1.Analysis of risk factors and construction of risk prediction model for batroxobin-related severe hypofibrinogenemia
Le CAI ; Yuqing ZHAO ; Jiazhu CUI ; Xiao WEN ; Daihong GUO ; Man ZHU
China Pharmacy 2026;37(4):462-467
OBJECTIVE To investigate the clinical characteristics and risk factors for batroxobin-related severe hypofibrinogenemia (HFIB) and construct a risk prediction model. METHODS A retrospective analysis was conducted on inpatients treated with batroxobin in the First Medical Center of a tertiary hospital from January 1, 2020, to December 31, 2024. Patients were categorized into non-severe HFIB group and severe HFIB group based on the severity of HFIB. Univariate and multivariate Logistic regression analyses were performed to identify the independent influencing factors for batroxobin-related severe HFIB. A nomogram was developed using the “rms” package in R 4.5 software. The predictive performance of the model was evaluated using the receiver operating characteristic curve. Calibration was assessed via the Bootstrap resampling method, and goodness-of-fit was evaluated with the Hosmer-Lemeshow test. RESULTS A total of 1 472 patients were included in this study. Of these, 1 445 developed HFIB, yi elding an incidence of 98.17%. Furthermore, 895 were classified as severe HFIB, accounting for 60.80% of the cohort. Multivariate Logistic regression analysis showed that increased age, high initial dose per 10 kg body weight, use of maintenance dose, and concomitant glucocorticoid use were independent risk factors for batroxobin-related severe HFIB, while high baseline fibrinogen (FIB) level was identified as a protective factor. The model demonstrated an area under the curve of 0.760 (95% CI: 0.735-0.785). The mean absolute error of the calibration curve was 0.006. The P value of the Hosmer-Lemeshow test was 0.609. CONCLUSIONS Batroxobin can rapidly and significantly reduce FIB levels and carries a risk of inducing severe HFIB. Patients with advanced age, high initial dose per 10 kg body weight, use of maintenance dose and concomitant glucocorticoid use had a higher risk of batroxobin-related severe HFIB, while high baseline FIB level had a lower risk of batroxobin-related severe HFIB. The risk prediction model developed based on these factors can be used to predict the likelihood of batroxobin-related severe HFIB.
2.Establishment of a high-risk medication list and preventive and therapeutic measures for drug-induced hypofi-brinogenemia based on the Delphi method
Xiao WEN ; Le CAI ; Ning LIU ; Ao GAO ; Man ZHU
China Pharmacy 2026;37(7):848-853
OBJECTIVE To establish a high-risk medication list and preventive and therapeutic measures for drug-induced hypofibrinogenemia, and to provide a reference for the prevention and treatment of this condition. METHODS By integrating domestic and international case reports, retrospective case-control studies, and spontaneous adverse drug reaction reporting databases, 19 domestically marketed high-risk drugs for drug-induced hypofibrinogenemia were identified. Based on the clinical characteristics and mechanisms of these drugs, relevant risk factors were systematically reviewed, and existing treatment options were summarized, leading to the preliminary development of recommended preventive and therapeutic measures. A two-round Delphi consultation was conducted to evaluate, revise, and ultimately reach consensus on the preliminary findings, using a mean importance score of ≥3.5 points for indicators and a coefficient of variation <0.3 as screening criteria. RESULTS The coefficient of expert authority for both rounds of expert consultation was 0.904. In the first round, the Kendall coordination coefficients (Kendall’s W ) for the high-risk medication list and the proposed preventive and therapeutic measures were 0.390 and 0.223 ( P <0.05), respectively. In the second round, the Kendall’s W were 0.227 and 0.200 ( P <0.05), respectively. After two rounds of expert consultation and discussion, 11 high-risk drugs for drug-induced hypofibrinogenemia, represented by hemocoagulase and certain anti-infective agents, were ultimately identified, along with 5 preventive and therapeutic measures spanning the entire process of “pre-medication assessment, intra-medication monitoring, and bleeding event management”. CONCLUSIONS This study has established a scientific and reliable high-risk medication list, and corresponding preventive and therapeutic measures for drug-induced hypofibrinogenemia, providing a theoretical basis and practical support for the early identification, stratified management, and precise intervention of this condition.
3.Analysis of the hotspots and advantages of adverse drug reaction automatic monitoring system based on CiteSpace and systematic review
Yan WANG ; Le KANG ; Wen CHEN ; Qi FANG ; Zhongwang YU ; Li CAO
Journal of Pharmaceutical Practice and Service 2026;44(7):362-369
Objective To provide a reference for the establishment, development and application of the adverse drug reaction (ADR) automated monitoring system, through verifying and quantifying the research hotspots and advantages of the system by CiteSpace software and systematic review. Methods Literature on ADR automated monitoring up to December 2023 were retrieved and screened from CNKI and web of science databases. CiteSpace 6.4.R1 software was used to conduct co-occurrence, clustering and emergence analysis, and to visualize and comparatively analyze the research hotspots, rules and distribution in the field of automated monitoring of ADR at home and abroad. In compliance with the preferred reporting items for systematic reviews and Meta-analyses (PRISMA), literature covering publications in English and Chinese including detection rates of ADR collected using Incident Reporting Systems (IRSs) and/or automated monitoring systems were retrieved and screened. The advantages and disadvantages of automated monitoring systems were analyzed by comparing the differences between these two systems in terms of the number of ADR reports and the types of positive signals. Results A total of 56 articles in English and 80 articles in Chinese were indexed by CiteSpace. The research hotspots in recent years included data mining, deep learning, text classification techniques, machine learning and so on. A total of seven studies compiled with the inclusion criteria for the systematic evaluation, all of which were completed between 1991 and 2021 in hospitals in four countries. 150 526 medical records were reviewed from 15 institutions. A total of 194 ADR reports were collected by IRSs. A total of 2 090 ADR reports were collected by the automated monitoring system over the same period, indicating a 977% increase in the number of ADR reports (P=0.0156) compared with the IRSs. Conclusion The ADR automatic monitoring system had significantly improved the level of drug risk identification and reduced costs, but it was necessary to optimize the algorithm, expand the data source and carry out standardization construction to overcome the current limitations.
4.Regulated cell death in age-related macular degeneration: Regulatory mechanisms and therapeutic potential.
Le-Le ZHANG ; Jia-Mei YU ; Zhong-Xi FAN ; Wen-Qi XIE ; Liang ZOU ; Feiya SHENG
Journal of Pharmaceutical Analysis 2025;15(11):101285-101285
Age-related macular degeneration (AMD) represents a predominant cause of blindness among older adults, with limited therapeutic options currently available. Oxidative stress, inflammation, and retinal pigment epithelium injury are recognized as key contributors to the pathogenesis of AMD. Regulated cell death plays a pivotal role in mediating cellular responses to stress, maintaining tissue homeostasis, and contributing to disease progression. Recent research has elucidated several regulated cell death pathways-such as apoptosis, ferroptosis, pyroptosis, necroptosis, and autophagy-that may contribute to the progression of AMD owing to cell death in the retinal pigment epithelium. These discoveries open new avenues for therapeutic interventions in patients with AMD. In this review, we provide a comprehensive summary and analysis of the latest advancements regarding the relationship between regulated cell death and AMD. Moreover, we examined the therapeutic potential of targeting regulated cell death pathways for the treatment and prevention of AMD, highlighting their roles as promising targets for future therapeutic strategies.
5.Association of Co-Exposure to Polycyclic Aromatic Hydrocarbons and Metal(loid)s with the Risk of Neural Tube Defects: A Case-Control Study in Northern China.
Xiao Qian JIA ; Yuan LI ; Lei JIN ; Lai Lai YAN ; Ya Li ZHANG ; Ju Fen LIU ; Le ZHANG ; Linlin WANG ; Ai Guo REN ; Zhi Wen LI
Biomedical and Environmental Sciences 2025;38(2):154-166
OBJECTIVE:
Exposure to polycyclic aromatic hydrocarbons (PAHs) or metal(loid)s individually has been associated with neural tube defects (NTDs). However, the impacts of PAH and metal(loid) co-exposure and potential interaction effects on NTD risk remain unclear. We conducted a case-control study in China among population with a high prevalence of NTDs to investigate the combined effects of PAH and metal(loid) exposures on the risk of NTD.
METHODS:
Cases included 80 women who gave birth to offspring with NTDs, whereas controls were 50 women who delivered infants with no congenital malformations. We analyzed the levels of placental PAHs using gas chromatography and mass spectrometry, PAH-DNA adducts with 32P-post-labeling method, and metal(loid)s with an inductively coupled plasma mass spectrometer. Unconditional logistic regression was employed to estimate the associations between individual exposures and NTDs. Least absolute shrinkage and selection operator (LASSO) penalized regression models were used to select a subset of exposures, while additive interaction models were used to identify interaction effects.
RESULTS:
In the single-exposure models, we found that eight PAHs, PAH-DNA adducts, and 28 metal(loid)s were associated with NTDs. Pyrene, selenium, molybdenum, cadmium, uranium, and rubidium were selected through LASSO regression and were statistically associated with NTDs in the multiple-exposure models. Women with high levels of pyrene and molybdenum or pyrene and selenium exhibited significantly increased risk of having offspring with NTDs, indicating that these combinations may have synergistic effects on the risk of NTDs.
CONCLUSION
Our findings suggest that individual PAHs and metal(loid)s, as well as their interactions, may be associated with the risk of NTDs, which warrants further investigation.
Humans
;
Neural Tube Defects/chemically induced*
;
Polycyclic Aromatic Hydrocarbons/adverse effects*
;
Female
;
Case-Control Studies
;
China/epidemiology*
;
Adult
;
Pregnancy
;
Environmental Pollutants
;
Maternal Exposure/adverse effects*
;
Metals/toxicity*
;
Young Adult
;
Risk Factors
6.Analysis of Serum Metabolic Biomarkers in Adult Patients with Kashin-Beck Disease and Degenerative Osteoarthritis in Qinghai Province.
Jia le XU ; Qiang LI ; Chuan LU ; Xin ZHOU ; Yan Mei ZHAO ; Jian Ling WANG ; Ji Quan LI ; Li MA ; Zhi Jun ZHAO ; Ke Wen LI
Biomedical and Environmental Sciences 2025;38(9):1173-1177
7.A prospective controlled study on degenerative lumbar spondylolisthesis treated with three steps and nine methods combined with physiotherapy.
Shu-Ming ZHANG ; Jia-le ZHENG ; Huan-Huan GU ; Jin-Hai XU ; Wen MO
China Journal of Orthopaedics and Traumatology 2025;38(8):769-778
OBJECTIVE:
To explore the clinical efficacy and safety of the "Three-Step Nine-Method Lumbar Correction" combined with physical therapy in the treatment of patients with degenerative lumbar spondylolisthesis(DLS).
METHODS:
From January 2021 to December 2021, 72 patients diagnosed with DLS were enrolled and divided into the Three-Step Nine-Method Lumbar Correction group and the pelvic traction group, with 36 cases in each group. In the Three-Step Nine-Method Lumbar Correction group, there were 15 males and 21 females;aged 54 to 66 years old, with an average of (59.07±5.69) years old;the course of disease was 14 to 26 years old, with an average of (20.35±5.66) years old. They were treated with the Three-Step Nine-Method Lumbar Correction combined with low-frequency physical therapy, 3 times a week, for a 4-week course. In the pelvic traction group, there were 12 males and 24 females;aged 54 to 66 years old, with an average of (59.69±5.59) years old;the course of disease was 13 to 26 years old, with an average of (19.74±5.80) years old. They were treated with pelvic traction combined with low-frequency physical therapy. Efficacy evaluation was conducted using the visual analogue scale(VAS), Oswestry disability index(ODI), Japanese Orthopaedic Association (JOA) score, and Short Form 36 Health Survey (SF-36) before treatment, after 2 and 4 weeks of treatment, and at the 8-week follow-up after the end of treatment. In addition, imaging parameters of paravertebral muscles were evaluated before treatment and at the completion of treatment.
RESULTS:
All 72 patients completed the follow-up for 8 weeks. At the 8-week follow-up after the end of treatment, in the Three-Step Nine-Method Lumbar Correction group, the VAS score for low back pain decreased from (6.25±1.23) points before treatment to (1.25±0.65) points, with a statistically significant difference (P<0.05);the ODI decreased from (57.17±7.13)% before treatment to (19.89±5.66)%, with a statistically significant difference (P<0.05);the JOA score and SF-36 score increased from (15.46±3.20) points and (35.25±9.28) points before treatment to (23.75±2.10) points and (62.31±13.03) points, respectively, with statistically significant differences (P<0.05). The improvement of each index in the Three-Step Nine-Method Lumbar Correction group was better than that in the pelvic traction group (P<0.05), but the change in imaging parameters was not significant (P>0.05). There was no statistically significant difference in the incidence of adverse reactions between the two groups (P>0.05), and no serious adverse events occurred.
CONCLUSION
The Three-Step Nine-Method Lumbar Correction combined with physical therapy has a definite efficacy in the treatment of DLS. It can significantly relieve pain symptoms, improve physical function and patients' quality of life. Its effect is better than that of pelvic traction combined with physical therapy, and it has high safety. However, its improvement on paravertebral muscles is not obvious.
Humans
;
Male
;
Female
;
Middle Aged
;
Spondylolisthesis/physiopathology*
;
Aged
;
Prospective Studies
;
Lumbar Vertebrae/physiopathology*
;
Physical Therapy Modalities
;
Adult
8.YOLOX-SwinT algorithm improves the accuracy of AO/OTA classification of intertrochanteric fractures by orthopedic trauma surgeons.
Xue-Si LIU ; Rui NIE ; Ao-Wen DUAN ; Li YANG ; Xiang LI ; Le-Tian ZHANG ; Guang-Kuo GUO ; Qing-Shan GUO ; Dong-Chu ZHAO ; Yang LI ; He-Hua ZHANG
Chinese Journal of Traumatology 2025;28(1):69-75
PURPOSE:
Intertrochanteric fracture (ITF) classification is crucial for surgical decision-making. However, orthopedic trauma surgeons have shown lower accuracy in ITF classification than expected. The objective of this study was to utilize an artificial intelligence (AI) method to improve the accuracy of ITF classification.
METHODS:
We trained a network called YOLOX-SwinT, which is based on the You Only Look Once X (YOLOX) object detection network with Swin Transformer (SwinT) as the backbone architecture, using 762 radiographic ITF examinations as the training set. Subsequently, we recruited 5 senior orthopedic trauma surgeons (SOTS) and 5 junior orthopedic trauma surgeons (JOTS) to classify the 85 original images in the test set, as well as the images with the prediction results of the network model in sequence. Statistical analysis was performed using the SPSS 20.0 (IBM Corp., Armonk, NY, USA) to compare the differences among the SOTS, JOTS, SOTS + AI, JOTS + AI, SOTS + JOTS, and SOTS + JOTS + AI groups. All images were classified according to the AO/OTA 2018 classification system by 2 experienced trauma surgeons and verified by another expert in this field. Based on the actual clinical needs, after discussion, we integrated 8 subgroups into 5 new subgroups, and the dataset was divided into training, validation, and test sets by the ratio of 8:1:1.
RESULTS:
The mean average precision at the intersection over union (IoU) of 0.5 (mAP50) for subgroup detection reached 90.29%. The classification accuracy values of SOTS, JOTS, SOTS + AI, and JOTS + AI groups were 56.24% ± 4.02%, 35.29% ± 18.07%, 79.53% ± 7.14%, and 71.53% ± 5.22%, respectively. The paired t-test results showed that the difference between the SOTS and SOTS + AI groups was statistically significant, as well as the difference between the JOTS and JOTS + AI groups, and the SOTS + JOTS and SOTS + JOTS + AI groups. Moreover, the difference between the SOTS + JOTS and SOTS + JOTS + AI groups in each subgroup was statistically significant, with all p < 0.05. The independent samples t-test results showed that the difference between the SOTS and JOTS groups was statistically significant, while the difference between the SOTS + AI and JOTS + AI groups was not statistically significant. With the assistance of AI, the subgroup classification accuracy of both SOTS and JOTS was significantly improved, and JOTS achieved the same level as SOTS.
CONCLUSION
In conclusion, the YOLOX-SwinT network algorithm enhances the accuracy of AO/OTA subgroups classification of ITF by orthopedic trauma surgeons.
Humans
;
Hip Fractures/diagnostic imaging*
;
Orthopedic Surgeons
;
Algorithms
;
Artificial Intelligence
9.Prognostic Value of CDKN2A Copy Number Deletion in Patients with Diffuse Large B-Cell Lymphoma.
Wei-Yuan MA ; Le-Tian SHAO ; Wen-Xin TIAN ; Sha LIU ; Yan LI
Journal of Experimental Hematology 2025;33(2):379-386
OBJECTIVE:
To investigate the relationship between CDKN2A copy number deletion and clinical features of patients with diffuse large B-cell lymphoma (DLBCL) and its prognostic value.
METHODS:
155 newly diagnosed DLBCL patients with complete clinical data in the Department of Hematology of People's Hospital of Xinjiang Uygur Autonomous Region from March 2009 to March 2022 were included, formalin-fixed paraffin-embedded tumor tissues were obtained and DNA was extracted from them, and next-generation sequencing technology was applied to target sequencing including 475 lymphoma-related genes, the relationship between CDKN2A copy number deletion and clinical features, high-frequency mutated genes and overall survival (OS) of DLBCL patients were analyzed.
RESULTS:
CDKN2A copy number deletion was present in 12.9% (20/155) of 155 DLBCL patients, grouped according to the presence or absence of copy number deletion of CDKN2A, and a higher proportion of patients with IPI≥3 were found in the CDKN2A copy number deletion group compared to the group with no CDKN2A copy number deletion (80% vs 51.5%, P =0.015) and were more likely to have bulky disease (20% vs 5.2%, P =0.037). Survival analysis showed that the 5-year OS of patients in the CDKN2A copy number deletion group was significantly lower than that of the non-deletion group (51.3% vs 69.2%, P =0.047). Multivariate Cox analysis showed that IPI score≥3 (P =0.007), TP53 mutation (P =0.009), and CDKN2A copy number deletion (P =0.04) were independent risk factors affecting the OS of DLBCL patients.
CONCLUSION
CDKN2A copy number deletion is an independent risk factor for OS in DLBCL, and accurate identification of CDKN2A copy number deletion can predict the prognosis of DLBCL patients.
Humans
;
Lymphoma, Large B-Cell, Diffuse/genetics*
;
Prognosis
;
Cyclin-Dependent Kinase Inhibitor p16/genetics*
;
DNA Copy Number Variations
;
Female
;
Male
;
Middle Aged
;
Gene Deletion
;
Adult
;
Aged
10.Efficacy and Safety of Decitabine-Based Myeloablative Preconditioning Regimen for allogeneic Hematopoietic Stem Cell Transplantation in Patients with Acute Myeloid Leukemia.
Xia-Wei ZHANG ; Jing-Jing YANG ; Ning LE ; Yu-Jun WEI ; Ya-Nan WEN ; Nan WANG ; Yi-Fan JIAO ; Song-Hua LUAN ; Li-Ping DOU ; Chun-Ji GAO
Journal of Experimental Hematology 2025;33(2):557-564
OBJECTIVE:
To analyze the efficacy and safety of decitabine-based myeloablative preconditioning regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with acute myeloid leukemia (AML).
METHODS:
The clinical characteristics and efficacy of 115 AML patients who underwent allo-HSCT at the First Medical Center of Chinese PLA General Hospital from August 2018 to August 2022 were retrospectively analyzed, including 37 patients treated with decitabine conditioning regimen (decitabine group) and 78 patients without decitabine conditioning regimen (non-decitabine group). The cumulative incidence of relapse (CIR), overall survival (OS), leukemia-free survival (LFS), non-relapse mortality (NRM) and graft versus host disease (GVHD) were analyzed.
RESULTS:
For the patients in first complete remission (CR1) state before allo-HSCT, the 1-year relapse rates of decitabine group(22 cases) and non-decitabine group(69 cases) were 9.1% and 29.6%, respectively, the difference was statistically significant(P =0.042). The 1-year cumulative incidence of acute graft-versus-host disease (aGVHD) in decitabine group and non-decitabine group was 62.2% and 70.5%, respectively, and the 1-year cumulative incidence of chronic inhibitor-versus-host disease (cGVHD) was 18.9% and 14.1%, respectively, there were no significant differences in the incidence of aGVHD and cGVHD between the two groups (P >0.05). Of the 115 patients, there were no significantly differences in the 1-year CIR(21.7% vs 28.8%, P =0.866), NRM(10.9% vs 3.9%, P =0.203), OS(75.2% vs 83.8%, P =0.131) and LFS(74.6% vs 69.1%, P =0.912) between the decitabine group(37 cases) and the non-decitabine group(78 cases).
CONCLUSION
Decitabine-based conditioning regimen could reduce the relapse rate of AML CR1 patients with good safety.
Humans
;
Leukemia, Myeloid, Acute/therapy*
;
Hematopoietic Stem Cell Transplantation/methods*
;
Decitabine/therapeutic use*
;
Transplantation Conditioning/methods*
;
Retrospective Studies
;
Graft vs Host Disease
;
Transplantation, Homologous
;
Male
;
Female
;
Adult
;
Middle Aged
;
Adolescent
;
Young Adult

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