1.Calcium channel modulators in the treatment of diabetic peripheral neuropathic pain:a rapid health technology assessment
Ning GAO ; Bing FENG ; Shengnan GAO ; Ranran ZHANG ; Yuxi ZHANG ; Guoqiang LIU
China Pharmacy 2025;36(8):1001-1007
OBJECTIVE To evaluate the efficacy, safety and economics of calcium channel modulators in the treatment of diabetic peripheral neuropathic pain (DPNP), and provide evidence-based evidence for clinical drug selection and decision-making. METHODS PubMed, Embase, Cochrane Library, CNKI, Wanfang data, VIP net, CBM and official websites of foreign health technology assessment (HTA) institutions were systematically searched to collect HTA reports, systematic review/meta-analyses, and pharmacoeconomic studies of pregabalin, gabapentin, crisugabalin, and mirogabalin for the treatment of DPNP. The timeframe for all searches was from the inception to June 2024. After data extraction and quality assessment, the results of the included studies were analyzed descriptively. RESULTS A total of 16 articles were included, involving 1 HTA report, 7 systematic reviews/meta- analyses, and 8 pharmacoeconomic studies. No studies on crisugabalin were retrieved. Compared with placebo, both pregabalin and mirogabalin reduced end point pain scores and increased the proportion of patients with ≥30% and/or ≥50% reduction in pain scores. Pregabalin also improved patient global impression of change (PGIC). Gabapentin was similar to placebo in reducing end point pain scores and increasing the proportion of patients with ≥30% and/or ≥50% reduction in pain scores, but gabapentin improved PGIC of patients. Compared with pregabalin, mirogabalin was more effective in the treatment of pain. The safety of pregabalin and mirogabalin was similar, and compared with placebo, both pregabalin and mirogabalin increased the risk of common adverse reactions such as dizziness and somnolence. The safety of gabapentin was similar to placebo and duloxetine. Compared with duloxetine, pregabalin and gabapentin were not cost-effective. Compared with gabapentin, pregabalin was cost-effective. Mirogabalin was cost-effective, as compared with placebo and pregabalin. CONCLUSIONS Pregabalin and mirogabalin are effective in the treatment of DPNP, the efficacy of mirogabalin is better than pregabalin, and the safety is similar between them. The economic conclusions vary from country to country, pending a pharmacoeconomic study based on our population.
2.Cost-utility analysis of benmelstobart plus anlotinib and chemotherapy as first-line treatment for extensive-stage small cell lung cancer
Bing FENG ; Ning GAO ; Shengnan GAO ; Yuxi ZHANG ; Ranran ZHANG ; Guoqiang LIU
China Pharmacy 2025;36(5):579-583
OBJECTIVE To evaluate the cost-utility of benmelstobart combined with anlotinib and chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) from the perspective of China’s healthcare system. METHODS Based on the data from the ETER 701 study, a partitioned survival model was constructed with a cycle of 3 weeks to simulate the total cost, quality-adjusted life years (QALY), and incremental cost-effectiveness ratio (ICER) over 10 years for patients with ES- SCLC treated with benmelstobart plus anlotinib and chemotherapy, or chemotherapy alone. One-way sensitivity analysis and probability sensitivity analysis were performed to verify the robustness of the simulation results. The willingness-to-pay (WTP) threshold was set at 3 times the per capita gross domestic product (GDP) of China in 2023, which amounted to 268 074 yuan/QALY. RESULTS Compared with chemotherapy alone, benmelstobart combined with anlotinib and chemotherapy gained 0.438 QALY more at the cost of 403 505.55 yuan more, with an ICER of 922 031.37 yuan/QALY, which was higher than the WTP threshold set in this study. One-way sensitivity analysis showed that benmelstobart’s cost and utility value of the progression-free survival state had a greater impact on the ICER value; probabilistic sensitivity analysis confirmed the robustness of the model; only when the price of benmelstobart was reduced by 75.4%, the combined regimen would be cost-effective. CONCLUSIONS The first-line treatment of ES-SCLC with benmelstobart combined with anlotinib and chemotherapy is not cost-effective from the perspective of China’s healthcare system at present.
3.Cost-utility analysis of capecitabine metronomic chemotherapy combined with aromatase inhibitor as first-line treatment for HR+/HER2- metastatic breast cancer
Ranran ZHANG ; Guoqiang LIU ; Yuxi ZHANG ; Shengnan GAO ; Ning GAO ; Bing FENG ; Ran LIU ; Qian LI
China Pharmacy 2025;36(15):1893-1898
OBJECTIVE To evaluate the cost-effectiveness of capecitabine metronomic chemotherapy combined with aromatase inhibitor (AI) versus AI monotherapy as first-line treatment for hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, thereby providing evidence-based support for clinical therapeutic decision- making and healthcare policy formulation. METHODS Based on the MECCA trial, a partitioned survival model was constructed using a 4-week cycle length to simulate outcomes over patients’ lifetime. The model outputs included total costs, quality-adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed to validate the robustness of base-case results, while scenario analyses examined the cost-effectiveness of both treatment strategies under 10-year, 20-year, and lifetime time horizons. RESULTS With the willingness-to-pay (WTP) threshold set at 1 times China’s 2024 per capita gross domestic product (GDP) (95 749 yuan/QALY), patients receiving capecitabine metronomic chemotherapy combined with AI regimen gained incremental utility (0.66 QALYs) while incurring higher costs, with ICER of 27 684.85 yuan/QALY. Results of the one-way sensitivity analysis showed that factors with significant impacts on ICER included the cost discount rate, drug costs of the capecitabine metronomic chemotherapy combined with AI group, utility value in the progression-free survival state, follow-up costs, and treatment costs in the subsequent stablephase. Probabilistic sensitivity analysis indicated that when the WTP threshold ≥49 250 yuan/QALY, the capecitabine metronomic chemotherapy combined with AI regimen had a 100% probability of being cost-effective. Scenario analysis results demonstrated that capecitabine metronomic chemotherapy combined with AI regimen was more cost-effective than the AI alone regimen across 10-year, 20-year, and lifetime study horizons. CONCLUSIONS Under the premise that the WTP threshold is set at 1 times China’s per capita GDP in 2024, capecitabine metronomic chemotherapy combined with AI regimen is more cost-effective than the AI alone regimen as the first-line treatment for HR+/HER2- metastatic breast cancer.
4.Cost-effectiveness analysis of sacituzumab tirumotecan versus single-agent chemotherapy in second-line and later-line treatment for metastatic triple-negative breast cancer
Ranran ZHANG ; Yuxi ZHANG ; Shengnan GAO ; Bing FENG ; Ning GAO ; Guoqiang LIU
China Pharmacy 2025;36(16):2024-2029
OBJECTIVE To evaluate the cost-effectiveness of sacituzumab tirumotecan (ST) versus chemotherapy treatment physician’s choice (TPC) as second-line and later-line treatment for metastatic triple-negative breast cancer (mTNBC) from the perspective of China’s healthcare system. METHODS A partitioned survival model was constructed based on the OptiTROP-Breast 01 trial, with a cycle length of 4 weeks and a time horizon of 10 years, applying a 5% discount rate. Quality adjusted life year (QALY) and costs were used as outcome measures, and the incremental cost-effectiveness ratio (ICER) of ST versus TPC for second-line and later-line treatment of mTNBC was calculated. Sensitivity analyses were conducted to validate the robustness of the base-case results. RESULTS At a willingness-to-pay threshold (WTP) of 3 times China’s 2024 per capita gross domestic product (GDP) (287 247 yuan/QALY), patients receiving ST gained incremental utility (0.42 QALY) at a higher cost, yielding an ICER of 205 562.07 yuan/QALY, which was lower than WTP, indicating that ST was more cost-effective compared to TPC. One-way sensitivity analysis revealed that key factors influencing the ICER included the utility value of progression-free survival and the price of ST. Probabilistic sensitivity analysis and scenario analysis showed that the base-case results were robust. CONCLUSIONS From the perspective of China’s healthcare system, at a WTP of 3 times China’s per capita GDP, ST is more cost-effective than TPC as second-line and later-line treatment for mTNBC.
5.Analysis of syncopal DRVR in blood donors: multicenter hemovigilance data (2020—2023)
Junhong YANG ; Qing XU ; Wenqin ZHU ; Fei TANG ; Ruru HE ; Zhenping LU ; Zhujiang YE ; Fade ZHONG ; Gang WU ; Guoqiang FENG ; Xiaojie GUO ; Jia ZENG ; Xia HUANG
Chinese Journal of Blood Transfusion 2025;38(8):1071-1076
Objective: Data on syncopal donation-related vasovagal reaction (DRVR) collected from 74 blood centers between 2020 and 2023 was statistically analyzed to provide a reference for developing preventive strategies against syncopal DRVR. Methods: Data on blood donation adverse reactions and basic information of donors from 2020 to 2023 were collected through the information management system at monitoring sentinel sites. Statistical analysis was performed on the following aspects of syncopal DRVR: characteristics of donors who experienced syncope, reported incidence, triggers, duration, presence and occurrence time of syncope-related trauma, clinical management including outpatient and inpatient treatment, and severity grading. Results: From 2020 to 2023, 45 966 donation-related adverse reactions were recorded. Of these, 1 665 (3.72%) cases were syncopal DRVR. The incidence of syncopal DRVR decreased with age, being the highest in the 18-22 age group. Incidence was significantly higher in female donors than male donors, in first-time donors than repeat donors, and in university and individual donors than group donors (all P<0.05). There was no statistically significant difference among different blood donation locations (P>0.05). The top three triggers were tension, fatigue, and needle phobia or fear of blood. Among syncopal DRVR cases, 60.36% occurred during blood collection, 87.63% lasted for less than 60 seconds, and 5.05% were accompanied by trauma. Notably, 57.14% of these traumas occurred after donor had left the blood collection site. Syncope severity was graded based on required treatment: grade 1 (fully recovered without treatment, 95.50%); grade 2 (recovered after outpatient treatment, 4.02%); and grade 3 (recovered after inpatient treatment, 0.48%). Conclusion: By analyzing the data of syncopal DRVR cases, it is possible to provide a reference for formulating blood donor safety policies.
6.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
7.Cost-utility analysis of dorzagliatin combined with metformin in the treatment of type 2 diabetes mellitus patients with poor glycemic control with metformin
Ning GAO ; Bing FENG ; Shengnan GAO ; Shan GUO ; Mengna NIU ; Guoqiang LIU
China Pharmacy 2024;35(6):724-728
OBJECTIVE To assess the long-term cost-effectiveness of five glucagon-like peptide-1 receptor agonists (GLP- 1RAs) in the treatment of poorly controlled type 2 diabetes mellitus (T2DM) treated with metformin. METHODS Baseline data from patients in previously published meta-analysis and included randomized controlled trials (RCTs) were extracted to predict survival, long-term efficacy, and costs for each group using the United Kingdom prospective diabetes study outcome model 2.1. The cost-effectiveness of 5 GLP-1RAs (liraglutide, lixisenatide, exenatide, dulaglutide, and semaglutide) was analyzed by cost- utility analysis. Sensitivity analysis and scenario analysis were also performed to verify the uncertainty of basic analysis results. RESULTS A total of 21 RCTs with 6 796 patients were included. Survival analysis curves showed the superiority of semaglutide in reducing the risk of death from cardiovascular disease and dulaglutide in reducing the risk of all-cause mortality over other GLP- 1RAs. The cost-utility analysis showed that the five drugs were economically superior to inferior in the order of lixisenatide, semaglutide, exenatide, dulaglutide, and liraglutide; one-way and probabilistic sensitivity analyses indicated that the results were robust. The scenario analysis results indicated that the price of semaglutide should decrease by at least 54.64% to 369.21 yuan, which is cost-effectiveness compared to lixisenatide. CONCLUSIONS For T2DM patients in China with poor glycemic control after treatment with metformin, lixisenatide and semaglutide may be considered as the preferred regimen.
8.Cost-effectiveness analysis of tislelizumab combined with chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
Bing FENG ; Ning GAO ; Shengnan GAO ; Shan GUO ; Mengna NIU ; Guoqiang LIU
China Pharmacy 2024;35(8):967-971
OBJECTIVE To evaluate the cost-effectiveness of tislelizumab combined with chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. METHODS The data of RATIONALE-305 study and related literature were used to establish a partitioned survival model from the perspective of China’s health system. The cycle was 3 weeks, the simulation time was set as 10 years, and the discount rate was 5%. The quality-adjusted life years (QALYs) were used as the health outcome indicator to evaluate the cost-effectiveness of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, and one-way sensitivity analysis and probabilistic sensitivity analysis were also conducted. RESULTS The base analysis showed that the patients received more 0.268 QALYs with tislelizumab plus chemotherapy, compared with placebo plus chemotherapy, but the cost increased by 70 404.81 yuan with an incremental cost- effectiveness ratio (ICER) of 262 431.62 yuan/QALY, which was less than three times China’s gross domestic product (GDP) per capita in 2023 as the willingness-to-pay (WTP) threshold (268 074 yuan/QALY). One-way sensitivity analysis showed that the efficacy value of progress free survive and the price of tislelizumab had a greater impact on the ICER value. The results of probability sensitivity analysis showed that when the WTP threshold was 3 times China’s GDP per capita in 2023, the probability of tislelizumab being cost-effective was 53.3%. CONCLUSIONS When the WTP threshold is 3 times China’s GDP per capita in 2023, tislelizumab plus chemotherapy is cost-effective for first-line treatment of locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, compared with placebo plus chemotherapy.
9.Problems and suggestions in the implementation of drug centralized volume-based procurement policies in the hospitals
Weihua KONG ; Qi QIAO ; Guoqiang LIU ; Nan CHEN ; Chengwu SHEN ; Qi CHEN ; Feng QIU ; Jianhua WANG ; Ling JIANG ; Qinghong LU ; Junyan WU ; Yafeng WANG ; Likai LIN ; Jiajia FENG ; Hong CHENG
Chinese Journal of Hospital Administration 2024;40(7):535-540
Objective:To explore the challenges in the implementation of drug centralized volume-based procurement policies in hospitals and propose corresponding optimization suggestions.Methods:From August to December 2023, a purposive sampling was conducted to select 11 pharmaceutical experts from tertiary hospitals in China for Delphi method. The survey content included " policy recommendations for promoting the acceleration and expansion of national drug centralized procurement and retaining surplus medical insurance funds for centralized procurement" .Results:Survey participants gave feedback on a set of existing problems found in the implementation of drug centralized procurement policies and proposed corresponding optimization methods. Kendall′s W coefficient of the specialist consultation was 0.332( P<0.05), demonstrating good consistency and concentration of the expert opinions. Among the problems, the score of drug supply guarantee was the highest(mean value of importance was 4.45). At the same time, the recommendation of strengthening monitoring and early warning, coordination and dispatch, and effectively ensuring the supply of centralized drug procurement had the highest score and concentration(mean value of importance was 4.91, coefficient of variation was 0.06). Conclusions:Through Delphi method, this study revealed issues and optimization methods in the implementation of drug centralized procurement policies in hospitals. The findings could provide valuable insights for improvements in the pharmaceutical sector and future policy adjustments.
10.Analysis of factors influencing premature birth in cases with placenta previa complicated by placenta ac-creta spectrum disorders
Jingyu WANG ; Yi HE ; Cuifang FAN ; Guoping XIONG ; Guoqiang SUN ; Shaoshuai WANG ; Suhua CHEN ; Jianli WU ; Dongrui DENG ; Ling FENG ; Haiyi LIU ; Xiaohe DANG ; Wanjiang ZENG
The Journal of Practical Medicine 2024;40(21):2982-2988
Objective To retrospectively analyze of factors influencing early preterm birth(EPB)and late preterm birth(LPB)in pregnancy women with placenta previa complicated by placenta accreta spectrum disorders(PAS),and assess maternal and infant outcomes.Methods We included 590 cases of pregnancy women with placenta previa complicated by PAS who underwent cesarean sections at five hospitals in Wuhan and Xianning cities between January 2018 and June 2021.These patients were divided into three groups based on delivery gesta-tional age:EPB,LPB,and term birth(TB).A multiple logistic regression model was employed to analyze the risk factors associated with EPB and LPB.Additionally,differences in early maternal and infant outcomes among these groups were examined.Results Among 590 pregnancy women with placenta previa complicated by PAS,the proportions of EPB and LPB were 9.7%and 54.4%.The use of uterine contraction inhibitors prior to cesarean section,vaginal bleeding,and previous cesarean sections history were identified as risk factors for both EPB and LPB.The proportion of severe postpartum hemorrhage was comparable between the EPB group and the LPB group;however,the incidence of neonatal asphyxia,low birth weight infants,and the rate of newborns transferred to the Neonatal Intensive Care Unit(NICU)within 24 hours after cesarean delivery were significantly higher in the EPB group compared to the LPB group.Conclusions Placenta previa complicated by PAS predominantly leads to LPB.The history of prior cesarean sections,uterine contractions,and vaginal bleeding prior to cesarean section,are sig-nificantly associated with both EPB and LPB.During the perinatal period,efforts should be made to extend gesta-tional weeks under close monitoring to minimize the incidence of premature births and thereby improve early mater-nal and infant outcomes.


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