1.Cost-utility analysis of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous NSCLC
Wenxiang JU ; Yingying ZHAO ; Luolan LU ; Xiaohan ZHANG ; Aizong SHEN
China Pharmacy 2024;35(11):1357-1362
OBJECTIVE To evaluate the cost-effectiveness of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous non-small cell lung cancer (NSCLC) from the perspective of China’s health system. METHODS A dynamic Markov model was established based on BEVERLY study data, with a cycle of 3 weeks, a research deadline until 99% of patients die, and an annual discount rate of 5%. The model outputs were total cost, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Taking 3 times China’s per capita gross domestic product (GDP) in 2023 as the willingness-to-pay (WTP) threshold, the cost-utility analysis was used to evaluate the cost-effectiveness of bevacizumab combined with erlotinib (observation group) versus erlotinib alone (control group) in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, and the single factor sensitivity analysis and probability sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The results of the basic analysis showed that compared with the erlotinib therapy plan, ICER of bevacizumab combined with erlotinib was 1 452 243.01 yuan/QALY, which was more than 3 times China’s per capita GDP in 2023 (268 074 yuan/QALY) as the WTP threshold, indicating that bevacizumab combined with erlotinib was not cost-effective. The results of single factor sensitivity analysis showed that the cost of bevacizumab, the utility value of progression-free survival and progressed disease status had a great influence on the results. The results of probability sensitivity analysis showed that when the WTP threshold was 1 740 000 yuan/QALY, the probability of cost-effective of bevacizumab combined with erlotinib plan was 50%. CONCLUSIONS Compared with erlotinib alone, bevacizumab combined with erlotinib is not cost-effective in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, when using 3 times China’s per capita GDP in 2023 as the WTP threshold.
2.Cost-utility analysis of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous NSCLC
Wenxiang JU ; Yingying ZHAO ; Luolan LU ; Xiaohan ZHANG ; Aizong SHEN
China Pharmacy 2024;35(11):1357-1362
OBJECTIVE To evaluate the cost-effectiveness of bevacizumab combined with erlotinib in the first-line treatment of advanced EGFR mutant non-squamous non-small cell lung cancer (NSCLC) from the perspective of China’s health system. METHODS A dynamic Markov model was established based on BEVERLY study data, with a cycle of 3 weeks, a research deadline until 99% of patients die, and an annual discount rate of 5%. The model outputs were total cost, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Taking 3 times China’s per capita gross domestic product (GDP) in 2023 as the willingness-to-pay (WTP) threshold, the cost-utility analysis was used to evaluate the cost-effectiveness of bevacizumab combined with erlotinib (observation group) versus erlotinib alone (control group) in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, and the single factor sensitivity analysis and probability sensitivity analysis were used to verify the robustness of the basic analysis results. RESULTS The results of the basic analysis showed that compared with the erlotinib therapy plan, ICER of bevacizumab combined with erlotinib was 1 452 243.01 yuan/QALY, which was more than 3 times China’s per capita GDP in 2023 (268 074 yuan/QALY) as the WTP threshold, indicating that bevacizumab combined with erlotinib was not cost-effective. The results of single factor sensitivity analysis showed that the cost of bevacizumab, the utility value of progression-free survival and progressed disease status had a great influence on the results. The results of probability sensitivity analysis showed that when the WTP threshold was 1 740 000 yuan/QALY, the probability of cost-effective of bevacizumab combined with erlotinib plan was 50%. CONCLUSIONS Compared with erlotinib alone, bevacizumab combined with erlotinib is not cost-effective in the first-line treatment of advanced EGFR mutant non-squamous NSCLC, when using 3 times China’s per capita GDP in 2023 as the WTP threshold.
3.Review indicators and barriers of exercise training in patients with peripheral arterial disease
Qin YANG ; Yan HUANG ; Yuming ZHAO ; Wenxiang XU ; Yuan CHEN
Chinese Journal of Modern Nursing 2024;30(4):469-474
Objective:To conduct evidence-based exercise training for patients with peripheral arterial disease, develop review indicators, analyze barriers and enablers in the evidence-based practice process, and develop change strategies.Methods:Guided by the clinical evidence application model of the Joanna Briggs Institute Evidence-Based Health Care Center, the study identified clinical nursing problems, formed the evidence-based practice team, systematically searched, evaluated, and summarized evidence of exercise training in patients with peripheral arterial disease, developed review indicators, and clarified review methods. The baseline review was conducted from October 1 to 31, 2022. The integrated-promoting action on research implementation in health services (i-PARIHS) framework was used to analyze the barriers and enablers of the baseline review results, and corresponding strategies were formulated.Results:A total of 20 best evidence were included, and 11 review indicators were developed, with only one indicator having a compliance rate of 100%. This study analyzed 22 barriers and 24 enablers, and formulated 14 change strategies.Conclusions:The review indicators constructed based on the best evidence are scientific, effective, appropriate, and feasible. The analysis of barriers and enablers, as well as the formulation of change strategies, can provide guarantees for promoting clinical practice of exercise training for patients with peripheral arterial diseases.
4.Establishment of a high performance liquid chromatography method for the detection of CD38 enzyme activity in blood
Xianghui ZHAO ; Xiaoxiao BU ; Hanyu ZHU ; Hongxia LI ; Jihua SHI ; Siming WANG ; Hongna MU ; Ziyun LI ; Zhu WU ; Jun DONG ; Wenxiang CHEN ; Ruiyue YANG
Chinese Journal of Laboratory Medicine 2023;46(10):1074-1082
Objective:A high performance liquid chromatography (HPLC) method was developed to determine the enzymatic activity of CD38 in blood, which was the major enzyme responsible for consuming nicotinamide adenine dinucleotide (NAD). Additionally, the study aimed to detect the differences in CD38 enzymatic activity among individuals of varying ages and health statuses.Methods:A 50 μl whole blood matrix and enzyme reaction substrate of 150 μl β-NAD at a concentration of 500 μmol/L were selected for the analysis. To eliminate the impact of endogenous β-NAD, the whole blood sample was pre-incubated at 37 ℃ for 20 minutes before adding the substrate. The reaction was terminated by perchloric acid (PCA) after incubation at 37 ℃ for 40 min. The change in product nicotinamide (NAM) before and after the enzymatic reaction was measured by HPLC to calculate the CD38 activity. The linearity, limit of detection, limit of quantification, precision, and stability of the method were evaluated. The CD38 enzymatic activities in 60 healthy volunteers and 30 colorectal cancer patients in blood were determined by the developed method.Results:Pre-incubation at 37 ℃ for 20 minutes eliminated the effect of endogenous β-NAD. The correlation coefficient of NAM was 0.999 in the concentration range of 0.1-3.2 μmol/L, with limit of detection of 0.5 nmol/L and limit of quantification of 2.1 nmol/L. The average within-run imprecision ( CV) and total CV were 3.22%-4.03% and 2.91%-4.70%, respectively. The recovery rate ranged from 94.82% to 96.81%. The CD38 activity of whole blood was stable by storage at 4 ℃ for 48 hours, storage at room temperature for 8 hours, thawing of frozen whole blood at room temperature for 2 hours, or repeated freeze-thawing three times. NAM, NAD standards, and pre-treatment samples were stable after 48 hours at 4 ℃ and 8 hours at room temperature. CD38 activity gradually decreased with increasing concentration of the added CD38 inhibitor 4-aminoquinoline derivative (78c). Measurement of 60 healthy physical examination population samples showed significantly higher CD38 enzyme activity in the elderly group than that in the young group ( t=-2.776, P=0.007) and measurement of 30 colorectal cancer patients showed significantly higher CD38 enzyme activity than that in healthy people ( t=-2.572, P=0.012). Conclusion:The established HPLC method for determining CD38 enzymatic activity is characterized by its simplicity, efficiency, accuracy, and reproducibility. This technique serves as a valuable tool for investigating aging and aging-related diseases.
5.Analysis of bacterial distribution and antibiotic resistance in children with severe pneumonia through bronchoalveolar lavage fluid
Mingdong GAO ; Shuqiong MIAO ; Li YANG ; Shuzhen ZHAO ; Wenxiang WANG ; Xiaoyan LEI
Chinese Pediatric Emergency Medicine 2022;29(5):363-367
Objective:To realize the bacterial distribution and antibiotic resistance in children with severe pneumonia in this region.Methods:A total of 203 children with severe pneumonia diagnosed in Gansu Provincial People′s Hospital from April 2018 to March 2020 were divided into 0-1, 1-3, 3-7 and 7-14 years old groups.Bronchoalveolar lavage fluid was collected for bacterial culture and identification, and antibiotic susceptibility tests were performed.Results:The positive rate of pathogens was 69.5% (141/203), including 72.3% (102 strains) of Gram-negative bacteria and 30.5%(43 strains)of Gram-positive bacteria.The infection rates were highest in 0-1 years old group and the lowest in 7-14 years old group, which were 45.2%(19/42) and 16.9%(10/59), respectively.The infection rates of Haemophilus influenzae, Escherichia coli and Branhamella catarrhalis in the 1-3 years old group were 30.30%(10/33), 33.33% (11/33), and 21.21% (7/33), respectively, which showed significant differences compared with other groups( P<0.05). The infection rate of Streptococcus pneumoniae in the 0-1 years old group was 42.9%(18/42), which was significantly different compared with other groups ( P<0.001). The resistance rate of Haemophilus influenzae to trimethoprim/sulfamethoxazole was 89.5%(34/38), and the Streptococcus pneumoniae to trimethoprim/sulfamethoxazole and tetracycline were both 82.4%(28/34). The highest antibiotic resistance rate of Escherichia coli was 34.6%(9/26), and the Branhamella catarrhalis to clindamycin was 56.3%(9/16). Conclusion:The dominant bacteria for severe pneumonia in children are Haemophilus influenzae, Streptococcus pneumoniae, Escherichia coli and Branhamella catarrhalis.The bacterial infection rate is highest within 1 year old, but gradually decreases with the increase of age.Haemophilus influenzae and Streptococcus pneumoniae have severe resistance to several antibiotics.
6.Commutability Assessment of Candidate External Quality Assessment Materials for Aminotransferase Activity Measurements Based on Different Approaches in China
Qichen LONG ; Tianqi QI ; Tianjiao ZHANG ; Jing WANG ; Jie ZENG ; Ying YAN ; Meng WANG ; Wei HUANG ; Haijian ZHAO ; Wenxiang CHEN ; Chuanbao ZHANG
Annals of Laboratory Medicine 2021;41(1):68-76
Background:
Using commutable external quality assessment (EQA) materials is important for monitoring successful harmonization efforts. We assessed the commutability of four human serum pool (HSP) preparations to identify candidate EQA materials for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activity measurement.
Methods:
One set each of 85 clinical samples (CSs) was collected for ALT and AST activity measurement. The 15 candidate EQA materials included four types of HSP preparations (A to D): materials A, C, and D contained human original recombinant (HOR) aminotransferases; materials B was mixed leftover samples. The CSs and 15 candidate EQA materials were analyzed using seven routine assays, and the ln-transformed results were analyzed in 21 assay pairs. Commutability was assessed using Deming regression, with a 95% prediction interval (CLSI approach) and the difference in bias with an error component model (International Federation of Clinical Chemistry and Laboratory Medicine [IFCC] approach).
Results:
For ALT, all materials were commutable for 14–21 assay pairs according to the CLSI and IFCC approaches. For AST, B01-03 showed commutability for 14-21 assay pairs, and C01-03 and D01-03 showed commutability for no less than 10 assay pairs according to the two approaches. A01-06 were commutable for 9-16 assay pairs according to the CLSI approach, but for 6-9 assay pairs according to the IFCC approach.
Conclusions
Mixed leftover samples showed desirable commutability characteristics as candidate EQA materials for routine aminotransferase activity measurements. Human serum bases supplemented with HOR were commutable for most routine ALT activity measurements.
7.Surgical treatment of thoracic aortic graft infection
Rui ZHAO ; Cuntao YU ; Juntao QIU ; Jinlin WU ; Wenxiang JIANG ; Jiawei QIU ; Enzehua XIE
Chinese Journal of Thoracic and Cardiovascular Surgery 2020;36(5):314-316
Aortic graft infections(AGI) are uncommon complications of aortic surgery, although they carry a high mortality. Due to its special anatomical location, the thoracic aorta has less surrounding covered tissue. Once the graft infection occurs, the condition is often more dangerous. Therefore, the treatment of AGI of thoracic aorta is particularly important. This article reviews the surgical treatment of thoracic aorta graft infections.
8.Clinical effects of type Ⅱ hybrid aortic arch repair for type A aortic dissection in elderly and non-elderly patients
Jiawei QIU ; Rui ZHAO ; De WANG ; Jinlin WU ; Juntao QIU ; Wenxiang JIANG ; Lu DAI ; Enzehua XIE ; Shuya FAN ; Wei GAO ; Fangfang CAO ; Bin HOU ; Cuntao YU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2020;27(09):1010-1014
Objective To discuss the efficacy of type Ⅱ hybrid aortic arch repair for type A aortic dissection in patients of different age groups. Methods We retrospectively analyzed the clinical data of 126 patients with type A aortic dissection admitted to the Fuwai Hospital between January 2016 and December 2018, including 78 (61.9%) males and 48 (38.1%) females, with an average age of 61.8±6.9 years. The patients were divided into an elderly group (≥60 years, n=82) and a non-elderly group (<60 years, n=44). The preoperative, intraoperative and postoperative data of patients in the two groups were compared. Results The age between the elderly and non-elderly group was significantly different (65.9±4.1 years vs. 54.3±4.1 years, P<0.010), and no significant difference was found between the two groups in other preoperative baseline data. There were 6 (4.8%) patients of early death, 3 (2.4%) patients of stroke and 2 (1.6%) patients of paralysis. A total of 194 stents were implanted, and the average dimeter of the stents was 33.6±1.8 mm and the average length was 199.0±6.7 mm. The non-elderly group had shorter mechanical ventilation time (31.9±41.7 h vs. 61.0±89.2 h, P=0.043) and ICU stay time (77.8±51.4 h vs. 143.1±114.4 h, P<0.001) than the elderly group. There was no significant difference in in-hospital mortality rate, reoperation rate or survival rate between the two groups (P>0.05). Follow-up time was 1-43 (22.6±10.8) months, and 3 patients were lost. There were 104 (82.5%) patients of complete thrombus formation of false lumen in stent and endoleak was reported in 11 (9.2%) patients. Conclusion Type Ⅱ hybrid aortic arch repair offers an alternative approach to acute type A aortic dissection with acceptable early and mid-term clinical effects. The non-elderly patients have a similar early treatment effect to the elderly patients, but have a better mid-term outcome.
9. Role of argatroban in repair of spinal cord injury in rats
Chenxi ZHAO ; Baoyou FAN ; Wenxiang LI ; Xu WANG ; Yilin PANG ; Xue YAO ; Shiqing FENG
Chinese Journal of Trauma 2020;36(1):86-92
Objective:
To investigate the effect of argatroban in repair of spinal cord injury in rats.
Methods:
A total of 54 female Wistar rats were selected and divided into three groups according to the random number table: sham group, injury group and Argatroban group, with 18 rats in each group. The sham group only took the T10lamina; the injury group used the spinal cord injury device to make the rat spinal cord injury model; the Argatroban group received Argatroban treatment after spinal cord injury. The recovery of hindlimb motor function was evaluated by BBB score and clined plate test before injury and 7, 14, 21, 28, 35 and 42 days after injury. The sensory evoked potentials (SEP) and motor evoked potentials (MEP) were detected 42 days after operation. HE staining was used to compare the size of the cavity in the local region 42 days after injury.
Results:
At day 7 after injury, the BBB score was (3.7±0.5)points and the inclined plane test was (28.0±2.6)° in the Argatroban group, which were better than those in the injury group [(3.3±0.5)points, (24.3±1.9)°] (
10. Commutability assessment of 16 processed materials for 17-hydroxyprogesterone based on two approaches in China
Qichen LONG ; Tianjiao ZHANG ; Ying YAN ; Weiyan ZHOU ; Xin LI ; Shuijun LI ; Haijian ZHAO ; Wenxiang CHEN ; Chuanbao ZHANG
Chinese Journal of Laboratory Medicine 2020;43(1):44-50
Objective:
The aim of this study is to evaluate the commutability of 16 processed materials for 17-hydroxyprogesterone by using 2 commutability assessment approaches.
Methods:
52 serum specimens were collected in Clinical Laboratory Department of Beijing Hospital from February 2018 to June 2019. According to the report of the Clinical and Laboratory Standards Institute (EP14-A3) document and the recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on commutabilityassessment, serum 17-hydroxyprogesterone isotope diluent chromatogram tandem mass spectrometry (ID-LC/MS/MS) was used for comparison. Three clinical routine analysis systems (1 radioimmunoassay, 2 LC/MS analysis methods) were used to determine the concentration of 17-hydroxyprogesterone in 52 human serum samples and 16 processed materialsfor commutabilityassessment.
Results:
Combined with the results of the two commutability assessment, all accuracy verification materials and national steroid hormone standards showed good commutability in the LC/MS analysis system, and 6/9 EQA materials showed commutability in the three routine analysis systems.All materials showed good commutability in the LC/MS analysis system of bias difference method.
Conclusions
The two kinds of commutability assessment results are different. Bias difference method has more clinical value, but it has certain application limitations. The use of fresh frozen human serum as a quality assessment materialfor serum 17-hydroxyprogesterone is meets the commutability requirement.

Result Analysis
Print
Save
E-mail