1.Cost-utility analysis of denosumab and teriparatide in the treatment of postmenopausal osteoporosis in Chinese women
Guiping DU ; Yukun LI ; Min LI ; Peng XUE ; Yan LIU ; Guoqiang LIU
China Pharmacy 2023;34(2):173-178
OBJECTIVE To evaluate the cost-effectiveness of denosumab and teriparatide in the treatment of postmenopausal osteoporosis in Chinese women, and provide reference for relevant decision-making. METHODS From the perspective of health system in China, Excel 2003 was used to establish Markov model, and cost-utility analysis was used to evaluate the cost- effectiveness of denosumab or teriparatide combined with Calcium carbonate D3 tablets in the treatment of postmenopausal osteoporosis in Chinese women. Pharmacotherapy effects were obtained with network meta-analysis, and cost and health utility value data were obtained from published literature. The model cycle was 1 year, and the simulation time limit was the patient’s lifetime. Univariate sensitivity analysis and probabilistic sensitivity analysis were used to evaluate the effects of model parameter changes on the robustness of the results. Through scenario analysis, the cost-effectiveness of domestic drug cost used as drug cost of terlipatide group was discussed; the influence of residual effects of teriparatide on the results and the cost-effectiveness of sequential use of desumamab after terlipatide withdrawal were also discussed. RESULTS The effect of denosumab regimen was better than that of terlipatide regimen [13.24 quality-adjusted life years (QALYs) vs. 12.96 QALYs], with lower cost (51 224.64 yuan vs. 167 102.67 yuan), denosumab regimen was the absolutely superior regimen. The results of single factor sensitivity analysis showed that the cost and discount rate of Terlipatide injection had greater impact on the results. The results of probability sensitivity analysis showed that when three times of China’s per capita gross domestic product (GDP) in 2021 was used as the threshold of willingness to pay, the probability of cost-effectiveness of denosumab regimen was 93.5%. The results of scenario analysis showed that, whether the drug cost of terlipatide regimen which was replaced by domestic drugs, or the residual effect of terlipatide was considered, or desulmonab was used sequentially after two years of terlipide treatment, denosumab regimen was always the absolute advantage regimen. CONCLUSIONS Denosumab combined with Calcium carbonate D3 tablets is more cost-effective than teriparatide combined with Calcium carbonate D3 tablets in the treatment of postmenopausal osteoporosis in Chinese women.
2.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.
3.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.
4.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.
5.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.
6.Advances in neoadjuvant therapy of esophageal cancer involved in organ preservation
Chen DU ; Siyu SU ; Lige WANG ; Guiping YU
Journal of International Oncology 2021;48(11):673-677
Esophageal squamous cell carcinoma is one of the most common cancer in China, and locally advanced stage remains a heterogeneous and complex disease. Its treatments are constantly evolving. To date, radiochemotherapy and surgery are involved in the comprehensive treatment of this disease. However, because of the specifical anatomical location of esophagus, its physiological function will be impaired after surgical resection. If similar survival is obtained in esophageal cancer, an organ preserving strategy without surgery is of great significance for improving the quality of life. As a non-invasive tumor treatment method, neoadjuvant therapy plays an important role in the comprehensive treatment of preserving the esophagus. Recently, there are studies investigating the role of organ preserving strategy in the comprehensive treatment of esophageal cancer with neoadjuvant therapy, and the recognition of these advances will provide reference value for the comprehensive treatment of esophageal cancer.
7. The value of acoustic parameters in the voice therapy for patients with unilateral vocal cord paralysis
Xiaoyu WANG ; Mei WEI ; Peng LIN ; Jianqun DU ; Wei WANG ; Guiping WANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2019;54(9):685-688
Objective:
To investigate the value of acoustic parameters in the voice therapy for patients with unilateral vocal cord paralysis (UVCP).
Methods:
From May 2015 to April 2018, 51 patients with UVCP and 59 healthy controls in Department of Otorhinolaryngology Head and Neck Surgery, Tianjin First Central Hospital, were involved in this research retrospectively. The UVCP patients were diagnosed with stroboscopic laryngoscopy. The minimum glottal area (MGA) was calculated by KIPS software when the people were pronouncing/i:/. The fundamental frequency (F0), Jitter, Shimmer and NHR were detected by CSL4500 multiple acoustic voice analyzer.
Results:
MGA of UVCP patients was much higher than that of healthy control (male: 433.68±64.52
8.Effects of self-efficacy intervention on activities of daily living and outcomes in patients with acute ischemic stroke complicated with white matter lesions
Guiping JIANG ; Yanbin WU ; Yunyun LIU ; Min LI ; Bing FU ; Juan DU
International Journal of Cerebrovascular Diseases 2019;27(1):17-20
Objective To investigate the effects of self-efficacy intervention on activities of daily living and outcomes in patients with acute ischemic stroke complicated with white matter lesions (WML).Methods From March 2016 to June 2017,patients with acute ischemic stroke complicated with WML admitted to the Departments of Neurology,the Second People's Hospital of Lianyungang were enrolled prospectively.They were randomly divided into intervention group and control group.The control group received routine treatment and nursing,and the intervention group implemented self-efficacy intervention on the basis of the control group.They were followed up until 90 d after onset.Stroke Self-Efficiency Questionnaire (SSEQ) was used to assess the stroke self-efficacy level.The Barthel Index (BI) was used to assess the activities of daily living (ADL) of the patients.The National Institutes of Health Stroke Scale (NIHSS) and the modified Rankin Scale (mRS) were used to assess the outcomes of the patients.Results The SSEQ scores in the intervention group were significantly higher than those at the time of admission and in the control group at 90 d (all P <0.01).The BI in the intervention group was significantly higher than that in the control group (66.51 ±22.35 vs.58.41 ±23.17;t =3.473,P =0.001),and the NIHSS score was significantly lower than the control group (5.51 ±2.98 vs.6.95 ±2.94;t =-2.094,P=0.040),and the proportion of patients with good outcomes (mRS score 0-2) was significantly higher than that of the control group (73.7% vs.56.6%;x2 =4.896,P =0.027).Conclusion For patients with acute ischemic stroke complicated with WML,active self-efficacy intervention could improve the ADL and it was helpful to improve the outcomes of patients.
9.Prognostic analysis of arterial embolectomy of acute cardiogenic cerebral embolism caused by atrial fibrillation
Juan DU ; Yiling CAI ; Yongqiang CUI ; Zheng WU ; Xiangkai KONG ; Wenbo DUAN ; Guiping WANG ; Hongqin SHI
Chinese Journal of Cerebrovascular Diseases 2017;14(9):459-464
Objective To investigate the related factors of the prognosis of arterial embolectomy of acute cardiogenic cerebral embolism caused by atrial fibrillation.Methods The clinical data of using vein thrombolysis bridging artery embolectomy or arterial embolectomy alone for the treatment of patients with acute cardiogenic cerebral embolism of cerebral large artery occlusion due to atrial fibrillation were analyzed retrospectively.From January 2015 to December 2016,22 consecutive inpatients with cardioembolic cerebral embolism caused by paroxysmal or persistent atrial fibrillation were enrolled,including 10 patients with the 90-day modified Rankin Scale (mRS) score 0-2 (good recovery group) and 12 patients with mRS scores 3-6 (poor recovery group).The clinical features,imaging data,and treatment of the patients in both groups were compared.The factors such as age,gender,preoperative international standardization ratio (INR),embolism position,whether bridging vein thrombolysis before thrombectomy,National Institutes of Health Stroke Scale (NIHSS) score at the onset,time of onset to reperfusion (TOR),whether using tirofiban,times of thrombectomy,modified Thrombolysis In Cerebral Infarction (mTICI) blood flow grade,and postoperative intracranial symptomatic intracerebral hemorrhage were analyzed.Results There were no significant differences in age,gender,preoperative INR,embolism position,the number of intravenous thrombolysis before thrombectomy,the number of using tirofiban in surgery,the proportion of the above mTICI 2b grade,and the proportion of symptomatic cerebral hemorrhage after surgery of the patients between the two groups (P>0.05).The NIHSS score 15.2±2.0 at the onset in the good recovery group was lower than 22.9±8.4 in the poor recovery group.There was significant difference between the two groups (P<0.05).The TOR time (307±86 min) in the good recovery group was less than that of the poor recovery group (426±145 min).There was significant difference between the two groups (P<0.05).Embolectomy was performed 1.5 (0.5,3.0) times in the good recovery group,which was less than the poor recovery group (4.0 [2.0,7.0] times).There was significant difference between the two groups (P<0.05).Conclusions Shortening the time of reperfusion and reducing the number of embolectomy during operation are the important factors for improving the prognosis of patients when atrial fibrillation causes arterial embolectomy in patients with acute cerebral embolism.However,a study of larger sample is needed for further exploration.
10.Characteristics of 99Tcm-MIBI hepatobiliary scintigraphy in biliary atresia model and its association with the expression of P-glycoprotein in intestinal tissues
Yongshuai QI ; Guiping LI ; Li DU ; Baodan HUANG ; Quanshi WANG ; Hubing WU ; Xiaohua CHI
Chinese Journal of Nuclear Medicine and Molecular Imaging 2016;36(6):533-537
Objective To establish rat models of extrahepatic biliary atresia,and to observe the characteristics of 99Tcm-MIBI hepatobiliary scintigraphy and evaluate its association with the expression Pglycoprotein (P-gp) in intestinal tissues.Methods A total of 12 SD rats were randomly divided into the normal control group (3 rats) and the group of common bile duct ligation (CBDL;9 rats).CBDL was used to establish the rat model of extrahepatic biliary atresia.99Tcm-MIBI hepatobiliary scintigraphy was performed at 2,3 and 4 weeks after ligation in the CBDL group and normal control group with continuous dynamic acquisition (3 min/frame) for 30 min and then delaying imaging at 30 min,1,2 and 3 h.After that,all rats were sacrificed,and the blood samples were taken out for the determination of serum ALT,AST,TBIL,DBIL,IBIL,ALP,γ-GT and TBA,and the tissues of duodenum,jejunum,ileum,colon and cecum were taken out for analyzing the expression level of P-gp by immunohistochemistry.Two-sample t test and one-way analysis of variance were used.Results Compared with the normal control group,the serum levels of ALT,AST,TBIL,DBIL,IBIL,ALP,γ-GT and TBA were significantly increasing at 2,3,4 weeks after ligation in CBDL group (t:-3.04 to-44.54,all P<0.05).99Tcm-MIBI hepatobiliary imaging showed that there was radioactive accumulation in colon or cecum area,excluding the duodenum,jejunum and ileum area,at 3 h after intravenous injection of 99Tcm-MIBI in CBDL group.The results of immunohistochemistry showed that with the obstruction time prolonged,the expression levels of P-gp in duodenum,jejunum and ileum segments were gradually decreased (F=5.17,9.07,23.52;all P<0.05),while the expression levels in the colon and cecum segments were not changed obviously (F=2.00,3.17;both P>0.05).Conclusion 99Tcm-MIBI can be excreted through intestinal mucosa,and this process may be associated with P-gp expression.

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