1.Cost-utility analysis of sacituzumab govitecan versus single-agent chemotherapy in the treatment of HR+/HER2- advanced metastatic breast cancer
Yinmei HE ; Xiao LI ; Xiaoli LIU ; Longzhou LI ; Yan GAO ; Jianguo YU ; Jiajie LUAN ; Yilai WU
China Pharmacy 2024;35(20):2493-2498
OBJECTIVE To estimate the cost-utility of sacituzumab govitecan (SG) versus single-agent chemotherapy in the treatment of hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced metastatic breast cancer. METHODS From the perspective of the Chinese medical system, a three-state partitioned survival model was constructed to examine the cost-utility of SG versus single-agent chemotherapy based on TROPiCS-02 trial. The cycle length was set to 1 month, and the time horizon was 10 years. The annual discount was 5%. The model output included total costs and quality adjusted life month (QALM), and incremental cost-effectiveness ratio (ICER) was calculated for cost-utility analysis, by setting willingness-to-pay (WTP) threshold at 3 times gross domestic product (GDP) per capita of China in 2023 (22 340 yuan/QALM). Univariate sensitivity analyses, probability sensitivity analyses, and scenario analyses were performed to evaluate the robustness of the results and calculate the price threshold when SG had economic advantages. RESULTS SG group gained incremental 4.25 QALM and 561 570 yuan compared with single-agent chemotherapy, which resulted in an ICER of 132 102/QALM that was higher than WTP. The results of the univariate sensitivity analysis showed that the monthly average cost of SG had the greatest impact on the results; the results of probability sensitivity analysis showed that the probability of SG scheme being cost-effective at the WTP threshold was 0. The results of scenario analysis showed that the conclusions of this study were robust under different time horizons (5, 10, 15 years). The price threshold for SG being cost-effective was 1 344 yuan per 180 mg. CONCLUSIONS Based on the perspective of Chinese medical system, SG appears to be not cost-effective compared with single-agent chemotherapy for HR+/ HER2- advanced metastatic breast cancer at the price of 8 400 yuan per 180 mg. A substantial price cut should be taken to be cost- effective.
2.Comparison of effectiveness,safety,and economy of generic and original levetiracetam concentrated solution for injection:a real-world study
Yingnan FENG ; Xianzhe DONG ; Jing PENG ; Ke WANG ; Zhizhou WANG ; Jiajie LUAN ; Lan ZHANG ; Xiaolin YUE
Chinese Journal of Pharmacoepidemiology 2024;33(2):152-157
Objective To evaluate the effectiveness,safety and economy of the clinical application of levetiracetam(LEV)concentrated solution for injection generic drug and the original drug in the national centralized volume-based procurement.Methods The information of inpatients using original LEV concentrated solution for injection in the Xuanwu Hospital of Capital Medical University(original drug group)and inpatients using generic LEV concentrated solution for injection in the First Affiliated Hospital of Wannan Medical College(generic drug group)was retrospectively analyzed after the implementation of the procurement policy(from November 2021 to March 2022).To compare the effectiveness,safety and economy of the two in the prevention and treatment of epilepsy.Results In the original drug group and the generic drug group,18 and 17 patients were enrolled in the treatment of epilepsy respectively,the effective rates were 50.00%and 58.82%,the incidence of adverse reactions were both 0%,and the median daily cost was 255.00(255.00,510.00)yuan and 131.78(131.78,131.78)yuan.After propensity score matching,both the original drug group and the generic drug group had 76 patients each received preventive medication,the effective rates were 97.37%and 100%(P>0.05),and the incidence of adverse reactions were both 0%.The median daily fee for the original the generic drug group was 170.00(170.00,170.00)yuan and 131.78(131.78,131.78)yuan,there were significant difference(P<0.01).Conclusion The clinical effect of generic and original LEV concentrated solution for injection in preventing epilepsy is basically the same,the clinical safety are equivalent,the generic has better economy than the original.The effective rate of the treatment of epilepsy is similar,while the sample size needs to be further expanded to verify the results.
3.Semaglutide in the treatment of type 2 diabetes mellitus:rapid health technology assessment
Sihua WANG ; Sheng WANG ; Yan WANG ; Jiajie LUAN
China Pharmacy 2023;34(12):1503-1508
OBJECTIVE To evaluate the efficacy, safety and cost-effectiveness of semaglutide in the treatment of type 2 diabetes mellitus (T2DM), and to provide reference for clinical drug use. METHODS Rapid health technology assessment was adopted. Retrieved from PubMed, Embase, Cochrane Library, Web of Science, CNKI, Wanfang database, CBM, domestic and foreign HTA official websites, HTA reports, systematic evaluation/meta-analysis and pharmacoeconomic studies about semaglutide in the treatment of T2DM were collected during the inception to May 1st, 2022. After data extraction and quality evaluation, descriptive analysis was performed on the results of included studies. RESULTS A total of 22 pieces of literature were included, involving 7 meta-analyses and 15 pharmacoeconomic studies. In terms of efficacy and safety, semaglutide showed significant advantages in controlling glycated hemoglobin (HbA1c), fasting blood glucose, postprandial mean glucose, body mass index and achieving a target of glycosylated hemoglobin level <7%; also, there was no increased risk of hypoglycaemia or the incidence of serious adverse effects, but the risk of gastrointestinal adverse effects was significantly higher than other interventions. In terms of cost-effectiveness, results of foreign studies showed that semaglutide was more cost-effective, compared with other glucagon-like peptide-1 receptor agonists, sodium-glucose transporter protein 2 inhibitors, dipeptidyl peptidase-4 inhibitors. Research based on the perspective of China’s health system showed that semaglutide had a clear cost-effectiveness advantage over dulaglutide when using GDP per capita in 2020 (72477 yuan) as the payment threshold. CONCLUSIONS The semaglutide has excellent efficacy and good safety for the treatment of T2DM, with cost-effectiveness advantages over a number of drugs, but attention should be paid to the occurrence of gastrointestinal adverse effects.
4. Establish and implement a pre-prescription system for outpatient based on Six Sigma DMAIC model
Lin WANG ; Jianguo YU ; Xiao LI ; Jiajie LUAN
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(7):780-787
AIM: The pre-prescription system of outpatient was established and implemented based on six sigma DMAIC model to ensure the safety of drug use and promote rational of drug use. METHODS: The rules database was made scientifically and precisely, according to DMAIC model of Six Sigma-define, measure, analyze, improve and control. The pre-prescription system of our hospital was established and improved, through adopting the prescription review mode of interception and Intervention. And the process management was continued to optimize. RESULTS: The rule-making of pre-trial system for outpatient prescription in our hospital was reasonable, and the rate of clinical approval and acceptance was high. After the system audit, the average rate of doctor's revision was 76.32%, and the average rate of Pharmacist's intervention was 63.23%, the effective rate and qualified rate of pharmacist intervention were 97.23% and 96.87%, respectively. CONCLUSION: Based on Six Sigma DMAIC model, the pre-trial system for outpatient prescription was established and implemented, which improved the level of rational drug use, effectively ensured the safety of drug use, and improved the satisfaction of patients.
5. Effects of CDA-G208A gene polymorphism on the efficacy of gemcitabine in the first-line treatment of lung squamous cell carcinoma
Yang HE ; Kui YANG ; Jiajie LUAN
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(3):299-306
AIM: To investigate the effect of CDAG208A gene polymorphism on the efficacy and safety of gemcitabine in the first-line treatment of lung squamous cell carcinoma. METHODS: Sixty-five first-line treated patients with locally advanced or metastatic lung squamous cell carcinoma in The First Affiliated Hospital of Wannan Medical College hospital were screened. Group A included 31 patients tested with the GG (wild homozygous) CDAG208A gene, and group B included 34 patients without testing. All patients received gemcitabine plus platinum chemotherapy for at least 2 cycles. The efficacy and safety were evaluated following the RECIST 1.1 standard and the NCI-CTC 5.0 standard, respectively. The primary study endpoint was progression-free survival (PFS), overall survival (OS) and the secondary study endpoints included objective effective rate (ORR), disease control rate (DCR), adverse reactions, and influencing factors of PFS. RESULTS: The results showed that the DCR was 74.5% and 50% in group A and group B, respectively (P=0.045); mPFS was 6.1 months and 5.0 months in group A and group B, respectively (P=0.034); and the mOS was 13.3 months and 12.0 months in group A and group B, respectively, and there was no statistical difference (P=0.388). The number of cases of grade III-IV neutropenia in group A and group B was 2 and 10, respectively (P=0.017); grade III-IV neutropenia was an independent prognostic factor affecting patients with PFS (P=0.045); the group with unknown G208A gene status was more likely to develop grade III-IV neutrophils (P= 0.029). The AUC of CDA-G208A gene predicting neutropenia caused by gemcitabine chemotherapy was 0.756. CONCLUSION: Non-GG type of CDAG208A gene can reduce the metabolic rate of gemcitabine in the body and cause neutropenia after chemotherapy. In severe cases, it can indirectly reduce the clinical efficacy of gemcitabine. The detection of CDA-G208A gene status before treatment can predict the neutropenia caused by gemcitabine chemotherapy.
6.Investigation and analysis of smoking behaviour of civil servants in Minhang District, Shanghai
Weiqing GUO ; Keying DING ; Jian WANG ; Hui CHEN ; Jing LUAN ; Zhilian LIU ; Tao LIU ; Jiajie WU ; Qinwen YANG
Journal of Environmental and Occupational Medicine 2022;39(1):47-52
Background The tobacco epidemic as one of the most serious public health problems in the world contributes great harm to human health. It is urgent to develop tobacco control strategy. Civil servants' behaviors as a role model for society have a great influence on the rest of society. Thus, it is important to promote tobacco control program on helping civil servants to quit smoking. Objective To understand the smoking and second-hand smoking exposures status, the awareness of knowledge of tobacco hazards, and the attitudes to tobacco control policies of civil servants in Minhang District, Shanghai. Furthermore, to explore the related strategies and measures for tobacco control, to provide a basis for the development and revision of relevant intervention measures and policies. Methods A total of 20 government agencies with newly installed smoking-free programs from 10 subdistricts and towns in Minhang District, including Xinzhuang, Wujing, Maqiao, Qibao, Meilong, Hongqiao, Zhuanqiao, Jiangchuan, Gumei, and Xinhong were selected as study sites.A questionnaire survey was conducted to investigate all civil servants (n=801) of selected agencies. The questionnaire included general characteristics, smoking and second-hand smoking exposure status, knowledge of tobacco hazard, and attitudes to tobacco control policies. Results A total of 794 civil servants returned valid questionnaires. The awareness rate of tobacco hazards in the smoking group was lower than that in the non-smoking group (P<0.05). Relatively high smoking rates were reported in those being male (17.08%), age ≥51 years old (25.61%), divorced or widowed (12.50%), technical secondary school or below education level (22.81%), having more than 10 years of working years (11.57%), being willing to dissuade indoor smoking (24.54%), having no punishment or warning measures for violation of smoking regulations in workplaces (18.37%), and having no dedicated smoking spot at home (15.38%). The results of multiple logistic regression analysis showed that age 31-40 years old (OR=3.446, 95%CI: 1.236-9.609) and to avoid confronting indoor smoking (OR=3.686, 95%CI: 1.041-13.049) were risk factors for smoking in civil servants. Conclusion Civil servants aged 31-40 years old who deliberately avoid confronting indoor smoking behaviors are the key intervention population of smoking control in Minhang District, Shanghai.
7. Distribution of CYP2C9∗3 and VKORC1-1639G>A gene polymorphism in Anhui Han population and their influence on the stable dose of warfarin
Yuanzhu WU ; Jun LIU ; Kui YANG ; Jing PENG ; Jiajie LUAN ; Jun LIU ; Kui YANG ; Jing PENG ; Jiajie LUAN ; Jun WEI ; Dafa ZHANG ; Shuai SONG ; Xiaolong YUAN ; Zhongfang WANG ; Nianbao ZHANG ; Dan XIE ; Peng JIANG ; Jie FAN
Chinese Journal of Clinical Pharmacology and Therapeutics 2022;27(6):652-659
AIM: To study the distribution of CYP2C9∗3 and VKORC1-1639G>A gene polymorphism in Han population in Anhui province and their influence on the stable dose of warfarin. METHODS: The blood samples of 1 169 patients from 6 tertiary general hospitals in 5 areas of Anhui province from January 2020 to December 2021 were selected, the genotype of CYP2C9∗3 and VKORC1-1639G>A was detected by fluorescent staining in situ hybridization technique. RESULTS: The distribution of CYP2C9∗3 genotypes in 1 169 patients: the frequencies of AA, AC and CC genes were 90.16%, 9.24% and 0.60%, respectively; The distribution of VKORC1 genotype: the frequencies of AA, AG and GG genes were 84.26%, 14.71% and 1.03% respectively; There was no significant difference between the two genotypes in gender, age and regional distribution (P>0.05). The average daily warfarin dose of CYP2C9∗3 AA genotype in 755 patients with stable warfarin dose was (3.02±0.59) mg/d, which was significantly higher than patients with AC genotype and CC genotype; The average daily warfarin dose of patients with VKORC1-1639AA genotype was (2.72±0.40) mg/d, which was significantly lower than that of patients with AG genotype and GG genotype (P<0.05). And the difference was statistically significant (P<0.05); There are significant differences in gender, age and clinical diagnosis between patients with stable dose of warfarin and those without stable dose (P<0.05). CONCLUSION: CYP2C9 and VKORC1 genotypes are associated with the stable dose of warfarin. Clinical anticoagulation therapy guided by CYP2C9 and VKORC1 genotypes can provide guidance for individualized medication of warfarin.
8.Tumor-Associated Macrophages in Hepatocellular Carcinoma:Friend or Foe?
Dexi ZHOU ; Jiajie LUAN ; Cheng HUANG ; Jun LI
Gut and Liver 2021;15(4):500-516
Hepatocellular carcinoma (HCC) is one of the most common malignancies worldwide, and it has diverse etiologies with multiple mechanisms. The diagnosis of HCC typically occurs at advanced stages when there are limited therapeutic options. Hepatocarcinogenesis is considered a multistep process, and hepatic macrophages play a critical role in the inflammatory process leading to HCC. Emerging evidence has shown that tumor-associated macrophages (TAMs) are crucial components defining the HCC immune microenvironment and represent an appealing option for disrupting the formation and development of HCC. In this review, we summarize the current knowledge of the polarization and function of TAMs in the pathogenesis of HCC, as well as the mechanisms underlying TAM-related anti-HCC therapies. Eventually, novel insights into these important aspects of TAMs and their roles in the HCC microenvironment might lead to promising TAM-focused therapeutic strategies for HCC.
9.Tumor-Associated Macrophages in Hepatocellular Carcinoma:Friend or Foe?
Dexi ZHOU ; Jiajie LUAN ; Cheng HUANG ; Jun LI
Gut and Liver 2021;15(4):500-516
Hepatocellular carcinoma (HCC) is one of the most common malignancies worldwide, and it has diverse etiologies with multiple mechanisms. The diagnosis of HCC typically occurs at advanced stages when there are limited therapeutic options. Hepatocarcinogenesis is considered a multistep process, and hepatic macrophages play a critical role in the inflammatory process leading to HCC. Emerging evidence has shown that tumor-associated macrophages (TAMs) are crucial components defining the HCC immune microenvironment and represent an appealing option for disrupting the formation and development of HCC. In this review, we summarize the current knowledge of the polarization and function of TAMs in the pathogenesis of HCC, as well as the mechanisms underlying TAM-related anti-HCC therapies. Eventually, novel insights into these important aspects of TAMs and their roles in the HCC microenvironment might lead to promising TAM-focused therapeutic strategies for HCC.
10.Fairness of blood bank resources allocation in China
Dandan GE ; Yong XIA ; Xiaoyun LIU ; Jiajie LUAN ; Mingshu SI
Chinese Journal of Blood Transfusion 2021;34(5):510-513
【Objective】 To study the fairness of blood bank resources allocation in China, aimed at providing references for reasonable allocation of blood bank resources. 【Methods】 A questionnaire survey was conducted among 32 provincial blood centers and 321 regional central blood banks across China in August 1~25, 2018. Resource allocation of blood banks in China was analyzed using descriptive methods, and the fairness of resource allocation were analyzed using Lorenz curve, Gini coefficient and Theil index. 【Results】 Blood bank resources and services showed an overall upward trend from 2013 to 2017. The fairness of institutional coverage was optimal in 2017 according to the Lorenz curve and Gini coefficient, suggesting the allocation of blood bank resources according to the population was better than geographic area. The fairness of health technicians staffing was the worst from the perspective of geographic area. The total Theil index was 0.448 5~0.526 7, and the differences was contributed more by intra group comparison than that of inter group. 【Conclusion】 The unbalanced development underlying in the provincial and regional blood centers has been observed, and the service capacity needs to be further improved. The resource allocation varies greatly among regions, and it is recommended to optimize the regional planning of blood bank resources.

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