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.Adhesion,proliferation,and vascular smooth muscle differentiation of bone marrow mesenchymal stem cells on different electrospinning membranes
Xianjuan SUN ; Qiuhua WANG ; Jinyi ZHANG ; Yangyang YANG ; Wenshuang WANG ; Xiaoqing ZHANG
Chinese Journal of Tissue Engineering Research 2025;29(4):661-669
		                        		
		                        			
		                        			BACKGROUND:Small diameter artificial vessels are urgently needed to treat coronary artery and peripheral artery diseases in clinical practice.At present,vascular tissue engineering has become the main method for preparing small diameter artificial vessels.Selecting suitable biomaterials and cell sources is the key factor for successful construction of small diameter tissue engineered vessels. OBJECTIVE:To observe the effect of four kinds of electrospinning membrane materials on proliferation,adhesion and differentiation of bone marrow mesenchymal stem cells into vascular smooth muscle cells. METHODS:Bone marrow mesenchymal stem cells were isolated and extracted from SD rats.The bone marrow mesenchymal stem cells were inoculated separately on polycaprolactone(PCL),polycaprolactone-hyaluronic acid(PCL-HA),polycaprolactone-silk-filament proteins(PCL-SF),and polycaprolactone-gelatin(PCL-GEL)electrospinning membrane materials.After 1,3,and 7 days of culture,the cell arrangement on the material was observed under scanning electron microscope.The proliferation and adhesion of the material were observed by phalloidin staining.The mRNA expressions of CD90,Meflin,and transforming growth factor β were detected by qRT-PCR.After 7 days of induced differentiation into vascular smooth muscle cells,the mRNA expression ofɑ-smooth muscle actin on the material was detected by qRT-PCR. RESULTS AND CONCLUSION:(1)Bone marrow mesenchymal stem cells were arranged along the fibers of the four kinds of electrospinning membranes under scanning electron microscopy.(2)Phalloidin staining showed the regular distribution of bone marrow mesenchymal stem cells on the four kinds of electrospinning membranes and parallel distribution along the fiber direction.Moreover,PCL-HA,PCL-SF,and PCL-GEL electrospinning membranes were more conducive to the proliferation and adhesion of bone marrow mesenchymal stem cells than PCL electrospinning membranes.Compared with PCL-HA and PCL-GEL electrospinning membranes,PCL-SF electrospinning membranes were more conducive to the proliferation and adhesion of bone marrow mesenchymal stem cells.(3)qRT-PCR showed that the four kinds of electrospun membrane materials could maintain the mRNA expression of CD90 and Meflin in bone marrow mesenchymal stem cells,but there was no significant difference between groups(P>0.05).The mRNA expression of transforming growth factor β in PCL-HA,PCL-SF,and PCL-GEL groups was higher than that in PCL group on days 1 and 7(P<0.05),and the mRNA expression of transforming growth factor β in PCL-SF group was higher than that in the other three groups on days 3 and 7(P<0.05).The mRNA expression of transforming growth factor β in PCL-HA group was higher than that in PCL-GEL group on day 7(P<0.05).(4)qRT-PCR showed that the mRNA expression of ɑ-smooth muscle actin in PCL-SF group was higher than that in the other three groups(P<0.05),and that in PCL-HA group was higher than that in PCL group(P<0.05).(5)The results indicate that compared with PCL,PCL-HA and PCL-GEL electrospinning membranes,PCL-SF electrospinning membranes combined with bone marrow mesenchymal stem cells are more suitable for the preparation of small diameter tissue engineered vessels.
		                        		
		                        		
		                        		
		                        	
3.Assessment of intervention measures on trihalomethane in finished water by interrupted time series analysis
Yangyang REN ; Hailei QIAN ; Saifeng PEI ; Xiaodong SUN ; Zheng WU ; Chen WU ; Jingxian ZHOU ; Aimin DU ; Shaofeng SUI
Journal of Environmental and Occupational Medicine 2024;41(4):420-424
		                        		
		                        			
		                        			Background The Qingcaosha Reservoir is facing issues of algal blooms and eutrophication, and the resulting increase in the level of chlorination disinfection by-products in the water has been a major concern. Objective To evaluate the impact of "Algae Monitoring and Control Program in Qingcaosha Reservoir" (hereinafter referred to as the program) on the control of trihalomethanes (THMs) in conventional finished water. Methods From 2011 to 2019, water samples were collected from the Lujiazui Water Plant once per season, one sample each time, and the concentrations of four THMs (trichloromethane, dichlorobromomethane, monochlorodibromomethane, and tribromomethane) were measured in the samples. Using 2014 when the program was implemented as a cut-off point, the entire study period was divided into two phases: pre-implementation (2011–2013) and post-implementation(2014–2019). Segmented linear regression with interrupted time series analysis was applied to assess the concentrations and trends of THMs in the finished water before and after the program launch. Results The concentration of total THMs in finished water increased by 1.561 µg·L−1 (P=0.010) for each season of time extension before launching the program. The change in the concentration of total THMs in finished water was not statistically significant after the program launch, but the THMs concentration showed a decreasing trend as the slope was −0.626 (P=0.001). From 2017 until the end of 2019, the average concentration of THMs in finished water of Lujiazui Water Plant dropped to 10 μg·L−1 or less. Conclusions The algae and eutrophication control measures in Qingcaosha Reservoir have achieved good results, controlling THMs in finished water at a low level, and the trend of THMs has changed from a yearly increase pattern before the program to a yearly decrease pattern after the program.
		                        		
		                        		
		                        		
		                        	
4.A case of recurrent renal pelvic sarcomatoid carcinoma treated with PD-1 inhibitor achieved complete remission
Lei GAO ; Chao LU ; Xiaokai SHI ; Yangyang SUN ; Xiaoli ZHOU ; Xiaopeng WU ; Lifeng ZHANG ; Li ZUO
Chinese Journal of Urology 2024;45(1):55-56
		                        		
		                        			
		                        			Sarcomatoid carcinoma of the renal pelvis accounts for a very low percentage of malignant tumors in the renal pelvis and has a poor prognosis. This article reported a patient with sarcomatoid carcinoma of the renal pelvis. The patient presented with macroscopic hematuria as the first symptom, and CT suggested left renal occupancy, unilateral nephrectomy was performed, and pathology suggested sarcomatoid carcinoma of the renal pelvis. Three weeks after surgery, a follow-up CT showed tumor recurrence. Programmed death 1(PD-1)inhibitor was given once every 3 weeks. Repeated CT examination after 24 weeks of continuous treatment suggested that the recurrent tumor disappeared. The patients was followed-up for 42 months without tumor recurrence or metastasis.
		                        		
		                        		
		                        		
		                        	
5.Chinesization of the HEMO-FISS-QoL questionnaire and its reliability and validity
Songpeng SUN ; Shan JIA ; Fangfang XU ; Tianyu LI ; Zhiyun ZHANG ; Qiaorong CAO ; Xinjian LI ; Yao WU ; Weiping WAN ; Bin SHI ; Jianguo WANG ; Hong NI ; Longyu LIANG ; Xingxiao HUO ; Tianqing YANG ; Lei TIAN ; Ying TIAN ; Mei LIN ; Zhanjun WANG ; Yangyang ZHOU ; Hongchuan CHU ; Riyu LIAO ; Kuerban XIEYIDA ; Junhong LONG ; Shuxin ZHANG
Chinese Journal of Behavioral Medicine and Brain Science 2024;33(1):75-82
		                        		
		                        			
		                        			Objective:To evaluate the reliability and validity of the Chinese version of HEMO-FISS-QoL(HF-QoL) questionnaire (HF-QoL-C) in the Chinese population with hemorrhoids.Methods:From November 2021 to November 2022, a self-constructed general information questionnaire, HF-QoL-C, and the 36-item short form health survey (SF-36), Goligher classification, and Giordano severity of hemorrhoid symptom questionnaire (GSQ) were used to conduct a questionnaire survey on 760 hemorrhoid patients in the anorectal department of six hospitals. The data was analyzed for reliability and validity using SPSS 21.0 and AMOS 26.0 software.Results:The Cronbach's α coefficient of HF-QoL-C and its dimension ranged from 0.831 to 0.960, and the split coefficient was 0.832-0.915. Four common factors were extracted through principal component exploratory factor analysis. Confirmatory factor analysis indicated acceptable structural validity( χ2/ df=8.152, RSMEA=0.097, CFI=0.881, IFI=0.881, NFI=0.867). HF-QoL-C was correlated with SF36 and GSQ( r=-0.694, 0.501, both P<0.01). There were differences in the total score and dimensional scores of HF-QoL-C between surgical and drug treated patients, different grades of Goligher classification for hemorrhoidal disease, and different ranges of hemorrhoid prolapse (all P<0.001). No ceiling effect was found in the total score and the scores of each dimension(0.3%-2.0%). There was a floor effect in both psychological function and sexual activity dimensions (16.7%, 35.1%). Conclusion:HF-QoL-C has good reliability and validity, which can be used to measure the quality of life of Chinese hemorrhoid patients.
		                        		
		                        		
		                        		
		                        	
6.Feasibility of single valvuloplastic esophagogastrostomy technique for laparoscopic proximal gastrectomy
Liming WANG ; Bolun SONG ; Yusong LUAN ; Peide REN ; Peng SUN ; Xuhao CAI ; Huijing CHANG ; Panxin PENG ; Yangyang WANG ; Xiaotong GUO ; Yuemin SUN ; Yinggang CHEN
Chinese Journal of Gastrointestinal Surgery 2024;27(8):850-854
		                        		
		                        			
		                        			Objective:To investigate the feasibility of oblique overlap anastomosis plus single flap valvuloplasty (OSF) for reconstruction after laparoscopic proximal gastrectomy.Methods:The C-shaped seromuscular flap (2.5 × 3.5 cm), which was 2 cm from the top of the remnant stomach, was extracorporeally created on the anterior wall of the remnant stomach. The stomach was opened approximately 1.0 cm above the lower edge of the mucosal flap. Four supporting stitches were sutured around the hole and the right wall of the esophageal stump was incised with a support suture to prevent the linear stapler from entering the submucosa. Liner stapler was inclined to the left side of the esophagus at an angle of about 30 degrees to the longitudinal axis of the esophagus for oblique anastomosis between the dorsal side of the esophagus and the anterior stomach and then esophagogastrostomy was performed with the length of anastomosis was 4 cm. Entry hole was suture with 3 stitches and then the linear stapler was used for closing the entry hole. Finally, the seromuscular flap was closed using barbed sutures.Results:Clinical data of 11 patients with Siewert type II esophagogastric junction adenocarcinoma who underwent radical gastrectomy and reconstruction by OSF between January 2022 and May 2023 were retrospectively collected. There were 7 males and 4 females. The average age was (69.9±7.8) years, the BMI was (21.7±7.2) kg/m 2 and the tumor size was (2.1±0.6) cm. OSF reconstruction was successfully completed in all 11 patients. The median operative time was 275 (270-428) minutes, the time for OSF reconstruction was 112 (80-140) minutes, and the blood loss was 50 (20-400) ml. The pathological stage was 0-I in 7 cases and II-III in 4 cases. The patients were fed on the 4th day (4-7 days) and discharged from hospital on the 7th day (6-9 days) after surgery. No patient had gastroesophageal reflux symptoms of grade B and above, and no patient took anti-reflux medicine. Conclusions:OSF is a safe and feasible treatment for Siewert type II esophagogastric junction adenocarcinoma.
		                        		
		                        		
		                        		
		                        	
7.Treatment of Gastric Ulcer in Active Stage with Carbuncle Theory in Toxicity-heat Theory Based on "State-target Medicine"
Liming CHEN ; Guozheng LIU ; Shuo YANG ; Yan LI ; Yangyang SUN ; Yuening BIAN ; Yilin ZHAO ; Jingdong XIAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):217-227
		                        		
		                        			
		                        			"State-target medicine" is a traditional Chinese medicine (TCM) diagnosis and treatment theoretical system proposed by Academician Tong Xiaolin based on the current development of modern medicine. The active stage of gastric ulcer, as a precancerous state of gastric cancer, has a great impact on people's health. Prof. ZHOU Xuewen, a master of TCM, innovatively put forward the theory of "toxicity-heat" etiology for the active stage of gastric ulcer, which plays an important guiding role in clinical diagnosis and treatment. The article took the theoretical system of "state-target medicine" as the framework to explain the rationale, method, formula, and medicine of Prof. ZHOU Xuewen, who applied the Xiaoyong Kuidekang based on the "toxicity-heat" theory to treat the gastric ulcer in the active stage. The Chinese medical name of gastric ulcer, "gastric carbuncle", was established, and it was believed that gastric ulcer is born due to "toxicity" and is based on "toxicity and heat". In the course of the disease, "toxicity", "heat", "deficiency", and "stasis" coexisted, and its pathogenesis was divided into three phases, namely, toxicity-heat accumulation phase, toxicity-heat affecting the health phase, and weakened body resistance and strengthened toxicity phase. According to the positioning of gastric ulcer as an "internal carbuncle", Prof. ZHOU Xuewen proposed the treatment of gastric ulcer in the active stage with "carbuncle theory" and introduced the surgical methods of "elimination", "support", and "tonifying" into the treatment of gastric ulcer in the active stage. Prof. ZHOU Xuewen took "clearing heat and removing toxins, eliminating carbuncle and generating muscle" as the basic treatment of the disease. For different stages of the disease, Prof. ZHOU Xuewen emphasized the use of the methods of clearing heat and removing toxins, supporting rot and muscle growth, and strengthening the spleen and harmonizing the stomach and created the representative formula for the treatment of gastric ulcer in the active stage with "carbuncle theory", namely "Xiaoyong Kuidekang", which could regulate state and targets. 
		                        		
		                        		
		                        		
		                        	
8.Phenotype and function of NK cell in colorectal cancer
Xujiao FENG ; Jianyue LIU ; Yangyang QI ; Jing SUN ; Lei SHEN
Journal of Shanghai Jiaotong University(Medical Science) 2024;44(6):713-722
		                        		
		                        			
		                        			Objective·To investigate the composition of immune cells in tumor microenvironment of colorectal cancer(CRC),and examine the proportion,phenotype and effector function of natural killer(NK)cells in CRC.Methods·Fresh tumor tissues,paired normal tissues adjacent to tumor,and peripheral blood samples in the same cohort were collected from CRC patients.Tissues were digested and prepared into single cell suspension.The major immune cell lineages were detected by flow cytometry.t-Distributed stochastic neighbor embedding(t-SNE)and statistical analysis were used to analyze the composition of immune cells in tumor microenvironment of CRC.To analyze the phenotype of NK cells,the expression levels of activation markers,including CD16,CD27,CD69,human leukocyte antigen-DR(HLA-DR),and T cell immunoglobulin domain and mucin domain-3(TIM-3),were detected by flow cytometry.NK cell subsets:CD38lowNK cells and CD38highNK cells were also examined by flow cytometry.To assess the effector function of NK cells,they were stimulated with cell stimulation cocktail and the expression levels of interferon-γ(IFN-y),tumor necrosis factor-α(TNF-α),and granulocyte-macrophage colony-stimulating factor(GM-CSF)were measured by flow cytometry.Results·Twenty-five pairs of fresh tumor tissues and normal tissues adjacent to tumor,and 15 peripheral blood samples in the same cohort were collected from CRC patients.The tumor microenvironment of CRC included diverse immune cell types,including T cells,B cells,NK cells and myeloid cells.The proportions of T cells(P=0.000)and myeloid cells(P=0.026)in tumor tissues were significantly higher than those in normal tissues.By contrast,the proportion of NK cells(P=0.007)in tumor was significantly reduced.The proportion of B cells was comparable between tumor and normal tissues.Compared to normal tissues,NK cells in tumor tissues expressed significantly lower CD27(P=0.000)and CD69(P=0.001),while the expression levels of CD16(P=0.008),HLA-DR(P=0.000)and TIM-3(P=0.024)were significantly elevated.The results indicated that NK cells in CRC tumor exhibited a phenotype of late activation and exhaustion.According to the expression level of CD38,NK cells could be divided into two subsets,CD38highNK cells and CD38lowNK cells.The proportion of CD38highNK cells(P=0.003)in tumor tissues was significantly lower than that in normal tissues,while the proportion of CD38lowNK cells was unaffected.Compared to CD38lowNK cells,CD38highNK cells expressed higher CD27,meanwhile significantly less CD16,NKp46,CD57,CD94,HLA-DR and CD158a(P=0.000).These results suggested that CD38highNK cells were at early differentiation state.The secretion of cytokines IFN-y(P=0.032),TNF-α(P=0.042),and GM-CSF(P=0.019)by tumor-infiltrated NK cells was significantly decreased compared to that in normal tissues.The results showed that the function of tumor-infiltrated NK cells was impaired.Conclusion·Together,these data suggest that NK cell compartment is disrupted in tumor tissues of CRC,leading to the impaired anti-tumor immunity mediated by NK cells.
		                        		
		                        		
		                        		
		                        	
9.The application of kissing-stent in treating chronic iliac-vena cava occlusion
Shaobo ZHAI ; Zhixiang LV ; Zhihua ZHANG ; Jifeng SUN ; Yangyang YU ; Cheng GAO
Journal of Interventional Radiology 2024;33(7):763-766
		                        		
		                        			
		                        			Objective To evaluate the clinical efficacy of kissing-stent implantation in the treatment of chronic iliac-vena cava occlusion.Methods The clinical data of 22 patients with chronic iliac-vena cava occlusion,who received kissing-stent implantation,were retrospectively analyzed.The surgical success rate and the procedure-related complications were recorded,the postoperative 3-,6-and 12-month stent patency rates were calculated,and the postoperative 6-month Villalta score was compared with its preoperative value.Results The technical success rate of kissing-stent implantation was 100%.No procedure-related surgical complications occurred.The postoperative 3-,6-and 12-month stent patency rates were 95.5%,90.9%and 86.1%respectively.The postoperative 6-month Villalta score was(12.14±2.80)points,which was remarkably lower than preoperative(20.91±3.16)points,the difference was statistically significant(P<0.05).Conclusion The implantation of kissing-stent can successfully reconstruct iliac-vena cava with satisfactory short-term efficacy for chronic iliac-vena cava occlusion.
		                        		
		                        		
		                        		
		                        	
10.Research and application analysis of technical support strategy of large medical equipment based on the perspective of metrological safety
Pengfei WANG ; Zhidong SUN ; Xiaochen ZHAO ; Liwen CHI ; Yangyang LI
China Medical Equipment 2024;21(11):121-125,136
		                        		
		                        			
		                        			Objective:To construct a metrological safety evaluation model for large medical equipment based on the perspective of metrological safety,and to explore its application value in the management of large medical equipment.Methods:According to the different safety risk sources,the diagnosis and treatment area of large medical equipment was divided into five types:light source,electricity,water,radiation and information.The metrological safety assessment indicators were empowered by combining subjective and objective methods,and engineering support strategies were developed according to the metrological safety levels and safety change trends.A total of 48 large medical equipment in clinical use in The 960th Hospital of PLA Joint Logistic Support Force from 2020 to 2023 were selected.The 42 sets of equipment used during 2020 to 2021 adopted the conventional fault maintenance support mode(referred to as the conventional support mode),and the 43 sets of equipment used from 2022-2023(including 37 in conventional mode and 6 newly added)adopted the metrology safety technical support mode(referred to as metrology safety support mode).The metrology safety management ability score,metrological inspection qualification levels and metrological safety management effects of large medical equipment were compared between the two management modes.Results:The evaluation scores of theoretical knowledge,safety awareness,practical operation and emergency level indicators of large medical equipment use management personnel of the metrology safety support model were(17.39±1.38)points,(17.87±1.08)points,(27.68±1.45)points and(27.96±1.24)points,respectively,which were higher than those of the conventional support mode,the difference was statistically significant(t=4.234,4.371,5.832,3.764,P<0.05).The average metrological inspection qualified rates(%)of medical imaging equipment,life support equipment,clinical laboratory equipment,operating room equipment and other equipment using the metrology safety support mode were(95.19±2.56)%,(95.56±1.79)%,(94.64±2.42)%,(96.20±2.01)%and(93.46±2.22)%,respectively,which were higher than those of the conventional support mode,the difference was statistically significant(t=3.846,2.809,2.405,2.492,2.742,P<0.05).The proportion of large medical equipment rated as high safety level and low safety level in the metrological safety support model were 67.44%(29/43)and 4.65%(2/43),respectively,the proportion of high safety level was higher than that in the conventional support mode,and the proportion of low safety level was lower than that in the conventional support mode,the difference was statistically significant(x2=4.261,7.085,P<0.05).Conclusion:The large medical equipment metrological safety support mode based on the safety perspective can improve the safety management ability of personnel related to equipment use and management,improve the operation quality and performance level of equipment,increase the proportion of high-safety level metrology safety of large medical equipment,and reduce the proportion of low-safety level.
		                        		
		                        		
		                        		
		                        	
            
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