1.Expert consensus on the medication catalog for drug-induced liver injury and rational drug use
Jianchun LI ; Di CHEN ; Pengfei JIN ; Gerontology NATIONAL ; Association GERIATRIC ; Research PHARMACY ; Society PHARMACY ; Association GERIATRIC
China Pharmacy 2026;37(3):273-280
OBJECTIVE To systematically sort out the drugs causing drug-induced liver injury (DILI) and their relevant information, and to develop the Expert consensus on the medication catalog for drug-induced liver injury and rational drug use (hereinafter referred to as the Consensus), so as to provide a reference for rational clinical use. METHODS Systematic searches were conducted across various literature databases, guideline retrieval websites and professional liver injury websites. Drugs identified as causing DILI from the included literature and online resources were extracted and assigned scores based on source credibility: three points for LiverTox A-class drugs and two points for B-class drugs; two points for drugs from Hepatox and guidelines; and one point for drugs from consensus and related literature sources. Drugs classified as LiverTox category A/B or with total scores ≥4 were included in the preliminary list of DILI-causing drugs. Opinions were collected and integrated from a multidisciplinary expert panel comprising 45 medical and pharmaceutical experts from 27 provinces across China through three rounds of the Delphi method (including questionnaires and discussion sessions), and after revision, the final version of Consensus was formed. RESULTS & CONCLUSIONS This Consensus included 12 traditional Chinese medicines (TCMs) such as Polygoni Multiflori Radix and Ephedrae Herba, 151 Western medicines including amiodarone and atorvastatin, along with rational use information. For TCM, eight rational use information were included: evidence-based score, liver injury classification based on pathogenesis, liver injury classification based on biochemical abnormality pattern, clinical phenotype, laboratory examination manifestations, latency period, recovery time, and management strategies. For Western medicines, six additional items were included based on the TCM, namely liver function monitoring, discontinuation, contraindications, cautions, dose adjustments, and risk factors, totaling 14 items. This Consensus systematically compiles DILI drugs and their rational use information, which will support clinicians in enhancing the prevention, identification, and management of DILI, reducing the incidence of liver injury, and ensuring patient medication safety and efficacy.
2.Expert consensus on the clinical rational use of hemocoagulase drugs
Zinan ZHAO ; Zaiwei SONG ; Yudi ZHANG ; Fei ZHAO ; Xin HU ; Pengfei JIN ; Association GERIATRIC ; Association PHARMACY ; Association CLINICAL
China Pharmacy 2026;37(17):2213-2223
OBJECTIVE To formulate Expert Consensus on the Clinical Rational Use of Hemocoagulase Drugs, thereby providing a decision-making basis for the rational clinical application and standardized management of hemocoagulase drugs (hereinafter referred to as “hemocoagulase”).METHODS Led by Beijing Hospital (National Center for Gerontology), in collaboration with 34 experts in clinical pharmacy, orthopedics, neurosurgery, emergency medicine, obstetrics and gynecology, gastroenterology, and other relevant fields, the consensus was developed through a systematic review of domestic and international research evidence and clinical practice experience pertaining to 10 clinical practice issues concerning hemocoagulase, followed by in-depth discussion.RESULTS A total of 24 recommendations were formulated, covering the following 10 aspects: the routes of administration and scope of application; dosage under different routes of administration; medication monitoring and management; adverse reaction management; medication monitoring and management in special populations; the combined use of hemocoagulase with common hemostatic drugs and/or hemostatic materials; the use of injectable hemocoagulase to reduce perioperative bleeding; the use of locally applied hemocoagulase to reduce perioperative bleeding; the application of hemocoagulase in reducing non-surgery-related bleeding; and the application of hemocoagulase in reducing trauma-related bleeding.CONCLUSIONS This consensus provides systematic, evidence-based guidance for the clinical application of hemocoagulase, facilitating the standardization of clinical practice, the optimization of dosing regimens, and the assurance of medication safety, thereby improving patient treatment outcomes.
3.Efficacy and safety of different classes of antibacterial agents for hospitalized adult patients with community-acquired pneumonia:a network meta-analysis
Tianqi LIU ; Ruixue LI ; Zinan ZHAO ; Wenfeng XU ; Zi LIANG ; Jiayu ZHANG ; Ting LI ; Pengfei JIN
China Pharmacy 2026;37(18):2442-2448
OBJECTIVE To compare the efficacy and safety of different classes of antibacterial agents in hospitalized adult patients with community-acquired pneumonia (CAP).METHODS PubMed, Embase,the Cochrane Library,Web of Science,CNKI,and Wanfang data were searched from inception to January 1,2026,to identify randomized controlled trials that evaluated different classes of antibacterial agents in hospitalized adults with CAP.After screening the literature, extracting the data, and evaluating the quality of the literature, a network meta-analysis was performed using Stata 18.0.RESULTS A total of 25 studies were included,involving 7 863 patients. In terms of efficacy,compared with carbapenems,penicillins,cephalosporins,macrolides,and pleuromutilins were associated with significantly higher treatment failure rates ( P <0.05),carbapenems and traditional tetracyclines were ranked as the top two by the surface under the cumulative ranking curve area (SUCRA). No statistically significant differences were observed in mortality among the interventions ( P >0.05),carbapenems and other quinolones were ranked as the top two by SUCRA. In terms of safety,no statistically significant differences were observed among the interventions in the incidence of adverse events or discontinuation rates ( P >0.05);traditional tetracyclines and novel tetracyclines were ranked as the top two by SUCRA for the incidence of adverse events,while novel tetracyclines and pleuromutilins were ranked as the top two by SUCRA for discontinuation rates.CONCLUSIONS Carbapenems significantly reduced the treatment failure rate in hospitalized adults with CAP. The safety profiles of all antibacterial agents were comparable, with novel tetracyclines showing a more favorable safety profile.
4.Application of master protocol design in the clinical evaluation of infectious disease vaccines
Wenqing LIU ; Yuqing LI ; Lairun JIN ; Pengfei JIN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(4):724-729
The master protocol design encompasses a comprehensive clinical trial protocol containing multiple sub-protocols, which can be used to evaluate the clinical intervention effects of various drugs or vaccines on various diseases. Particularly, this design strategy represents an efficient and innovative approach to trial design in the context of precision medicine. The master protocol design can be used for emerging infectious diseases and urgent vaccine development in complex situations. This review aims to outline the types and concepts of master protocol design, analyze the key points and details, and discuss its application scenarios in vaccine clinical evaluations. Additionally, it will explore potential challenges that may arise during implementation to provide references for optimizing emergency clinical trial designs of infectious disease vaccines in China.
5.Analysis of the incidence and age characteristics of colorectal cancer in cancer registration areas of Jiangsu Province from 2009 to 2019
Jin ZHOU ; Weigang MIAO ; Jinyi ZHOU ; Ran TAO ; Pengfei CAI ; Pengfei LUO ; Renqiang HAN
Chinese Journal of Preventive Medicine 2025;59(7):1054-1062
Objective:To analyze the trend of colorectal cancer incidence and age changes in cancer registration areas of Jiangsu Province from 2009 to 2019.Methods:Based on the continuous and complete data of 16 cancer registries with qualified quality control in Jiangsu Province from 2009 to 2019, the crude incidence rate, age-standardized incidence rate by Segi World Standard Population (ASIRW), age-specific incidence rate, mean age at onset, standardized mean age at onset, standardized age-specific incidence proportion, and incidence proportion of the population over 60 years old of colorectal cancer were calculated. Joinpoint software was used to calculate the average annual percentage change (AAPC) of crude incidence rate, ASIRW, age-specific incidence rate, and incidence proportion of the population over 60 years, respectively. Birth cohort models were constructed to analyze the incidence of colorectal cancer and its trends in the population born from 1929 to 2019. Linear regression models were used to analyze the correlation between mean age at onset, standardized mean age at onset and the year of onset.Results:From 2009 to 2019, a total of 48 036 new cases of colorectal cancer were collected from 16 cancer registries in Jiangsu Province, including 27 508 males and 20 528 females. The crude incidence rate and ASIRW of colorectal cancer in Jiangsu Province increased from 19.00/100 000 and 12.32/100 000 in 2009 to 33.49/100 000 and 16.75/100 000 in 2019, respectively, showing a significant upward trend (CR: AAPC=5.99%, ASIRW: AAPC=3.54%, P<0.001). The increase of ASIRW was greater in males than that observed in females (males: AAPC=4.31%, females: AAPC=2.34%, P<0.001), and greater in rural areas than in urban areas (rural areas: AAPC=4.03%, urban areas: AAPC=3.13%, P<0.001). The incidence of people over 50 years old increased significantly by year, with the 60~69 age group exhibiting a more rapid increase ( AAPC=4.97%, P<0.05). In the birth cohort, the incidence increased rapidly in the population over 50 years with the passage of birth year, with AAPCs ranging from 1.76% to 7.05% ( P<0.05). From 2009 to 2019, the standardized mean age at onset of colorectal cancer increased by 0.10 years annually. The proportion of standardized age-specific incidence exhibited a trend of increase in older age groups, and the incidence proportion of the population over 60 years old showed a significant yearly increase ( AAPC=0.86%, P<0.001). Conclusion:From 2009 to 2019, the incidence, mean age at onset and the incidence proportion of the population over 60 years old of colorectal cancer in Jiangsu Province could exhibit a rapid upward trend. The increase is particularly pronounced in males and rural areas. Additionally, the age-specific incidence distribution reveals a trend of increase in older age groups. Therefore, targeted adjustments and comprehensive prevention measures should be strengthened.
6.Progress of research on drug resistance mechanisms of coagulase-negative Staphylococci and intervention measures
Ruixue LI ; Liang LIANG ; Pengfei JIN ; Wenfeng XU
Chinese Journal of Nosocomiology 2025;35(18):2856-2860
Coagulase-negative Staphylococci(CoNS)are a group of gram-positive cocci incapable of producing co-agulase,which distinguishes them from Staphylococcus aureus.CoNS are widely distributed in natural environ-ment and are commonly found on skin,mucous membranes and other host-associated tissues.In recent years,CoNS have become one of the significant pathogenic factors for hospital-associated infections and have been partic-ularly prevalent among the patients with impaired immune function.Although the pathogenicity of CoNS is gener-ally considered lower than that of coagulase-positive Staphylococci,the widespread use of implanted medical de-vices and extensive use of antibiotics has led to increasingly serious problems of drug resistance,which has atta-ched great importance to the hospital.The databases such as PubMed,Embase and CNKI were retrieved to reveal the drug resistance mechanisms of CoNS,aiming to push forward the research and development of new drugs against drug-resistant bacteria and emerging diagnosis and treatment measures and provide scientific bases for sol-ving the problems of antibiotics resistance around the globe.
7.Improvement effects and mechanism of Xiangsha yiwei tang on gastric mucosal injury in rats with chronic atrophic gastritis
Pengfei XIA ; Di JIN ; Jin LIANG ; Yi YU ; Jinjun DU ; Zhanyong JIN ; Jun FANG ; Xia YANG ; Huiwu LIU
China Pharmacy 2025;36(11):1311-1316
OBJECTIVE To investigate the improvement effects and mechanism of Xiangsha yiwei tang on gastric mucosal injury in rats with chronic atrophic gastritis (CAG). METHODS Rats were randomly assigned into normal control group, model group, Xiangsha yiwei tang low-, medium- and high-dose groups (6, 12, 18 g/kg, calculated by crude drug), and high-dose group of Xiangsha yiwei tang+740 Y-P [Xiangsha yiwei tang 18 g/kg+transforming growth factor β1/phosphatidyl inositol 3 kinase/ protein kinase B(TGF-β1/PI3K/Akt) pathway activator group 740 Y-P 10 mg/kg], with 18 rats in each group. Rats in each group were administered the corresponding drugs via oral gavage or injection, once daily, for 4 consecutive weeks. Gastric mucosal blood flow, the levels of serum gastrointestinal hormones [including motilin (MTL), gastrin (GAS), and pepsinogen (PP)], as well as inflammatory cytokines [including tumor necrosis factor- α (TNF- α), interleukin-1β (IL-1β), IL-6] in rats were measured. Pathological damage to gastric mucosal tissue was observed in rats; the apoptotic rate of gastric mucosal cells was detected. The expressions of TGF-β1/PI3K/Akt signaling pathway-related proteins and apoptosis-related proteins [including B-cell lymphoma-2 (Bcl-2) and Bcl-2-associated X protein (Bax)] in the gastric mucosal tissues of rats were assessed. RESULTS Compared with normal control group, model group had abnormal gastric mucosal tissue structure, with shedding of gastric mucosal epithelial cells, and prominent infiltration of inflammatory cells. Gastric mucosal blood flow, the serum levels of MTL, GAS, PP, and Bcl-2 protein expression were lowered significantly, while serum levels of TNF-α, IL-1β and IL-6, apoptosis rate, protein expressions of Bax and TGF-β1, the phosphorylations of PI3K and Akt were increased significantly (P<0.05). Compared with model group, Xiangsha yiwei decoction groups exhibited attenuated histopathological injuries in gastric mucosal tissues, reduced inflammatory cell infiltration, and significant improvements in the aforementioned quantitative parameters (P<0.05). Compared with high-dose group of Xiangsha yiwei tang, high-dose group of Xiangsha yiwei decoction combined with 740 Y-P exhibited significantly aggravated histopathological injuries in gastric mucosal tissues, and the aforementioned quantitative parameters were markedly reversed (P<0.05). CONCLUSIONS Xiangsha yiwei tang can alleviate gastric mucosal damage in CAG rats, and its mechanism of action is related to the inhibition of TGF-β1/PI3K/Akt signaling pathway.
8.Real-world efficacy and safety of azvudine in hospitalized older patients with COVID-19 during the omicron wave in China: A retrospective cohort study.
Yuanchao ZHU ; Fei ZHAO ; Yubing ZHU ; Xingang LI ; Deshi DONG ; Bolin ZHU ; Jianchun LI ; Xin HU ; Zinan ZHAO ; Wenfeng XU ; Yang JV ; Dandan WANG ; Yingming ZHENG ; Yiwen DONG ; Lu LI ; Shilei YANG ; Zhiyuan TENG ; Ling LU ; Jingwei ZHU ; Linzhe DU ; Yunxin LIU ; Lechuan JIA ; Qiujv ZHANG ; Hui MA ; Ana ZHAO ; Hongliu JIANG ; Xin XU ; Jinli WANG ; Xuping QIAN ; Wei ZHANG ; Tingting ZHENG ; Chunxia YANG ; Xuguang CHEN ; Kun LIU ; Huanhuan JIANG ; Dongxiang QU ; Jia SONG ; Hua CHENG ; Wenfang SUN ; Hanqiu ZHAN ; Xiao LI ; Yafeng WANG ; Aixia WANG ; Li LIU ; Lihua YANG ; Nan ZHANG ; Shumin CHEN ; Jingjing MA ; Wei LIU ; Xiaoxiang DU ; Meiqin ZHENG ; Liyan WAN ; Guangqing DU ; Hangmei LIU ; Pengfei JIN
Acta Pharmaceutica Sinica B 2025;15(1):123-132
Debates persist regarding the efficacy and safety of azvudine, particularly its real-world outcomes. This study involved patients aged ≥60 years who were admitted to 25 hospitals in mainland China with confirmed SARS-CoV-2 infection between December 1, 2022, and February 28, 2023. Efficacy outcomes were all-cause mortality during hospitalization, the proportion of patients discharged with recovery, time to nucleic acid-negative conversion (T NANC), time to symptom improvement (T SI), and time of hospital stay (T HS). Safety was also assessed. Among the 5884 participants identified, 1999 received azvudine, and 1999 matched controls were included after exclusion and propensity score matching. Azvudine recipients exhibited lower all-cause mortality compared with controls in the overall population (13.3% vs. 17.1%, RR, 0.78; 95% CI, 0.67-0.90; P = 0.001) and in the severe subgroup (25.7% vs. 33.7%; RR, 0.76; 95% CI, 0.66-0.88; P < 0.001). A higher proportion of patients discharged with recovery, and a shorter T NANC were associated with azvudine recipients, especially in the severe subgroup. The incidence of adverse events in azvudine recipients was comparable to that in the control group (2.3% vs. 1.7%, P = 0.170). In conclusion, azvudine showed efficacy and safety in older patients hospitalized with COVID-19 during the SARS-CoV-2 omicron wave in China.
9.Application of master protocol design in the clinical evaluation of infectious disease vaccines
Wenqing LIU ; Yuqing LI ; Lairun JIN ; Pengfei JIN ; Fengcai ZHU ; Jingxin LI
Chinese Journal of Epidemiology 2025;46(4):724-729
The master protocol design encompasses a comprehensive clinical trial protocol containing multiple sub-protocols, which can be used to evaluate the clinical intervention effects of various drugs or vaccines on various diseases. Particularly, this design strategy represents an efficient and innovative approach to trial design in the context of precision medicine. The master protocol design can be used for emerging infectious diseases and urgent vaccine development in complex situations. This review aims to outline the types and concepts of master protocol design, analyze the key points and details, and discuss its application scenarios in vaccine clinical evaluations. Additionally, it will explore potential challenges that may arise during implementation to provide references for optimizing emergency clinical trial designs of infectious disease vaccines in China.
10.Impact of Postoperative Reduction Quality on Biomechanics of the Femoral Head Following Internal Fixation of Femoral Neck Fractures
Shixiong ZHANG ; Jianxiong MA ; Bin LU ; Ying WANG ; Aixian TIAN ; Lei SUN ; Zhe HAN ; Jiahui CHEN ; Jing DAI ; Haohao BAI ; Hongzhen JIN ; Jie ZHAO ; Pengfei LI ; Xinlong MA
Journal of Medical Biomechanics 2025;40(5):1144-1149
Objective To investigate the effect of postoperative reduction quality in femoral neck fracture internal fixation on mechanical properties of the femoral head from the perspective of trabecular bone biomechanics.Methods From patients who underwent hip replacement surgery for femoral neck fractures,a total of 26 femoral head slice specimens were obtained.The central axis of the primary compressive trabeculae was defined as the 0° group,with the intersection point of the primary compressive trabeculae and the femoral calcar serving as the center.By rotating the specimens to simulate different reduction angles,the cut femoral head slice specimens were randomly divided into five groups:-10°,-5°,0°,5°,and 10°,representing femoral heads with varying reduction qualities.The specimens were subjected to single compression load tests and fatigue load tests.The load was set from 70 N to 1 400 N,at a frequency of 1 Hz,with 10 000 cycles.Axial stiffness,displacement,and the number of collapse cycles were measured,to compare the biomechanical properties of femoral head specimens under different reduction qualities.Results There were differences in the axial stiffness,displacement,and number of collapse cycles among the femoral head specimens in different groups.Under 800 N load,the axial stiffness of 0° group was significantly greater than that of±10° groups(P<0.05).The axial stiffness of 0° group was also greater than that of the±5° groups,but the differences were not statistically significant(P>0.05).The axial stiffness of±5° groups was greater than that of±10° groups(P<0.05).0° group had a lower displacement than±5° groups and±10° groups.However,the differences in displacement between 0° group and±5° groups were not statistically significant(P>0.05),while the differences between the 0° group and±10° groups were statistically significant(P<0.05).The differences in displacement between±5° groups and±10° groups were also statistically significant(P<0.05).0° group had a significantly higher number of collapse cycles than±10° groups(P<0.05).The number of collapse cycles in 0° group was also higher than that in±5° groups,but the differences were not statistically significant(P>0.05).The number of collapse cycles in±5° groups was significantly higher than that±10° groups(P<0.05).Conclusions The quality of reduction after internal fixation of femoral neck fractures significantly affects the biomechanical properties of the femoral head.This study provides a scientific basis for optimizing treatment and postoperative management,aiming to improve clinical outcomes and patients' quality of life.

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