1.Analysis and study on clinical blood transfusion of 4 157 patients with emergency transfusion
Jie SUN ; Yunhua SUN ; Renyu WANG ; Gang FAN ; Hongji FAN ; Dongfu XIE ; Junjie LIN
Chinese Journal of Blood Transfusion 2026;39(2):203-208
Objective: To provide evidence for improving emergency blood supply protocols by analyzing the clinical characteristics and disease distribution of emergency transfusion patients, especially those receiving≥10 units of red blood cells (RBCs). Methods: The data of 4 157 patients who urgently applied for large-volume blood transfusion in various hospitals in Shanghai from May 2024 to April 2025 were selected and analyzed statistically. Results: Tertiary gradeA hospitals accounted for the largest proportion of total transfusion volume (U) (48.79%, 8 420/17 256.5), with no statistically significant differences in RBC transfusion volumes among hospitals of different grades (P>0.05). All blood products are most widely used in tertiary hospitals. Obstetric blood transfusion (U)(19.07%, 3 277.5/17 190.5) was the most frequent. A-mong the hospitals of patients who received emergency blood transfusion with red blood cell suspension≥10 U, tertiary gradeA hospitals also had the largest transfusion volume (U)(47.19%, 1 107/2 346). In terms of disease types, the top three diseases in terms of blood transfusion volume (U) were obstetric transfusion (24.59%, 572/2 326), digestive diseases (14.53%, 338/2 326) and tumors (14.19%, 330/2 326). Conclusion: Tertiary grade A hospitals are the main demand units for emergency blood transfusion, with pregnant women and cancer patients being the core blood-using groups. It is suggested that the safety, timeliness and sufficiency of emergency blood transfusion be guaranteed by establishing a hierarchical blood supply mechanism, formulating single-disease blood transfusion plans and promoting precise blood transfusion guided by thromboelastography.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
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.
3.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
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.
4.Efficacy and safety of anlotinib combined with ICI as first-line treatment for advanced lung squamous cell carcinoma: a single-center retrospective cohort study of 37 patients
LIN Yong1△ ; XIAO Chunmei2△ ; XIE Qiang2 ; CHEN Qun2 ; SHI Qin2 ; LUO Yang2 ; HU Ying2 ; LIN Heng2
Chinese Journal of Cancer Biotherapy 2026;33(2):155-162
[摘 要] 目的:探讨安罗替尼联合免疫检查点抑制剂(ICI)作为一线方案治疗晚期肺鳞状细胞癌(LUSC)的有效性及安全性。方法:采用单中心回顾性队列设计,连续纳入2018年10月至2023年12月福建省福州肺科医院收治的37例初治晚期LUSC患者。所有患者接受安罗替尼(剂量为8、10或12 mg/d,用药2周/停药1周)联合ICI治疗。主要终点为无进展生存期(PFS),次要终点包括客观缓解率(ORR)、疾病控制率(DCR)及治疗相关不良事件(TRAE)。结果:全组患者中位随访15.2个月,ORR达54.1%(20/37),DCR为97.3%(36/37),中位PFS为11.8个月(95%CI:8.3~NA),12个月PFS率为48.6%。探索性亚组分析显示:安罗替尼12 mg剂量组的中位PFS(未达到 vs 7.5个月,HR = 0.09,95%CI:0.01~0.67,P < 0.01)及ORR(100% vs 42.9%,P < 0.01)均显著优于8/10 mg组。分期分层显示ⅢB/ⅢC期患者ORR显著优于Ⅳ期(84.6% vs 41.7%,P = 0.02)。安全性方面,62.2%(23/37)的患者发生TRAE,以1~2级高血压[29.7%(11/37)]、手足综合征[21.6%(8/37)]为主,3例(8.1%)因3级TRAE终止治疗。结论:安罗替尼联合ICI作为晚期LUSC一线治疗方案具有良好的疗效前景和可管理的安全性。其中,12 mg剂量组在探索性分析中显示出更优疗效的潜在信号,早期分期患者ORR更高。该结果值得开展大规模前瞻性研究进行进一步验证。
5.Impact of visceral fat area on significant liver fibrosis in patients with nonalcoholic fatty liver disease and establishment of a predictive model
Jingkai YUAN ; Fengming ZHAO ; Huangqi LIN ; Meijie SHI ; Huanming XIAO ; Yubao XIE ; Xiaoling CHI
Journal of Clinical Hepatology 2026;42(2):312-318
ObjectiveTo investigate whether visceral fat area (VFA) is an independent risk factor for significant liver fibrosis in patients with nonalcoholic fatty liver disease (NAFLD) based on clinical data, and to establish an effective diagnostic model. MethodsA total of 222 NAFLD patients who attended Department of Hepatology, Guangdong Provincial Hospital of Traditional Chinese Medicine, from January 2021 to April 2025 were enrolled, and according to liver stiffness measurement (≥8 kPa or not), they were divided into significant fibrosis group and non-significant fibrosis group. Propensity score matching (PSM) was performed at a ratio of 1∶1 to balance the baseline data between the two groups. The independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between two groups; the chi-square test was used for comparison of categorical data between groups. A Spearman correlation analysis was used to determine the correlation of VFA and other indicators with significant liver fibrosis; univariate and multivariate logistic regression analyses were used to identify whether VFA was an independent risk factor for significant liver fibrosis in NAFLD patients, and the receiver operating characteristic (ROC) curve was plotted to assess the predictive performance of related indicators. ResultsA total of 45 patients with significant liver fibrosis and 177 patients without significant liver fibrosis were enrolled, and after PSM, 90 patients (45 pairs) were finally included in analysis. Compared with the non-significant fibrosis group, the significant fibrosis group had significantly higher levels of body mass index (BMI), fasting blood glucose (FBG), glycated hemoglobin (HbA1c), uric acid (UA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase (GGT), controlled attenuation parameter (CAP), and VFA, as well as a significantly higher proportion of patients with visceral fat obesity or three or more metabolic risk factors (all P<0.05). VFA, BMI, AST, and HbA1c were strongly correlated with significant liver fibrosis (all r>0.5, all P <0.05), and ALT, GGT, UA, FBG, and CAP were significantly positively correlated with significant liver fibrosis (r=0.3 — 0.5, all P<0.05). VFA (odds ratio [OR]=1.040, 95% confidence interval [CI]: 1.018 — 1.062, P<0.05), FBG (OR=2.372, 95%CI: 1.199 — 4.691, P<0.05), and AST (OR=1.032, 95%CI: 1.003 — 1.058, P<0.05) were independent risk factors for significant liver fibrosis in NAFLD patients. The new diagnostic model based on VFA, FBG, and AST (with an area under the ROC curve [AUC] of 0.907) had a significantly better performance than aspartate aminotransferase-to-platelet ratio index (AUC=0.834), fibrosis-4 (AUC=0.660), triglyceride-glucose index (AUC=0.656), and NAFLD fibrosis score (AUC=0.768) in predicting significant liver fibrosis in NAFLD patients (all P<0.05). ConclusionVFA is an independent risk factor for significant liver fibrosis in NAFLD patients, and the noninvasive diagnostic model based on VFA, FBG, and AST can effectively predict the onset of significant liver fibrosis in NAFLD patients.
6.Research hotspots and visual analysis on the medical artificial intelligence ethics at home and abroad
Mengze LYU ; Hongji LIN ; Ya’nan BA ; Yan ZHANG ; Jin XIE ; Yun LIU
Chinese Medical Ethics 2026;39(3):287-299
To conduct a bibliometric and keyword analysis on the domestic and international literature of medical artificial intelligence (AI) ethics, explore the research frontiers, hotspots, and development trends in this field, and provide references for promoting the construction of China’s ethical governance system on medical AI. Utilizing CiteSpace software, a comparative analysis was conducted between the reviewed domestic and international literature regarding their publication volume, author and institutional collaboration networks, as well as keyword co-occurrence, clustering, timeline graph, and burst, to explore the research hotspots and development trends in the field. A total of 2 393 Chinese and English publications were included. In recent years, research topics in medical AI ethics both domestically and internationally focused on three aspects, encompassing their theoretical research, emerging domains and their ethical risks, as well as the ethical governance and regulation of medical AI. International research hotspots included federated learning, computer-aided detection, informed consent, and other aspects, whereas domestic research hotspots were smart healthcare, responsibility ethics, ethical values, and other aspects. Internationally, greater attention was placed on ethical issues concerning population health and healthcare in the public health domain, whereas domestic research topics tended to focus more on theoretical discussions and the establishment of ethical principles. The ethical governance of medical AI represents a shared global challenge, necessitating enhanced research into both the variances and commonalities in this field.
7.Analysis of the Burden of Acute Lymphoid Leukemia in China and Globally from 1990 to 2021
Derong LIN ; Jingya FANG ; Yue LI ; Xiaohua XIE ; Xiaolin YE ; Xiaowen ZHANG ; Jiexuan LI ; Aiguo XUE
Medical Journal of Peking Union Medical College Hospital 2026;17(2):463-475
To analyze the disease burden of acute lymphoid leukemia(ALL) and its changing trends in China and globally from 1990 to 2021, aiming to provide a theoretical basis for disease prevention, treatment, and policy formulation. Data on the incidence, prevalence, mortality, and disability adjusted life years(DALYs) of ALL in China and globally from 1990 to 2021 were extracted from the Global Burden of Disease(GBD) 2021 database. The Joinpoint regression model was used to calculate the average annual percentage change(AAPC) to assess the trends in disease burden. Decomposition analysis was employed to identify and quantify the contributions of different factors to the changes in ALL disease burden. The population attributable fraction(PAF) was used to compare the risk factors for ALL in China and globally in 1990 and 2021. Stratified by the sociodemographic index(SDI), the locally estimated scatterplot smoothing(LOESS) method was used to assess the association between age-standardized incidence rate(ASIR), age-standardized mortality rate(ASMR), and SDI. The incidence-mortality ratio(IMR) was calculated to evaluate the diagnostic level and current treatment status of ALL. From 1990 to 2021, ASIR of ALL in the Chinese population increased from 3.385/100 000 to 3.637/100 000(AAPC: 0.005), the age-standardized prevalence rate(ASPR) increased from 6.596/100 000 to 22.022/100 000(AAPC: 0.478), the ASMR decreased from 3.051/100 000 to 1.357/100 000(AAPC: -0.056), and the age-standardized DALYs rate(ASDR) decreased from 195.792/100 000 to 74.063/100 000(AAPC: -3.996). Globally, the corresponding figures were: ASIR decreased from 1.789/100 000 to 1.371/100 000(AAPC: -0.014), ASPR increased from 4.122/100 000 to 5.425/100 000(AAPC: 0.039), ASMR decreased from 1.551/100 000 to 0.898/100 000(AAPC: -0.021), and ASDR decreased from 94.894/100 000 to 48.858/100 000(AAPC: -1.494). During this period, the aforementioned disease burden indicators were generally higher in males than in females, both in China and globally.In 2021, the peak incidence of ALL in China and globally was primarily concentrated in the 0-19 years age group, with the highest rate observed in those under 5 years of age. The burden of prevalence and DALYs was also mainly concentrated in this age group. Regarding mortality, the death burden in China was predominantly observed in the older adult age group, particularly among those aged ≥60 years. Globally, the mortality burden was highest in the under-5 age group, while remaining at a relatively high level in the older adult population. SDI correlation analysis based on data from 204 countries/regions globally from 1990 to 2021 showed that ASIR gradually increased with increasing SDI, whereas ASMR showed an initial increase followed by a decreasing trend. The ASIR and ASMR for the overall Chinese population and by sex were higher than expected. PAF results indicated that smoking and high body mass index were the main attributable risk factors for ALL mortality and DALYs burden, with their contribution consistently increasing. Decomposition analysis revealed that population growth and epidemiological changes were the primary drivers behind the changes in ALL incidence and mortality burden. Compared with 1990, the IMR for ALL in both China and globally increased in 2021. Over the past three decades, the ASMR and ASDR for ALL in China and globally have generally declined. During the same period, the ASIR and ASPR for ALL increased in China, while globally, the ASIR decreased and the ASPR increased. However, the disease burden of ALL remains high in males, children, and the older adult population. Differentiated prevention and control measures should be implemented in accordance with changes in SDI. The findings highlight the importance of strengthening prevention and early diagnosis, and suggest the need for targeted screening and treatment strategies for different age and sex groups. Concurrently, attention should be paid to the role of weight management and tobacco control in comprehensive prevention and control efforts to further reduce the disease burden of ALL.
8.The specific immune response of dendritic cell vaccine pulsed with ALDH1A1 mRNA on nasopharyngeal carcinoma stem cells in vitro
XIE Yunqing ; XU Yangmei ; CHEN Shanshan ; LIN Xiaowei ; LIU Qinying
Chinese Journal of Cancer Biotherapy 2026;33(5):486-493
[摘 要] 目的:探讨乙醛脱氢酶1A1(ALDH1A1)mRNA负载树突状细胞(DC)疫苗体外诱导抗鼻咽癌干细胞免疫反应的能力。方法:体外转录ALDH1A1 mRNA并电转染至人外周血DC,构建ALDH1A1-DC疫苗,转染EGFP mRNA为对照。流式细胞术检测DC表型、淋巴细胞亚群、细胞毒性T 淋巴细胞(CTL)增殖和细胞因子分泌。分选ALDH+和ALDH- C666-1细胞,检测干细胞标志物(CD24、CD133)和干性基因(OCT4、SOX2、Nanog)的表达水平,采用CCK-8法评估ALDH1A1-DC疫苗诱导的特异性免疫杀伤能力。结果:EGFP-DC荧光表达率显著高于未转染DC(P < 0.000 1),ALDH1A1-DC抗原提呈分子HLA-ABC、共刺激分子CD86、CD40和CCR7表达与未转染DC相比显著增强(P = 0.001 3、P = 0.005 9、P = 0.000 4及P = 0.001 9)。与单独淋巴细胞组(T)及空载DC诱导的淋巴细胞组(DC-T)相比,ALDH1A1-DC诱导的CTL比例最高(均P < 0.000 1),分裂指数最高(P = 0.000 2、P = 0.000 3),且CD8+CD69+(P = 0.000 5、P < 0.000 1)和CD8+ IFN-γ+(P = 0.012 6、P = 0.001 9)细胞亚群比例均显著提高。ALDH1A1-DC-T细胞对ALDH+C666-1悬浮细胞球的杀伤效果显著优于ALDH-细胞球(P = 0.001 0),且与其他各组淋巴细胞相比表现出较强的抗ALDH+C666-1悬浮细胞球的免疫效应(P = 0.001 0,P < 0.000 1)。然而,HLA-ABC阻断后其对ALDH+C666-1细胞的特异性杀伤效应显著降低(P < 0.000 1)。结论:mRNA转染DC后可翻译蛋白并促进DC成熟,增强其诱导特异性CTL免疫反应的能力。
9.Aquaporin 1 promotes proliferation and migration of tumor by up-regulating claudin-1 expression in colon cancer
Wei Wei XIE ; Lin XU ; Qian LI ; Dao Quan ZHANG ; Yu Bao ZHOU
Journal of Pathology and Translational Medicine 2026;60(3):307-318
With the rising incidence of colon cancer, several studies have indicated that aquaporin 1 (AQP1) expression is associated with the development of colon cancer. This study aims to elucidate the potential molecular mechanisms between them. Methods: We screened data from The Cancer Genome Atlas (TCGA) database and retrospectively examined AQP1 protein expression in 127 colon cancer patients to analyze the relationship between AQP1 expression and pathological stages, prognosis. We created stable colon cancer cell lines with differential AQP1 expression, the effect of AQP1 expression on the proliferation and migration of colon cancer cells was assessed by in vitro and in vivo studies, and explored potential molecular mechanisms through Western blotting. Results: High AQP1 expression was associated with poorer survival (overall survival [OS], p = .028) in colon cancer patients from the TCGA database. Similarly, retrospective clinical data indicated that high AQP1 expression was associated with reduced disease-free survival and OS (p = .036 and p = .017, respectively). The low-expressing AQP1 colon cancer cells exhibited a decrease in proliferation and migration ability of colon cancer cells compared to the overexpressing AQP1 group (p < .05) in vitro and in vivo. Immunohistochemistry and western blotting experiments validated heightened expression of N-cadherin, vimentin, and claudin- 1 in the tumor tissues of the overexpressing AQP1 group. Conversely, reduced AQP1 expression resulted in decreased expression of claudin- 1. Conclusions: AQP1 correlates with unfavorable prognosis in colon cancer and potentially enhances the proliferation and migration of colon cancer by up-regulating claudin-1 expression.
10.Pre-operative risk assessment of hepatocellular carcinoma recurrence in liver transplant recipients by non-invasive detection of pre-existing genetic lesions
Suqin YANG ; Sunbin LING ; Jianhua LI ; Yan WANG ; Jiapei WANG ; Qiwei HUANG ; Fanming LIU ; Yiqi ZHUANG ; Yingyu ZHENG ; Rui WANG ; Zhe YANG ; Xiaoping ZHENG ; Kai WANG ; Zhikun LIU ; Jun CHEN ; Jianguo WANG ; Haiyang XIE ; Lin ZHOU ; Leiming CHEN ; Guoqiang CAO ; Dandan CHEN ; Junfang JI ; Bin ZHAO ; Chao JIANG ; Di LU ; Xuyong WEI ; Hangjin JIANG ; Qiaonan SHAN ; Hengbo SHI ; Yong-Zhen XU ; Shusen ZHENG ; Zhengxin WANG ; Shengda LIN ; Xiao XU
Clinical and Molecular Hepatology 2026;32(2):884-903
Background/Aims:
Liver transplantation (LT) following total hepatectomy is a life-saving treatment for hepatocellular carcinoma (HCC). The HCC recurrence after LT hinders the effectiveness of the procedure. The objective of this study is to develop a pre-operative risk stratification model based on a liquid biopsy.
Methods:
We conducted a comprehensive multi-omics study of 260 HCC patients from three centers, including clinical data, low-coverage whole-genome sequencing of cell-free DNA (cfDNA) from plasma, as well as whole-exome, single-nucleus RNA, and spatial transcriptomics from matched tumor and non-tumor tissues.
Results:
We identified cfDNA-derived copy number alteration (CNA) signatures associated with post-transplant recurrence. By integrating cfDNA-derived CNA profiles with single-cell transcriptomic data, we traced recurrence-associated cfDNA to a distinct subpopulation of malignant cells within the primary tumor. These cells were embedded in a pro-metastatic microenvironment of specialized endothelial subtypes and cancer-associated fibroblasts. Notably, most recurrence-associated lesions were detectable in cfDNA prior to liver transplantation (LT). Building on these insights, we developed the ZJU Criteria based on CNA fragments and tumor markers, a pre-LT risk prediction tool that integrates conventional clinical factors with cfDNA-derived CNA signatures, and validated it using internal and independent external cohorts.
Conclusion
Our findings suggest that post-transplant recurrence commonly originates from advanced subclones that emerge late during tumor evolution. The ZJU Criteria provides an accurate, non-invasive strategy that significantly improves pre-LT risk stratification and clinical decision-making for patients with HCC.

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