1.Cost-utility analysis of ciclesonide and budesonide in the treatment of mild to moderate bronchial asthma
Jie ZOU ; Jieying HUANG ; Lina WANG ; Wenwen DU ; Wei XU
China Pharmacy 2025;36(2):203-207
OBJECTIVE To evaluate the cost-utility of ciclesonide (CIC) versus budesonide (BUD) for the maintenance treatment of mild to moderate bronchial asthma. METHODS From the perspective of Chinese health service system, a Markov model was established based on the data from a clinical trial in China and some literature. The cycle length was 1 week, the time horizon was 60 years. A discount rate of 5% per year was applied. Cost-utility analysis was performed on therapeutic scheme of CIC and BUD using three times of China’s per capita gross domestic product (GDP) in 2023 as the threshold of willing-to-pay (WTP). One-way sensitivity analysis, probabilistic sensitivity analysis and scenario analysis were applied to test the uncertainty of basic analysis. RESULTS Compared with BUD scheme, the incremental cost of the CIC scheme was 9 401.67 yuan, and the incremental quality-adjusted life years(QALYs) were 0.001 3; incremental cost-effectiveness ratio (ICER) was 6 928 868.26 yuan/QALY, far beyond the threshold of WTP 268 074 yuan/QALY. One-way sensitivity analysis showed that the usage, dosage and unit price of CIC and BUD were parameters that had a significant impact on ICER; probabilistic sensitivity analysis showed that the basic analysis results were relatively robust; scenario analysis showed that, when the price of CIC reduced to 159.95 yuan/branch, the probability of CIC scheme having economics was similar to that of BUD scheme. CONCLUSIONS At the current price, CIC is not economical compared with BUD for the maintenance treatment of mild to moderate asthma, using three times of China’s GDP in 2023 as the threshold of WTP.
2.Cost-utility analysis of ciclesonide and budesonide in the treatment of mild to moderate bronchial asthma
Jie ZOU ; Jieying HUANG ; Lina WANG ; Wenwen DU ; Wei XU
China Pharmacy 2025;36(2):203-207
OBJECTIVE To evaluate the cost-utility of ciclesonide (CIC) versus budesonide (BUD) for the maintenance treatment of mild to moderate bronchial asthma. METHODS From the perspective of Chinese health service system, a Markov model was established based on the data from a clinical trial in China and some literature. The cycle length was 1 week, the time horizon was 60 years. A discount rate of 5% per year was applied. Cost-utility analysis was performed on therapeutic scheme of CIC and BUD using three times of China’s per capita gross domestic product (GDP) in 2023 as the threshold of willing-to-pay (WTP). One-way sensitivity analysis, probabilistic sensitivity analysis and scenario analysis were applied to test the uncertainty of basic analysis. RESULTS Compared with BUD scheme, the incremental cost of the CIC scheme was 9 401.67 yuan, and the incremental quality-adjusted life years(QALYs) were 0.001 3; incremental cost-effectiveness ratio (ICER) was 6 928 868.26 yuan/QALY, far beyond the threshold of WTP 268 074 yuan/QALY. One-way sensitivity analysis showed that the usage, dosage and unit price of CIC and BUD were parameters that had a significant impact on ICER; probabilistic sensitivity analysis showed that the basic analysis results were relatively robust; scenario analysis showed that, when the price of CIC reduced to 159.95 yuan/branch, the probability of CIC scheme having economics was similar to that of BUD scheme. CONCLUSIONS At the current price, CIC is not economical compared with BUD for the maintenance treatment of mild to moderate asthma, using three times of China’s GDP in 2023 as the threshold of WTP.
3.Level of vitamin D in children with cholestatic liver disease and its clinical features
Ziyun GUO ; Lina DU ; Xiaoxuan XIE ; Yan YANG
Journal of Clinical Hepatology 2025;41(1):99-103
ObjectiveTo investigate vitamin D level in children with cholestatic liver disease, and to provide a theoretical basis for vitamin D supplementation therapy in children with this disease. MethodsA total of 116 children with cholestatic liver disease who attended Department of Traditional Chinese Medicine, Beijing Children’s Hospital, Capital Medical University, for the first time from January 2022 to January 2024 were enrolled and divided into groups for comparison based on sex, age, vitamin D supplementation dose, course of the disease, and etiology. The data on the serum level of 25-hydroxyvitamin D (25-OH-D) and related biochemical parameters were collected to assess the correlation between vitamin D level and biochemical parameters. The chi-square test or the Fisher’s exact test was used for comparison of categorical data between groups, and the Spearman rank correlation test was used for correlation analysis. ResultsAmong the 116 children, 76 (65.5%) had vitamin D deficiency or insufficiency. The children with vitamin D deficiency or insufficiency accounted for 65.7% (46/70) among boys and 65.2% (30/46) among girls, with no significant difference between boys and girls (χ2=0.003, P=0.956). The children with vitamin D deficiency or insufficiency accounted for 83.3% (25/30) among the children who had never received vitamin D supplementation, 58.7% (27/46) among the children with a daily supplementation dose of 500 IU, 64.3% (18/28) among the children with a daily supplementation dose of 700 IU, and 50.0% (6/12) among the children with a daily supplementation dose of>700 IU, and there was no significant difference between these groups (χ2=6.460, P=0.091). Comparison between the groups with different etiologies showed that the children with vitamin D deficiency or insufficiency accounted for 57.7% (15/26) in the infectious disease group, 66.7% (10/15) in the inherited metabolic disease group, 66.7% (6/9) in the drug-induced liver injury group, 100.0% (8/8) in the group with abnormal structure of the biliary system, and 63.8% (37/58) in the group with unknown etiology, and there was no significant difference between these groups (χ2=5.304, P=0.252). Comparison between the groups with different courses of the disease showed that the children with vitamin D deficiency or insufficiency accounted for 78.4% (29/37) in the<1 month group, 54.3% (25/46) in the 1 — 3 months group, 53.3% (8/15) in the 3 — 6 months group, and 77.8% (14/18) in the>6 months group, with no significant difference between these groups (χ2=7.432, P=0.059). Comparison between different age groups showed that compared with the infant group, the children group had a significantly higher proportion of children with vitamin D deficiency or insufficiency (χ2=9.504, P=0.018). The correlation analysis showed that serum aspartate aminotransferase and alanine aminotransferase had no significant correlation with 25-OH-D (P>0.05); serum alkaline phosphatase (ALP) (r=-0.286, P=0.002), gamma-glutamyl transpeptidase (GGT) (r=-0.248, P=0.007), total bilirubin (TBil) (r=-0.353, P<0.001), direct bilirubin (DBil) (r=-0.299, P=0.001), and total bile acid (r=-0.236, P=0.011) were negatively correlated with 25-OH-D, while serum calcium (r=0.263, P=0.004) and phosphorus (r=0.385, P<0.001) were positively correlated with 25-OH-D. ConclusionMost children with cholestatic liver disease have vitamin D deficiency or insufficiency, and the increase in serum ALP, GGT, TBil, DBil or total bile acid and the reduction in calcium or phosphorus may suggest vitamin D deficiency or insufficiency.
4.One case report and literature review of severe cardiotoxicity by oxaliplatin combined with capecitabine
Lina XU ; Yingli FANG ; Xiangling WANG ; Pengcheng DU
China Pharmacy 2025;36(10):1248-1253
OBJECTIVE To explore the relationship between severe cardiotoxicity caused by oxaliplatin combined with capecitabine and genetic polymorphism, thereby providing references for safe clinical medication use. METHODS Clinical pharmacists conducted a correlation analysis on a case of severe cardiotoxicity in a rectal cancer patient at Qilu Hospital of Shandong University following first-time treatment with standard doses of oxaliplatin combined with capecitabine. Case reports of cardiotoxicity caused by oxaliplatin and capecitabine were retrieved from the Chinese and English databases such as CNKI and PubMed.Basic patient information, drug treatment plan, and cardiotoxic manifestations were extracted and summarized. Combined with the patient’s genetic polymorphism test results related to the metabolism and excretion of platinum-based and fluorouracil drugs, potential mechanisms and prevention strategies for cardiotoxicity induced by oxaliplatin and capecitabine were discussed. RESULTS The patient exhibited homozygous mutations in ABCB1 C3435T and G2677T/A, a heterozygous mutation in MTHFR A1298C, and a heterozygous mutation in GSTP1 A105G, indicating impaired metabolism and excretion of oxaliplatin and capecitabine. The pharmacists recommended discontinuing oxaliplatin and reducing capecitabine to 50% of the original dose for subsequent treatment. The physicians adopted this advice, and the patient experienced no further severe adverse reactions with stable disease progression. CONCLUSIONS Oxaliplatin and capecitabine may cause severe cardiotoxicity. Medical institutions with adequate resources should perform genetic polymorphism test related to drug metabolism and excretion in patients prescribed these agents. For patients with multiple gene mutations, close monitoring and appropriate dose reductions are recommended to ensure medication safety and efficacy.
5.Progress on elimination of radioactive nuclides by polysaccharides
Shuxiu ZHANG ; Bochuan YUAN ; Lina DU ; Yiguang JIN
Journal of Pharmaceutical Practice and Service 2025;43(6):270-274
Radionuclides can be hazardous by absorbed through the skin, respiratory and digestive tracts. Chelating agents and adsorbents already could effectively remove them, however traditional chelators have side effects such as nephrotoxicity, teratogenicity, and embryotoxicity. As a new type of nuclide adsorbent, polysaccharide has the advantages of safety, biocompatibility, and high clearance rate. In this paper, the main types and perniciousness of radionuclides, and the latest research of polysaccharides in radionuclide removal were summarized. The application of polysaccharide as an effective adsorption molecule for radio nuclides in nuclear wars, nuclear accidents and other sudden nuclear events is promising.
6.Recommendations for Standardized Reporting of Systematic Reviews and Meta-Analysis of Animal Experiments
Qingyong ZHENG ; Donghua YANG ; Zhichao MA ; Ziyu ZHOU ; Yang LU ; Jingyu WANG ; Lina XING ; Yingying KANG ; Li DU ; Chunxiang ZHAO ; Baoshan DI ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2025;45(4):496-507
Animal experiments are an essential component of life sciences and medical research. However, the external validity and reliability of individual animal studies are frequently challenged by inherent limitations such as small sample sizes, high design heterogeneity, and poor reproducibility, which impede the effective translation of research findings into clinical practice. Systematic reviews and meta-analysis represent a key methodology for integrating existing evidence and enhancing the robustness of conclusions. Currently, however, the application of systematic reviews and meta-analysis in the field of animal experiments lacks standardized guidelines for their conduct and reporting, resulting in inconsistent quality and, to some extent, diminishing their evidence value. To address this issue, this paper aims to systematically delineate the reporting process for systematic reviews and meta-analysis of animal experiments and to propose a set of standardized recommendations that are both scientific and practical. The article's scope encompasses the entire process, from the preliminary preparatory phase [including formulating the population, intervention, comparison and outcome (PICO) question, assessing feasibility, and protocol pre-registration] to the key writing points for each section of the main report. In the core methods section, the paper elaborates on how to implement literature searches, establish eligibility criteria, perform data extraction, and assess the risk of bias, based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement, in conjunction with relevant guidelines and tools such as Animal Research: Reporting of in Vivo Experiments (ARRIVE) and a risk of bias assessment tool developed by the Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE). For the presentation of results, strategies are proposed for clear and transparent display using flow diagrams and tables of characteristics. The discussion section places particular emphasis on how to scientifically interpret pooled effects, thoroughly analyze sources of heterogeneity, evaluate the impact of publication bias, and cautiously discuss the validity and limitations of extrapolating findings from animal studies to clinical settings. Furthermore, this paper recommends adopting the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology to comprehensively grade the quality of evidence. Through a modular analysis of the entire reporting process, this paper aims to provide researchers in the field with a clear and practical guide, thereby promoting the standardized development of systematic reviews and meta-analysis of animal experiments and enhancing their application value in scientific decision-making and translational medicine.
7.Remyelination Regulated by microRNAs in Neurodegenerative Diseases: A Review
Manjing LI ; Qi LI ; Qingsen RAN ; Kunni CHEN ; Xinke DU ; Lina YANG ; Chunxia NIE ; Qing YANG ; Yujie LI ; Ying CHEN ; Yajie WANG ; Xiaogang WENG ; Weiyan CAI ; Xiaoxin ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(1):223-231
Demyelination of the central nervous system often occurs in neurodegenerative diseases, such as multiple sclerosis (MS). The myelin sheath, a layer of myelin membrane wrapping the axon, plays a role in the rapid conduction and metabolic coupling of impulses for neurons. The exposure of the axon will lead to axonal degeneratio, and further neuronal degeneration, which is the main cause of dysfunction and even disability in patients with demyelinating neurodegenerative diseases. In addition to the demyelination of mature myelin sheath, remyelination disorder is also one of the major reasons leading to the development of the diseases. The myelin sheath is composed of oligodendrocytes (OLs) derived from oligodendrocyte progenitor cells (OPCs) which are differentiated from neural stem cells (NSCs). The process of myelin regeneration, i.e., remyelination, is the differentiation of NSCs into OLs. Recent studies have shown that this process is regulated by a variety of genes. MicroRNAs, as important regulators of neurodegenerative diseases, form a complex regulatory network in the process of myelin regeneration. This review summarizes the main molecular pathways of myelin regeneration and microRNAs involved in this process and classifies the mechanisms and targets. This review is expected to provide a theoretical reference for the future research on the treatment of demyelinating diseases by targeting the regulation of microRNAs.
8.Role of apical sodium-dependent bile acid transporter in hepatobiliary diseases
Xiaoxuan XIE ; Lina DU ; Ziyun GUO ; Yan YANG
Journal of Clinical Hepatology 2024;40(1):199-203
Apical sodium-dependent bile acid transporter (ASBT) is a key transporter responsible for intestinal reabsorption of bile acid and plays an important role in maintaining bile acid and cholesterol homeostasis, and its expression is regulated by various factors including transcription factors, nuclear receptors, and intestinal microflora. The abnormal expression and function of ASBT can lead to disorders in the metabolism of bile acid and cholesterol, causing a variety of hepatobiliary diseases. At present, ASBT has attracted wide attention as a therapeutic target. This article elaborates on the biological characteristics and expression regulation mechanism of ASBT and reviews the role of ASBT in hepatobiliary diseases, in order to provide a new direction for the treatment of related diseases.
9.Ginger oil-loaded transdermal adhesive patch treats post-traumatic stress disorder
Xingshuang Song ; Yizhi Zhang ; Ziyan Tang ; Jing Dai ; Yanping Wu ; Guiyu Huang ; Hong Niu ; Yaxin Wang ; Xu Jin ; Lina Du
Journal of Traditional Chinese Medical Sciences 2024;11(3):316-329
Objective:
To find a viable alternative to reduce the number of doses required for the patients with post-traumatic stress disorder (PTSD), and to improve efficacy and patient compliance.
Methods:
In this study, we used ginger oil, a phytochemical with potential therapeutic properties, to prepare ginger oil patches. High-performance liquid chromatography (HPLC) was used to quantify the main active component of ginger oil, 6-gingerol. Transdermal absorption experiments were conducted to optimize the various pressure-sensitive adhesives and permeation enhancers, including their type and concentration. Subsequently, the ginger oil patches were optimized and subjected to content determination and property evaluations. A PTSD mouse model was established using the foot-shock method. The therapeutic effect of ginger oil patches on PTSD was assessed through pathological sections, behavioral tests, and the evaluation of biomarkers such as tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), brain-derived neurotrophic factor (BDNF), and melatonin (MT).
Results:
The results demonstrated that ginger oil patches exerted therapeutic effects against PTSD by inhibiting inflammatory responses and modulating MT and BDNF levels. Pharmacokinetic experiments revealed that ginger oil patches maintained a stable blood drug concentration for at least one day, addressing the rapid metabolism drawback of 6-gingerol and enhancing its therapeutic efficacy.
Conclusions
Ginger oil can be prepared as a transdermal drug patch that meets these requirements, and the bioavailability of the prepared patch is better than that of oral administration. It can improve PTSD with good patient compliance and ease of administration. Therefore, it is a promising therapeutic formulation for the treatment of PTSD.
10.Cancer cell membrane-coated bacterial ghosts for highly efficient paclitaxel delivery against metastatic lung cancer.
Dandan LING ; Xueli JIA ; Ke WANG ; Qiucheng YAN ; Bochuan YUAN ; Lina DU ; Miao LI ; Yiguang JIN
Acta Pharmaceutica Sinica B 2024;14(1):365-377
Chemotherapy is one of the major approaches for the treatment of metastatic lung cancer, although it is limited by the low tumor delivery efficacy of anticancer drugs. Bacterial therapy is emerging for cancer treatment due to its high immune stimulation effect; however, excessively generated immunogenicity will cause serious inflammatory response syndrome. Here, we prepared cancer cell membrane-coated liposomal paclitaxel-loaded bacterial ghosts (LP@BG@CCM) by layer-by-layer encapsulation for the treatment of metastatic lung cancer. The preparation processes were simple, only involving film formation, electroporation, and pore extrusion. LP@BG@CCM owned much higher 4T1 cancer cell toxicity than LP@BG due to its faster fusion with cancer cells. In the 4T1 breast cancer metastatic lung cancer mouse models, the remarkably higher lung targeting of intravenously injected LP@BG@CCM was observed with the almost normalized lung appearance, the reduced lung weight, the clear lung tissue structure, and the enhanced cancer cell apoptosis compared to its precursors. Moreover, several major immune factors were improved after administration of LP@BG@CCM, including the CD4+/CD8a+ T cells in the spleen and the TNF-α, IFN-γ, and IL-4 in the lung. LP@BG@CCM exhibits the optimal synergistic chemo-immunotherapy, which is a promising medication for the treatment of metastatic lung cancer.


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