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.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.
3.Effect of acid-base diluent on the determination of 19 elements in whole blood by inductively coupled plasma mass spectrometry
Qi SUN ; Shan BAO ; Liang DING ; Yifu LU
Chinese Journal of Laboratory Medicine 2024;47(4):428-436
Objective:To analyze the effect of acidic or alkaline diluents of the direct dilution method on the results of multiple elements measurement in whole blood by inductively coupled plasma mass spectrometry (ICP-MS) and to explore the possibility whether the two diluents can be substituted for each other in elemental measurement results.Methods:A total of 162 human whole blood samples collected from the National Human Biomonitoring Programme in August 2018 were used for dilution with different diluents followed by centrifugation, then the supernatants of the samples were measured by ICP-MS. The methodological characteristics of the two pre-treatment methods including acidic diluent (0.1% nitric acid+0.01% tralatone solution) and alkaline diluent (0.05% n-butanol+0.01% tralatone+1% ammonium hydroxide solution) were evaluated separately. Spearman correlation coefficient analysis was used for the correlation of 19 elements results in whole blood measured by 2 diluents, then, Passing-Bablok linear regression and Bland-Altman plots were used to evaluate the consistency of the 19 elements results in 162 whole blood samples between the two diluents.Results:The methodological data of 19 elements using the two diluents were good, with the limits of quantification (LOQ) of the 19 elements were 0.1-15.8 μg/L for acidic diluents and 0.3-19.2 μg/L for alkaline diluents, and the linear correlation coefficients of the standard curves of the 19 elements using the acidic and alkaline diluents were all≥0.995. Except for strontium, cadmium, tin, and thallium, the recovery percents of the 19 elements were all in the range of 80%-120%, and for all elements the total coefficients of variation of within-and between-run in the acidic and alkaline diluents were 0.5%-12.4%. The correlation coefficients of the two diluents for the measured values of chromium, manganese, cobalt, zinc, copper, arsenic, selenium, strontium, molybdenum, silver, cadmium, antimony, barium, mercury, and lead were relatively strong ( R2>0.8), while the correlation coefficients of vanadium, nickel, tin, and thallium were relatively weak ( R2<0.8). For the vanadium, cadmium, tin, barium, and mercury, 95% confidence intervals of slopes were<1. The 95% confidence intervals of intercepts of chromium, nickel, arsenic, silver, barium, and mercury contain point 0. The Bland-Altman plot showed that vanadium, chromium, arsenic, strontium, silver, cadmium, tin, and mercury have good consistency in using acidic and alkaline diluents. Conclusion:The results of the mean values measured with the 2 diluents differed among different elements and could not be completely substituted.
4.Comprehensive Comparative Analysis of Sepsis Animal Models and Characteristics of Clinical Syndromes in Integrated Traditional Chinese and Western Medicine
Shan LI ; Chao LI ; Yiwen WU ; Jingwen XUE ; Qingqing CHEN ; Tengxiao LIANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(20):212-218
This study, anchored in the traditional Chinese medicine (TCM) syndrome differentiation and treatment principles alongside the clinical characteristics of sepsis in Western medicine, extensively gathers and meticulously dissects the latest research findings on sepsis animal models from both Chinese and international sources. Adhering strictly to TCM syndrome diagnostic criteria for sepsis, the study conducts a thorough evaluation of various animal models across multiple dimensions, including clinical manifestations, pathological changes, and biomarker expressions, so as to reflect the degree of resemblance these models have to human sepsis TCM syndromes. The results reveal that the colon stent implantation model exhibits a higher degree of congruence with both TCM and Western medicine standards, particularly aligning with the diagnosis of the "Fu-Qi obstruction syndrome". Conversely, the extraperitoneal sepsis model shows a higher degree of congruence with TCM, fitting more closely with the diagnosis of "acute deficiency syndrome" and emphasizing the core pathogenesis of Qi deficiency in sepsis. These findings not only augment the diversity of sepsis animal models but also highlight the necessity and potential of integrated TCM and western medicine research. Current sepsis animal models predominantly focus on western pathophysiological mechanisms, with limited direct incorporation of TCM syndrome differentiation elements. This underscores the need, in future study designs, to actively explore integrating TCM syndrome classification and intervention principles into model development. This could be achieved by manipulating model-inducing factors and observing more TCM-specific symptoms and signs among other strategies, so as to establish sepsis models that more closely resemble clinical reality and incorporate both TCM and western medical perspectives.
5.Expert consensus on the biosafety recommendation for arthropods of medical importance in field and laboratory
HE Changhua ; LUO Huanle ; YIN Feifei ; HAN Qian ; LIANG Lei ; SHI Yongxia ; YU Xuedong ; SUN Yi ; LIU Qiyong ; WANG Huanyu ; WANG Rong ; SHAN Chao ; DENG Fei ; YUAN Zhiming ; XIA Han
China Tropical Medicine 2024;24(2):119-
The emerging and re-emerging arthropod-borne infectious diseases pose a serious threat to global public health security. Field and laboratory studies of arthropods of medical importance are essential and critical for the prevention and control of arthropod-borne infectious diseases. Various institutions or universities in China have been conducting research in the field or laboratory study of arthropods of medical importance, but up to 2023, it is still lacking detailed biosafety guidelines or recommendations that can guide the related work for arthropods of medical importance. In order to proactively address potential biosafety issues in the field or laboratory activities related to arthropods of medical importance, improve the standardization of arthropod biosafety classification, operations, and protection, and ensure the safety of practitioners, an expert consensus on the biosafety recommendation of arthropods of medical importance in field and laboratory has been developed, aiming to guide the future work of arthropods and ensure the national biosafety and biosecurity of China.
6.Comparison of accuracy and postoperative efficacy of robot and navigation technology assisted placement of pedicle screws
Houkun LI ; Liang YAN ; Lequn SHAN ; Yongchao DUAN ; Kai SUN ; Xuefang ZHANG ; Yadong ZHANG ; Dingjun HAO
Chinese Journal of Orthopaedics 2024;44(13):851-857
Objective:To compare the accuracy and efficacy of robot assisted and navigation assisted pedicle screw fixation.Methods:Retrospective analysis of 764 patients with lumbar spine disorders who underwent internal fixation treatment at the Department of Spine Surgery, Honghui Hospital, Xi'an Jiaotong University, from June 2017 to April 2023 were performed. They were divided into the Renaissance group (212 cases), the Tinavi group (301 cases), and the S8 navigation group (251 cases), according to the method of assisted placement of pedicle screws. The operation time, fluoroscopy time, X-ray radiation dose, intra-operative blood loss, accuracy of screw placement, screw revision rate, pain visual analogue scale (VAS), Oswestry disability index (ODI) and postoperative infection rate were compared among the three groups.Results:922 screws were placed in the Renaissance group, 1,260 screws in the Tinavi group, and 1,044 screws in the S8 navigation group. The accuracy of clinically acceptable pedicle screw placement was 92.08% (849/922), 99.68% (1,256/1,260), and 99.43% (1,038/1,044) in the three groups, respectively, with the Renaissance group being smaller than the Tinavi group and the S8 group (χ 2=90.334, P<0.001; χ 2=68.446, P<0.001), and the Tinavi group and the S8 group had no statistically significant difference (χ 2=0.380, P=0.537). The operation time of the three groups was 173.64±62.23 min, 177.11±60.85 min, 176.02±60.93 min, and the intraoperative blood loss was 118.16±58.26 ml, 121.84±55.91 ml, 123.62±59.84 ml, respectively, and the differences between the groups were not statistically significant ( P>0.05). The fluoroscopy time of the three groups was 8.73±2.92 s, 10.67±2.85 s, and 11.31±2.89 s, and the X-ray radiation doses were 18.83±7.41 μSv, 20.40±7.60 μSv, and 22.88±7.47 μSv, respectively, with statistically significant differences between the groups and the two comparisons ( P<0.05). All patients were given follow-up for 3-30 months. Three cases in the postoperative Renaissance group underwent screw revision for nerve root irritation due to screw penetration of the pedicle cortex, and none of the other two groups underwent screw revision. Postoperatively, one case in the Renaissance group and one case in the Tinavi group had superficial infections, which were cured after prolonged antibiotic use. At 3 months postoperatively, the VAS scores for leg pain in the Renaissance group, the Tinavi group, and the S8 navigation group were 3.52±1.14, 3.59±1.12, and 3.39±1.16, and the VAS scores for back pain were 3.54±1.14, 3.57±1.12, and 3.51±1.15, respectively; the ODI scores were 12.48%±4.53%, 12.01%±4.57%, and 12.28%±4.60%, and none of the differences between the groups were statistically significant ( P>0.05). Conclusion:The accuracy of screw placement by the Tinavi robot was comparable to that of the S8 navigation, and both were superior to that of the Renaissance robot; the fluoroscopy time and radiation dose of the Renaissance robot were smaller than those of the Tinavi robot, which was smaller than that of the S8 navigation. The early efficacy of robotics and navigation-assisted pedicle screw internal fixation for lumbar spine disorders is similar.
7.Multidimensional supportive psychological intervention in clinical practice teaching of andrological nursing
Li-Hong LI ; Ya-Ting SUN ; De-Yu KONG ; Shan-Na SU ; Xue ZHANG ; Liang ZHANG ; Hong-En XIANG ; Xuan LUO ; Xu-Qiang WANG
National Journal of Andrology 2024;30(3):229-232
Objective:To examine the application of a novel pedagogical approach multidimensional supportive psychological intervention(MSPI)in the clinical practice teaching of andrological nursing care.Methods:Using the Hamilton Depression Scale(HAMD),we assessed the psychology of 100 nursing interns about to enter clinical practice in the Department of Andrology from De-cember 2021 to December 2022.We equally randomized the subjects into an experimental and a control group,the former receiving MSPI and the latter trained on the conventional teaching model without any psychological support intervention.Results:Compared with the baseline,the HAMD scores were significantly decreased in the experimental group after intervention(12.4±2.1 vs 8.9±2.4,P<0.01),but increased in the controls(13.1±1.8 vs 14.7±1.9,P<0.01);the skill scores dramatically increased in the experimental group(82.6±4.7 vs 91.2±2.4,P<0.01),but decreased in the control group after intervention(81.0±3.5 vs 80.4±2.7,P=0.28).Conclusion:MSPI can significantly enhance the learning enthusiasm of nursing students in a short period,re-duce their psychological stress and improve teaching outcomes.This approach,combining psychology with teaching,can also strength-en the mental resilience of nursing students and better confront them with future professional challenges.
8.Research on clinical application of urine sediment score in the diagnosis of acute kidney injury
Hui ZHANG ; Wei XU ; Linlin QU ; Chunhe ZHAO ; Hongli SHAN ; Qin ZHANG ; Hongchen GAO ; Wenrui SUN ; Lina ZHU ; Yue ZHANG ; Xin YAN ; Xiaoquan YANG ; Wanning WANG ; Dong ZHANG ; Yao FU ; Xu ZHAO ; Liang HE
Chinese Journal of Laboratory Medicine 2024;47(5):548-553
Objective:To evaluate the clinical application of urine sediment score (USS) in early diagnosis, etiological differentiation, staging and prognosis of acute kidney injury (AKI), and to investigate the diagnostic efficacy of independent USS and its combination with blood urea nitrogen(Bun) serum creatinine(sCr) and uric acid(UA) in AKI.Methods:From August 23 to September 28, 2023, 9 020 morning urine samples of hospitalized patients in the First Hospital of Jilin University were detected by Sysmex UF5000.A total of 3 226 ssamples with small and round cell (SRC) > 1/μl and/or CAST>1/μl were screened for microscopic examination, and 404 cases with positive renal tubular epithelial cells and/or cast were enrolled in this study. There were 218 males and 186 females, aged 59.5 (49.0, 71.0) years. The 404 cases were divided into the USS AKI group (345 cases) and the USS non-AKI group (59 cases) according to the USS results based on the microscopic findings. According to Kidney Disease: Improving Global Outcomes (KDIGO) criteria, they were divided into KDIGO criteria AKI group (63 cases) and KDIGO criteria non-AKI group (341 cases), and the AKI group was divided into renal AKI group (33 cases) and non-renal AKI group (30 cases). According to the clinical diagnosis recorded in the medical records, they were divided into clinically diagnosed AKI group (29 cases) and clinically diagnosed non-AKI group (375 cases).The χ 2 test or Fisher exact test was used to compare USS in different AKI causes and stages. Logistic regression was used to calculate the odds ratio of renal AKI and stage 3 AKI. The area under the receiver operating characteristic curve was used to evaluate the sensitivity and specificity of USS, sCr, UA and Bun alone and in combination in the diagnosis of AKI, and the best cut-off value, sensitivity and specificity in the diagnosis of AKI were calculated. P < 0.05 was considered statistically significant. Results:The USS was used to identify the etiology of KDIGO standard AKI group,and there were significant differences in USS between renal AKI group and non-renal AKI group (χ 2=11.070, P<0.001). Compared to USS=1, the odds ratio of renal AKI was 8.125 when USS≥2 (95% CI 2.208—29.901). There was a statistically significant difference in the comparison of USS between groups in each stage of the AKI staging study based on USS (χ 2=15.724, P<0.05). Compared to USS=1, the odds ratio of stage 3 AKI was 9.714 when USS≥2 (95% CI 1.145-82.390). The AUC of independent USS in the diagnosis of AKI was 0.687 (95% CI 0.618-0.757, P<0.001), the specificity was 65.7% and the sensitivity was 61.9%. The AUC of USS combined with Bun, sCr, UA in the diagnosis of AKI was 0.794 (95% CI 0.608-0.980, P<0.05), the specificity was 82.4%, and the sensitivity was 88.9%. Conclusions:There wasan increased likelihood of renal AKI or stage 3 AKI while USS≥2,and whose combination with Bun, sCr and UA will improve the diagnostic efficiency of AKI.
9.RNA polymerase I subunit D activated by Yin Yang 1 transcription promote cell proliferation and angiogenesis of colorectal cancer cells
Jianfeng SHAN ; Yuanxiao LIANG ; Zhili YANG ; Wenshan CHEN ; Yun CHEN ; Ke SUN
The Korean Journal of Physiology and Pharmacology 2024;28(3):265-273
This study aims to explore possible effect of RNA polymerase I subunit D (POLR1D) on proliferation and angiogenesis ability of colorectal cancer (CRC) cells and mechanism herein. The correlation of POLR1D and Yin Yang 1 (YY1) expressions with prognosis of CRC patients in TCGA database was analyzed. Quantitative realtime polymerase chain reaction (qRT-PCR) and Western blot were applied to detect expression levels of POLR1D and YY1 in CRC cell lines and CRC tissues. SW480 and HT-29 cells were transfected with si-POLR1D or pcDNA3.1-POLR1D to achieve POLR1D suppression or overexpression before cell migration, angiogenesis of human umbilical vein endothelial cells were assessed. Western blot was used to detect expressions of p38 MAPK signal pathway related proteins and interaction of YY1 with POLR1D was confirmed by dual luciferase reporter gene assay and chromatin immunoprecipitation (ChIP). TCGA data showed that both POLR1D and YY1 expressions were up-regulated in CRC patients. High expression of POLR1D was associated with poor prognosis of CRC patients. The results showed that POLR1D and YY1 were highly expressed in CRC cell lines. Inhibition or overexpression of POLR1D can respectively suppress or enhance proliferation and angiogenesis of CRC cells. YY1 inhibition can suppress CRC progression and deactivate p38 MAPK signal pathway, which can be counteracted by POLR1D overexpression. JASPAR predicted YY1 can bind with POLR1D promoter, which was confirmed by dual luciferase reporter gene assay and ChIP. YY1 transcription can up-regulate POLR1D expression to activate p38 MAPK signal pathway, thus promoting proliferation and angiogenesis ability of CRC cells.
10.Effect of transcutaneous auricular vagus nerve stimulation on functional connectivity in the related brain regions of patients with depression based on the resting-state fMRI.
Yue MA ; Chun-Lei GUO ; Ji-Fei SUN ; Shan-Shan GAO ; Yi LUO ; Qing-Yan CHEN ; Yang HONG ; Lei ZHANG ; Jiu-Dong CAO ; Xue XIAO ; Pei-Jing RONG ; Ji-Liang FANG
Chinese Acupuncture & Moxibustion 2023;43(4):367-373
OBJECTIVE:
To explore the brain effect mechanism and the correlation between brain functional imaging and cognitive function in treatment of depressive disorder (DD) with transcutaneous auricular vagus nerve stimulation (taVNS) based on the resting-state functional magenetic reasonance imaging (rs-fMRI).
METHODS:
Thirty-two DD patients were included in a depression group and 32 subjects of healthy condition were enrolled in a normal group. In the depression group, the taVNS was applied to bilateral Xin (CO15) and Shen (CO10), at disperse-dense wave, 4 Hz/20 Hz in frequency and current intensity ≤20 mA depending on patient's tolerance, 30 min each time, twice daily. The duration of treatment consisted of 8 weeks. The patients of two groups were undertaken rs-fMRI scanning. The scores of Hamilton depression scale (HAMD), Hamilton anxiety scale (HAMA) and Wisconsin card sorting test (WCST) were observed in the normal group at baseline and the depression group before and after treatment separately. The differential brain regions were observed before and after treatment in the two groups and the value of degree centrality (DC) of fMRI was obtained. Their correlation was analyzed in terms of HAMD, HAMA and WCST scores.
RESULTS:
The scores of HAMD and HAMA in the depression group were all higher than those in the normal group (P<0.05). After treatment, the scores of HAMD and HAMA were lower than those before treatment in the depression group; the scores of total responses, response errors and perseverative errors of WCST were all lower than those before treatment (P<0.05). The brain regions with significant differences included the left inferior temporal gyrus, the left cerebellar peduncles region 1, the left insula, the right putamen, the bilateral supplementary motor area and the right middle frontal gyrus. After treatment, the value of DC in left supplementary motor area was negatively correlated to HAMD and HAMA scores respectively (r=-0.324, P=0.012; r=-0.310, P=0.015); the value of DC in left cerebellar peduncles region 1 was negatively correlated to the total responses of WCST (r=-0.322, P=0.013), and the left insula was positively correlated to the total responses of WCST (r=0.271, P=0.036).
CONCLUSION
The taVNS can modulate the intensity of the functional activities of some brain regions so as to relieve depressive symptoms and improve cognitive function.
Humans
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Depression/therapy*
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Magnetic Resonance Imaging/methods*
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Vagus Nerve Stimulation/methods*
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Brain/diagnostic imaging*
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Transcutaneous Electric Nerve Stimulation/methods*
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Vagus Nerve

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