Ping Ji

University of Hong Kong

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Chandrahas G. Sahajwalla

Center for Drug Evaluation and Research

Yaning Wang

Binzhou Medical University

Yingying Chen

China Academy of Chinese Medical Sciences

Xiao‐Yong Fan

Shanghai Public Health Clinical Center

Ying Wang

First Affiliated Hospital of Xi'an Jiaotong University

Keke Lin

Beijing University of Chinese Medicine

Sarah Yim

Center for Drug Evaluation and Research

Zhidong Hu

Shanghai Public Health Clinical Center

Guoping Zhao

Chinese Academy of Sciences

Xiaoyan Yan

Peking University

Cooperative Institutions

Peking University

Shanghai Jiao Tong University

Center for Drug Evaluation and Research

Chinese Academy of Medical Sciences & Peking Union Medical College

United States Food and Drug Administration

Capital Medical University

Sun Yat-sen University

Huazhong University of Science and Technology

Chinese Academy of Sciences

Fudan University

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Challenges and Opportunities in Analysis of Drug Combination Clinical Trial Data

Chapman and Hall/CRC eBooks (2014)

Yaning Wang Hao Zhu Liang Zhao Ping Ji

Combination therapy is not a new phenomenon. It has been used in the treatment of diseases such as cancer, cardiovascular disease, infectious diseases, pain, and transplant rejection. Fixed combination drugs are two or more drugs combined in a single dosage form when each component makes a contribution to the claimed effects. Special cases of this are where a component is added to the existing principle active component to enhance the safety or effectiveness and to minimize the potential for abuse of the principle active component. Fixed combination drugs may also help lower the cost and increase the convenience in terms of administration and compliance.1 In settings where combination therapy provides therapeutic advantage, there is growing interest in the development of combinations of investigational drugs not previously developed for any purpose. However, whether it is for the development of a new compound as an add-on to the existing regimen or multiple new compounds as a new combination regimen, there are unique challenges in the drug development process. With two or more active ingredients in the same dosage form, it is important to ensure that these active ingredients are physically and chemically compatible along with their excipients, and do not generate new impurities or raise new drug-drug interactions. General issues relating to the clinical study design should also be addressed when assessing the contribution of each component or the add-on therapy: doses, endpoints, study duration, and data analysis issues.

Drug trial

10.1201/b17965-11

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Identification of HLA-A2-Restricted Mycobacterial Lipoprotein Z Peptides Recognized by T CellsFrom Patients With ActiveTuberculosis Infection

Frontiers in Microbiology (2018)

Yuanyong Liu Wei Sha Shiqiang Xu Xuwei Gui Liliang Xia

Identification of HLA-restricted peptides derived from mycobacterial antigens that are endowed with high affinity and strong antigenicity is not only of interest in tuberculosis (TB) diagnostics and treatment efficacy evaluation, but might also provide potential candidates for the development of therapeutic vaccines against drug-resistant TB. Our previous work demonstrated that lipoprotein Z (LppZ) displayed high immunogenicity and antigenicity in active TB patients. In the present study, ten HLA-A2-restricted LppZ peptides (LppZp1-10) were predicted by bioinformatics, among which LppZp7 and LppZp10 were verified to possess high affinity to HLA-A2 molecules using T2 cell-based affinity binding assay. Moreover, results from ELISpot assay showed that both LppZp7 and LppZp10 peptides were able to induce more IFN-γ producing cells upon ex vivo stimulation of PBMC from HLA-A2+ active TB (ATB) patients as compared to those from healthy controls (HCs). Also, the numbers of LppZp7 and LppZp10-specific IFN-γ producing cells exhibited positive correlations with those of ESAT-6 peptide (E6p) or CFP-10 peptide (C10p) in ATB. Interestingly, stimulation with LppZp7/p10 mixture was able to induce higher intracellular expression of IFN-γ and IL-2 cytokines in CD8+ and CD4+ T cells from ATB as compared to HC, associated with lower expression of TNF-α in both CD8+ and CD4+ T cells. Taken together, HLA-A2-restricted LppZp7 and LppZp10 peptides display high immunoreactivity in HLA-matched ATB patients demonstrated by high responsiveness in both CD8+ and CD4+ T cells. With the ability to induce strong antigen-specific cellular responses, LppZp7 and LppZp10 are of potential value for the future applications in the prevention and control of TB.

ELISPOT

Antigenicity

Ex vivo

10.3389/fmicb.2018.03131

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Citations (3)

Improving health history taking and writing ability for nursing undergraduates

Chinese Journal of Medical Education (2012)

Keke Lin Yu-mei Sun Ping Ji

Objective To explore the effect of role playing and clinical history taking process on nursing undergraduates' health history taking and writing ability.Methods 30 nursing undergraduates were conveniently selected.A questionnaire was administered to them before role playing and after clinical history taking process.Written scores of health history were also examined.Results In terms of history taking and writing ability,except for “psychological assessment”,statistical significances were found in the self-rating scores of other aspects before role playing and after clinical history taking process.In terms of overall evaluation,the average score for “be helpful to improve history taking ability and writing ability”was above 8.Most aspects writing scores were above 9 except for “present history” and “psychological assessment”.Conclusions Role playing and clinical history taking process can improve health history taking and writing ability for nursing undergraduates,thus,help to train their clinical thinking ability. Key words: Nursing undergraduate; Health history; History taking and writing

Medical History

Clinical history

10.3760/cma.j.issn.1673-677x.2012.02.038

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A clinical model predicting the risk of esophageal high-grade lesions in opportunistic screening: a multicenter real-world study in China

Gastrointestinal Endoscopy (2020)

Zhen Liu Chuanhai Guo Yujie He Yun Chen Ping Ji

Bootstrapping (finance)

Akaike information criterion

10.1016/j.gie.2019.12.038

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Citations (27)

Adenylate kinase: a novel antigen for immunodiagnosis and subunit vaccine against tuberculosis

Journal of Molecular Medicine (2016)

Yang-jiong Xiao Wei Sha Zhao Feng Tian Yingying Chen Ping Ji

10.1007/s00109-016-1392-5

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Citations (17)

Clinical endpoint sensitivity in rheumatoid arthritis: modeling and simulation

Journal of Pharmacokinetics and Pharmacodynamics (2014)

Lian Ma Liang Zhao Yun Xu Sarah Yim Suresh Doddapaneni

Clinical endpoint

10.1007/s10928-014-9385-x

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An Overview of the Pediatric Medications for the Symptomatic Treatment of Allergic Rhinitis, Cough, and Cold

Journal of Pharmaceutical Sciences (2013)

Ying Fan Ping Ji Andrea Leonard-Segal Chandrahas G. Sahajwalla

Regimen

Drug Development

Clinical Pharmacology

10.1002/jps.23720

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Citations (10)

[Multiple dose pharmacokinetic and bioavailability studies of oral sustained release and conventional formulations of isosorbide-5-mononitrate in healthy volunteers].

PubMed (1998)

Q Zhang Xinyuan Huang Ping Ji Ling Fu Biao Yan

The pharmacokinetics of a new sustained release tablets (40 mg, qd) of isosorbide-5-mononitrate (IS-5-MN) was investigated together with a conventional preparation (20 mg, bid) after multiple oral administration in ten healthy human subjects using an open, randomized two-way crossover experimental design. Based on three statistical analyses of the area under the plasma concentration-time curve (AUC), the two tablet formulations are judged to be bioequivalent (P > 0.1), with a relative bioavailability of 108.95% for the IS-5-MN sustained release formulation. Pharmacokinetic data showed that the sustained release formulation reached mean peak plasma levels significantly later and lower minimum plasma concentration (Cmin), compared with the conventional preparation. But no statistically significant difference was found for other pharmacokinetic parameters including peak plasma levels (Cmax), AUC, elimination constant (Ke), elimination half-life (T1/2) and fluctuation index (FI) between the two preparations (P > 0.05).

Bioequivalence

Isosorbide mononitrate

Cmin

Crossover study

Elimination rate constant

Source

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The combinative effects of orem self-care theory and PDCA nursing on cognitive function, neurological function and daily living ability in acute stroke.

Yue-Xiu Si Hong Yuan Ping Ji Xiaohong Chen

Objective The combined effects of Orem Self-care Theory and PDCA nursing on cognitive function, neurological function and daily living ability of patients with acute stroke were analyzed in this research. Methods 126 patients, who admitted to our hospital with acute stroke from January 2019 to March 2020, were enrolled in this study as research subjects. The subjects were divided into control-group (n=61) and observation-group (n=65) in accordance with their admission time. The control-group received routine nursing care; and the observation-group, was applied with the combined nursing interventions of Orem's self-care mode and PDCA nursing management in addition to conventional treatment. Subsequently, the changes in daily living ability (ADL score), neurological function (GCS score, NIHSS score) and cognitive function (MoCA and MMSE scores) of the two groups before and after receiving nursing care were compared accordingly. Results After the implementation of nursing measures, the ADL scores of the two groups improved dramatically than before (P Conclusion On the basis of Orem Self-care theory, the application of PDCA nursing in daily nursing work to acute stroke patients can actively improve their cognitive function, neurological function and daily life ability. This has a positive role in promoting medical staff to improve the quality of care and provide patients with more comprehensive and thoughtful nursing services.

PDCA

Stroke

Nursing Interventions Classification

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Citations (10)

Draining Lymph Node Metastasis Model for Assessing the Dynamics of Antigen-Specific CD8<sup>+</sup> T Cells During Tumorigenesis

Journal of Visualized Experiments (2024)

Yan Zhang Xingxing Su Lisha Wang Zhengliang Yue Qiao Liu

Tumor antigen-specific CD8+ T cells from draining lymph nodes gain an accumulating importance in mounting anti-tumor immune response during tumorigenesis. However, in many cases, cancer cells form metastatic loci in lymph nodes before further metastasizing to distant organs. To what extent the local and systematic CD8+ T cell responses were influenced by LN metastasis remains obscure. To this end, we set up a murine LN metastasis model combined with a B16F10-GP melanoma cell line expressing the surrogate neoantigen derived from lymphocytic choriomeningitis virus (LCMV), glycoprotein (GP), and P14 transgenic mice harboring T cell receptors (TCRs) specific to GP-derived peptide GP33-41 presented by the class I major histocompatibility complex (MHC) molecule H-2Db. This protocol enables the study of antigen-specific CD8+ T cell responses during LN metastasis. In this protocol, C57BL/6J mice were subcutaneously implanted with B16F10-GP cells, followed by adoptive transfer with naive P14 cells. When the subcutaneous tumor grew to approximately 5 mm in diameter, the primary tumor was excised, and B16F10-GP cells were directly injected into the tumor draining lymph node (TdLN). Then, the dynamics of CD8+ T cells were monitored during the process of LN metastasis. Collectively, this model has provided an approach to precisely investigate the antigen-specific CD8+ T cell immune responses during LN metastasis.

Adoptive Cell Transfer

10.3791/65646

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