1.Advances in polymorphisms of genes associated with oxaliplatin-induced peripheral neurotoxicity
China Pharmacy 2026;37(1):130-136
Peripheral neurotoxicity represents one of the most severe dose-limiting adverse reactions associated with oxaliplatin, with genetic polymorphisms playing a significant role in oxaliplatin-induced peripheral neuropathy (OIPN). OIPN can be categorized as acute or chronic based on onset timing. The former presents clinically as sensory abnormalities or even motor disorders, while the latter presents clinically as limb sensory disorders that persist, numbness or pain in the hands and feet. The transporter genes OCT2, OCTN2, and NHE1 may be implicated in OIPN; drug-metabolizing enzyme gene GSTP1 Ile105Val, DPYD rs1801265, voltage-gated sodium channel (NaV) gene SCN4A rs2302237, SCN9A rs6746030, SCN10A rs12632942, and other associated genes such as HLA-G rs1610696, rs371194629 and CCNH rs2230641, rs3093816 are associated with severe OIPN. Conversely, DNA repair-related gene XRCC1 rs23885, NaV gene SCN9A rs3750904, rs12478318 and rs6754031 are associated with reduced OIPN risk. In the future, the genetic research findings on OIPN can be translated into clinical applications, ultimately achieving individualized precision medicine for patients.
2.Epidemiological characteristics and spatial-temporal clustering of severe fever with thrombocytopenia syndrome in Huai'an City from 2011 to 2024
XIA Wenling ; GAO Qiang ; LI Yang ; CAI Ben ; WAN Chunyu ; CUI Zhizhen ; ZHANG Zheng ; PAN Enchun
Journal of Preventive Medicine 2026;38(1):55-59,65
Objective:
To investigate the epidemiological characteristics and spatial-temporal clustering of severe fever with thrombocytopenia syndrome (SFTS) in Huai'an City, Jiangsu Province from 2011 to 2024, so as to provide a basis for optimizing local SFTS prevention and control strategies, and identifying high-risk areas and key populations.
Methods:
Data on SFTS incidence and deaths in Huai'an City from 2011 to 2024 were collected from the Infectious Disease Reporting Information System of the Chinese Disease Prevention and Control Information System. The reported incidence, mortality, and fatality rates were calculated. Descriptive analysis was performed on temporal, population, and regional distribution. The average annual percent change (AAPC) was used to analyze the trend in the reported incidence of SFTS. Global and local spatial autocorrelation analyses were employed to examine the spatial distribution patterns and spatial association patterns of SFTS incidence while spatio-temporal scanning analyses was used to assess the spatial-temporal clustering of SFTS.
Results:
A total of 337 SFTS cases were reported in Huai'an City from 2011 to 2024, with the reported incidence rising from 0.17/100 000 to 1.88/100 000. There were 20 deaths, with an average annual mortality of 0.03/100 000, and a fatality rate of 5.93%. The incidence showed obvious seasonality, with a peak in May and June (148 cases, accounting for 43.92%). Spring and summer accounted for 107 cases (31.75%) and 159 cases (47.18%), respectively. The reported SFTS cases were mainly male, farmers, and individuals aged ≥41 years, accounting for 56.38%, 79.23%, and 96.74%, respectively. The population distribution of death cases was basically consistent with that of incident cases. Xuyi County was a high-incidence area, with a total of 332 reported cases, accounting for 98.52%. All death cases were reported in this county. Spatial autocorrelation analyses revealed a positive spatial correlation in SFTS incidence from 2019 to 2024, with Moran's I values ranging from 0.214 to 0.336 (all P<0.05). Heqiao Town, Tianquanhu Town, and Guiwu Town in Xuyi County were identified as high-high clustering areas. Spatio-temporal scanning analyses showed that cluster 1 was consistent with the high-high clustering areas, with an aggregation time from the second quarter of 2019 to the second quarter of 2022.
Conclusions
From 2011 to 2024, the reported incidence of SFTS in Huai'an City showed an upward trend, with a high incidence in spring and summer. Males, farmers, and the middle-aged and elderly population were the key populations for prevention and control. Xuyi County was the key area for prevention and control.
3.Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Wenxi PENG ; Meng QIAO ; Lianxin WANG ; Yuanyuan LI ; Xiuhui LI ; Xin CUI ; Zijia CHEN ; Xinyi CHEN ; Yi DENG ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):152-160
The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines (hereinafter referred to as the Guidelines) is first specialized in the field of drug safety for oral Chinese patent medicines (OCPMs) in China. Rooted in China's healthcare context, the Guidelines address the unique usage patterns and risk characteristics of OCPMs, filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines, and to promote the standardized development of pharmacovigilance practices for OCPMs, this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting, the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment, the Guidelines were examined from three dimensions of formulation components, medication behaviors, and population to address complex safety issues arising from medicinal constituents, irrational use, and individual susceptibility. In the area of risk control, the analysis focused on context-based interventions and dynamic closed-loop management strategies, exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore, this paper evaluated the applied value of the Guidelines and identified implementation challenges, such as insufficient capacity at the primary-care level and limited digital infrastructure. In response, the study proposed optimization strategies including establishing a dynamic updating mechanism, strengthening training at the grassroots level, and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders (including manufacturers), pharmaceutical distributors, healthcare institutions, and research organizations, ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.
4.Serological characteristics of individuals with hepatitis C virus/hepatitis B virus overlapping infection
Yanfei CUI ; Xia HUANG ; Chao ZHANG ; Yingjie JI ; Song QING ; Yuanjie FU ; Jing ZHANG ; Li LIU ; Yongqian CHENG
Journal of Clinical Hepatology 2026;42(1):74-79
ObjectiveTo investigate the status of overlapping hepatitis B virus (HBV) infection in patients with chronic hepatitis C virus (HCV) infection and the serological characteristics of such patients. MethodsA total of 8 637 patients with HCV infection who were hospitalized from January 1, 2010 to December 31, 2020 and had complete data of HBV serological markers were enrolled, and the composition ratio of patients with overlapping HBV serological markers was analyzed among the patients with HCV infection. The patients were divided into groups based on age and year of birth, and serological characteristics were analyzed, and the distribution of HBV-related serological characteristics were analyzed across different HCV genotypes. ResultsThe patients with HCV/HBV overlapping infection accounted for 5.85%, and the patients with previous HBV infection accounted for 48.10%; the patients with protective immunity against HBV accounted for 14.67%, while the patients with a lack of protective immunity against HBV accounted for 31.39%. The patients were divided into groups based on age: in the 0 — 17 years group, the patients with protective immunity against HBV accounted for 61.41% (304 patients); the 18 — 44 years group was mainly composed of patients with previous HBV infection (698 patients, 37.31%), the 45 — 59 years group was predominantly composed of patients with previous HBV infection (1 945 patients, 50.38%), and the ≥60 years group was also predominantly composed of patients with previous HBV infection (1 486 patients, 61.66%). The patients were divided into groups based on the year of birth: in the pre-1992 group, the patients with previous HBV infection accounted for 51.63% (4 112 patients); in the 1992 — 2005 group, the patients with protective immunity against HBV accounted for 54.72% (168 patients); in the post-2005 group, the patients with protective immunity against HBV accounted for 64.38% (235 patients). In this study, 6 301 patients underwent HCV genotype testing: the patients with genotype 1b accounted for the highest proportion of 51.71% (3 258 patients), followed by those with genotype 2a (1 769 patients, 28.07%), genotype 3b (63 patients, 1.00%), genotype 3a (10 patients, 0.16%), genotype 4 (21 patients, 0.33%), and genotype 6a (5 patients, 0.08%). ConclusionWith the implementation of hepatitis B planned vaccination program in China, there has been a significant reduction in the proportion of patients with previous HBV infection among the patients with HCV/HBV overlapping infection, but there is still a relatively high proportion of patients with a lack of protective immunity against HBV.
5.Establishment of a new predictive model for esophagogastric variceal rebleeding in liver cirrhosis based on clinical features
Wen GUO ; Xuyulin YANG ; Run GAO ; Yaxin CHEN ; Kun YIN ; Qian LI ; Manli CUI ; Mingxin ZHANG
Journal of Clinical Hepatology 2026;42(1):101-110
ObjectiveTo establish a new noninvasive, simple, and convenient clinical predictive model by identifying independent predictive factors for rebleeding after endoscopic therapy in cirrhotic patients with esophagogastric variceal bleeding (EGVB), and to provide a basis for individualized risk assessment and development of clinical intervention strategies. MethodsCirrhotic patients with EGVB who were diagnosed and treated in The First Affiliated Hospital of Xi’an Medical University from September 2018 to October 2023 were enrolled as subjects, and according to whether the patient experienced rebleeding within 1 year after endoscopic therapy, they were divided into rebleeding group with 93 patients and non-rebleeding group with 84 patients. Clinical data were collected and analyzed. The independent samples t-test was used for comparison of normally distributed continuous data between two groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between two groups; the chi-square test was used for comparison of categorical data between two groups. A Logistic model was established based on the results of the univariate and multivariate analyses, and the receiver operating characteristic (ROC) curve and the area under the ROC curve (AUC) were used to assess the accuracy of the model. R software was used to visualize the model by plotting a nomogram, and the Bootstrap method was used for internal validation of the model. ResultsThe multivariate analysis showed that red blood cell count (RBC), cholinesterase (ChE), alkaline phosphatase (ALP), albumin (Alb), thrombin time (TT), portal vein trunk diameter, sequential therapy, and primary prevention were independent predictive factors for rebleeding. Based on the results of the multivariate analysis, a logistic model was established as logit(P)=-0.805-1.978×(RBC)+0.001×(ChE)-0.020×(ALP)-0.314×(Alb)+0.567×(TT)+0.428×(portal vein trunk diameter)-2.303×[sequential therapy (yes=1, no=0)]-2.368×[primary prevention (yes=1, no=0)]. The logistic model (AUC=0.928, 95% confidence interval [CI]: 0.893—0.964, P<0.001) had a better performance in predicting rebleeding than MELD score (AUC=0.603, 95%CI: 0.520—0.687, P=0.003), Child-Pugh class (AUC=0.650, 95%CI: 0.578—0.722, P=0.001), and FIB-4 index (AUC=0.587, 95%CI: 0.503—0.671, P=0.045). The model had an optimal cut-off value of 0.607, a sensitivity of 0.817, and a specificity of 0.817. Internal validation confirmed that the model had good predictive performance and accuracy. ConclusionSequential therapy, implementation of primary prevention, an increase in RBC, and an increase in Alb are protective factors against rebleeding, while prolonged TT and widened main portal vein diameter are risk factors. The logistic model based on these independent predictive factors can predict rebleeding and thus holds promise for clinical application.
6.Expert Consensus on Blood Flow and Oxygen Delivery Phenotyping and Clinical Management of Septic Shock(2025)
Wei HUANG ; Xinchen WANG ; Wenzhao CHAI ; Keliang CUI ; Bo YAO ; Zhiqun XING ; Cui WANG ; Jingjing LIU ; Shiyi GONG ; Dongkai LI ; Wanhong YIN ; Xiaoting WANG ; Wei DU
Medical Journal of Peking Union Medical College Hospital 2026;17(1):40-58
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock is the primary cause of mortality in sepsis, with its core pathophysiological mechanism being severe ischemia and hypoxia in critical units—composed of microcirculation and the mitochondria of functional cells—resulting from disruptions in blood flow and oxygen flow following a dysregulated host response. Due to the systemically convergent yet clinically heterogeneous nature of the host response, current understanding and management strategies for hemodynamics remain inconsistent, often leading to inadequate resuscitation or overtreatment. To improve the quality of care, based on a systematic review of the "blood flow-oxygen flow" theory, an expert panel emphasizes reevaluating septic shock from an integrated perspective of blood flow and oxygen flow, and has formulated the
7.Standards for the Application of Hemodynamic Monitoring Technology in Critical Care
Hua ZHAO ; Hongmin ZHANG ; Xin DING ; Huan CHEN ; Jun DUAN ; Wei DU ; Bo TANG ; Yuankai ZHOU ; Dongkai LI ; Xinchen WANG ; Cui WANG ; Gaosheng ZHOU ; Xiaoting WANG
Medical Journal of Peking Union Medical College Hospital 2026;17(1):73-85
With the rapid advancement of hemodynamic indices and monitoring technologies, their classification methods and application processes have become increasingly complex. Currently, no unified standard hasbeen established, making it difficult to fully meet the clinical requirements for hemodynamic management. To assist in hemodynamic monitoring assessment and therapeutic decision-making in critically ill patients, the Critical Hemodynamic Therapy Collaborative Group, in conjunction with the Critical Ultrasound Study Group, has jointly developed the Standard for the Application of Hemodynamic Monitoring Techniques in Critical Care. The first part of this standard systematically categorizes hemodynamic indicators into flow indicators, pressure and its derivative indicators, and tissue perfusion indicators, while elaborating on the clinical application of each. The second part establishes a standardized clinical implementation pathway for hemodynamic monitoring. It proposes a tiered monitoring strategy-comprising basic, advanced, indication-specific, and special scenario monitoring-tailored to different clinical settings. It emphasizes the central role of critical care ultrasound across all levels of monitoring and establishes hemodynamic assessment standards for organs such as the brain, kidneys, and gastrointestinal tract. This standard aims to provide a unified framework for clinical practice, teaching, training, and research in critical care medicine, thereby promoting standardized development within the discipline.
8.Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies
Qingyong ZHENG ; Yongjia ZHOU ; Tengfei LI ; Jianguo XU ; Chen TIAN ; Hui LIU ; Min TIAN ; Ziyu ZHOU ; Caihua XU ; Yating CUI ; Junfei WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2026;46(1):138-148
Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.
9.Efficacy and safety of Tripterygium wilfordii polyglycoside combined with finerenone in the treatment of diabetic nephropathy
Xincheng ZHAO ; Ruimin LI ; Shuxia CUI
China Pharmacy 2026;37(4):486-490
OBJECTIVE To explore the efficacy and safe ty of Tripterygium wilfordii polyglycoside combined with finerenone in the treatment of diabetic nephropathy (DN). METHODS This study selected 104 DN patients admitted to the Nephrology Department of Handan Central Hospital from January 2023 to May 2024 as the subjects and randomly assigned them into the control group (52 cases) and the combination group (52 cases). All patients received basic treatment such as lipid-lowering and blood glucose control. On this basis, patients in the control group received finerenone, while those in the combination group received a combination therapy of T. wilfordii polyglycoside and finerenone. Both groups underwent treatment for a duration of three months. The two groups were compared in terms of clinical efficacy, renal function indicators [24-hour urine protein excretion (24 h UPE), urinary albumin-to-creatinine ratio (UACR), urinary albumin excretion rate (UAER) ] , inflammatory factors [high mobility group box 1 protein (HMGB1), interleukin-6 (IL-6), nuclear factor-κB (NF-κB), high-sensitivity C reactive protein (hs-CRP) ] , and oxidative stress indicators [total antioxidant capacity (T-AOC), superoxide dismutase (SOD), advanced oxidation protein products (AOPP), malondialdehyde (MDA) ] before and after treatment. Additionally, the occurrence of adverse drug reactions was recorded. RESULTS In terms of efficacy, the total effective rate of patients in the combination group was higher than that of the control group ( P <0.05). After treatment, the levels of 24-h UPE, UACR, UAER, HMGB1, IL-6, NF-κB, hs-CRP, AOPP and MDA in the two groups were significantly lower than those in the same group before treatment; the levels of T-AOC and SOD in the two groups were significantly higher than those in the same group before treatment, with the combination group showing superior changes in the above indicators compared to the control group at the corresponding time point ( P <0.05). In terms of safety, there was no statistical significance in the total incidence of adverse drug reactions between the two groups ( P >0.05). CONCLUSIONS Compared to finerenone monotherapy, the combination therapy of T. wilfordii polyglycoside and finerenone demonstrates significant efficacy in treating DN. It effectively reduces proteinuria levels, alleviates inflammatory reaction, mitigates oxidative stress, and does not increase the risk of adverse reactions.
10.Practical exploration of ethical review in decentralized drug clinical trials
Xu ZUO ; Yingshuo HUANG ; Yue LI ; Lihan XING ; Chunxiu YANG ; Yan CUI
Chinese Medical Ethics 2025;38(1):40-45
ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials, promote clinical trial progress, and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials, analyzing the advantages and challenges of decentralized drug clinical trials, and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review, and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility, applicability, and rationality, the adequacy of informed consent, the protection of rights and interests and privacy of subjects, as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties, pay attention to the rights and interests of subjects, and gradually promote the implementation of decentralized drug clinical trials.


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