1.Cost-utility analysis of benmelstobart plus anlotinib and chemotherapy as first-line treatment for extensive-stage small cell lung cancer
Bing FENG ; Ning GAO ; Shengnan GAO ; Yuxi ZHANG ; Ranran ZHANG ; Guoqiang LIU
China Pharmacy 2025;36(5):579-583
OBJECTIVE To evaluate the cost-utility of benmelstobart combined with anlotinib and chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) from the perspective of China’s healthcare system. METHODS Based on the data from the ETER 701 study, a partitioned survival model was constructed with a cycle of 3 weeks to simulate the total cost, quality-adjusted life years (QALY), and incremental cost-effectiveness ratio (ICER) over 10 years for patients with ES- SCLC treated with benmelstobart plus anlotinib and chemotherapy, or chemotherapy alone. One-way sensitivity analysis and probability sensitivity analysis were performed to verify the robustness of the simulation results. The willingness-to-pay (WTP) threshold was set at 3 times the per capita gross domestic product (GDP) of China in 2023, which amounted to 268 074 yuan/QALY. RESULTS Compared with chemotherapy alone, benmelstobart combined with anlotinib and chemotherapy gained 0.438 QALY more at the cost of 403 505.55 yuan more, with an ICER of 922 031.37 yuan/QALY, which was higher than the WTP threshold set in this study. One-way sensitivity analysis showed that benmelstobart’s cost and utility value of the progression-free survival state had a greater impact on the ICER value; probabilistic sensitivity analysis confirmed the robustness of the model; only when the price of benmelstobart was reduced by 75.4%, the combined regimen would be cost-effective. CONCLUSIONS The first-line treatment of ES-SCLC with benmelstobart combined with anlotinib and chemotherapy is not cost-effective from the perspective of China’s healthcare system at present.
2.Application value of machine learning models based on CT radiomics for assessing split renal function
Junjie ZOU ; Ruidong LI ; Hu SONG ; Feng WANG ; Ning DING ; Kongyuan ZHANG
Chinese Journal of Radiological Health 2025;34(1):108-113
Objective Based on the radiomics features extracted from the unenhanced CT images of the lower abdomen, a variety of machine learning models were constructed to explore their application value in the assessment of split renal function. Methods A retrospective analysis was conducted on the unenhanced CT images from 240 single kidneys in patients with clinically suspected renal dysfunction. Based on the results of single-photon emission computed tomography renal dynamic imaging, the cases were classified into the normal glomerular filtration rate group (n=118) and the decreased glomerular filtration rate group (n=122). The region of interest was outlined on the unenhanced CT images and the radiomics features were extracted. The features were selected by correlation analysis and least absolute shrinkage and selection operator, and the machine learning models were constructed based on the algorithms of decision tree, support vector machine, random forest, logistic regression, and extreme gradient boosting. Area under the receiver operating characteristic curve, accuracy, sensitivity, and specificity were calculated to compare the performance of different models. Results Sixteen radiomics features were selected for constructing the machine learning models. The support vector machine model showed relatively high performance for the assessment of split renal function on the test set, with an area under the receiver operating characteristic curve value of 0.883 (95% confidence interval: 0.804-0.961), an accuracy of 0.778, a sensitivity of 0.811, and a specificity of 0.743. Conclusion The machine learning models constructed based on unenhanced CT radiomics can be used to preliminarily assess split renal function, which provides an innovative, convenient, and safe method for clinical diagnosis and has positive significance for treatment.
3.Diagnosis and malignant analysis of mass versus pneumonia type of primary pulmonary mucinous adenocarcinoma
Yihui FENG ; Xiaolei ZHU ; Shaohan FANG ; Xiaowen ZHANG ; Ning LI ; Guojun GENG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):360-365
Objective To investigate the relationship between primary pulmonary mucinous adenocarcinoma (PPMA) mass type and pneumonia type and their difference in malignant degree, and to analyze the role of clinical manifestations and CT features in the diagnosis of this disease. Methods The clinical data of PPMA patients admitted in the First Affiliated Hospital of Xiamen University from May 2011 to March 2022 were retrospectively analyzed. According to CT features, they were divided into a mass type group and a pneumonia type group. The clinical manifestations, CT features and the degree of malignancy between the two groups were analyzed and compared. Results A total of 57 PPMA patients were enrolled. There were 17 males and 40 females, with an average age of (53.82±10.65) years, and 28 (49%) patients had reversed hato-like sign. There were 42 patients in the mass type group and 15 patients in the pneumonia type group. PPMA often occurs in both lower lungs, with clinical manifestations mainly of coughing and expectorating white mucoid sputum. There were statistical differences between the two groups in the maximum diameter of tumor (P<0.001), boundary condition (P<0.001) and pleural indentation sign (P=0.019). There was no statistical difference between the two groups in Ki-67 index (P>0.05). Conclusion There is no statistical difference in the degree of malignancy between the two types of PPMA. Considering their clinical manifestations and differences in imaging features, it is supported that the pneumonia type is just a progression of the mass type. CT can present various manifestations, among which the reversed hato-like sign is expected to become an important imaging feature. Combined with a high proportion of solid components, pleural indentation sign, and vacuole sign, reversed hato-like sign can play a significant role in the diagnosis of PPMA.
4.Calcium channel modulators in the treatment of diabetic peripheral neuropathic pain:a rapid health technology assessment
Ning GAO ; Bing FENG ; Shengnan GAO ; Ranran ZHANG ; Yuxi ZHANG ; Guoqiang LIU
China Pharmacy 2025;36(8):1001-1007
OBJECTIVE To evaluate the efficacy, safety and economics of calcium channel modulators in the treatment of diabetic peripheral neuropathic pain (DPNP), and provide evidence-based evidence for clinical drug selection and decision-making. METHODS PubMed, Embase, Cochrane Library, CNKI, Wanfang data, VIP net, CBM and official websites of foreign health technology assessment (HTA) institutions were systematically searched to collect HTA reports, systematic review/meta-analyses, and pharmacoeconomic studies of pregabalin, gabapentin, crisugabalin, and mirogabalin for the treatment of DPNP. The timeframe for all searches was from the inception to June 2024. After data extraction and quality assessment, the results of the included studies were analyzed descriptively. RESULTS A total of 16 articles were included, involving 1 HTA report, 7 systematic reviews/meta- analyses, and 8 pharmacoeconomic studies. No studies on crisugabalin were retrieved. Compared with placebo, both pregabalin and mirogabalin reduced end point pain scores and increased the proportion of patients with ≥30% and/or ≥50% reduction in pain scores. Pregabalin also improved patient global impression of change (PGIC). Gabapentin was similar to placebo in reducing end point pain scores and increasing the proportion of patients with ≥30% and/or ≥50% reduction in pain scores, but gabapentin improved PGIC of patients. Compared with pregabalin, mirogabalin was more effective in the treatment of pain. The safety of pregabalin and mirogabalin was similar, and compared with placebo, both pregabalin and mirogabalin increased the risk of common adverse reactions such as dizziness and somnolence. The safety of gabapentin was similar to placebo and duloxetine. Compared with duloxetine, pregabalin and gabapentin were not cost-effective. Compared with gabapentin, pregabalin was cost-effective. Mirogabalin was cost-effective, as compared with placebo and pregabalin. CONCLUSIONS Pregabalin and mirogabalin are effective in the treatment of DPNP, the efficacy of mirogabalin is better than pregabalin, and the safety is similar between them. The economic conclusions vary from country to country, pending a pharmacoeconomic study based on our population.
5.Aerobic Exercise Improves Cognitive Function of Aging Mice by Regulating Intestinal Flora-metabolite Network
An-Feng WANG ; Tong WU ; Hu ZHANG ; Ji-Ling LIANG ; Ning CHEN
Progress in Biochemistry and Biophysics 2025;52(6):1484-1498
ObjectiveThis study aimed to explore the effects of aerobic exercise on cognitive function in aging mice and to elucidate the underlying molecular mechanisms by which aerobic exercise ameliorates cognitive decline through the regulation of gut microbiota-metabolite network. By providing novel insights into the interplay between exercise, gut microbiota, and cognitive health, this research seeks to offer a robust theoretical foundation for developing anti-aging strategies and personalized exercise interventions targeting aging-related cognitive dysfunction. MethodsUsing naturally aged C57BL/6 mice as the experimental model, this study employed a multi-omics approach combining 16S rRNA sequencing and wide-targeted metabolomics analysis. A total of 18 mice were divided into 3 groups: young control (YC, 4-month-old), old control (OC, 21-month-old), and old+exercise (OE, 21-month-old with 12 weeks of moderate-intensity treadmill training) groups. Behavioral assessments, including the Morris water maze (MWM) test, were conducted to evaluate cognitive function. Histopathological examinations of brain tissue sections provided morphological evidence of neuronal changes. Fecal samples were collected for gut microbiota and metabolite profiling via 16S rRNA sequencing and ultra-performance liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry (UPLC-QTOF-MS). Data were analyzed using a combination of statistical and bioinformatics tools to identify differentially abundant microbial taxa and metabolites and to construct interaction networks between them. ResultsBehavioral tests revealed that 12 weeks of aerobic exercise significantly improved spatial learning and memory capacity of aged mice, as evidenced by reduced escape latency and increased target area exploration and platform crossings in the MWM. Histopathological analysis demonstrated that exercise mitigated aging-related neuronal damage in the hippocampus, enhancing neuronal density and morphology. 16S rRNA sequencing indicated that exercise increased gut microbiota α‑diversity and enriched beneficial bacterial genera, including Bifidobacterium, Parabacteroides, and Rikenella. Metabolomics analysis identified 32 differentially regulated metabolites between OC and OE groups, with 94 up-regulated and 30 down-regulated in the OE group when compared with OC group. These metabolites were primarily involved in energy metabolism reprogramming (e.g., L-homocitrulline), antioxidant defense (e.g., L-carnosine), neuroprotection (e.g., lithocholic acid), and DNA repair (e.g., ADP-ribose). Network analysis further revealed strong positive correlations between specific bacteria and metabolites, such as Parabacteroides with ADP-ribose and Bifidobacterium with lithocholic acid, suggesting potential neuroprotective pathways mediated by the gut microbiota-metabolite axis. ConclusionThis study provides comprehensive evidence that aerobic exercise elicits cognitive benefits in aging mice by modulating the gut microbiota-metabolite network. These findings highlight three key mechanisms: (1) the proliferation of beneficial gut bacteria enhances metabolic reprogramming to boost DNA repair pathways; (2) elevated neuroinflammation-inhibiting factors reduce neurodegenerative changes; and (3) enhanced antioxidant defenses maintain neuronal homeostasis. These results underscore the critical role of the “microbiota-metabolite-brain” axis in mediating the cognitive benefits of aerobic exercise. This study not only advances our understanding of the gut-brain axis in aging but also offers a scientific basis for developing personalized exercise and probiotic-based interventions targeting aging-related cognitive decline. Future research should further validate these mechanisms in non-human primates and human clinical trials to establish the translational potential of exercise-induced gut microbiota-metabolite modulation for combating neurodegenerative diseases.
6.Cost-utility analysis of capecitabine metronomic chemotherapy combined with aromatase inhibitor as first-line treatment for HR+/HER2- metastatic breast cancer
Ranran ZHANG ; Guoqiang LIU ; Yuxi ZHANG ; Shengnan GAO ; Ning GAO ; Bing FENG ; Ran LIU ; Qian LI
China Pharmacy 2025;36(15):1893-1898
OBJECTIVE To evaluate the cost-effectiveness of capecitabine metronomic chemotherapy combined with aromatase inhibitor (AI) versus AI monotherapy as first-line treatment for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, thereby providing evidence-based support for clinical therapeutic decision- making and healthcare policy formulation. METHODS Based on the MECCA trial, a partitioned survival model was constructed using a 4-week cycle length to simulate outcomes over patients’ lifetime. The model outputs included total costs, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed to validate the robustness of base-case results, while scenario analyses examined the cost-effectiveness of both treatment strategies under 10-year, 20-year, and lifetime time horizons. RESULTS With the willingness-to-pay (WTP) threshold set at 1 times China’s 2024 per capita gross domestic product (GDP) (95 749 yuan/QALY), patients receiving capecitabine metronomic chemotherapy combined with AI regimen gained incremental utility (0.66 QALYs) while incurring higher costs, with ICER of 27 684.85 yuan/QALY. Results of the one-way sensitivity analysis showed that factors with significant impacts on ICER included the cost discount rate, drug costs of the capecitabine metronomic chemotherapy combined with AI group, utility value in the progression-free survival state, follow-up costs, and treatment costs in the subsequent stablephase. Probabilistic sensitivity analysis indicated that when the WTP threshold ≥49 250 yuan/QALY, the capecitabine metronomic chemotherapy combined with AI regimen had a 100% probability of being cost-effective. Scenario analysis results demonstrated that capecitabine metronomic chemotherapy combined with AI regimen was more cost-effective than the AI alone regimen across 10-year, 20-year, and lifetime study horizons. CONCLUSIONS Under the premise that the WTP threshold is set at 1 times China’s per capita GDP in 2024, capecitabine metronomic chemotherapy combined with AI regimen is more cost-effective than the AI alone regimen as the first-line treatment for HR+/HER2- metastatic breast cancer.
7.Cost-effectiveness analysis of sacituzumab tirumotecan versus single-agent chemotherapy in second-line and later-line treatment for metastatic triple-negative breast cancer
Ranran ZHANG ; Yuxi ZHANG ; Shengnan GAO ; Bing FENG ; Ning GAO ; Guoqiang LIU
China Pharmacy 2025;36(16):2024-2029
OBJECTIVE To evaluate the cost-effectiveness of sacituzumab tirumotecan (ST) versus chemotherapy treatment physician’s choice (TPC) as second-line and later-line treatment for metastatic triple-negative breast cancer (mTNBC) from the perspective of China’s healthcare system. METHODS A partitioned survival model was constructed based on the OptiTROP-Breast 01 trial, with a cycle length of 4 weeks and a time horizon of 10 years, applying a 5% discount rate. Quality adjusted life year (QALY) and costs were used as outcome measures, and the incremental cost-effectiveness ratio (ICER) of ST versus TPC for second-line and later-line treatment of mTNBC was calculated. Sensitivity analyses were conducted to validate the robustness of the base-case results. RESULTS At a willingness-to-pay threshold (WTP) of 3 times China’s 2024 per capita gross domestic product (GDP) (287 247 yuan/QALY), patients receiving ST gained incremental utility (0.42 QALY) at a higher cost, yielding an ICER of 205 562.07 yuan/QALY, which was lower than WTP, indicating that ST was more cost-effective compared to TPC. One-way sensitivity analysis revealed that key factors influencing the ICER included the utility value of progression-free survival and the price of ST. Probabilistic sensitivity analysis and scenario analysis showed that the base-case results were robust. CONCLUSIONS From the perspective of China’s healthcare system, at a WTP of 3 times China’s per capita GDP, ST is more cost-effective than TPC as second-line and later-line treatment for mTNBC.
8.Research progress on Buyang Huanwu Decoction in preventing and treating vascular dementia by regulating inflammatory factors
Yan-Hong LIU ; Shu-Yuan CONG ; Feng WU ; Ke-Wu ZHAO ; Xiao-Hong DONG ; Ning ZHANG ; Bin LIU
The Chinese Journal of Clinical Pharmacology 2024;40(5):749-753
Objective Vascular dementia(VD)is a clinical syndrome caused by various cerebrovascular diseases,including ischemic,hemorrhagic,and acute and chronic hypoxic cerebrovascular diseases,leading to impaired brain function and affecting patients'cognitive ability,daily life,and work abilities.Vascular dementia is a preventable and reversible form of dementia,second only to Alzheimer's disease as the second common cause of dementia.At present,the relevant pathogenesis of vascular dementia is not clear,and there is no clear treatment method.However,its pathogenesis may be related to neuroinflammation,oxidative stress,neuronal damage and white matter lesions.Its main risk factors include genetic factors,hypercholesterolemia,diabetes,hypertension,etc.Neuroinflammatory response plays a major role in the process of secondary brain injury caused by cerebral ischemia,and inflammatory factors lead to an inflammatory cascade reaction that exacerbates damage to the nervous system.Inhibiting the inflammatory pathway and reducing the expression of inflammatory factors can improve the symptoms of vascular dementia patients and animal models,indicating that neuroinflammation may play an important role in the pathogenesis of vascular dementia.This article explores the effects of Buyang Huanwu Decoction on inflammatory factors from the perspective of summarizing relevant literature in recent years.It mainly reviews the pharmacological effects of Buyang Huanwu Decoction on treating vascular dementia,the relationship between inflammatory factor levels and vascular dementia,and the prevention and treatment of vascular dementia by regulating inflammatory factor levels.
9.Effects of GSTT1, GSTM1 and EPHX1 genes on skin injury in workers exposed to coal tar pitch
Xiaochen SUN ; Ning LI ; Fengjiang SONG ; Donghong SU ; Tao WANG ; Fang ZHANG ; Feng CUI ; Hua SHAO
China Occupational Medicine 2024;51(5):528-532
Objective To investigate the effects of glutathiones-transferase (GST) T1, GSTM1 and epoxide hydrolase (EPHX1) genes on skin injury in workers exposed to coal tar pitch. Methods Workers from a carbon manufacturing company involved in coal tar pitch production and use were selected as the study subjects using a judgment sampling method. Workers with skin injury after exposed to coal tar were selected as the case group (55 cases), and those with the same workshop and type of work but without skin abnormalities were selected as the control group (197 cases). Urine and blood samples were collected from the workers, and levels of polycyclic aromatic hydrocarbon metabolites, including 1-pyrenol (1-OH-P), 1-naphthol (1-OH-N) and 2-naphthol (2-OH-N), in urine were measured using ultra high-performance liquid chromatography tandem mass spectrometry. The GSTT1, GSTM1 and EPHX1 genes in blood were detected by polymerase chain reaction. Results In the case group, all 55 workers reported skin stinging, 25 workers reported itching and flaking, and 15 workers reported blackheads and pigmentation. Urinary levels of 1-OH-N and 2-OH-N were lower in the worker in the case group than that in the control group (all P<0.05). However, there was no significant difference in the level of 1-OH-P between the two groups (P>0.05). There were significant differences in the number of workers with GSTT1, GSTM1 and EPHX1(His139His) genes between the two groups (all P<0.01). The GSTT1 and GSTM1 genes were positively correlated with post-shift urinary levels of 1-OH-N, 1-OH-P, and 2-OH-N (all P<0.01). The EPHX1 (139Arg locus) gene was positively correlated with post-shift 2-OH-N levels (P=0.03). The GSTT1, GSTM1, and EPHX1 (139Arg locus) genes were associated with reduced skin damage among coal tar workers (all P<0.01), after controlling for age, length of service, gender, smoking, and alcohol consumption. Conclusion Exposure to coal tar pitch can cause skin injury in workers, and the GSTT1, GSTM1, and EPHX1 (139Arg locus) genes are protective factors against skin injury in those workers.
10.Methodological Consideration on Combination Model of TCM Clinical Practice Guidelines and Real-world Study
Guozhen ZHAO ; Huizhen LI ; Ning LIANG ; Haili ZHANG ; Bin LIU ; Qianzi CHE ; Feng ZHOU ; He LI ; Xiaowen CHEN ; Long YE ; Jiahao LIN ; Xingyu ZONG ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):87-93
The clinical practice guidelines of traditional Chinese medicine (TCM) have problems such as limited clinical application and unclear implementation effects, which may be related to the lack of clinical practice evidence. To provide reliable and precise evidence for clinical practice, this article proposes a model of combining TCM guidelines with real-world study, which includes 4 steps. Firstly, during the implementation process of the guidelines, a high-quality research database is established. Secondly, the recommendations in the guidelines are evaluated based on the established database in multiple dimensions, including applicability, effectiveness, safety, and cost-effectiveness, and thus their effectiveness in practical applications can be determined. Thirdly, based on the established database, core prescriptions are identified, and the targeted populations and medication plans are determined. That is, the best treatment regimen is established based on the analysis of abundant clinical data regarding the effects of different medication frequencies, dosages, and duration on efficacy. Fourthly, the guidelines are updated according to the real-world evidence. The research based on this model can provide real-world evidence for ancient and empirical prescriptions, improving their application in clinical practice. Moreover, this model can reduce research costs and improve research efficiency. When applying this model, researchers need to pay attention to the quality of real-world evidence, ensuring that it can truly reflect the situation in clinical practice. In addition, importance should be attached to the clinical application of guideline recommendations, ensuring that doctors can conduct standardized diagnosis and treatment according to the guidelines. Finally, full-process participation of multidisciplinary experts is encouraged to ensure the comprehensiveness and scientificity of the study. In conclusion, the application of this model will contribute to the development of TCM guidelines responsive to the needs of clinical practice and achieve the goal of promoting the homogenization of TCM clinical diagnosis and treatment.

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