1.Pharmacoeconomic evaluation of durvalumab combined with chemotherapy as first-line therapy for advanced biliary tract cancer
Liman HUO ; Yangyang DUAN ; Ping LIANG ; Bin SHAN ; Xiaoli SUN ; Rui FENG
China Pharmacy 2025;36(17):2141-2147
OBJECTIVE To assess the cost-effectiveness of durvalumab combined with chemotherapy as a first-line treatment for advanced biliary tract cancer from the perspective of the Chinese healthcare system. METHODS Using data from the TOPAZ-1 clinical trial, a three-state Markov model comprising progression-free survival (PFS), progressive disease (PD) and death was developed, with a cycle length of 21 days and a 10-year time horizon. Patients in the observation group received durvalumab in combination with gemcitabine and cisplatin, whereas those in the control group received placebo plus the same chemotherapy regimen. The evaluation indexes were quality-adjusted life year (QALY) and the incremental cost-effectiveness ratio (ICER). The willingness-to-pay (WTP) threshold was set at three times the 2024 Chinese per capita gross domestic product (GDP) (287 247 yuan/QALY). The sensitivity analyses, along with scenario analyses, were performed. RESULTS In the base-case analysis, the ICER of observation group compared to control group was 1 166 344.46 yuan/QALY, far exceeding the WTP threshold, indicating that the regimen was not cost-effective. One-way sensitivity analysis identified the PD state utility, discount rate, cost of durvalumab, and PFS state utility as the main drivers of ICER variation. Probabilistic sensitivity analysis showed that, at the above WTP threshold, the probability of the acceeptance of this regimen was 0, further supporting the robustness of the base-case findings. In the scenario analysis, inclusion of a patient assistance program reduced the ICER to 235 885.16 yuan/ QALY, below the above WTP threshold, suggesting cost-effectiveness under this assistance program. However, when applying a regional WTP threshold set at three times the per capita GDP (158 475 yuan/QALY) of Gansu Province (the province with the lowest GDP in China in 2024), the ICER remained above the threshold, indicating that the regimen was not cost-effective at the regional level. CONCLUSIONS At current pricing, durvalumab plus chemotherapy as a first-line treatment for advanced biliary tract cancer is not cost-effective in China. Although the introduction of a patient assistance program can substantially reduce the ICER and achieve cost-effectiveness at a WTP threshold set at three times the 2024 per capita GDP of China, due to limited affordability in low-income areas, the program remains not cost-effective.
2.Analysis of clinical characteristics and influential factors of drug-induced liver injury in children caused by intravenous azithromycin
Wanhui LI ; Xiaoqian LYU ; Dan SU ; Baofeng HUO ; Hejun CHEN ; Ping YAN
China Pharmacy 2025;36(20):2566-2570
OBJECTIVE To analyze the clinical characteristics and influential factors of drug-induced liver injury (DILI) in children caused by intravenous azithromycin. METHODS Clinical data of 157 DILI pediatric cases caused by intravenous azithromycin, reported by the Hengshui Adverse Drug Reaction Monitoring Center from January 2015 to January 2025, were collected as the observation group. Clinical data of pediatric patients who received intravenous azithromycin but did not develop DILI during the same period at Hengshui People’s Hospital were collected in a 1∶1 ratio to serve as the control group. The clinical classification, severity and prognosis of DILI in pediatric patients from the observation group were analyzed. Univariate and multivariate Logistic regression analyses were used to screen the independent risk factors for DILI in children caused by intravenous azithromycin. RESULTS Among 157 DILI cases, 92 cases (58.60%) had hepatocellular injury-type, 51 cases (32.48%) had cholestatic-type, and 14 cases (8.92%) had mixed-type. DILI severity was grade 1 in 117 cases (74.52%), grade 2 in 33 cases (21.02%), and grade 3 in 7 cases (4.46%). Liver function had all recovered after stopping medication and symptomatic treatment. Combined with acetaminophen [OR=3.769, 95%CI (1.615, 8.235), P=0.021], daily dose of azithromycin>10 mg/kg [OR= 2.237, 95%CI (1.075, 4.655), P=0.034] were independent risk factors for DILI in children caused by intravenous azithromycin. CONCLUSIONS Hepatocellular injury-type and cholestatic-type are relatively common in children with DILI caused by intravenous azithromycin, with mild severity being predominant and showing a favorable prognosis. Combination with acetaminophen and daily dose>10 mg/kg are independent risk factors for azithromycin-induced DILI in children.
3.Construction of induced pluripotent stem cells derived from peripheral blood mononuclear cells of a patient with facioscapulo-humeral muscular dystrophy and their differentiation into skeletal muscle cells
Jiao JIAO ; Haiqin HUO ; Xiuqing JI ; Yiyun XU ; Hao CHEN ; Zhengfeng XU ; Ping HU
Chinese Journal of Clinical Laboratory Science 2024;42(7):527-534
Objective To construct and identify the induced pluripotent stem cells(iPSCs)derived from peripheral blood mononuclear cells(PBMCs)of a patient with facioscapulohumeral muscular dystrophy(FSHD),initially explore their differentiation ability into skeletal muscle cells,and evaluate the feasibility of using this cell model for disease mechanism research.Methods The PBMCs from one FSHD patient were collected and transfected with Sendai virus containing four reprogramming transcription factors,including OCT4,SOX2,KLF4 and c-MYC,so as to obtain the iPSCs from the FSHD patient.Then,the iPSCs were induced to differentiate into skeletal muscle cells.The characteristics of the iPSCs and skeletal muscle cells were evaluated by the optical genome mapping technolo-gy,karyotyping analysis,immunofluorescence staining,and real-time fluorescence quantitative PCR.Results The iPSCs from the FSHD patient were successfully obtained,which could express the markers of iPSCs.The karyotype and D4Z4 repeat unit of the iPSCs were consistent with that of the patient.The iPSCs could be induced to differentiate into skeletal muscle cells in vitro,which expressed the pathogenic gene DUX4 and its regulatory genes.Conclusion The PBMCs from one FSHD patient can be reprogrammed into iPSCs,which can be differentiated into disease-related myogenic progenitor cells and myotubes.This provides a useful cell model for in vitro studies of the pathogenesis of FSHD and a tool for the effective treatment of FSHD.
4.Observation on Clinical Efficacy of Therapy of Clearing Heat,Percolating Dampness and Lowering Turbidity Combined with Silibin Meglumine Tablets in the Treatment of Non-alcoholic Steatohepatitis of Damp-Heat Accumulation Type
Hua-Lu FU ; Huo-Cheng YE ; Zi-Chen OUYANG ; Yan-Ping LU ; Shu LI ; Jing-Bao HU
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(7):1744-1750
Objective To investigate the clinical efficacy of therapy of clearing heat,percolating dampness and lowering turbidity combined with Silibin Meglumine Tablets in the treatment of non-alcoholic steatohepatitis(NASH)patients with abnormal alanine aminotransferase(ALT)level of damp-heat accumulation type.Methods A retrospective study was conducted.According to the medication,80 patients with NASH with abnormal ALT level of damp-heat accumulation type were divided into control group and observation group,with 40 cases in each group.The control group was treated with Silibin Meglumine Tablets,and the observation group was treated with therapy of clearing heat,percolating dampness and lowering turbidity on the basis of treatment for the control group.The course of treatment covered 12 weeks.The changes of liver function indicators of ALT,aspartate aminotransferase(AST),and gamma glutamyl transpeptidase(GGT),blood lipid indicators of total cholesterol(CHOL)and triglyceride(TRIG),and the degree of hepatic steatosis in the two groups were observed before and after treatment.After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)After 12 weeks of treatment,the total effective rate of the observation group was 95.00%(38/40),and that of the control group was 77.50%(31/40).The curative effect of the observation group was significantly superior to that of the control group,and the difference was statistically significant(P<0.05).(2)After treatment,the levels of ALT,AST and GGT in the two groups were significantly lower than those before treatment(P<0.05),and the decrease of ALT,AST and GGT in the observation group was significantly superior to that in the control group(P<0.05).(3)After treatment,the levels of CHOL and TRIG in the two groups were significantly lower than those before treatment(P<0.05),and the decrease of CHOL and TRIG in the observation group was significantly superior to that in the control group(P<0.05).(4)After treatment,the degree of hepatic steatosis in the two groups was significantly lower than that before treatment(P<0.05),and the decrease of the degree of hepatic steatosis in the observation group was significantly superior to that in the control group(P<0.05).(5)During the treatment,no obvious adverse reactions occurred in the two groups,indicating high safety.Conclusion The therapy of clearing heat,percolating dampness and lowering turbidity combined with Silibin Meglumine Tablets exerts certain effect in the treatment of NASH patients with abnormal ALT level of damp-heat accumulation type,and the therapy can significantly enhance the clinical efficacy of Silibin Meglumine Tablets alone for NASH.
5.Comparison of thermal ablation combined with synchronous TACE and TACE in liver metastasis of neuroendocrine tumors of different pathologic grades
Sothea YAV ; Hui-Yi SUN ; Fei-Hang WANG ; Dan-Yang ZHAO ; Zi-Hao HUO ; Yi CHEN ; Zhi-Ping YAN ; Ling-Xiao LIU
Fudan University Journal of Medical Sciences 2024;51(3):323-330,337
Objective To compare the efficacy and safety between thermal ablation combined with synchronous transcatheter arterial chemoembolization(TACE)and TACE in patients with liver metastasis of neuroendocrine tumors of different pathologic grades.Methods A retrospective analysis was performed on patients with liver metastases of neuroendocrine tumors admitted to Department of Interventional Radiology,Zhongshan Hospital,Fudan University from Nov 1,2006 to Jul 31,2022.The patients were divided into synchronous ablation group and TACE group according to treatment mode and subgroups according to pathological grade.The lesions were evaluated by postoperative imaging examination.The patients were followed up until Jul 31,2023,and surgery-related complications were recorded.The endpoint of prognosis were progression-free survival(PFS)and overall survival(OS).Results A total of 86 patients with neuroendocrine tumor were collected,including 34 patients in simultaneous ablation group and 52 patients in TACE group.According to WHO classification,21 patients at G1 stage,45 patients at G2 stage and 20 patients at G3 stage were included.No serious postoperative complications occurred in all patients.The median OS was 47.0(95%CI:31.2-62.8)months in the TACE group and 56.0(95%CI:8.3-73.4)months in the synchronous ablation group,with no statistical difference between the two groups(P=0.50).The median PFS was 18.0(95%CI:6.0-30.0)months in the TACE group and 29.0(95%CI:10.0-48.0)months in the synchronous ablation group,with no statistical difference between the two groups(P=0.22).Of the 45 patients at G2 stage,27 received TACE with a median OS of 47.0 months,and 18 received synchronous ablation with a median OS of 59.0 months,and there was no statistical difference between the two groups(P=0.45).The median PFS was 12.0 months in the TACE group and 32.0 months in the synchronous ablation group,and the difference between the two groups was statistically significant(P=0.03).Conclusion Comparing with TACE,simultaneous ablation can delay disease progression in patients with liver metastasis of neuroendocrine tumors to a certain extent and has good safety,especially for patients with liver metastases of neuroendocrine tumors with intermediate or low grade.
6.Research progress on breed characteristics and germplasm resources itilization of Zi goose
Mingdong HUO ; Jiaqiang DONG ; Ping LI ; Wenkai GUO ; Zhifeng CHEN ; Zhigang MA ; Nian-Dong WEI ; Yue ZOU ; Hong ZHANG ; Zhiqiang WANG ; Haotian YANG ; Caihong HAO ; Mingzhe LYU ; Yuxiang HUANG
Chinese Journal of Veterinary Science 2024;44(11):2496-2501
Zi goose is a small local variety with high fecundity,good meat quality,roughage resist-ance,strong adaptability and excellent down quality.It is an excellent female parent for cross breeding among varieties.With the rapid development of goose industry,the variety of Zi goose has not been well protected,the variety is hybrid and degraded seriously,and the number of pure Zi goose is decreasing day by day.This paper reviewed the research progress on the breeding distribu-tion and preservation status of Zi goose and the variety characteristics of Zi goose,in order to pro-vide reference for the research,protection and utilization of germplasm resources of Zi goose and the stable development of goose industry.
7.New trends in the development of artificial intelligence-assisted cerebrospinal fluid morphologic examination
Hui ZHAO ; Kun CHEN ; Hong LYU ; Siqi HAN ; Yunzhuan ZHAO ; Ping HAN ; Bei SONG ; Yang LIU ; Yishan HUO ; Ming GUAN ; Guojun ZHANG
Chinese Journal of Laboratory Medicine 2024;47(5):480-485
Cerebrospinal fluid morphology examination is an important method of diagnosing central nervous system diseases, but manual microscopy has shortcomings such as low efficiency, long staff training period, and poor homogeneity of test results. In recent years, the application of artificial intelligence in the medical field has developed rapidly, providing new technical means for cerebrospinal fluid morphology examination. In the future, AI-assisted morphological examination of cerebrospinal fluid will not only realize digitalization and networking, but also improve the level and efficiency of intelligent diagnosis of cerebrospinal fluid morphology, which has a broad application prospect in the intelligent assisted diagnosis of cerebrospinal fluid.
8.Traditional Chinese medicine regulates the gut microbiota-bile acids-FXR axis to intervene in the development of colorectal cancer
Ya-ni WANG ; Xiao-yu ZHANG ; Yu-ping LIU ; Xiao-ying QIN ; Jie-ge HUO ; Yan CHEN ; Huang-qin ZHANG
Acta Pharmaceutica Sinica 2024;59(11):3027-3041
The gut microbiota plays a crucial role in the development of colorectal cancer (CRC). The imbalanced gut microbiota causes damage to the body and disrupts bile acids metabolism, increases susceptibility to CRC, and affects the signaling of farnesol X receptor (FXR), thereby promoting CRC progression. Traditional Chinese medicine has unique advantages in the treatment of CRC due to its synergistic regulatory effects of multiple components, targets, and pathways. It can regulate gut microbiota, intervene in bile acids metabolism, and activate its receptor FXR to inhibit the occurrence and development of CRC. Based on this, this article discusses the main role of the gut microbiota-bile acids-FXR axis in the development of CRC, and reviews the anti CRC effects and mechanisms of traditional Chinese medicine intervention on gut microbiota-bile acids-FXR axis, in order to provide new ideas and methods for the prevention and treatment of CRC.
9.Related factors of endogenous erythropoietin and its association with 10-year risks of cardiovascular disease in a community-based Chinese study.
Chu Yun CHEN ; Peng Fei SUN ; Jing ZHAO ; Jia JIA ; Fang Fang FAN ; Chun Yan WANG ; Jian Ping LI ; Yi Meng JIANG ; Yong HUO ; Yan ZHANG
Journal of Peking University(Health Sciences) 2023;55(6):1068-1073
OBJECTIVE:
To investigate the associated factors of endogenous erythropoietin (EPO) and its association with 10-year risks of atherosclerotic cardiovascular disease in a Chinese community-based general population.
METHODS:
The participants of this study were from an atherosclerosis cohort survey which was established by the Department of Cardiology, Peking University First Hospital in 2011. The cohort survey was performed in the Gucheng and Pingguoyuan communities of Shijingshan district in Beijing, China. The inclusion criteria of this study were: (1) endogenous EPO was measured; (2) health questionnaire data and other clinical data were complete; (3) participatants who had cardiovascular or cerebrovascular diseases (defined as self-reported coronary heart disease, stroke or transient ischemic attack) or anemia or estimated glomerular filtration rate (eGFR) < 60 mL/(min·1.73 m2) at baseline were excluded. Multivariate linear regression model was used to examine the associated factors of endogenous EPO. The participants were grouped into low (< 5%), moderate (5%-10%) and high risk (≥10%) groups, based on predicted 10-year cardiovascular disease risk using the prediction for atherosclerotic cardiovascular disease risk in China (China-PAR) equations.
RESULTS:
A total of 4 013 participants were included. Mean age of them was (55.9±8.2) years, 62.2% (n=2 496) of them were female, and 46.3% (n=1 859), 70.9% (n=2 845), 21.9% (n=879) had hypertension, dyslipidemia and diabetes, individually. The average body mass index was (26.1±3.3) kg/m2. The median of EPO level was 12.8 (9.3-17.4) IU/L and 25.1% (n=998) were at high 10-years risk of cardiovascular disease. Hemoglobin (β=-0.05, 95%CI: -0.07 to -0.04) and eGFR ≥90 mL/(min·1.73 m2) (β=-0.05, 95%CI: -0.07 to -0.04) were associated with lower in transformed EPO levels while hypertension (β=0.08, 95%CI: 0.05 to 0.12) and obesity (β=0.14, 95%CI: 0.09 to 0.18) were associated with higher in transformed EPO levels in multivariate linear regression analyses. Ten-year cardiovascular disease risks were positively associated with in transformed EPO levels (β=0.07, 95%CI: 0.05 to 0.09). The participants at moderate and high cardiovascular disease risks had significant higher EPO levels than the low risk group (all P < 0.05).
CONCLUSION
In community-based Beijing populations, endogenous EPO was associated with hemoglobin, renal function, obesity and hypertension. Individuals at high 10-years cardiovascular disease risks have higher endogenous EPO levels. Endogenous EPO may be a potential risk marker of cardiovascular disease.
Female
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Humans
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Male
;
Middle Aged
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Cardiovascular Diseases/epidemiology*
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Erythropoietin
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Hemoglobins
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Hypertension/epidemiology*
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Obesity
;
Risk Factors
10.Application of the new left ventricular circulation assist device iVAC 2L in high-risk percutaneous coronary intervention
Jian-Fang LUO ; Guan-Chang TAN ; Jun-Qing YANG ; You-Nan YAO ; Yu-Wei LIU ; Jian-Ping LI ; Yong HUO
Chinese Journal of Interventional Cardiology 2023;31(12):929-934
Objective To evaluate the efficacy and safety of the new left ventricular circulation assist device iVAC 2L in high-risk percutaneous coronaryintervention(HR-PCI)in Chinese patients.Methods We reported 6 PCIs in 5 patients supported by iVAC 2L,a new left ventricular circulation assist device,performed in Macao from September 2022 to March 2023.All patients were assessed by heart team and categorize to be high-risk for procedure.Clinical and intra-procedural data were analyzed.iVAC 2L-related complications and 30-day results were also documented.Results Insertion and removement of iVAC 2L successfully performed in all the 5 patients.Three of them underwent complete revascularization in the index procedure;one failed for the first time due to intolerance of the prolonged procedure,but succeeded for the reattempt of complete revascularization a month later,with the support of iVAC 2L.PCI was abandoned due to poor vessel condition.iVAC 2L,the new left ventricular circulation assist device,supported effectively during the 6 procedures.The patients were stable during the procedure.The success rate of hemodynamic support was 100%.No iVAC 2L-related complications and 30-day major adverse cardiac and cerebral events occurred,the 30-day survival was 100%.Conclusions Initial experience suggested that the new left ventricular circulation assist device iVAC 2L could provide effective and safe support in high-risk PCI.

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