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Pharmacokinetics,efficacy,and safety of a novel aripiprazole microsphere-based long-acting injectable formulation for schizophrenia:A multicenter,randomized controlled trial 认领 引用
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作者 An-Ning Li Sheng-Chun Jin +14 位作者 De-Wei Shang Jian-Xiong Guo Hua-Li Lin Ming Zhang Bo Wei Feng Wan Yun-Long Tan Li-Li Wang Jian-Chu Zhou Ping Liu Lian-Lian Fan Ju-Shui Sun Bin Chen Yimin Cui Gang Wang 《Journal of Pharmaceutical Analysis》 SCIE CAS CSCD 2026年第1期305-308,共4页
Schizophrenia is a severe and chronic psychiatric disorder with a lifetime prevalence of approximately 0.7%–1%worldwide[1].Aripiprazole is widely used for schizophrenia treatment,and known as a dopamine system stabil... Schizophrenia is a severe and chronic psychiatric disorder with a lifetime prevalence of approximately 0.7%–1%worldwide[1].Aripiprazole is widely used for schizophrenia treatment,and known as a dopamine system stabilizer due to its partial agonist activity as the dopamine-2(D2)and serotonin 5-hydroxytryptamine 1A(5-HT1A)receptors,as well as antagonist action at the 5-HT2A receptors[2].The investigational microsphere-based aripiprazole injection in this study is a novel long-acting formulation designed to optimize the release profile at the dose of 350 mg monthly.The objective of this study was to evaluate the pharmacokinetics,efficacy,and safety of the microsphere-based formulation,particularly the fluctuations in the peak-to-trough plasma concentration ratio. 展开更多
关键词 psychiatric disorder schizophrenia long acting injectable pharmacokinetics safety aripiprazole efficacy microsphere based
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Controllable synthesis and structure-activity relationship of Ni doping in SmCrO3for improved magnetic and dielectric properties 认领 引用
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作者 Wenjie Huang Rui Li +2 位作者 Ruoxuan Zhang Yimin Cui Rongming Wang 《International Journal of Minerals,Metallurgy and Materials》 SCIE EI CAS CSCD 2025年第7期1739-1749,共11页
Doping small amounts at the A-site or B-site of SmCrO3ceramics is a promising approach for modifying their microstructure,as well as their magnetic and dielectric properties.In this study,polycrystalline ceramics o... Doping small amounts at the A-site or B-site of SmCrO3ceramics is a promising approach for modifying their microstructure,as well as their magnetic and dielectric properties.In this study,polycrystalline ceramics of Sm1-xNixCrO3(x=0,0.05,and 0.20)and SmCr1-yNiyO3(y=0.05 and 0.20)were synthesized via a conventional solid-state reaction.X-ray diffraction validated that all the doped ceramics maintained an orthorhombic crystalline structure consistent with the Pbnm space group.Furthermore,X-ray photoelectron spectroscopy demonstrated the presence of Ni2+ions in the doped specimens.Notably,doping resulted in significant enhancement of low-temperature magnetic properties,particularly in samples doped at the A-site,such as Sm0.80Ni0.20CrO3.Compared with the pristine sample,the maximum magnetization of Sm0.80Ni0.20CrO3increased by approximately 60.9%and 93.5%in the zero-field cooling and field-cooling modes,respectively,in an external magnetic field of 100 Oe.Furthermore,the dielectric constants of the Ni-doped ceramics initially exceeded that of the pristine sample as the temperature increased.At equivalent doping ratios,A-site doping demonstrated superior performance over B-site doping,including higher magnetization,lower dielectric loss,and enhanced electrical quality factors. 展开更多
关键词 samarium orthochromite Ni dopants magnetic properties dielectric properties
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Investigations and feedback on the training mode of professional master's degree of clinical pharmacy in Peking University and the preliminary exploration of Pharm. D. Education 认领 引用 被引量：9
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作者 Zhiyan Liu Xiaoyan Nie +2 位作者 Qian Xiang Luwen Shi Yimin Cui 《Journal of Chinese Pharmaceutical Sciences》 CAS CSCD 2018年第2期131-137,共7页
In order to carry out the comprehensive reform of the professional master’s degree training mode of clinical pharmacy, we carried out interviews among 91 persons on the professional master’s degree of clinical pharm... In order to carry out the comprehensive reform of the professional master’s degree training mode of clinical pharmacy, we carried out interviews among 91 persons on the professional master’s degree of clinical pharmacy in Peking University School of Pharmaceutical Sciences and collected extensive feedback. We preliminaries explore the mode of Doctor of Pharmacy（Pharm. D.） Education, laying the foundation for Doctor’s education of professional clinical pharmacy in China. We conducted investigations and interviews among 91 clinical pharmacists and students of Peking University School of Pharmaceutical Sciences on the training of professional master’s degree and Pharm. D. education mode, which includes 67 postgraduates and 24 clinical pharmacists. Respondents put forward the problems of training mode and corresponding suggestions and opinions from different aspects during the investigation and interview. The results mainly divide into four aspects： curriculum setting, clinical practice, assessme nt system and teaching resources. Respondents put forward effective feedback on the above four aspects, which are beneficial to the comprehensive reform of the training mode of professional master degree in clinical pharmacy and preliminary exploration of Pharm. D. Education in China. 展开更多
关键词 Clinical pharmacy Training mode Pharm D Education Investigations
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The influence of genetic polymorphisms in drug metabolism enzymes and transporters on the pharmacokinetics of different fluvastatin formulations 认领 引用 被引量：1
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作者 Qian Xiang Weidang Wu +10 位作者 Nan Zhao Chuan Li Junyu Xu Lingyue Ma Xiaodan Zhang Qiufen Xie Zhuo Zhang Jiancheng Wang Weiren Xu Xia Zhao Yimin Cui 《Asian Journal of Pharmaceutical Sciences》 SCIE CAS 2020年第2期264-272,共9页
The purpose of the present study was to investigate the impact of genetic polymorphism on fluvastatin pharmacokinetics.In addition,we compared the fluvastatin pharmacokinetics differences between extended-release(ER)8... The purpose of the present study was to investigate the impact of genetic polymorphism on fluvastatin pharmacokinetics.In addition,we compared the fluvastatin pharmacokinetics differences between extended-release(ER)80 mg tablet and immediate-release(IR)40 mg capsule in terms of drug metabolism enzyme and transporter genetic polymorphisms.In this open-label,randomized,two-period,two-treatment,crossover study(n=24),effects of ABCG2,SLCO1B1,ABCB1,CYP2C9 and CYP3A5 polymorphisms on the pharmacokinetics of fluvastatin were analyzed.The administration dosage for IR 40 mg and ER 80 mg were twice and once daily,respectively,for total 7 d.Blood samples for pharmacokinetic evaluation were taken on the 1st and 7th d.The lower exposure following ER was observed.For ER tablets,SLCO1B1 T521C genotype correlated with AUC 0-24 of repeat doses(P=0.010).SLCO1B1 T521C genotype had no statistically significant effect on AUC 0-24 of IR capsule of fluvastatin after single or repeated doses.In vitro study demonstrated that when the concentration of fluvastatin was low(1μmol/l),transport velocity of fluvastatin by HEK293-OATP1B1 with SLCO1B1521TT(K m=11.4μmol/l)and with SLCO1B1521TCC(K m=15.1μmol/l)tend to be the same.It suggests that the increased effect of SLCO1B1 T521C genotype on ER formulation of fluvastatin was mainly caused by lower blood concentrations.We recommend that formulation should be incorporated into future pharmacogenomics studies. 展开更多
关键词 Genetic polymorphisms SLCO1B1 Fluvastatin Immediate-release Extended-release
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Association between CYP3A4 gene polymorphisms and clopidogrel response in patients with cardio-cerebrovascular diseases:a systematic review and Meta-analysis 认领 引用 被引量：1
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作者 Sibei Qin Tong Jia +7 位作者 Yu Fu Junlei Li Xinyi Zhang Chunsu Zhu Guangkai Liang Xiaoyan Nie Luwen Shi Yimin Cui 《Journal of Chinese Pharmaceutical Sciences》 CAS CSCD 2021年第9期762-772,共11页
CYP3A4 plays a critical role in clopidogrel activation in the liver.The polymorphism of CYP3A4 may have an important effect on clopidogrel response in patients with cardio-cerebrovascular diseases.We conducted a syste... CYP3A4 plays a critical role in clopidogrel activation in the liver.The polymorphism of CYP3A4 may have an important effect on clopidogrel response in patients with cardio-cerebrovascular diseases.We conducted a systematic review and meta-analysis to evaluate the impact of CYP3A4 polymorphism on platelet reactivity after clopidogrel treatment and the outcomes of patients.A systematic literature search(up to 7th October,2019)was performed on the PubMed,EMBASE,Cochrane Library,clinicaltrials.gov,and Chinese databases,including China National Knowledge Infrastructure(CNKI)and Wan Fang Data.Cohort studies or case-control studies evaluated platelet reactivity and patients‟outcomes in different genotype patients.The Review Manager software was used for data analysis,and the NOS scale was used to assess the quality of included studies.A total of 18 articles were included in the Meta-analysis.The results showed the platelet reactivity after clopidogrel administration had no significant difference between CYP3A4 variant carriers and non-carriers.The occurrence of composite ischemic events or stent thrombosis had no significant difference between CYP3A4 variant carriers and non-carriers,either.In conclusion,there was no significant association between CYP3A4 polymorphism and clopidogrel response in patients with cardio-cerebrovascular diseases. 展开更多
关键词 Clopidogrel CYP3A4 Meta-analysis
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The Safety and Tolerance of Herbal Anti-Angina Drug Compound Danshen Droplet Pill in Healthy Volunteers 认领 引用
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作者 Ying Zhou Yimin Cui +5 位作者 Xia Zhao Yong Huo Zhaohong Nie Min Zhao Zhixin Guo He Sun 《Pharmacology & Pharmacy》 2013年第6期490-495,共6页
Background: Compound Salvia Pellet (T89), consisting of Danshen (salvia miltiorrhiza), Sanqi (panax notoginseng), and Borneol (Cinnamomum camphora), has been used worldwide for 14 years for chronic angina treatment. P... Background: Compound Salvia Pellet (T89), consisting of Danshen (salvia miltiorrhiza), Sanqi (panax notoginseng), and Borneol (Cinnamomum camphora), has been used worldwide for 14 years for chronic angina treatment. Purpose: A dose escalation study to determine the maximum tolerance dose (MTD) in Chinese population to support a proposed dose regimen change. Methods: Forty-six participants (age 18 to 45 yrs, male to female ratio = 1:1) were divided into a series of 6 patients cohorts, and sequentially assigned into one of the escalating dose groups, starting from 540 mg, the clinical doses, until 4 out of 6 subjects experience clinical Adverse Events (AEs) or when the pre-defined 3510 mg dose level is reached and completed. All doses were given orally as a single dose 2 hours after breakfast. Adverse events, vital signs, 12-lead ECG, clinical and laboratory parameters and medical evaluation were conducted as outcome measures. Results: Study completed at the highest pre-defined dose level of 3510 mg dose as never had 4/6 of subject experience AEs in any dose levels studied. All participants completed the study and data were included in the safety analysis. The only moderate AE observation (muscle damage) was observed at 2970 mg dose and was recovered without any medical treatment, and all other AEs (ECG, dizziness, muscle damage) were mild and may (5 cases) or may not (9 cases) be related to testing drug and were all self-resolved within 30 min after dose. Conclusion: Given as single oral dose, Compound Salvia Pellet is safe and well-tolerated up to the 3510 mg studied. The MTD value of Compound Salvia Pellet is unknown from this trial and must be higher than 3510 mg, 13 times higher than its current clinical dose. 展开更多
关键词 Compound Salvia Pellet Safety Tolerance Chronic Angina Treatment
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Possible Metformin-Induced Toe Nails Disorder 认领 引用
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作者 Min Lu Ying Zhou Yimin Cui 《Pharmacology & Pharmacy》 2013年第3期275-276,共2页
The aim of this article was to report a case of toe nails disorder associated with metformin use in an elderly patient with type2diabetes. Two years ago, after receiving metformin 0.5 g three times daily for 6 months,... The aim of this article was to report a case of toe nails disorder associated with metformin use in an elderly patient with type2diabetes. Two years ago, after receiving metformin 0.5 g three times daily for 6 months, a 60-year-old Chinese man found his ten toe nails gradually thickened and yellowed (especially two thumbs). The symptoms improved and recovered after metformin discontinuance. Half year ago, metformin 0.5 g three times daily adopted again and toe nails disorder occurred again. Physician modified the therapy plan and replaced metformin with acarbose to control blood glucose level of this patient. According to the follow up 3 months after his discharge, ten toe nails recovered significantly and new parts of the nails were normal. Nail disorder was rarely reported in the worldwide, but the physicians should keep awareness of this adverse drug reaction (ADR), proper actions should be taken once it occurred to avoid unnecessary suffering of the patient. 展开更多
关键词 Metformin Nail Disorder Adverse Drug Reaction
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The applications and advances of artificial intelligence in drug regulation:A global perspective 认领 引用 被引量：21
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作者 Lixia Fu Guoshu Jia +2 位作者 Zhenming Liu Xiaocong Pang Yimin Cui 《Acta Pharmaceutica Sinica B》 SCIE CAS CSCD 2025年第1期1-14,共14页
Artificial intelligence(AI)has emerged as a transformative force in healthcare,with applications spanning diagnostics to drug development.However,its integration into drug regulation remains nascent,with varying degre... Artificial intelligence(AI)has emerged as a transformative force in healthcare,with applications spanning diagnostics to drug development.However,its integration into drug regulation remains nascent,with varying degrees of adoption and implementation across different regulatory bodies worldwide.This review aims to provide a comprehensive overview of the current state of AI in drug regulation,encapsulating AI-related policies,initiatives,and its practical application in regulatory agencies globally.It further discusses the challenges and future prospects of AI in this field.The findings reveal that numerous agencies have launched action plans and initiatives to incorporate AI,aiming to streamline regulatory processes and enhance data-driven regulatory decision-making.Moreover,AI’s deployment in safety surveillance,workflow optimization,and regulatory science research is expanding,highlighting its increasing impact on drug regulation.Nonetheless,key challenges persist,such as data quality and reliability,technical limitations,talent shortage and the absence of standards.The review concludes that interdisciplinary collaboration is crucial to harness AI’s full potential in drug regulation and overcoming its current limitations.In the future,AI may become a pivotal catalyst in drug regulation,promising a new era of enhanced scrutiny,efficiency,and innovation that will benefit public health on a global scale. 展开更多
关键词 Artificial intelligence Machine learning Regulatory science Safety surveillance Pharmacovigilance Regulation Emerging technology
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Comparative Assessment of Pivotal Trials Supporting the Indication Approvals of Innovative and Modified New Anticancer Drugs in China,2016-2022 认领 引用 被引量：3
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作者 Lixia Fu Ruifen Xue +3 位作者 Jie Chen Guoshu Jia Xiaocong Pang Yimin Cui 《Health Data Science》 CSCD 2025年第1期191-204,共14页
Background:Since the launch of drug regulatory reform in 2015,China has substantially increased the availability of new cancer therapies.However,the efficacy evidence criteria for modified new anticancer drugs have no... Background:Since the launch of drug regulatory reform in 2015,China has substantially increased the availability of new cancer therapies.However,the efficacy evidence criteria for modified new anticancer drugs have not been evaluated.This cross-sectional study aimed to assess the pivotal trials supporting the indication approvals of innovative and modified new chemical anticancer drugs in China.Methods:The characteristics of indications,regulatory aspects,and pivotal trial designs were extracted and described.The primary efficacy endpoints of the pivotal clinical trials,including overall survival(OS)and progression-free survival(PFS),were quantitatively assessed by meta-analysis.Results:Between 2016 and 2022,77 cancer therapeutics for 107 indications were approved in China based on 128 pivotal trials.Among the 107 indications,64(59.8%)were classified as innovative anticancer drugs,and 43(40.2%)as modified new anticancer drugs.The study found that pivotal trials for innovative approvals tended to be single-arm trials,while modified approvals were more likely to employ randomized clinical trials with larger sample sizes and rigorous designs.Despite innovative drugs often receiving more expedited regulatory designations,there were no statistically significant differences in clinical benefit of OS or PFS outcomes between innovative and modified approvals.Conclusions:These results suggest that the current regulatory framework may prioritize the speed of approval for innovative drugs over the strength of supporting evidence.These findings align with the strategic trends of pharmaceutical companies and regulatory inclinations that aim to expedite the approval of innovative anticancer drugs with a high unmet need,thereby accelerating patients’accessibility to treatment. 展开更多
关键词 chemical anticancer drugs pivotal trial designs innovative drugs efficacy evidence criteria modified new anticancer drugs pivotal trials drug regulatory reform
Response to“Anticancer Drug Approval in China:From Acceleration of Access to Certainty of Benefits” 认领 引用
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作者 Lixia Fu Yimin Cui 《Health Data Science》 CSCD 2025年第1期18-20,共3页
Thank you for your thorough review and insightful comments on our research[1].Your observations are highly pertinent and provide valuable insights for our continued examination of China’s evolving anticancer drug reg... Thank you for your thorough review and insightful comments on our research[1].Your observations are highly pertinent and provide valuable insights for our continued examination of China’s evolving anticancer drug regulatory framework. 展开更多
关键词 anticancer drug regulatory framework drug access China therapeutic benefits anticancer drug approval regulatory framework
Targeting integrin pathways:mechanisms and advances in therapy 认领 引用 被引量：110
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作者 Xiaocong Pang Xu He +7 位作者 Zhiwei Qiu Hanxu Zhang Ran Xie Zhiyan Liu Yanlun Gu Nan Zhao Qian Xiang Yimin Cui 《Signal Transduction and Targeted Therapy》 SCIE CSCD 2023年第2期381-422,共42页
Integrins are considered the main cell-adhesion transmembrane receptors that play multifaceted roles as extracellular matrix(ECM)-cytoskeletal linkers and transducers in biochemical and mechanical signals between cell... Integrins are considered the main cell-adhesion transmembrane receptors that play multifaceted roles as extracellular matrix(ECM)-cytoskeletal linkers and transducers in biochemical and mechanical signals between cells and their environment in a wide range of states in health and diseases.Integrin functions are dependable on a delicate balance between active and inactive status via multiple mechanisms,including protein-protein interactions,conformational changes,and trafficking.Due to their exposure on the cell surface and sensitivity to the molecular blockade,integrins have been investigated as pharmacological targets for nearly 40 years,but given the complexity of integrins and sometimes opposite characteristics,targeting integrin therapeutics has been a challenge.To date,only seven drugs targeting integrins have been successfully marketed,including abciximab,eptifibatide,tirofiban,natalizumab,vedolizumab,lifitegrast,and carotegrast.Currently,there are approximately 90 kinds of integrin-based therapeutic drugs or imaging agents in clinical studies,including small molecules,antibodies,synthetic mimic peptides,antibody-drug conjugates(ADCs),chimeric antigen receptor(CAR)T-cell therapy,imaging agents,etc.A serious lesson from past integrin drug discovery and research efforts is that successes rely on both a deep understanding of integrin-regulatory mechanisms and unmet clinical needs.Herein,we provide a systematic and complete review of all integrin family members and integrin-mediated downstream signal transduction to highlight ongoing efforts to develop new therapies/diagnoses from bench to clinic.In addition,we further discuss the trend of drug development,how to improve the success rate of clinical trials targeting integrin therapies,and the key points for clinical research,basic research,and translational research. 展开更多
关键词 drugs mechanisms inactive
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Research and development of Chinese anti-COVID-19 drugs 认领 引用 被引量：9
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作者 Xiwei Ji Xiangrui Meng +2 位作者 Xiao Zhu Qingfeng He Yimin Cui 《Acta Pharmaceutica Sinica B》 SCIE CAS CSCD 2022年第12期4271-4286,共16页
The outbreak and spread of coronavirus disease 2019(COVID-19)highlighted the importance and urgency of the research and development of therapeutic drugs.Very early into the COVID-19 pandemic,China has begun developing... The outbreak and spread of coronavirus disease 2019(COVID-19)highlighted the importance and urgency of the research and development of therapeutic drugs.Very early into the COVID-19 pandemic,China has begun developing drugs,with some notable progress.Herein,we summarizes the anti-COVID-19 drugs and promising drug candidates originally developed and researched in China.Furthermore,we discussed the developmental prospects,mechanisms of action,and advantages and disadvantages of the anti-COVID-19 drugs in development,with the aim to contribute to the rational use of drugs in COVID-19 treatment and more effective development of new drugs against severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)and the variants.Neutralizing antibody is an effective approach to overcome COVID-19.However,drug resistance induced by rapid virus mutation will likely to challenge neutralizing antibodies.Taking into account current epidemic trends,small molecule drugs have a crucial role in fighting COVID-19 due to their significant advantage of convenient administration and affordable and broad-spectrum.Traditional Chinese medicines,including natural products and traditional Chinese medicine prescriptions,contribute to the treatment of COVID-19 due to their unique mechanism of action.Currently,the research and development of Chinese anti-COVID-19 drugs have led to some promising achievements,thus prompting us to expect even more rapidly available solutions. 展开更多
关键词 Chinese anti-COVID-19 drug Small-molecule drug Neutralizing antibody Protein drug Traditional Chinese medicine Natural product Drug candidate Development prospect
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Discovery of C19-9 as a novel non-RGD inhibitor of αvβ3 to overcome enzalutamide resistance in castration-resistant prostate cancer 认领 引用 被引量：2
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作者 Xiaocong Pang Xiaojiao Sun +7 位作者 Yanlun Gu Xu He Kan Gong Song Song Jixin Zhang Jie Xia Zhenming Liu Yimin Cui 《Signal Transduction and Targeted Therapy》 SCIE CSCD 2023年第3期891-894,共4页
Dear Editor,The integrinαvβ3 receptor is a promising target for anticancer therapy.1,2 However,there are no effective marketed treatments targetingαvβ3.One possible limitation of Arginine-Glycine-Aspartic(RGD)-mim... Dear Editor,The integrinαvβ3 receptor is a promising target for anticancer therapy.1,2 However,there are no effective marketed treatments targetingαvβ3.One possible limitation of Arginine-Glycine-Aspartic(RGD)-mimeticαvβ3 antagonists has been shown to cause partial agonism,which could induce major conformational changes that trigger paradoxical cell adhesion and angiogenesis. 展开更多
关键词 αvβ3 overcome resistance
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Effect of plateletcrit and methylenetetrahydrofolate reductase(MTHFR)C677T genotypes on folic acid efficacy in stroke prevention 认领 引用 被引量：2
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作者 Yuncong Shi Zhengzhipeng Zhang +9 位作者 Binyan Wang Yu Wang Xiangyi Kong Yong Sun Aimin Li Yimin Cui Yan Zhang Jianping Li Yong Huo Hui Huang 《Signal Transduction and Targeted Therapy》 SCIE CSCD 2024年第6期2694-2701,共8页
Previous studies have shown that low platelet count combined with high plasma total homocysteine(tHcy)increased stroke risk and can be lowered by 73% with folic acid.However,the combined role of other platelet activat... Previous studies have shown that low platelet count combined with high plasma total homocysteine(tHcy)increased stroke risk and can be lowered by 73% with folic acid.However,the combined role of other platelet activation parameters and the methylenetetrahydrofolate reductase(MTHFR)C677T genotypes on stroke risk and folic acid treatment benefit remain to be examined.This study aimed to investigate if platelet activation parameters and MTHFR genotypes jointly impact folic acid treatment efficacy in first stroke prevention.Data were derived from the China Stroke Primary Prevention Trial.This study includes a total of 11,185 adult hypertensive patients with relevant platelet activation parameters and MTHFR genotype data.When simultaneously considering both platelet activation parameters(plateletcrit,platelet count,mean platelet volume,platelet distribution width)and MTHFR genotypes,patients with both low plateletcrit(Q1)and the TT genotype had the highest stroke incidence rate(5.6%)in the enalapril group.This subgroup significantly benefited from folic acid treatment,with a 66% reduction in first stroke(HR:0.34;95%CI:0.14-0.82;p=0.016).Consistently,the subgroup with low plateletcrit(Q1)and the CC/CT genotype also benefited from folic acid treatment(HR:0.40;95%CI:0.23-0.70;p=0.001).In Chinese hypertensive adults,low plateletcrit can identify those who may greatly benefit from folic acid treatment,in particular,those with the TT genotype,a subpopulation known to have the highest stroke risk. 展开更多
关键词 prevention treatment MTHFR
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