1.Cost-utility analysis of amivantamab combined with lazertinib in the first-line treatment of EGFR-mutated advanced NSCLC
Ran LIU ; Shengnan GAO ; Yuxi ZHANG ; Ranran ZHANG ; Congxin LI ; Guoqiang LIU
China Pharmacy 2026;37(5):633-638
OBJECTIVE To evaluate the cost-effectiveness of amivantamab combined with lazertinib (hereinafter referred to as “AL”) regimen as first-line treatment for EGFR -mutated advanced non-small cell lung cancer (NSCLC) from the perspective of China’s healthcare system. METHODS A partitioned survival model was established based on updated data from the MARIPOSA study, with a 10-year time horizon and 28-day cycles. The primary outcome index was quality adjusted life year (QALY), and the willingness-to-pay (WTP) threshold was set at three times China’s per capita GDP in 2024 (287 247 yuan/QALY). Cost-utility analysis was used to calculate the incremental cost-effectiveness ratio (ICER) of AL regimen versus osimertinib monotherapy regimen as first-line treatment for EGFR -mutated advanced NSCLC. One-way and probabilistic sensitivity analyses were performed to test model robustness. Scena rio analyses were conducted to explore the impact of utility values for different health states on the outcomes and determine the required price reductions of amivantamab and lazertinib to achieve cost-effectiveness. RESULTS Compared with the osimertinib monotherapy regimen, the ICER for the AL regimen as first-line treatment for advanced EGFR -mutated NSCLC was 2 062 096.15 yuan/QALY, significantly exceeding the WTP threshold established in this study. One-way sensitivity analysis revealed that the utility value of progression-free survival state and the price of amivantamab were the primary factors influencing the ICER. Probabilistic sensitivity analysis revealed that the AL regimen only became cost-effective when the WTP threshold was set at 2 050 000 yuan/QALY. Scenario analysis indicated that altering the utility value still rendered the AL regimen non-cost-effective. When amivantamab (350 mg) prices decreased by 80%, 85%, and 90% respectively, lazertinib (80 mg) prices would need to decrease by 95.97%, 40.63%, 5.29%, respectively. This would enable the AL regimen’s ICER to consistently fall within the WTP threshold established in this study. CONCLUSIONS At the WTP threshold established in this study, the AL regimen does not demonstrate cost-effectiveness for first-line treatment of advanced EGFR -mutated NSCLC compared to the osimertinib monotherapy regimen. Significant price reductions for both drugs would be required to alleviate the financial burden on patients.
2.Pharmacoeconomic evaluation of culmerciclib combined with fulvestrant in the second-line treatment of HR+/HER2− locally advanced or metastatic breast cancer
Ran LIU ; Shengnan GAO ; Congxin LI ; Yuxi ZHANG ; Ranran ZHANG ; Yue WANG ; Ziyi LIU ; Guoqiang LIU
China Pharmacy 2026;37(8):1033-1038
OBJECTIVE To evaluate the cost-effectiveness of culmerciclib combined with fulvestrant as second-line treatment for patients with hormone receptor-positive(HR+)/human epidermal growth factor receptor 2-negative (HER2–) locally advanced or metastatic breast cancer, within the context of the Chinese healthcare system. METHODS A partitioned survival model was established based on the CULMATE-1 study, with a simulation time horizon set at 15 years and a cycle length of 28 days. The incremental cost-effectiveness ratio (ICER) of culmerciclib combined with fulvestrant versus fulvestrant monotherapy as second-line treatment for HR+/HER2– breast cancer was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model. Meanwhile, scenario analysis of culmerciclib price reduction was conducted; the required price reduction and price to reach the willingness-to-pay (WTP) threshold in this study were calculated. RESULTS The results of the base-case analysis indicated that, compared with the fulvestrant monotherapy regimen, culmerciclib combined with fulvestrant yielded an additional 0.823 quality-adjusted life year (QALY), with a corresponding ICER of 371 696.26 yuan/QALY, which exceeded the WTP threshold (199 330 yuan/QALY). The results of the univariate sensitivity analysis indicated that the cost of culmerciclib, the discount rate, the utility values for progression disease and progression free survival status were significant factors influencing the ICER; both the univariate sensitivity analysis and the probabilistic sensitivity analysis validated the robustness of the model results. Scenario analysis indicated that when the price of culmerciclib was reduced by 30%, 55% and 85% respectively, the corresponding ICER values fell below 3, 2, and 1 times China’s per capita GDP in 2025, with the probability of cost-effectiveness being 3.00%, 94.90%, 100%. When the cost of culmerciclib (60 mg) was reduced by 52.6% to 50.96 yuan, the ICER value met the WTP threshold established in this study. CONCLUSIONS When the WTP threshold is set at twice China’s per capita GDP in 2025, second-line treatment with culmerciclib combined with fulvestrant for HR+/HER2– locally advanced or metastatic breast cancer does not exhibit cost-effectiveness advantage over fulvestrant monotherapy. Therefore, a reasonable price reduction is required to alleviate the financial burden on patients.
3.A novel MRI radiomics-based nomogram for preoperative prediction of perineural invasion in intrahepatic cholangiocarcinoma
Huize SUI ; Zheyu ZHOU ; Shuya CAO ; Xiaoliang XU ; Guoqiang LI
Acta Universitatis Medicinalis Anhui 2026;61(4):736-742
ObjectiveTo evaluate a novel nomogram based on contrast-enhanced MRI radiomics combined with clinical variables for the preoperative prediction of perineural invasion (PNI) in intrahepatic cholangiocarcinoma (ICC). MethodsThe clinical data of 59 ICC patients were retrospectively collected. According to postoperative pathology reports, the patients were divided into the non-PNI group (n = 33) and the PNI group (n = 26). Regions of interest (ROI) were delineated from five MRI sequences. Radiomics features were then extracted and filtered to select those with the strongest discriminative power for PNI identification. These selected features were used to construct a radiomics model, which subsequently generated a quantitative radiomics score (radiomics score, Radscore). Univariate analysis was applied to identify clinical variables associated with PNI, and the glm function was subsequently used to construct clinical and combined models. Finally, the models were evaluated using receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA). The combined model was then visualized as a nomogram. ResultsThe clinical model included age, carbohydrate antigen 19-9 (CA19-9), red blood cell distribution width, and albumin, whereas the Radscore included five radiomic features. The areas under the ROC curves (AUCs) for the clinical and radiomics models were 0.717 (95%CI: 0.586-0.848) and 0.896 (95%CI: 0.820-0.973), respectively, whereas the combined model further improved its AUC to 0.917 (95% CI:0.848-0.987). The calibration curves and DCA showed that the nomogram was well calibrated and provided the greatest net clinical benefit. ConclusionThe novel nomogram may serve as a basis for preoperative prediction of PNI status, thereby assisting clinical decision-making and guiding personalized treatment.
4.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.
5.A comparison of short-term efficacy and safety of small-caliber polyvinyl alcohol microsphere-based versus conventional TACE for unresectable hepatocellular carcinoma
Shaowei LI ; Jianguo LI ; Junchen WANG ; Shuxia WANG ; Guoqiang MA ; Yumin LI ; Li GUO ; Wei HU
China Pharmacy 2026;37(20):2732-2738
OBJECTIVE To compare the short-term efficacy and safety of small-caliber polyvinyl alcohol (PVA) microsphere-based transcatheter arterial chemoembolization (TACE) versus conventional iodized oil emulsion-based TACE in the treatment of unresectable hepatocellular carcinoma (HCC).METHODS Clinical data of 146 patients with unresectable HCC who underwent TACE at Gansu Provincial Second People’s Hospital (Affiliated Hospital of Northwest Minzu University) from June 1, 2024, to June 30, 2025, were retrospectively collected. According to the treatment strategy, the patients were divided into the control group (conventional iodized oil emulsion-based TACE, n =79) and the observation group (small-caliber PVA microsphere-based TACE, n =67). One-to-one propensity score matching (PSM) was performed, and the matched cohort (62 patients in each group) was used for the primary analysis. The objective response rate (ORR) and disease control rate (DCR) at 1 and 3 months post-treatment, serum levels of tumor markers (alpha-fetoprotein, alpha-fetoprotein lectin-binding fraction L3, and protein induced by vitamin K absence or antagonist-Ⅱ) before treatment and at 1 and 3 months post-treatment, the occurrence of adverse events, progression-free survival (PFS), and overall survival (OS) were compared between the two groups. Sensitivity and interaction analyses were also performed.RESULTS After PSM, the ORRs in the observation group at 1 and 3 months post-treatment were both 59.7%, and the DCRs were 91.9% and 93.5%, respectively, significantly higher than those in the control group (ORRs: 41.9% and 38.7%; DCRs: 77.4% and 75.8%; P <0.05). At 1 and 3 months post-treatment, the serum levels of tumor markers decreased significantly from baseline in both groups, with significantly lower levels in the observation group than in the control group ( P <0.05). No statistically significant differences were observed in the overall incidence of adverse events or the incidence of grade≥3 adverse events between the two groups ( P >0.05). The median PFS was 10.6 months in the control group and 14.3 months in the observation group, with no statistically significant difference [hazard ratio (HR) of 0.69, 95% confidence interval (CI) of 0.44-1.09, P =0.111]. During follow-up, 8 and 9 patients died in the control and observation groups, respectively, and the median OS was not reached in either group. The 12-month OS rates were 88.8% and 87.3%, respectively, with no statistically significant difference (HR of 0.88, 95%CI of 0.35-2.24, P =0.790). After adjustment for potential confounding factors in the original cohort, the ORR at 3 months post-treatment remained significantly higher in the observation group than in the control group (adjusted odds ratio of 2.67, 95%CI of 1.28-5.56, P =0.009). Additionally, the interaction between treatment modality and Barcelona Clinic Liver Cancer staging had no statistically significant impact on the ORR at 3 months post-treatment ( P =0.391).CONCLUSIONS For patients with unresectable HCC, compared with conventional iodized oil emulsion-based TACE, small-caliber PVA microsphere-based TACE demonstrates superior efficacy in terms of early radiological response and improvement in tumor markers, and the two regimens are comparable in terms of safety.
6.Research progress of meibomian gland dysfunction-related dry eye
Jianbo ZHONG ; Guoqiang ZENG ; Yi ZHANG ; Xiaoyan DOU ; Wanmei TANG ; Kunling CHEN ; Li CAI
International Eye Science 2025;25(2):259-263
In recent years, with the endless emergence of meibomian gland dysfunction(MGD)diagnostic equipment, rich treatment methods, and in-depth clinical and basic research on MGD at home and abroad, the understanding of MGD has entered a new stage. MGD-related dry eye is considered to be the main cause of lipid abnormal dry eye, and its occurrence and development is a chronic and multi-factorial pathological process. This article reviews the pathogenesis, imaging analysis and clinical treatment progress of MGD-related dry eye, in order to provide scientific evidence and ideas for clinical diagnosis and therapy of MGD-related dry eye.
7.The value of machine learning models based radiomics for predicting high-risk molecular subtypes of lower-grade gliomas
Xiangli YANG ; Guoqiang YANG ; Wenju NIU ; Xueting LI ; Yan TAN ; Xiaochun WANG ; Lizhi XIE ; Hui ZHANG
Chinese Journal of Radiology 2025;59(8):909-916
Objective:To evaluate the clinical utility of machine learning model based radiomics in predicting high-risk molecular subtypes of lower-grade gliomas(LrGGs).Methods:This was a cross-sectional study. A total of 287 patients diagnosed with LrGGs in the First Hospital of Shanxi Medical University, Shanxi Provincial People′s Hospital, and the Third Hospital of Shanxi Medical University from January 2011 to September 2023 were retrospectively collected, including 166 males and 121 females; 114 cases of high-risk molecular subtypes and 173 cases of non-high-risk molecular subtypes. All patients were divided into 201 cases in the training set and 86 cases in the test set according to 7∶3 in simple randomized grouping method. All patients underwent contrast-enhanced T 1WI (CE-T 1WI) and T 2-weighted fluid-attenuated inversion recovery sequence imaging (T 2-FLAIR), and the imaging features of high-risk and non-high-risk molecular subtypes were analyzed. Analysis of variance, recursive feature elimination, and Kruskal-Wallis were used for radiomics feature screening, and a support vector machine (SVM) classifier was used to construct a radiomics-based classifier model. Univariate and multivariate logistic regression were used to analyze clinical variables independently influencing high-risk molecular subtypes of LrGGs to construct a clinical model; a combined model was developed by integrating radiomics labels and clinical variables. Receiver operating characteristic curve and area under the curve (AUC), calibration curve, and decision curve were used to compare the predictive performance of different models. Results:The patient′s age ( OR=1.042, 95% CI 1.018-1.068, P=0.001), pathological grade ( OR=2.270, 95% CI 1.212-4.311, P=0.011), MGMT methylation status ( OR=0.456, 95% CI 0.238-0.866, P=0.017), and ependymal involvement ( OR=7.335, 95% CI 2.929-18.370, P<0.001) were independent influencing factors for the high-risk molecular subtype of LrGGs, and a clinical model was developed based on these factors. An SVM model was constructed based on 12 radiomics features (3 radiomics features based on CE-T 1WI and 9 radiomics features based on T 2-FLAIR). The radiomics score of the probability output by the SVM model was combined with age, pathological grade, MGMT methylation status, and ependymal involvement to develop a combined model. The AUC values of the SVM model for predicting the high-risk molecular subtype of LrGGs were 0.824 and 0.859 in the training set and test set, respectively; the AUC values of the clinical model in the training set and test set were 0.759 and 0.721, respectively; and the AUC values of the combined model in the training set and test set were 0.823 and 0.815, respectively. The combined model had a high clinical net benefit. Conclusion:The machine learning MRI radiomics model can preoperatively predict high risk molecular subtypes of LGGrs, assist in individualized treatment decisions.
8.Arthrolysis versus revision arthroplasty for arthrofibrosis-related stiffness following total knee arthroplasty: comparison of medium- to long-term outcomes
Zhisen GAO ; Haoling DING ; Tian GAO ; Guoqiang ZHANG ; Rui LI ; Wei CHAI
Chinese Journal of Orthopaedic Trauma 2025;27(6):499-506
Objective:To compare the mid- to long-term clinical outcomes of arthrolysis versus revision arthroplasty for arthrofibrosis-related stiffness following total knee arthroplasty (TKA).Methods:A retrospective analysis was conducted of the 20 patients (26 knees) with post-TKA arthrofibrosis who had been treated at Department of Orthopedics, The Fourth Medical Center of Chinese PLA General Hospital between January 2004 and January 2020. The patients were divided into 2 groups based on their treatment: an arthrolysis group of 8 cases (10 knees) [1 male (2 knees)and 7 females (8 knees); median age: 44.0 (21.0, 62.0) years] and a revision arthroplasty group of 13 cases (16 knees) [4 males (6 knees)and 9 females (10 knees); median age: 41.5 (30.0, 56.0) years]. The knee range of motion (ROM) and the American Hospital for Special Surgery (HSS) knee score as well as their improvements were compared between preoperation and the last follow-up, as well as between the 2 groups; the satisfaction of the patients at the last follow-up was compared between the 2 groups.Results:No significant differences in the baseline characteristics were observed between the 2 groups, indicating comparability ( P>0.05). The preoperative knee ROM [55.0° (48.8°, 61.3°)] and HSS knee score [54.0 (47.0, 61.8) points] in the arthrolysis group were significantly higher than those in the revision group [27.5° (6.3°, 50.0°), 33.0 (27.3, 47.8) points] ( P<0.05). In the arthrolysis and revision arthroplasty groups, the knee ROMs [90.0° (65.0°, 100.0°), 90.0° (63.5°, 98.8°)] and HSS knee scores [(69.8±19.9) points, (77.6±11.3) points] at the last follow-up were significantly improved compared with those before operation ( P<0.05). In the revision arthroplasty group, the improvement in knee ROM (48.9°±21.7°) was insignificantly larger than that in the arthrolysis group (34.5°±13.2°) ( P>0.05), but the improvement in HSS knee score [39.5 (25.3, 57.0) points] was significantly larger than that in the arthrolysis group [16.0 (10.5, 25.3) points] ( P<0.05). Respectively, 14 and 3 knees in the revision arthroplasty group and the arthrolysis group resulted in patient satisfaction, showing a significant difference between the 2 groups ( P<0.05). Conclusions:Both arthrolysis and revision arthroplasty can significantly improve knee ROM and HSS knee score in post-TKA arthrofibrosis. However, since revision arthroplasty demonstrates superior improvements in HSS knee score and patient satisfaction, it is preferable for patients with lower preoperative knee ROM.
9.A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C
Lai WEI ; Jia SHANG ; Xuan AN ; Guoqiang ZHANG ; Yujuan GUAN ; Hongxin PIAO ; Jinglan JIN ; Lang BAI ; Xingxiang YANG ; Daokun YANG ; Xinhua LUO ; Shufang YUAN ; Yingren ZHAO ; Yingjie MA ; Guangming LI ; Feng LIN ; Xiaoping WU ; Jiawei GENG ; Guizhou ZOU ; Jiabao CHANG ; Zuojiong GONG ; Xiaorong MAO ; Jing ZHU ; Wentao GUO ; Qingwei HE ; Lin LUO ; Yulei ZHUANG ; Hongming XIE ; Yingjun ZHANG
Chinese Journal of Hepatology 2025;33(6):560-569
Objective:To assess the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of chronic hepatitis C (CHC) of various genotypes, without cirrhosis or with compensated cirrhosis.Methods:394 cases with CHC from 22 centers were collected from October 2021 to April 2023. They were randomly assigned to receive either the experimental drugs (antaitasvir phosphate 100 mg+yiqibuvir 600 mg) or placebo treatment in a 3∶1 ratio. The patients were administered drugs once a day for 12 consecutive weeks, and then followed up for 24 weeks after treatment cessation. All subjects were unblinded at the four-week follow-up following drug discontinuation, with the experimental drug group continuing to complete subsequent post-discontinuation follow-up. The placebo group was switched to receive the experimental drugs for a repeated 12-week treatment period and followed up for another 24 weeks after discontinuation of the drug (placebo delayed treatment phase).The sustained virologic response rate (SVR12) was observed for subjects in the double-blind phase and the placebo delayed-treatment phase at 12 weeks after treatment cessation.Virological resistance analysis was performed on subjects who failed treatment. The primary efficacy endpoint was SVR12. The number and percentage of subjects who achieved "HCV RNA
10.Analysis of learning curve of TiRobot-assisted lumbar pedicle screw fixation based on the cumulative sum test
Yuquan LIU ; Xiang LI ; Qi FEI ; Kuo CHEN ; Weiyang ZUO ; Bin ZHU ; Guoqiang ZHANG ; Lingjia YU ; Xuehu XIE ; Ning LIU ; Haining TAN ; Hai MENG ; Tianqi FAN ; Yong YANG
Chinese Journal of Postgraduates of Medicine 2025;48(1):10-17
Objective:To analyze the learning curve of TiRobot-assisted lumbar pedicle screw fixation (LPSF) by cumulative sum (CUSUM) test method.Methods:The clinical data of 50 patients who underwent TiRobot-assisted LPSF from January 2020 to December 2022 in Beijing Friendship Hospital, Capital Medical University were retrospectively analyzed. CUSUM analysis and learning curve fitting were performed with robot usage time as the main indicator with the time for each step refined (robot registration time, path planning time and guide wire placement time), to select the best learning curve fitting model with the R2 value closest to 1. Using the turning point of the learning curve as the boundary, the learning curve was divided into two stages as learning stage and maturity stage, and then the observation indexes were compared between the two stages. Results:All 50 patients successfully completed the surgery without perioperative complications, with a total of 244 pedicle screws implanted. The total robot usage time and robot registration time showed a gradually decreasing trend with the increase of case number, and the learning curves were successfully fitted and reached their peaks at the seventeenth and thirteenth cases respectively. The entire learning process was divided into learning stage (17 cases) and maturity stage (33 cases) based on the turning point of the learning curve of total robot usage time. The path planning time and guide wire placement time did not show significant changes with the increase in the case number. The total robot usage time, robot registration time and the intraoperative blood loss in the learning stage were significantly higher than those in the maturity stage: (35.35 ± 1.58) min vs. (30.61 ± 0.43) min, (20.83 ± 1.56) min vs. (14.94 ± 0.29) min and 400 (150, 500) ml vs. 200 (110, 300) ml, the guide wire placement time of per screw was significantly lower than that in the maturity stage: 2.00 (1.83, 2.34) min/screw vs. 2.33 (2.13, 2.69) min/screw, and there were statistical differences ( P<0.05 or <0.01). There were no statistical difference in the path planning time, path planning time of per screw, guide wire placement time and the accuracy of screw placement between two stages ( P>0.05). Conclusions:TiRobot-assisted LPSF is a new technology with safety and effectiveness, and it has a relatively short learning curve. To achieve technological maturity, at least 17 surgeries are required with accumulated experience, and the robot registration is the main step of the learning process. After reaching maturity stage, the robot usage time is significantly shortened and intraoperative trauma is significantly reduced while the relatively high screw placement accuracy is ensured.

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