1.Cost-utility analysis of rezivertinib versus gefitinib as first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer
Xiaowei ZHU ; Tongming ZHU ; Jia YI ; Wenqiang LI ; Piaopiao LU ; Aizong SHEN
China Pharmacy 2026;37(1):55-60
OBJECTIVE To evaluate the cost-effectiveness of rezivertinib versus gefitinib as first-line treatment for epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC) from the perspective of the Chinese healthcare system. METHODS A Markov model was constructed based on the REZOR trial data, with a cycle length of 3 weeks and a study duration of 5 years. Both costs and health outcomes were discounted at an annual rate of 5%. A cost-utility analysis was conducted using 3 times China’s 2024 per capita gross domestic product as the willingness-to-pay (WTP) threshold. The economic differences between the rezivertinib regimen versus the gefitinib regimen were evaluated using the incremental cost- effectiveness ratio (ICER) and incremental net monetary benefit (INMB). Sensitivity and scenario analyses were performed to verify the robustness of the model. RESULTS Compared to the gefitinib regimen, the rezivertinib regimen saved 225 310.47 yuan and gained an additional 0.57 quality- adjusted life years (QALYs), resulting in an ICER of -395 562.80 yuan/QALY, which was much lower than the WTP threshold of this study, indicating that rezivertinib had an absolute economic advantage. The INMB analysis (389 041.26 yuan) further validated this conclusion. One-way and probabilistic sensitivity analyses confirmed the robustness of the model. Scenario analysis, incorporating a 15% reduction in drug prices and adjustments to the utility values for progression free survival and progression disease, yielded consistent results with the base case analysis. CONCLUSIONS Compared to gefitinib, rezivertinib as a first-line treatment for EGFR mutation-positive advanced NSCLC has an absolute economic advantage.
2.Key Information Research and Modern Clinical Application of Xiaofengsan
Weilu NIU ; Mengjie YANG ; Chengqi LYU ; Cuicui SHEN ; Ningli WANG ; Huangchao JIA ; Liyun WANG ; Xuewei LIU ; Mingsan MIAO ; Xiaomeng WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):238-249
Employing bibliometric methods and adhering to principles of textual research, this study systematically investigated prescription source, formula name, composition evolution, dose evolution, origin, processing, ancient and modern applications of Xiaofengsan. Xiaofengsan, also known as Renshen Xiaofengsan and Chantui Xiaofengsan, was first recorded in the Taiping Huimin Hejijufang(hereafter referred to as Jufang) of the Southern Song dynasty. The formula composition included Schizonepetae Spica, Glycyrrhizae Radix et Rhizoma, Chuanxiong Rhizoma, Notoptery Rhizoma et Radix, Bombyx Batryticatus, Saposhnikoviae Radix, Poria, Cicadae Periostracum, Pogostemonis Herba, Ginseng Radix et Rhizoma, Magnoliae Officinalis Cortex and Citri Reticulatae Pericarpium, a total of 12 medicinal materials. In terms of the evolution of formula composition, formulas across dynasties largely aligned with those recorded in Jufang, with only minor variations in application. The results of the formula dosage research indicated that one dose of medication in Jufang corresponded to the following modern dosages:Schizonepetae Spica of 82.6 g, Glycyrrhizae Radix et Rhizoma of 82.6 g, Chuanxiong Rhizoma of 82.6 g, Notoptery Rhizoma et Radix of 82.6 g, Bombyx Batryticatus of 82.6 g, Saposhnikoviae Radix of 82.6 g, Poria of 82.6 g, Cicadae Periostracum of 82.6 g, Pogostemonis Herba of 82.6 g, Ginseng Radix et Rhizoma of 82.6 g, Magnoliae Officinalis Cortex of 20.65 g and Citri Reticulatae Pericarpium of 20.65 g, the origins of all the constituent drugs were consistent with the 2020 edition of Pharmacopoeia of the People's Republic of China. The results of the investigation into the decoction method indicated that the aforementioned drugs should be finely ground into powder(pass through the No.5 sieve), and 8.26 g was taken for each dose, which was taken with the clear liquid obtained by steeping tea leaves in boiling water for several minutes. This mixture was administered three times daily, 30 min after meals. The ancient functional indications of this formula mainly involved dispelling wind-heat, eliminating pathogenic factors and regulating the middle Jiao. It primarily treated all wind-heat syndromes manifesting as skin diseases, predominantly affecting the upper body, especially the head and face. The diseases involved in modern applications were mostly dermatological diseases, including urticaria, eczema, atopic dermatitis and others. In this paper, by combing the relevant ancient literature, the key information of Xiaofengsan was textual researched, in order to provide reference for the modern application and development of this formula.
3.Study on the safety and efficacy of micro-perfusion device for preserving isolated porcine limbs
Pengkai LI ; Zhaodi MI ; Shen LI ; Man YUAN ; Xiwei PENG ; Jia LÜ ; Sice WANG ; Zhibo JIA ; Xiangyu SONG ; Yixuan ZHU ; Chonghui LI ; Moling XIAO ; Wenjing XU ; Jiang PENG
Organ Transplantation 2026;17(3):422-431
Objective To evaluate the safety and efficacy of a self-developed micro-normothermic machine perfusion (NMP) system (micro-perfusion device) for preserving isolated porcine limbs. Methods Five healthy Landrace pigs were selected, and their left and right forelimbs were randomly divided into the NMP group and static cold storage (SCS) group. The NMP group was perfused with the self-developed micro-perfusion device and polymerized hemoglobin perfusate for 32 hours at normothermia, while the SCS group was preserved at 4 ℃. Hemodynamic parameters such as perfusion pressure and flow were monitored. The pH value, partial pressure of oxygen (PO2), lactic acid (Lac), creatine kinase (CK) and lactate dehydrogenase (LDH) in the perfusate were measured. Hematoxylin-eosin staining was used to assess the muscle tissue structure, terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling was employed to evaluate muscle cell apoptosis, and immunohistochemistry staining was applied to detect the expressions of tumor necrosis factor (TNF)-α and interleukin (IL)-6. A mixed-effects model was used to analyze the effects of time and treatment methods on tissue structure, cell apoptosis and inflammatory factors. Results The device could stably maintain a perfusion pressure of (69±15) mmHg and a flow rate of (117±42) mL/min. The pH value and electrolytes of the perfusate were generally stable, with PO2 maintained at a high level. Lac was maintained at 5.38(3.81, 6.45) mmol/L, while CK and LDH increased over time. After 32 hours of perfusion in the NMP group, both the myocyte spacing and apoptosis rate were better than those in the SCS group. Mixed-effects model analysis showed that there were statistically significant differences in the effects of NMP treatment and SCS treatment on myocyte spacing and apoptosis rate per unit time (both P < 0.05). There were no statistically significant differences in TNF-α and IL-6 between the two groups, and mixed-effects model analysis showed no statistically significant differences in the effects of NMP treatment and SCS treatment on TNF-α and IL-6 per unit time (both P > 0.05). Conclusions The micro-perfusion device used in this study may achieve 32-hour normothermic preservation in a porcine limb amputation model, maintain basic metabolism and ionic homeostasis, reduce muscle structural damage and cell apoptosis without inducing additional inflammatory responses. This technology is expected to significantly extend the time window for replantation of amputated limbs in disaster rescue and long-distance transportation, providing an important technical basis for clinical translation and subsequent replantation research.
4.5G remote robot-assisted thoracoscopic lobectomy/segmentectomy for ten patients
Fan SHEN ; Jia HUANG ; Yu TIAN ; Hanbo PAN ; Jiantao LI ; Long JIANG ; Hong GUO ; Bentong YU ; Qingquan LUO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(06):908-912
Objective To explore the safety and feasibility of 5G remote robot-assisted thoracoscopic anatomic lobectomy and segmentectomy. Methods A retrospective analysis was conducted on patients who underwent 5G remote robot-assisted thoracoscopic anatomic lobectomy or segmentectomy between July and September 2024. The surgeries were performed collaboratively by Shanghai Chest Hospital, Affiliated Hospital of Yangzhou University, and The First Affiliated Hospital of Nanchang University. Perioperative outcomes were recorded and analyzed. Results Ten patients were included, comprising 4 anatomic lobectomies and 6 segmentectomies. The median age was 61.0 (56.0, 72.0) years. The median intraoperative bi-directional network latency was 52.5 (39.0, 54.0) ms. There were no instances of network interruption, robot-related adverse events, or conversions to open thoracotomy. The median postoperative chest tube drainage volume was 500.0 (375.0, 600.0) mL, and the median hospital stay was 5.5 (4.0, 6.0) days. No complications of Clavien-Dindo grade Ⅱor higher occurred. All patients were recurrence-free and alive during the 6-month postoperative follow-up period. Conclusion 5G remote robot-assisted thoracoscopic surgery demonstrates high safety and operational stability. This technology shows promising potential for clinical application and is worthy of further development and utilization.
5.Rheumatic diseases and portal hypertension
Li SHEN ; Weijia DUAN ; Tingting LYU ; Jidong JIA
Journal of Clinical Hepatology 2025;41(5):812-816
Rheumatic diseases are a group of chronic disorders characterized by abnormalities in the immune system, while portal hypertension occurs due to increased blood flow or heightened resistance in the portal venous system or obstruction of hepatic venous outflow. Both rheumatic diseases and their medications can lead to noncirrhotic portal hypertension. The hypercoagulable state associated with rheumatic diseases can result in thrombosis within the portal and hepatic venous systems, and damage to the intrahepatic portal system and hepatic sinusoidal endothelial system can lead to porto-sinusoidal vascular disease and hepatic sinusoidal obstruction syndrome. Moreover, drugs used for the treatment of rheumatic diseases may cause liver parenchymal injury, which further leads to liver fibrosis and cirrhosis, or they may damage the hepatic vascular endothelium and thus cause noncirrhotic portal hypertension. This article elaborates on the mechanisms and characteristics by which common rheumatic diseases and their therapeutic agents lead to portal hypertension, in order to provide insights and assistance for clinical diagnosis, treatment, and follow-up monitoring.
6.Predictive effects of different motor evoked potential warning thresholds on motor function recovery fol-lowing decompression for cervical and thoracic ossification of the posterior longitudinal ligament
Li LI ; Huan LI ; Kai CHEN ; Jia LIU ; Wenwen SHEN ; Yuqing WANG ; Xiufang WU ; Yushu BAI ; Qiang LI ; Jian-min LIU
The Journal of Practical Medicine 2025;41(18):2898-2905
Objective To explore the optimal warning threshold of motor evoked potentials(MEP)in decompression surgery for ossification of the posterior longitudinal ligament(OPLL)at cervical and thoracic segments,and the predictive role of different MEP parameters on postoperative lower extremity motor function.Methods A retrospective analysis was conducted on the clinical data of 227 patients diagnosed with cervical or thoracic OPLL and underwent decompression surgery from January 2022 to January 2024 in the hospital.There were 131 males and 96 females,with an average age of(60±10)years.All patients underwent continuous neuro-physiological monitoring during the operation,and the minimum ratio of MEP amplitude change to the baseline at the beginning of the operation(Dmax)and the ratio of MEP terminal amplitude change to the baseline at the end of the operation(Dend)were recorded.The correlations between these two ratios and the lower extremity motor func-tion immediately after the operation and at 1 year were compared.According to the Medical Research Council muscle strength score(MRC)standard,a postoperative score increase of≥1 point compared to preoperative was defined as postoperative motor dysfunction.Pearson correlation coefficients were used to evaluate the correlations between Dmax and Dend and the lower extremity motor function immediately after the operation and at 1 year.Receiver operating characteristic(ROC)curves were drawn to predict postoperative lower extremity motor dysfunc-tion using Dmax and Dend.Results Among the 227 patients,186 had cervical OPLL and 41 had thoracic OPLL.The incidence of lower extremity motor dysfunction immediately after the operation and at 1 year was 7 cases(3.76%)and 2 cases(1.08%)in the cervical group,and 9 cases(21.95%)and 3 cases(7.32%)in the thoracic group,respectively.The incidence of lower extremity motor dysfunction in the thoracic group was higher than that in the cervical group(P<0.001).The baseline induction rate of bilateral lower extremity MEPs was 98.92%(368/372)in the cervical group and 96.34%(79/82)in the thoracic group.The Pearson correlation coefficients of Dend with the bilateral lower extremity motor function immediately after the operation in the cervical and thoracic groups were both greater than those of Dmax,and the differences were statistically significant(cervical group:r=0.669,0.517,P=0.001 2;thoracic group:r=0.882,0.727,P=0.003 6),while the differences in the Pearson corre-lation coefficients of Dend and Dmax with the bilateral lower extremity motor function at 1 year were not statistically significant(cervical group:r=0.457,0.352,P=0.088;thoracic group:r=0.760,0.625,P=0.098).The cut-off values of Dend for the cervical group were 0.853 immediately after the operation and at 1 year,and the cut-off values of Dmax were 0.881 and 0.978,respectively.For the thoracic group,the cut-off values of Dend were 0.532 immediately after the operation and 0.639 at 1 year,and the cut-off values of Dmax were 0.532 and 0.640,respec-tively.Conclusions In OPLL surgery,the MEP monitoring strategy should be adjusted according to the surgical segment.For the cervical segment,Dmax should be emphasized to balance high sensitivity and specificity,while for the thoracic segment,Dmax or Dend can be flexibly selected.Higher MEP warning thresholds are required for cervical OPLL surgery(Dmax:0.881 immediately after the operation and 0.978 at 1 year;Dend:0.853),while significantly lower thresholds are needed for thoracic OPLL(Dmax/Dend:0.532 immediately after the operation and 0.640 at 1 year).
7.Interpretation of the Standard Establishment Approach and Compilation Rationale for Metallic Pharmaceutical Packaging Standard Development in the 2025 Edition of the Pharmacopeia of the People's Republic of China
Fangfang ZHANG ; Rong CAI ; Wanling LAN ; Lei CHEN ; Lin YAO ; Hao DING ; Weiyi LU ; Yaju ZHOU ; Fenglan ZHANG ; Yuan LIU ; Kai XU ; Liang CHANG ; Yan LIU ; Feifei JIA ; Ying LI ; Yan JIANG ; Dandan WANG ; Shengli WU ; Yong SHEN ; Xiangwei XU ; Yanggege LYU
Herald of Medicine 2025;44(11):1745-1751
To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.
8.Establishment of a LC-MS/MS method for detecting gamma-aminobutyric acid in plasma and its clinical application
Jia-qian QIN ; Lei CAO ; Ying-fei PENG ; Fang-jun CHEN ; Bai-shen PAN ; Bei-li WANG ; Wei GUO
Fudan University Journal of Medical Sciences 2025;52(5):708-716
Objective To establish a stable liquid chromatography-tandem mass spectrometry(LC-MS/MS)method for detecting gamma-aminobutyric acid(GABA)in plasma,and to evaluate the value of GABA detection in the diagnosis of sleep disorders.Methods GABA was detected using a UPLC Xevo TQs system.The method was pre-validated and its performance was verified to establish a reference range for healthy individuals.The difference in plasma GABA levels between apparently healthy individuals and patients with sleep disorders was compared.Results We employed deuterated compounds as isotopic internal standards and utilized an Amide chromatographic column for separation.The mobile phase was 0.050%formic acid in water and 90%acetonitrile in water containing 0.175%formic acid and 5 mmol/L ammonium acetate with gradient elution in the column temperature of 35℃.The linear range for the detection of GABA by LC-MS/MS was 0.05-10.00 μmol/L,with a lower limit of quantification of 0.02 μmol/L,the inter-day CV<3.00%and intra assay CV<4.00%,respectively,and the recovery rate was 101.06%-109.02%.The reference ranges for plasma GABA were established by analyzing 300 healthy controls stratified by age:18-34 years(0.08-0.15 μmol/L),35-49 years(0.10-0.20 μmol/L),and≥50 years(0.12-0.23 μmol/L).Then plasma GABA was used as a biomarker for auxiliary diagnosis of sleep disorders in analyzing 221 patients and 300 healthy controls,which revealed that AUC values were 0.510(P=0.850),0.686(P=0.002),and 0.890(P<0.001)in the groups of 18-34 years,35-49 years,and≥50 years,respectively,with optimal cut-off values of 0.09,0.10 and 0.11 μmol/L.Conclusion A reliable LC-MS/MS method for detecting GABA has been established,which can detect plasma GABA levels sensitively and accurately and can be used in assisting the clinical diagnosis of sleep disorders.
9.Changing antimicrobial resistance profiles of Burkholderia cepacia in hospitals across China:results from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Chunyue GE ; Yunjian HU ; Xiaoman AI ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Hui LI ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2025;25(5):557-562
Objective To examine the changing prevalence and antimicrobial resistance profiles of Burkholderia cepacia in 52 hospitals across China from 2015 to 2021.Methods A total of 9 261 strains of B.cepacia were collected from 52 hospitals between January 1,2015 and December 31,2021.Antimicrobial susceptibility of the strains was tested using Kirby-Bauer method or automated antimicrobial susceptibility testing systems according to a unified protocol.The results were interpreted according to the breakpoints released in the Clinical & Laboratory Standards Institute(CLSI)guidelines(2023 edition).Results A total of 9 261 strains of B.cepacia were isolated from all age groups,especially elderly patients.The proportion was 11.1%(1 032 strains)in children,significantly lower than the proportion in adults.About half(46.5%,4 310/9 261)of the strains were isolated from patients at least 60 years old and 42.3%(3 919/9 261)of the strains were isolated from young adults.Most isolates(71.1%)were isolated from sputum and respiratory secretions,followed by urine(10.7%)and blood samples(8.1%).B.cepacia isolates were highly susceptible to the five antimicrobial agents recommended in the CLSI M100 document(33rd edition,2023).B.cepacia isolates showed relatively higher resistance rates to meropenem and levofloxacin.However,the resistance rates to ceftazidime,trimethoprim-sulfamethoxazole,and minocycline remained below 8.1%.The percentage of B.cepacia strains resistant to levofloxacin was the highest compared to other antibiotics in any of the three age groups(from 12.4%in the patients<18 years old to 20.6%in the patients aged 60 years or older).Conclusions B.cepacia is one of the clinically important non-fermenting gram-negative bacteria.Accurate and timely reporting of antimicrobial susceptibility test results and ongoing antimicrobial resistance surveillance are helpful for rational prescription of antimicrobial agents and proper prevention and control of nosocomial infections.
10.The study on the optimization of portal vein image quality in liver cirrhosis by combining deep learning image reconstruction with"three low techniques"spectrum CT with low keV
Ming LI ; Yongjun JIA ; Li SHEN ; Junfeng FAN ; Nan YU ; Yong YU ; Danqing ZHANG
Journal of Practical Radiology 2025;41(10):1729-1733
Objective To explore the value of deep learning image reconstruction(DLIR)combined with"three low(low radiation dose,low contrast dose,and low contrast injection rate)techniques"of spectrum CT with low keV in optimizing the image quality of portal vein for liver cirrhosis.Methods Sixty patients with liver cirrhosis who underwent computed tomography portal venography(CTPV)were selected and randomly divided into standard protocol group(group A,n=30)and"three-low"protocol group(group B,n=30).The group A with 120 kVp,contrast dose of 1.4 mL/kg,injection rate of 4.0-5.0 mL/s,and reconstructed 50%adaptive statistical iterative reconstruction-Veo(ASIR-V)image.The group B with 80 kVp/140 kVp double instantaneous switching gemstone spectral imaging(GSI)scan,contrast dose of 1.0 mL/kg,injection rate of 3.0-3.5 mL/s,and reconstructed 40 keV DLIR-M and DLIR-H images.The quality of portal vein images,effective dose(ED),contrast dose and injection rate were compared between the two groups.Results The ED of(4.10±1.56)mSv in group B was lower than that of(7.88±1.08)mSv in group A(P<0.001),and the contrast dose of(67.26±8.74)mL in group B was lower than that of(99.12±8.84)mL in group A(P<0.001).The injection rate of 3.0-3.5 mL/s in group B was reduced by 25%-30%compared with group A.Group B had the greatest contrast-to-noise ratio(CNR)and signal-to-noise ratio(SNR)of portal vein in the 40 keV DLIR-H.The subjective image quality scores were in good agreement between the two physicians(Kappa value>0.75).The subjective DLIR score in group B was higher than that in group A.Conclusion DLIR combined with"three low techniques"spectrum CT with low keV can improve the image quality of portal vein in liver cirrhosis patients.

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