1.Perspectives on assessing the clinical value of novel drugs for achieving functional cure of chronic hepatitis B
Shuning ZUO ; Yuting ZHONG ; Jianzhong ZHAO
Journal of Clinical Hepatology 2026;42(8):1773-1777
China bears a substantial disease burden of chronic hepatitis B (CHB). Under current clinical management regimens for CHB, achieving functional cure (also termed clinical cure) is the core goal for the treatment of patients meeting treatment indications. To achieve the goal of functional cure, drug regulatory authorities in China and globally have successively issued technical criteria to provide guidance for the overall design and scientific evaluation of clinical trials for innovative drugs. However, the rapid development in scientific research, clinical practice, and new drug research and development in this field has brought new challenges, especially those concerning the assessment of the clinical value of investigational drugs. This article reviews the current status of clinical research and development of new drugs for achieving the functional cure of CHB worldwide, analyzes the characteristics of available clinical trial data, and focuses on key aspects of pivotal clinical trials for CHB functional cure drugs, including target populations (baseline HBsAg level), HBsAg seroclearance response, HBsAg seroreversion after drug withdrawal, and clinically meaningful target threshold of functional cure response rate, in order to provide a reference for further refinement of related technical criteria.
2.Early prediction and decision curve analysis of venous thrombosis risk in patients after acute stroke
Wei SU ; Jianzhong XIONG ; Yaqun LI ; Wenmiao JIE
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(7):925-930
Objective To construct a risk prediction model for venous thromboembolism(VTE)in patients with acute stroke and analyze its predictive value with decision curve.Methods Clinical data of 265 patients with acute stroke admitted to Department of Neurology of Pingxiang People's Hospital between May 2022 and May 2024 were collected,and 185 of them(69.8%)were assigned to a training set and 80 cases(30.2%)into a validation set.Based on the results of color Doppler ultrasound examination,the patients in the training set were divided into the VTE group(72 cases)and the non-VTE group(113 cases).Multivariate logistic regression analysis was used to identify the risk factors for VTE occurrence in the patients.A prediction model was constructed and a nomegram was developed to visually present the logistic regression prediction model.ROC curve and decision curve analyses were applied to evaluate the predictive performance of the logis-tic regression model.Results The VTE group had significantly larger intracranial hemorrhage volume,higher fibrinogen(FIB),D-dimer and C-reactive protein(CRP)levels,and lower Glasgow Coma Scale(GCS)score than the non-VTE group(P<0.01).Multivariate logistic regression analysis indicated that intracranial hemorrhage volume(OR=1.243,95%CI:1.015-1.522),FIB(OR=3.161,95%CI:1.711-5.841),CRP(OR=1.595,95%CI:1.283-1.981),and D-dimer(OR=6.234,95%CI:2.693-14.434)were independent risk factors for the occurrence of VTE in the patients with acute stroke,while GCS score(OR=0.587,95%CI:0.413-0.834,P=0.003)was an independent protective factor against the occurrence.A VTE prediction model based on these influencing factors obtained a consistency index of 0.978.The calibration curve results showed that the observed values were in good agreement with the predicted values.ROC curve analysis indicated that the AUC value of the prediction model was 0.978(95%CI:0.945-0.994)in the training set and 0.959(95%CI:0.890-0.991)in the validation set.Decision curve analysis revealed that the model achieved higher net benefit when the threshold probability was between 20%and 80%.Conclusion Intracranial bleeding volume,GCS score,CRP,Didimer and FIB are related influencing factors of VTE in patients with acute stroke,and the prediction model of deci-sion curve based on the above factors is of high prediction efficiency.
3.Expert consensus on non-surgical treatment for acute lateral ankle sprain (version 2025)
Hui CHE ; Wenge DING ; Shiming FENG ; Xueping GU ; Qinwei GUO ; Jianchao GUI ; Yinghui HUA ; Yuefeng HAO ; Qinglin HAN ; Bo HU ; Xiaojun LIANG ; Guoping LI ; Yunxia LI ; Qi LI ; Yanlin LI ; Xin MA ; Jun MA ; Xudong MIAO ; Jianzhong QIN ; Xiaodong QIN ; Xu SUN ; Kefu SUN ; Weidong SONG ; Dai SHI ; Zhongmin SHI ; Youlun TAO ; Xu WANG ; Youhua WANG ; Liheng WANG ; Anli WANG ; Aiguo WANG ; Weidong WU ; Yajun XU ; Weidong XU ; Renjie XU ; Yongsheng XU ; Tengbo YU ; Lianqi YAN ; Xiaodong YUAN ; Yuan ZHU ; Mingzhu ZHANG ; Hongtao ZHANG ; Xintao ZHANG ; Xiaofei ZHENG
Chinese Journal of Trauma 2025;41(6):517-529
Acute lateral ankle sprain (ALAS) is one of the most common sport injuries, with high incidence, recurrence and disability rates. Currently, exercise rehabilitation-based non-surgical treatment is the primary management approach for ALAS. However, there remain improper practices such as excessive immobilization or uncontrolled activity, which contribute to recurrent sprains and chronic ankle instability, significantly impairing patients′ athletic function and quality of life. To standardize the non-surgical management of ALAS, improve the cure rates, and reduce the recurrence and disability rates, Chinese Sports Rehabilitation Medicine Training Project of Chinese Medical Association, Foot and Ankle Basics and Orthopedics Group, Orthopedic Branch of Chinese Medical Doctor Association, and Sports Medicine Branch of Jiangsu Medical Association organized relevant experts to formulate Expert consensus on non-surgical treatment for acute lateral ankle sprain ( version 2025), following the principles of scientific vigor, practicality, and innovation. Thirteen recommendations were proposed for standardized treatment protocols across different healing phases, aiming to provide references for standard management of ALAS and improve the therapeutic outcomes.
4.Research progress on non-pharmacological intervention strategies for elderly patients with chronic constipation
Jianting TANG ; Yanran LI ; Jianzhong HU ; Minhui LIU ; Yanfang LONG ; Jiao XU ; Weihong HUANG ; Li LI
Chinese Journal of Geriatrics 2025;44(6):835-840
The prevalence of chronic constipation among the elderly is significant, exerting adverse effects on both their physical and mental health.Presently, pharmacological therapy remains the predominant treatment modality for elderly patients with chronic constipation; however, prolonged use can lead to drug dependence, tolerance, and adverse effects.This article systematically reviews non-pharmacological interventions for chronic constipation in elderly patients, both domestically and internationally, aiming to provide a comprehensive reference for clinical practice.
5.Clinical guideline for diagnosis and treatment of nonunion of osteoporotic vertebral fractures (version 2025)
Haipeng SI ; Le LI ; Junjie NIU ; Wencan ZHANG ; Fuxin WEI ; Jinqiu YUAN ; Qiang YANG ; Hongli WANG ; Guangchao WANG ; Shihong CHEN ; Yunzhen CHEN ; Xiaoguang CHENG ; Jianwen DONG ; Shiqing FENG ; Rui GU ; Yong HAI ; Tianyong HOU ; Bo HUANG ; Xiaobing JIANG ; Lei ZANG ; Chunhai LI ; Nianhu LI ; Hua LIN ; Hongjian LIU ; Peng LIU ; Xinyu LIU ; Sheng LU ; Shibao LU ; Chunshan LUO ; Lvy CHAOLIANG ; Lvy WEIJIA ; Xuexiao MA ; Wei MEI ; Chunyang MENG ; Cailiang SHEN ; Chunli SONG ; Ruoxian SONG ; Jiacan SU ; Honglin TENG ; Hui SHENG ; Beiyu WANG ; Bingwu WANG ; Liang WANG ; Xiangyang WANG ; Nan WU ; Guohua XU ; Yayi XIA ; Jin XU ; Youjia XU ; Jianzhong XU ; Cao YANG ; Maowei YANG ; Zibin YANG ; Xiaojian YE ; Hailong YU ; Xijie YU ; Hua YUE ; Zhili ZENG ; Xinli ZHAN ; Hui ZHANG ; Peixun ZHANG ; Wei ZHANG ; Zhenlin ZHANG ; Jianguo ZHANG ; Tengyue ZHU ; Qiang LIU ; Huilin YANG
Chinese Journal of Trauma 2025;41(10):932-945
Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.
6.Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique (version 2025)
Sihao HE ; Junchao XING ; Tongwei CHU ; Zhengqi CHANG ; Xigao CHENG ; Fei DAI ; Xiaobing JIANG ; Jie HAO ; Jiang HU ; Jinghui HUANG ; Tianyong HOU ; Fei LUO ; Bo LIAO ; Changqing LI ; Lei LIU ; Guodong LIU ; Peng LIU ; Sheng LU ; Weishi LI ; Yang LIU ; Zhen LIU ; Wei MEI ; Peifu TANG ; Bing WANG ; Bing WANG ; Ce WANG ; Hongli WANG ; Liang WANG ; Shengru WANG ; Xiaobin WANG ; Yang WANG ; Yingfeng WANG ; Zheng WANG ; Jianzhong XU ; Guoyong YIN ; Haiyang YU ; Qiang YANG ; Zhaoming YE ; Bin ZHANG ; Chengmin ZHANG ; Jun ZOU ; Qiang ZHOU ; Min ZHAO ; Rui ZHOU ; Xiaojun ZHANG ; Yongfei ZHAO ; Zhongrong ZHANG ; Zehua ZHANG ; Yingze ZHANG
Chinese Journal of Trauma 2025;41(11):1035-1047
For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.
7.Clinical guideline for the diagnosis and treatment of sacroiliac complex injuries (version 2025)
Fulin TAO ; Jinlei DONG ; Gang WANG ; Xianzhong MA ; Guanglin WANG ; Jiandong WANG ; Zhanying SHI ; Wei FENG ; Shiwen ZHU ; Gang LYU ; Guangyao LIU ; Dahui SUN ; Yuqiang SUN ; Ming LI ; Weixu LI ; Yan ZHUANG ; Kaifang CHEN ; Dapeng ZHOU ; Qishi ZHOU ; Zhangyuan LIN ; Chengla YI ; Longpo ZHENG ; Jianzhong GUAN ; Zhiyong HOU ; Shuquan GUO ; Xiaodong GUO ; Xiaoshan GUO ; Xiaodong QIN ; Hua CHEN ; Shicai FAN ; Dongsheng ZHOU ; Lianxin LI
Chinese Journal of Trauma 2025;41(8):709-720
Sacroiliac complex injuries are commonly seen in high-energy pelvic fractures. The injuries make a big difference in treatment patterns due to the diverse injury types, posing considerable challenges in formulating optimal treatment strategies, and hence are persistent clinical difficulties in orthopedic trauma. The clinical management of sacroiliac complex injuries presents several key challenges such as a non-negligible rate of missed diagnoses in associated vascular and visceral injuries, absence of standardized protocols for surgical approaches and reduction-fixation strategies across different injury patterns, and ongoing controversies regarding surgical indications and optimal timing for patients combined with concomitant lumbosacral plexus injuries. Currently, no systematic clinical guidelines are available for the diagnosis and treatment of sacroiliac complex injuries both domestically and internationally. To this end, the Pelvic and Acetabular Surgery Group, Orthopedic Branch, China International Exchange and Promotive Association for Medical and Health Care and Orthopedic Physician Branch, Chinese Medical Doctor Association organized a panel of domestic experts in the field to develop the Clinical guideline for the diagnosis and treatment of sacroiliac complex injuries ( version 2025), based on evidence-based medicine and adhering to the principles of scientific rigor, clinical applicability, and innovation. These guidelines provided 11 recommendations covering diagnosis, therapeutic principles and techniques, management protocols for lumbosacral plexus injuries, outcome evaluation, and postoperative rehabilitation pathways, etc., aiming to standardize the clinical management of sacroiliac complex injuries.
8.Research progress on optical coherence tomography angiography (OCTA) for evaluation of retinal microcirculation in patients with diabetes mellitus, hypertension and dyslipidemia
Tong WU ; Jianzhong HU ; Ying XIE
Chinese Journal of General Practitioners 2025;24(2):223-228
Diabetes mellitus is a metabolic disease characterized by chronic hyperglycemia, which can damage the blood-retinal barrier and cause diabetic retinopathy (DR); hypertension can cause arteriosclerosis of retinal arterioles with the disease progression; dyslipidemia can cause atherosclerosis, and severe hypertriglyceridemia can lead to fundus changes. Optical coherence tomography angiography (OCTA) is a novel non-invasive fundus angiography technique to quantify the changes of retinal microcirculation. This article elaborate the principle and advantages of OCTA technique, reviews its application in evaluation of fundus microcirculation in patients with DR, hypertensive retinopathy and dyslipidemia, and also discusses the development prospect of OCTA in analysis of retinal microcirculation in the future.
9.Clinical research advances in the treatment of alopecia areata with systemic small-molecule drugs and biologics
Xiangqian LI ; Jianzhong ZHANG ; Cheng ZHOU
Chinese Journal of Dermatology 2025;58(7):646-649
Alopecia areata (AA) is an autoimmune-mediated, hair follicle-targeting, inflammatory, non-scarring hair loss. The treatment of severe AA has long been a focus and challenge. Currently, novel therapeutic agents, such as Janus kinase (JAK) inhibitors, have been increasingly employed in the treatment of severe AA. This review provides an overview of new small-molecule targeted drugs and biologics for AA.
10.Construction and identification of a sizeable naive human Fab phage display antibody library
Yakun ZHAO ; Xiaoyue WEI ; Fanliang MENG ; Wentao LIU ; Jiaming FAN ; Lijin LONG ; Wanting WANG ; Jianling CHEN ; Jianzhong ZHANG ; Lihua HE ; Liyong LIU ; Rui ZHAO ; Di SUN ; Xuezhen YUAN ; Xiaomei YAN
Chinese Journal of Epidemiology 2025;46(2):288-295
Objective:To construct a sizeable naive human Fab phage display antibody library to screen high-affinity specific antibodies in vitro. Methods:Total RNA was extracted from peripheral blood mononuclear cells (PBMCs) of 126 healthy individuals, subsequently reverse-transcribed into cDNA, and used as a template. PCR amplification was performed to obtain the V H from IgG, IgM and light chain κ, λ, separately, with the initial PCR products serving as templates for a second round of PCR. Overlap extension PCR was employed to generate fragments of the κ and λ light chains. These fragments were ligated with the phage vector pNC3, which harbors the variable region 1 of the heavy chain, to construct a recombinant phage plasmid. This plasmid was then electroporated into competent Escherichia Coli TG1 cells to establish a naive human Fab phage display antibody library. One hundred clones were randomly selected for identification and sequencing, and antibody gene polymorphisms were analyzed using the IMGT database and MAFFT software. Recombinant α-hemolysin from Staphylococcus aureus was utilized to screen Fab antibody fragments through biopanning of the antibody library, followed by random selection of phage ELISA-identified clones. The positive clones (antigen A450∶blank control A450≥2.1) were sequenced. Results:Two large naive Fab phage display antibody libraries were successfully constructed, in which the capacity of κ and λ chain antibody libraries were 1.25×10 11 and 1.54×10 11, respectively. The titers for two antibody libraries were 6.04×10 13 CFU/ml and 3.50×10 13 CFU/ml. The positive transformation insertion rates for κ and λ chain antibody libraries were 96% (96/100) and 100% (100/100), respectively. Sequence analysis revealed that all antibody sequences were unique. The amino acid sequences in the skeletal region were relatively conserved. In contrast, significant variations in the length of the complementarity determining region (CDR) were found, and the diversity of amino acid sequence of the complementary determining region was high, especially the CDR3. Analysis using the IMGT database indicated that the sequences exhibited a broad distribution across variable-diversity-joining gene families. After six rounds of panning, specific phage antibodies enrichment targeting α-hemolysin were achieved. A total of 142 monoclonal antibodies were sequenced, yielding 8 distinct Fab antibody sequences. Conclusion:This study successfully constructed two naive human Fab phage display antibody libraries with large capacity and good diversity, which can be used for screening human antibodies for serum epidemiology.

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