activities of the human body were dominated by the five internal organs, that is, the five internal organs were the body and the five spirits were the function. And it highlighted the viewpoint that the five internal organs store the spirits and are actually one. The heart governs the spirit and belongs to the four internal organs. On this basis, Synopsis of Golden Chamber used the internal organs to diagnose and treat mental diseases, integrating the theory of the five spirits into it, forming a unique method of diagnosis and treatment with the heart as the leading factor and regulating the qi and blood of the four internal organs. It identified the pathogenesis of diseases such as pathogenic crying, lily disease, and hysteria from five levels: heart deficiency and weak qi, heart-lung disharmony, heart-liver disharmony, the heart of the loss of the spleen nourishment, and disharmony between heart and kidney. The treatment was mainly to replenish the deficiency of the viscera and eliminate the pathogens, reflecting the characteristics of regulating the mind and calming the four internal organs. This unique view on diagnosis and treatment has profoundly influenced the diagnosis and treatment theories of mental illnesses by later doctors, and is of great significance to the current clinical treatment of such illnesses.
6.Detection method of fatty acid composition and methoxyaniline value in pharmaceutical excipient castor oil
Lulu WANG ; Rui YANG ; Xiaofeng WANG ; Xiaosong SONG ; Jing ZHAO ; Luxia ZHENG ; Lei CHEN ; Baoming NING ; Xia ZHAO ; Hui-min SUN
Drug Standards of China 2025;26(2):156-161
Objective:To establish a detection method for fatty acid composition and methoxylaniline value in pharmaceutical excipient castor oil.Methods:The detection of fatty acid composition involves pre-test of the sam-ple using the methanol sodium methylation method,followed by direct injection analysis using gas chromatography,and finally calculating the content of each fatty acid composition using the area normalization method with correction factors.The detection of methoxylaniline value is achieved by dissolving and diluting the sample with isooctane:isopropanol(8∶2,volume ratio),reacting with 4-methoxylaniline,measuring the absorbance at a wavelength of 350 nm,and calculating the methoxylaniline value.Results:Under the composition of fatty acids,the 8 kinds of fatty acids have good separation degree.The methyl ricinoleate and methyl stearate have good linear relationship in the range of 0.1-5.0 mg·mL-1.The repeatabilityand intermediate precision(RSD)ofthe determination results of each fatty acid in the sample are all less than 5%.It is also found that only α-type of linolenic acid is present in castor oil,without γ-type.In the determination of methoxyaniline value,the blank solvent does not interfere with the determination of the sample,and the repeatability RSD is 3.6%.Conclusion:The detection method for fatty acid composition and meth-oxylaniline value established in this article is accurate and reliable,and can be used for the detection of fatty acid composition and methoxylaniline value in pharmaceutical excipient castor oil.
7.Pharmacological Mechanism of Chinese Medicine in Systemic Lupus Erythematosus: A Narrative Review.
Bo-Yu ZHU ; Zhi-Chao LIU ; Zhen-Xi ZHAO ; Hui-Ping HUANG ; Na ZHANG ; Jia XIA ; Wei-Wei CHEN
Chinese journal of integrative medicine 2025;31(2):157-169
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder affecting multiple systems, characterized by the development of harmful autoantibodies and immune complexes that lead to damage in organs and tissues. Chinese medicine (CM) plays a role in mitigating complications, enhancing treatment effectiveness, and reducing toxicity of concurrent medications, and ensuring a safe pregnancy. However, CM mainly solves the disease comprehensively through multi-target and multi-channel regulation process, therefore, its treatment mechanism is often complicated, involving many molecular links. This review introduces the research progress of pathogenesis of SLE from the aspects of genetics, epigenetics, innate immunity and acquired immunity, and then discusses the molecular mechanism and target of single Chinese herbal medicine and prescription that are commonly used and effective in clinic to treat SLE.
Lupus Erythematosus, Systemic/immunology*
;
Humans
;
Medicine, Chinese Traditional
;
Drugs, Chinese Herbal/pharmacology*
;
Animals
8.Threshold-Effect Associations of Serum 25-hydroxyvitamin D on Bone Turnover Markers and GC rs2282679 Variants in Chinese Women of Childbearing Age.
Xiao Yun SHAN ; Yu Ting LI ; Xia Yu ZHAO ; Yi Chun HU ; Si Ran LI ; Hui di ZHANG ; Yang CAO ; Rui WANG ; Li Chen YANG
Biomedical and Environmental Sciences 2025;38(4):433-446
OBJECTIVE:
This study aimed to investigate possible serum 25-hydroxyvitamin D [25(OH)D] cutoffs for the associations between 25(OH)D and Bone turnover markers (BTMs), and how GC gene variation influences such cutoffs in Chinese women of childbearing age.
METHODS:
In total, 1,505 non-pregnant or non-lactating women (18-45 years) were recruited from the 2015 Chinese Adult Chronic Disease and Nutrition Surveillance. Serum 25(OH)D, osteocalcin (OC), procollagen type 1 N-terminal propeptide (P1NP), β-CrossLaps of type 1 collagen containing cross-linked C-telopeptide (β-CTX), and single nucleotide polymorphisms were determined. Locally weighted regression and smoothing scatterplot and segmented regression were performed to estimate the 25(OH)D thresholds.
RESULTS:
The median serum 25(OH)D was 16.63 (11.96-22.55) ng/mL and the prevalence of low serum 25(OH)D (< 12 ng/mL) was 25.2%. Women with the lowest 25(OH)D had the highest β-CTX. After adjustment for the confounders, 25(OH)D cutoffs for OC [14.04 (12.84-15.23) ng/mL], β-CTX [13.94 (12.49-15.39) ng/mL], and P1NP [13.87 (12.37-15.37) ng/mL] in the whole population, cutoffs for OC [12.30 (10.68-13.91) ng/mL], β-CTX [12.23 (10.22-14.23) ng/mL], and P1NP [11.85 (10.40-13.31) ng/mL] in women with the GC rs2282679 G allele, and cutoffs for OC [12.75 (11.81-13.68) ng/mL], β-CTX [13.05 (11.78-14.32) ng/mL], and P1NP [12.81 (11.57-14.06) ng/mL] in women with the GC rs2282679 T allele, were observed. Below these cutoffs, BTMs were negatively associated with 25(OH)D, while above these cutoffs, BTMs plateaued.
CONCLUSION
In Chinese women of childbearing age, there were thresholds effect of serum 25(OH)D concentrations on BTMs. The results indicated that serum 25(OH)D concentrations < 13.87 ng/mL in this population had adverse influences on maintaining bone remodeling. BTMs were suppressed at a relatively lower serum 25(OH)D in women with the GC rs2282679 G allele compared with those with the T allele.
Humans
;
Female
;
Vitamin D/blood*
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Adult
;
Middle Aged
;
Polymorphism, Single Nucleotide
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Adolescent
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Young Adult
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China
;
Biomarkers/blood*
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Bone Remodeling/genetics*
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Vitamin D-Binding Protein/genetics*
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Procollagen/blood*
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Osteocalcin/blood*
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Peptide Fragments/blood*
;
East Asian People
10.Integrating Internet Search Data and Surveillance Data to Construct Influenza Epidemic Thresholds in Hubei Province: A Moving Epidemic Method Approach.
Cai Xia DANG ; Feng LIU ; Heng Liang LYU ; Zi Qian ZHAO ; Si Jin ZHU ; Yang WANG ; Yuan Yong XU ; Ye Qing TONG ; Hui CHEN
Biomedical and Environmental Sciences 2025;38(9):1150-1154


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