1.Study on fluorescent quantum dot immunofiltration assay for quantitative detection of C-reactive protein
Weihua WU ; Jia CHEN ; Pengfei ZHANG ; Guiping RAN
International Journal of Laboratory Medicine 2014;(11):1471-1473
Objective To study the feasibility of using fluorescent immunofiltration test based on quantum dots (QDs)for rapid and quantitative detection of C-reactive protein.Methods Based on homemade QDs and QDs-antibody bioconjugates,an immune de-tection method was established via the double antibodies sandwich technique on the immunochromatography card.The test results could be read under the irradiation of UV light,and quantitative results could be measured through the combination of a laser and fluorescent spectroscopy.Results Under UV light irradiation,the minimum detection concentration of CRP was 0.156 mg/L.U-sing the quantitative detection method,the fluorescent intensities on the cards could be established a linear relationship with the con-centration of CRP,and the linear equation was that log(Y )=0.563 log(X)+4.570,r2 =0.958.Conclusion The fluorescent quan-tum dot immunofiltration assay can be used for quantitative detection of CRP;The quantum dots immuno-labels have the potential to develop new type of immune-diagnostic reagents.
2.Value of serum GSTP1 gene quantitative methylation analysis for early diagnosis of hepatocellular carcinoma
Guiping RAN ; Guozhen YANG ; Wen FANG ; Yong YUAN ; Ruixia ZHANG
International Journal of Laboratory Medicine 2014;(5):540-542
Objective To establish a real-time fluorescence quantitative methylation assay to investigate the methylation status of GSH-sulphur-transferase P1(GSTP1) gene promoter region in hepatocellular carcinoma(HCC) and to investigate whether which can be used as the early diagnostic indicator of HCC .Methods Ninety-five serum samples were collected from 40 patients with HCC ,30 patients with liver cirrhosis and 25 individuals with healthy physical examination as controls .The methylation level of GSTP1 gene in these serum samples were quantitatively determined by using the real-time fluorescence quantitative methylated spe-cific PCR technique .The receiver-operation characteristic(ROC) curves were adopted to evaluate its diagnostic value for HCC .Re-sults The methylation quantitative level of GSTP1 gene in HCC serum was significantly higher than that in the healthy controls (P<0 .05) .The ROC curve analysis demonstrated that the methylation quantitative analysis of GSTP1 gene could efficiently distin-guish HCC and cirrhosis from healthy controls (AUC=0 .8641) .With the methylation rate of 2% as the critical value for diagno-sing HCC ,its diagnostic specificity was 87 .5% ,the sensitivity was 69 .6% ;the combination detection of serum GSTP1 gene methy-lation and serum AFP could increase the detection rate of HCC to 75% .Conclusion The real-time fluorescence quantitative methyl-ation assay can accurately quantify the methylation level of serum GSTP1 gene ,which has certain application value for the early di-agnosis of HCC .
3.Iron isomaltoside for the treatment of iron deficiency anemia:a rapid health technology assessment
Xuting LIU ; Shengnan GAO ; Ran QI ; Guiping DU ; Guoqiang LIU
China Pharmacy 2022;33(24):3040-3044
OBJECTIVE To evaluate the effectiveness, safety and economy of iron isomaltoside in the treatment of iron deficiency anemia using a rapid health technology assessment (HTA) method, and provide an evidence-based basis for clinical decision-making. METHODS PubMed, Embase, Cochrane Library, CNKI, Wanfang database and foreign HTA official websites were systematically searched, and the search time frame of the databases was from the establishment of the database to May 25th 2022. After data extraction and quality evaluation of the literature according to the inclusion and exclusion criteria, a descriptive analysis of the effectiveness, safety and economy of iron isomaltoside in the treatment of iron deficiency anemia was performed. RESULTS & CONCLUSIONS A total of 1 HTA report, 3 systematic reviews/meta-analysis and 5 economic studies were included. In terms of effectiveness, compared with ferric carboxymaltose, the hemoglobin level of patients using iron isomaltoside increased more, but there was no significant difference in the proportion of responding patients; compared with iron sucrose, it had non- inferiority in increasing and maintaining hemoglobin level, and there was no difference in the quality of life. In terms of safety, the incidence of adverse events of ferric carboxymaltose, iron sucrose and iron isomaltoside were 12.0%, 15.3% and 17.0%, respectively. Iron isomaltoside had a lower incidence of hypophosphatemia, compared with ferric carboxymaltose. There was no statistical difference in the incidence of hypophosphatemia among iron isomaltoside, iron sucrose, iron-dextrin and nanocrystalline iron oxide. The conclusion of the incidence of treatment-emergent adverse event, the incidence of serious adverse events and the withdrawal rate of patients due to adverse events was not clear. In terms of economy, the economy of iron isomaltoside is better than that of iron sucrose, and the economy of iron isomaltoside versus that of ferric carboxymaltose had not been finalized.
4.Cost-utility analysis of denosumab and zoledronic acid in the treatment of postmenopausal osteoporosis
Guiping DU ; Shengnan GAO ; Ran QI ; Xuting LIU ; Guoqiang LIU
China Pharmacy 2022;33(14):1742-1747
OBJECTIVE To evaluate the cost-effectiveness of denosumab and zoledronic acid in the treatment of postmenopausal osteoporosis ,and to provide reference for relevant decision-making. METHODS From the perspective of Chinese health system ,Excel 2003 software was used to establish Markov model ,and cost-utility analysis was used to evaluate the cost-effectiveness of denosumab or zoledronic acid combined with calcium carbonate D 3 in the treatment of postmenopausal osteoporosis. Pharmacotherapy effects were obtained from the network Meta-analysis ,and cost and health-utility value data were obtained from the published literature or network ,etc. The model cycle was 1 year,and the simulation time limit was the patient ’s lifetime. One-way sensitivity analysis and probabilistic sensitivity analysis were used to evaluate the impact of model parameter changes on the robustness of the results ;and the cost-effectiveness of changing the medication cycle of zoledronic acid were explored through scenario analysis. RESULTS Denosumab regimen was more effective than zoledronic acid regimen (12.77 QALYs vs. 11.98 QALYs),and its cost was also higher than zoledronic acid regimen (51 224.56 yuan vs. 49 221.67 yuan), and the incremental cost-effectiveness ratio was 2 544.14 yuan/QALY. One-way sensitivity analysis showed that the cost of Zoledronic acid injection and that of Denosumab injection had great impact on the results. The results of probabilistic sensitivity analysis showed that when using 3 times of per capita gross domestic product (GDP)in China in 2021 as the threshold of willingness to pay ,the probability of Denosumab regimen being cost-effective was 85.4%. The results of the scenario analysis showed that the Denosumab regimen was still more cost-effective when the dosing cycle of zoledronic acid was changed. CONCLUSIONS Under the threshold of 1-3 times of Chinese per capita GDP in 2021,denosumab combined with calcium carbonate D 3 is more cost-effective than zoledronic acid combined with calcium carbonate D 3 in the treatment of postmenopausal osteoporosis.
5.Cost-utility analysis of pembrolizumab combined with chemotherapy in the first-line treatment of advanced or metastatic esophageal carcinoma
Ran QI ; Guiping DU ; Xuting LIU ; Shengnan GAO ; Guoqiang LIU
China Pharmacy 2022;33(12):1466-1473
OBJECTIVE To evaluate the cost-utility of pembrolizumab combined with chemotherapy versus chemotherapy alone in the first-line treatment of advanced or metastatic esophageal carcinoma. METHODS Cost-utility analysis of pembrolizumab combined with chemotherapy versus chemotherapy alone for advanced or metastatic esophageal carcinoma was conducted by using a three-state partitioned survival model from the perspective of health system in China. The model use d a lifetime simulation time frame with 3 weeks as a cycle. The survival data were extrapolated using KEYNOTE- 590 data;cost data were obtained from the median of 2022 public winning bid on Yaozhi network ,among which the price of pembrolizumab was obtained after discounting by a patient assistance program ;utility data were obtained from the literatures ,and a 5% discount rate was used for both cost and utility. One-way sensitivity analysis and probabilistic sensitivity analysis were also conducted to examine model robustness. RESULTS Analysis of the base case results showed that compared to chemotherapy alone ,the incremental cost-effectiveness ratio (ICER)of pembrolizumab combined with chemotherapy regimens were 950 528.42 yuan/QALY,107 845.39 yuan/QALY and 315 754.56 yuan/QALY for esophageal squamous cell carcinoma (ESCC),programmed deathligand- 1 combined positive score (PD-L1 CPS)≥10 and intention-to-treat population (ITT),respectively. The results of sensitivity analysis verified the robustness of the basic analysis results. CONCLUSIONS Under our healthcare system ,using a threshold of willingness-to-pay of 1-3 times our GDP per capita in 2021,pembrolizumab combined with chemotherapy regimen isn ’t cost-utility compared with chemotherapy alone in the ESCC and ITT subgroups of patients ,while it is cost-utility in the PD-L 1 CPS≥10 subgroup of patients.
6.Cost-utility analysis of durvalumab for consolidation therapy after chemoradiotherapy for stage Ⅲ non-small cell lung cancer
Jian SHI ; Ran QI ; Shengnan GAO ; Xuting LIU ; Guiping DU ; Guoqiang LIU
China Pharmacy 2022;33(15):1860-1864
OBJECTIVE To evaluate the cost-effectiveness of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer from the perspective of the Chinese health care system. METHODS A Markov model was developed by using updated four-year survival data from the PACIFIC trial in May 2021 and relevant literature. The cost-effectiveness of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer was evaluated by using quality-adjusted life years (QALYs)as health output index with 20-year simulation time frame and a 2-week cycling period. The costs and health output were discounted using discount rate of 5%;one-way sensitivity analysis and probabilistic sensitivity analysis were used to examine the robustness of the model simulation results. RESULTS The results of the base analysis showed that compared with placebo group ,durvalumab resulted in 0.73 QALYs at an incremental cost of 1 076 062.86 yuan and an incremental cost-utility ratio (ICER)of 1 467 546.54 yuan/QALY,which was much higher than 3-fold per capita gross domestic products (GDP)in 2020(217 713 yuan)as willingness-to-pay (WTP)threshold. The results of one-way sensitivity analysis showed that the price of durvalumab and discount rate had a great impact on ICER. Probabilistic sensitivity analysis showed no cost-effective advantage for durvalumab when the WTP threshold was three times of GDP per capita in 2020 (217 713 yuan). CONCLUSIONS From the perspective of Chinese health care system ,there is no cost-effective advantage to the use of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer when the WTP threshold was three times of GDP per capita in 2020.