1.Material Basis and Its Distribution in vivo of Qili Qiangxin Capsules Analyzed by UPLC-Q-Orbitrap-MS
Jianwei ZHANG ; Jiekai HUA ; Rongsheng LI ; Qin WANG ; Xinnan CHANG ; Wei LIU ; Jie SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):185-193
ObjectiveBased on ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap high resolution mass spectrometry(UPLC-Q-Orbitrap-MS), the chemical constituents of Qili Qiangxin capsules was identified, and their distribution in vivo was analyzed. MethodsUPLC-Q-Orbitrap-MS was used to detect the sample solution of Qili Qiangxin capsules, as well as the serum, brain, heart, lung, spleen, liver and kidney tissues of mice after oral administration. Using the Thermo Xcalibur 2.2 software, the compound information database was constructed, and the molecular formulas of compounds corresponding to the quasi-molecular ions were fitted. Based on the information of retention time, accurate relative molecular mass and fragments, the compounds and their distribution in vivo were analyzed by comparing with the data of reference substances and literature. ResultsA total of 233 compounds, including 70 terpenoids, 60 flavonoids, 23 organic acids, 17 alkaloids, 20 steroids, 7 coumarins and 36 others, were identified or predicted from Qili Qiangxin capsules, 73 of which were identified matching with standard substances. Tissue distribution results showed that 71, 17, 38, 33, 32, 58 and 43 migrating components were detected in blood, brain, heart, lung, spleen, liver and kidney, respectively. Thirty-seven components were absorbed into the blood and heart, including quinic acid, benzoylaconitine benzoylmesaconine and so on. Fourteen components were absorbed into the blood and six tissues, including calycosin, methylnissolin, formononetin, alisol B, alisol A and so on. ConclusionThis study comprehensively analyzes the chemical components of Qili Qiangxin capsules and their distribution in vivo. Among them, astragaloside Ⅳ, salvianolic acid B, ginsenoside Rb1, ginsenoside Rb3, ginsenoside Rd, ginsenoside Rg3, calycosin-7-glucoside, and sinapine may be the important components for the treatment of heart failure, which can provide useful reference for its quality control and research on pharmacodynamic material basis.
2.Paclitaxel Oral Preparations: A Review
Jie GAO ; Shiyang LI ; Jing GUO ; Rongsheng LI ; Zhenyu XUAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):322-330
Paclitaxel, a highly effective natural antitumor drug, has been demonstrated to be efficacious in the treatment of a variety of cancers, including breast cancer, ovarian cancer, and lung cancer. The traditional paclitaxel injections have been observed to present certain issues, including overt adverse reactions and a decline in the quality of life of patients following treatment. This ultimately leads to an inability to meet the comprehensive needs of patients, thereby limiting the clinical applications of the drugs. Compared with injectable administration, the oral administration can avoid the risk of infection present in the invasive route, is conducive to improving patient compliance and quality of life, and reduces healthcare costs, and has a good application prospect. However, paclitaxel has low solubility, poor permeability, and is susceptible to the exocytosis of P-glycoprotein, which presents a significant challenge in the development of its oral preparations. Novel drug delivery technologies can enhance the solubility of paclitaxel and facilitate its controlled release, which is beneficial for the oral absorption and efficacy. The paper reviews the development history of oral preparations of paclitaxel, and summarizes the delivery technologies such as polymer micelles, nanoparticles, nanoemulsions and nanocrystals, and discusses the application mechanisms, advantages and limitations of these technologies and their adaptability in different cancer treatments. Finally, the challenges faced in the development of oral preparations of paclitaxel are summarized, and future research directions are proposed in order to provide new ideas for the development of oral delivery of paclitaxel.
3.Paclitaxel Oral Preparations: A Review
Jie GAO ; Shiyang LI ; Jing GUO ; Rongsheng LI ; Zhenyu XUAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):322-330
Paclitaxel, a highly effective natural antitumor drug, has been demonstrated to be efficacious in the treatment of a variety of cancers, including breast cancer, ovarian cancer, and lung cancer. The traditional paclitaxel injections have been observed to present certain issues, including overt adverse reactions and a decline in the quality of life of patients following treatment. This ultimately leads to an inability to meet the comprehensive needs of patients, thereby limiting the clinical applications of the drugs. Compared with injectable administration, the oral administration can avoid the risk of infection present in the invasive route, is conducive to improving patient compliance and quality of life, and reduces healthcare costs, and has a good application prospect. However, paclitaxel has low solubility, poor permeability, and is susceptible to the exocytosis of P-glycoprotein, which presents a significant challenge in the development of its oral preparations. Novel drug delivery technologies can enhance the solubility of paclitaxel and facilitate its controlled release, which is beneficial for the oral absorption and efficacy. The paper reviews the development history of oral preparations of paclitaxel, and summarizes the delivery technologies such as polymer micelles, nanoparticles, nanoemulsions and nanocrystals, and discusses the application mechanisms, advantages and limitations of these technologies and their adaptability in different cancer treatments. Finally, the challenges faced in the development of oral preparations of paclitaxel are summarized, and future research directions are proposed in order to provide new ideas for the development of oral delivery of paclitaxel.
4.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
5.Analysis of the working model of pharmacy consultation in medical institutions in China:a scoping review
Pengxiang ZHOU ; Xiaoxia LIU ; Xiaofei LI ; Xiaomin XING ; Sitao TAN ; Rongsheng ZHAO
China Pharmacy 2024;35(16):1946-1950
OBJECTIVE To systematically summarize the working model of pharmacy consultation in medical institutions in China, and to provide reference for the normalization of process, standardization of content and homogenization of services of pharmacy consultation. METHODS A systematic search of Chinese and English literature databases was conducted to incorporate the literature on the working model of pharmacy consultation published by medical institutions in China. Two researchers screened and extracted the key information, and ultimately conducted qualitative summary and descriptive analysis. RESULTS Based on the included 11 articles, the pharmacy consultation working models were explored by clinical pharmacists in China. The contents of consultation mainly involved anti-infection, parenteral nutrition, cancer pain, etc. The general concept of pharmacy consultation should refer to the constructed flowchart, specific consultation problems could refer to the pathway, mind map, or decision tree and other framework guidance to carry out the work. Finally, consultation opinions could be written according to the consultation system or specialty consultation templates, and the adoption of a new working model (such as pharmacist active consultation) could also promote the number and acceptance rate of pharmacy consultation. CONCLUSIONS A series of working models of pharmacy consultation have been initially explored in medical institutions in China. However, it is not yet perfect and lacks a unified quality control and evaluation system for pharmacy consultation, which should be the focus of future research and practice.
6.Pharmacoeconomic evaluation of Bacillus Calmette-Guérin for post-TUR-BT perfusion therapy in patients with intermediate-to high-risk non-muscle invasive bladder cancer in China
Zhicheng SU ; Lu LI ; Qiang YAO ; Cairong ZHU ; Tao JIA
China Pharmacy 2024;35(22):2773-2778
OBJECTIVE To evaluate the cost-effectiveness of using Bacillus Calmette-Guérin (BCG) versus epirubicin for intravesical perfusion after transurethral resection of bladder tumor (TUR-BT) in patients with intermediate- to high-risk non-muscle- invasive bladder cancer (NMIBC). METHODS From the perspective of China’s health system, a Markov cohort model was constructed based on the ChiCTR-IIR-16008357 study. Quality-adjusted life years (QALYs) were used as the health outcome measure, with the willingness-to-pay(WTP) threshold set at one time the per capita gross domestic product of China in 2023 (89 358 yuan/QALY). A cost-utility analysis was used to compare the incremental cost-effectiveness ratio (ICER) of the BCG regimen relative to the epirubicin regimen for intravesical perfusion after TUR-BT in patients with intermediate- to high-risk NMIBC in China. In addition, sensitivity analysis was performed. RESULTS The incremental cost of the BCG regimen compared to the epirubicin regimen was 34 309.51 yuan, with an incremental utility of 0.800 QALYs, resulting in an ICER of 42 871.33 yuan/QALY, which is below the WTP threshold. When the WTP threshold was 89 358 yuan/QALY, the probability that the BCG regimen would be acceptable was 77.70% in the probabilistic sensitivity analysis, higher than that of the epirubicin regimen, and the acceptability of the BCG regimen increased with increasing in the WTP threshold. CONCLUSIONS When the WTP threshold was set at one time the per capita gross domestic product of China in 2023, compared to epirubicin, BCG used for intravesical perfusion after TUR-BT in patients with intermediate- to high-risk NMIBC demonstrated better cost-effectiveness.
7.Projecting the Dynamic Trends of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome:Modeling the Epidemic in Sichuan Province,China
Li YUAN ; Liu QINXI ; Luan RONGSHENG ; Yang YI ; Wu TAO ; Yang BIHUI
Biomedical and Environmental Sciences 2024;37(9):1003-1014
Objective Our study aimed to provide a comprehensive overview of the current status and dynamic trends of the human immunodeficiency virus (HIV) prevalence in Sichuan,the second most heavily affected province in China,and to explore future interventions. Methods The epidemiological,behavioral,and population census data from multiple sources were analyzed to extract inputs for an acquired immunodeficiency syndrome (AIDS) epidemic model (AEM). Baseline curves,derived from historical trends in HIV prevalence,were used,and the AEM was employed to examine future intervention scenarios. Results In 2015,the modeled data suggested an adult HIV prevalence of 0.191% in Sichuan,with an estimated 128,766 people living with HIV/AIDS and 16,983 individuals with newly diagnosed infections. Considering current high-risk behaviors,the model predicts an increase in the adult prevalence to 0.306% by 2025,projecting an estimated 212,168 people living with HIV/AIDS and 16,555 individuals with newly diagnosed infections. Conclusion Heterosexual transmission will likely emerge as the primary mode of AIDS transmission in Sichuan. Furthermore,we anticipate a stabilization in the incidence of AIDS with a concurrent increase in prevalence. Implementing comprehensive intervention measures aimed at high-risk groups could effectively alleviate the spread of AIDS in Sichuan.
8.Signal mining and analysis of adverse drug reactions for polatuzumab vedotin based on FAERS database
Zaiwei SONG ; Xinya LI ; Peng MEN ; Dan JIANG ; Fei DONG ; Rongsheng ZHAO ; Jun YANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(7):752-761
AIM:To evaluate and analyze the post-marketing adverse drug reaction(ADR)signals of polatuzumab vedotin,so as to provide reference for clinical safety management.METHODS:Using the FDA adverse drug event reporting system(FAERS)database and OpenVigil data platform,the ADR reports of polatuzumab vedotin were collect-ed from June 10,2019(FDA approval for market-ing)to the March 31,2023.The ADR signals were detected by using the reporting odds ratio(ROR)and proportional reporting ratio(PRR)in the pro-portional imbalance method.To increase the threshold and obtain stronger and more frequently occurring ADRs,a second screening of signals was performed.RESULTS:A total of 2 408 ADR reports related to polatuzumab vedotin were collected,and 83 ADR signals were detected after secondary screening.26 ADR signals were not mentioned in the drug instructions such as abnormal spinal mag-netic resonance imaging,increased bone resorp-tion,osteolysis,decreased aspartate aminotransfer-ase,decreased alanine aminotransferase,hypofibri-nogenemia,and pulmonary embolism.The system organ classes with a high signal counts or cumula-tive number of cases included infections and inva-sive diseases(24 signals,632 cases),various exami-nations(17 signals,675 cases),blood and lymphat-ic system diseases(11 signals,734 cases),various nervous system diseases(7 signals,153 cases),im-mune system diseases(3 signals,95 cases),system-ic diseases and various reactions at the site of ad-ministration(2 signals,145 cases),and systemic dis-eases and various reactions at the site of adminis-tration(2 signals,87 cases),etc.CONCLUSION:In addition to the common ADRs suggested by the in-structions,this study identified new ADR risk sig-nals for polatuzumab vedotin.In the clinical appli-cation of polatuzumab vedotin,in addition to the ADR mentioned in the instructions such as infec-tions,myelosuppression,peripheral neuropathies,infusion-related reactions,and abnormal liver func-tion,attention should also be paid to the risk sig-nals not mentioned such as abnormal spinal mag-netic resonance imaging,and increased bone re-sorption.
9.Construction of pharmacogenomics-guided individualized medication list for elderly patients
Xinya LI ; Jingjing WU ; Liwei JI ; Qingxia ZHANG ; Li YANG ; Hui LI ; Shuang LIU ; Ting LI ; Rongsheng ZHAO ; Zhanmiao YI
China Pharmacy 2023;34(3):257-262
OBJECTIVE To develop an individualized medication list for elderly patients by evidence-based pharmacy method, and to support clinical decisions on rational use of METHODS Firstly, drugs with risk genetic information were screened out by systematically reviewing evidence-based pharmacy information. Secondly, researchers investigated the included drugs in lists from different data E- sources. Drugs included in three or more data sources and drugs proposed by the expert committee were then included in the medication list. Thirdly, for the drugs included in two data sources, researchers designed questionnaires to investigate the necessity of drug-related gene testing. According to the scoring results of the expert questionnaire, drugs with higher scores were included in the list. Data sources included real-world data (list of high frequency medication in hospitals, high frequency medication for elderly outpatients and inpatients in National Health Care Claims Data, drugs related to frequent medication errors and so on) and evidence-based pharmacy evidence (the websites of Clinical Pharmacogenomics Implementation Consortium, Dutch Pharmacogenetics Working Group, Food and Drug Administration and so on). RESULTS The study obtain 68 drugs with risk genetic information which were included in three data sources. Combined with 23 drugs proposed by the expert committee, a list containing 74 drugs was preliminarily formed after de-duplication. A total of 37 drugs included in two databases with risk genetic information were scored through the questionnaire survey to form a supplementary list of 26 drugs. This is the final composition of the list of 100 drugs developed in this study. Among them, there are 43 drugs for the central nervous system, 15 drugs for the cardiovascular system, 12 anti-tumor drugs and so on. Twelve drugs were included in six or more data sources, which mainly consisted of drugs for digestive system, all proton pump inhibitors. CONCLUSION In this study, a list of 100 commonly used drugs which require individualized medication for the elderly was developed by evidence-based pharmacy method. The drug list will be updated in time as available evidence changes, and can provide guidance for rational use of medicines for elderly patients.
10.Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein
Xiaofeng NI ; Sha DIAO ; Siyi HE ; Xuefeng JIAO ; Xiao CHENG ; Zhe CHEN ; Zheng LIU ; Linan ZENG ; Deying KANG ; Bin WU ; Chaomin WAN ; Binwu YING ; Hui ZHANG ; Rongsheng ZHAO ; Liyan MIAO ; Zhuo WANG ; Xiaoyu LI ; Maobai LIU ; Benzhi CAI ; Feng QIU ; Feng SUN ; Naihui CHU ; Minggui LIN ; Wei SHA ; Lingli ZHANG
China Pharmacy 2023;34(4):391-396
OBJECTIVE To evaluate the effectiveness, safety, economy, innovation, suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein (EC), and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin (TB-PPD) were analyzed by the method of systematic review. Cost minimization analysis, cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD, and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation, suitability and accessibility were determined by systematic review and improved Delphi expert consultation, and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness, safety, economy, innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent, while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight, the scores of effectiveness, safety, economy, innovation, suitability, accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD, EC performs better in all dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. However, it is worth noting that EC should further improve its availability in the dimension of accessibility.

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