• 제목/요약/키워드: clinical therapeutics

검색결과 1,025건 처리시간 0.029초

Trends of clinical trials from 2014 to 2016 in South Korea

  • Huh, Ki Young;Hwang, Jun Gi;Lee, SeungHwan
    • Translational and Clinical Pharmacology
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    • 제26권4호
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    • pp.172-176
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    • 2018
  • Mandatory registration of clinical trials in public registry can ensure the transparency of clinical trials. Public clinical trial registry of can provide current chronological and geographical distribution of clinical trial throughout the country. We used public clinical trial registry provided by Ministry of Food and Drug Safety to analyze current status of clinical trial from 2014 to 2016 in South Korea. The number of clinical trials in antineoplastic and immunomodulating agents area was the greatest, followed by cardiovascular system and antiinfectives for systemic use as a whole. From 2014 to 2016, overall number of clinical trials decreased while the number of phase I clinical trials increased. Seoul accounted for more than half number of clinical trials in Korea. Supports for clinical trials in non-metropolitan area needs to be considered.

Growth Inhibitory and Pro-Apoptotic Effects of Hirsuteine in Chronic Myeloid Leukemia Cells through Targeting Sphingosine Kinase 1

  • Gao, Shan;Guo, Tingting;Luo, Shuyu;Zhang, Yan;Ren, Zehao;Lang, Xiaona;Hu, Gaoyong;Zuo, Duo;Jia, Wenqing;Kong, Dexin;Yu, Haiyang;Qiu, Yuling
    • Biomolecules & Therapeutics
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    • 제30권6호
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    • pp.553-561
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    • 2022
  • Chronic myeloid leukemia (CML) is a slowly progressing hematopoietic cell disorder. Sphingosine kinase 1 (SPHK1) plays established roles in tumor initiation, progression, and chemotherapy resistance in a wide range of cancers, including leukemia. However, small-molecule inhibitors targeting SPHK1 in CML still need to be developed. This study revealed the role of SPHK1 in CML and investigated the potential anti-leukemic activity of hirsuteine (HST), an indole alkaloid obtained from the oriental plant Uncaria rhynchophylla, in CML cells. These results suggest that SPHK1 is highly expressed in CML cells and that overexpression of SPHK1 represents poor clinical outcomes in CML patients. HST exposure led to G2/M phase arrest, cellular apoptosis, and downregulation of Cyclin B1 and CDC2 and cleavage of Caspase 3 and PARP in CML cells. HST shifted sphingolipid rheostat from sphingosine 1-phosphate (S1P) towards the ceramide coupled with a marked inhibition of SPHK1. Mechanistically, HST significantly blocked SPHK1/S1P/S1PR1 and BCR-ABL/PI3K/Akt pathways. In addition, HST can be docked with residues of SPHK1 and shifts the SPHK1 melting curve, indicating the potential protein-ligand interactions between SPHK1 and HST in both CML cells. SPHK1 overexpression impaired apoptosis and proliferation of CML cells induced by HST alone. These results suggest that HST, which may serve as a novel and specific SPHK1 inhibitor, exerts anti-leukemic activity by inhibiting the SPHK1/S1P/S1PR1 and BCR-ABL/PI3K/Akt pathways in CML cells, thus conferring HST as a promising anti-leukemic drug for CML therapy in the future.

불면증 디지털 치료제의 임상 적용 (Clinical Application of Digital Therapeutics for Insomnia)

  • 조철현
    • 수면정신생리
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    • 제28권1호
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    • pp.6-12
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    • 2021
  • Insomnia is one of the most common sleep disorders experienced by modern people, and treatment is often not adequate due to various limitations. Digital therapeutics for insomnia are expected to play a revolutionary role in supplementing and satisfying unmet needs in real-world clinical treatment. Digital therapeutics for insomnia were developed based on cognitive-behavioral therapy for insomnia, which is the first standard treatment for insomnia. The effectiveness of digital therapeutics for insomnia developed by several companies has been proven through well-designed clinical research. Various approaches have been used for practical application of digital therapeutics for insomnia. Thus far, meaningful results have been drawn, but there are areas that need to be improved upon based on real-world evidence. Sleep researchers need to validate the safe and effective application of digital therapeutics for the treatment of insomnia.

A Simple Dosing Scheme for Intravenous Busulfan Based on Retrospective Population Pharmacokinetic Analysis in Korean Patients

  • Choe, Sang-Min;Kim, Gayeong;Lim, Hyeong-Seok;Cho, Sang-Heon;Ghim, Jong-Lyul;Jung, Jin-Ah;Kim, Un-Jib;Noh, Gyu-Jeong;Bae, Kyun-Seop;Lee, Dong-Ho
    • The Korean Journal of Physiology and Pharmacology
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    • 제16권4호
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    • pp.273-279
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    • 2012
  • Busulfan is an antineoplastic agent with a narrow therapeutic window. A post-hoc population pharmacokinetic analysis of a prospective randomized trial for comparison of four-times daily versus once-daily intravenous busulfan was carried out to search for predictive factors of intravenous busulfan (iBu) pharmacokinetics (PK). In this study the population PK of iBu was characterized to provide suitable dosing recommendations. Patients were randomized to receive iBu, either as 0.8 mg/kg every 6 h or 3.2 mg/kg daily over 4 days prior to hematopoietic stem cell transplantation. In total, 295 busulfan concentrations were analyzed with NONMEM. Actual body weight and sex were significant covariates affecting the PK of iBu. Sixty patients were included in the study (all Korean; 23 women, 37 men; mean [SD] age, 36.5 [10.9] years; weight, 66.5 [11.3] kg). Population estimates for a typical patient weighing 65 kg were: clearance (CL) 7.6 l/h and volume of distribution (Vd) 32.2 l for men and 29.1 L for women. Inter-individual random variabilities of CL and $V_d$ were 16% and 9%. Based on a CL estimate from the final PK model, a simple dosage scheme to achieve the target $AUC_{0-inf}$ (defined as median AUC0-inf with a once-daily dosage) of 26.18 $mg/l{\cdot}hr$, was proposed: $24.79{\cdot}ABW^{0.5}mg$ q24h, where ABW represents the actual body weight in kilograms. The dosing scheme reduced the unexplained interindividual variabilities of CL and Vd of iBu with ABW being a significant covariate affecting clearance of iBU. We propose a new simple dosing scheme for iBu based only on ABW.

수면 장애가 있는 환자에게 적용한 디지털 치료기기의 임상적 유효성에 대한 체계적 문헌고찰: 대조군분류에 따른 하위 분석 (A Systematic Review on the Clinical Efficacy of Digital Therapeutics for Sleep Disorders: Subgroup Analysis by Control Groups)

  • 전효선;강은지;유수정
    • 한국임상약학회지
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    • 제33권4호
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    • pp.221-241
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    • 2023
  • Background: The purpose of this systematic review was to investigate the effects of digital therapeutics for insomnia on sleep disorders and mental health improvement compared to the control group. Methods: Following the guidelines on systematic review(PRISMA, NECA), a literature search was conducted through PubMed, Cochrane Library, EMBASE, RISS, KISS, and KoreaMed using keywords. The Cochrane Risk of Bias Tool and Review Manager version 5.3 were used for risk of bias and effect size assessment. Results: Thirty eight RCT met criteria for inclusion. When compared against three control conditions, the digital therapeutics for insomnia was an effective intervention for improvement sleep disorders and mental health in comparison to waiting list and Patient-directed care with some intervention by medical staff. However, digital therapeutics for insomnia were no more effective than face-to-face CBT-I control group. Conclusion: The efficacy of digital therapeutics for insomnia was evaluated differently depending on the control group. Therefore, in phase 3 clinical trials for efficacy evaluation, it is necessary to review whether the control group has been properly established.