• Title/Summary/Keyword: drug design

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Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer] (간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Ga-jin;Kim, Dong-hun;Park, Eun-joo;Seong, Sin;Kim, Sung-su;Leem, Jung-tae
    • The Journal of Internal Korean Medicine
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    • v.40 no.1
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    • pp.89-116
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    • 2019
  • Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

Correlation between GenoType MTBDRplus Assay and Phenotypic Susceptibility Test for Prothionamide in Patients with Genotypic Isoniazid Resistance

  • Lee, Joo Hee;Jo, Kyung-Wook;Shim, Tae Sun
    • Tuberculosis and Respiratory Diseases
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    • v.82 no.2
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    • pp.143-150
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    • 2019
  • Background: The purpose of this study was to analyze the relationship between the gene mutation patterns by the GenoType MTBDRplus (MTBDRplus) assay and the phenotypic drug susceptibility test (pDST) results of isoniazid (INH) and prothionamide (Pto). Methods: A total of 206 patients whose MTBDRplus assay results revealed katG or inhA mutations were enrolled in the study. The pDST results were compared to mutation patterns on the MTBDRplus assay. Results: The katG and inhA mutations were identified in 68.0% and 35.0% of patients, respectively. Among the 134 isolated katG mutations, three (2.2%), 127 (94.8%) and 11 (8.2%) were phenotypically resistant to low-level INH, high-level INH, and Pto, respectively. Among the 66 isolated inhA mutations, 34 (51.5%), 18 (27.3%) and 21 (31.8%) were phenotypically resistant to low-level INH, high-level INH, and Pto, respectively. Of the 34 phenotypic Pto resistant isolates, 21 (61.8%), 11 (32.4%), and two (5.9%) had inhA, katG, and both gene mutations. Conclusion: It is noted that Pto may still be selected as one of the appropriate multidrug-resistant tuberculosis regimen, although inhA mutation is detected by the MTBDRplus assay until pDST confirms a Pto resistance. The reporting of detailed mutation patterns of the MTBDRplus assay may be important for clinical practice, rather than simply presenting resistance or susceptibility test results.

Effects of an Educational Program Based on Mobile SMS and Counseling for Colonoscopy in the Elderly (Mobile SMS와 상담을 기반으로 한 노인용 대장내시경 교육프로그램의 효과)

  • Lee, Yeong Sun;Lee, Bong Jo;Ha, Chang Yoon;Jeon, Mi Yang
    • Journal of Korean Biological Nursing Science
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    • v.23 no.1
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    • pp.64-71
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    • 2021
  • Purpose: This study was conducted to examine the effects of an educational program based on mobile SMS and counseling for colonoscopy in elderly people. Methods: The study utilized a non-equivalent control group with a non-synchronized design as a quasi-experimental research. The study subjects consisted of 72 elderly people (36 elderly people in the experimental group and 36 in the control group). Among the subjects, 49 were male (68.1%) and 23 were female (31.9%), and the age was 69.04±6.14 years. Forty-five subjects (62.5%) answered that they had underlying diseases, eight subjects (11.1%) had a family history of colon disease, and 61 subjects (84.7%) had undergone a colonoscopy. The experimental group was provided with an educational program based on mobile SMS and counseling when three days and one day before the test. The control group received verbal explanations using information sheet. The data were analyzed using descriptive statistics, the Chi-squares test, and the independent t-test with SPSS/WIN 21.0. Results: Significant differences were found in bowel cleanliness scores (t= 3.60, p= .003) between the groups. No significant differences were seen between the groups in the sedation drug dosage (propofol (t= 1.02, p= .730), midazolam (t= 0.66, p= .380)) and time for colonoscopy (t= 1.08, p= .235). Conclusion: Based on the results of this study, an educational program based on mobile SMS and counseling for colonoscopy was proposed as an educational program before colonoscopy.

Safety and antifatigue effect of Korean Red Ginseng capsule: A randomized, double-blind and placebo-controlled clinical trial

  • Yang, Yi;Wang, Hong;Zhang, Ming;Shi, Mengxue;Yang, Cailing;Ni, Qiang;Wang, Qi;Li, Jing;Wang, Xuemei;Zhang, Chen;Li, Zhi
    • Journal of Ginseng Research
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    • v.46 no.4
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    • pp.543-549
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    • 2022
  • Background: In physical activity or labor, the human body is in a state of high intensity stress, and all parts or physiological functions of the body respond positively to maintain or balance the need for movement. The human body has many physiological changes in the process of movement, and fatigue is the external manifestation of various complex changes inside the human body. Fatigue is also a physiological mechanism of self-protection after the body reaches a certain level of activity, which can prevent the occurrence of life-threatening excessive functional failure. The generation of fatigue is a very complex process, and its mechanism has not been concluded yet. Therefore, it is an important work to search and screen the effective components of natural plants that have anti-fatigue effect and to explore their mechanism. Methods: This was a 8-week, randomized, double-blind, placebo-controlled clinical trial. A total of 110 subjects who passed physical examination were included according to the scheme design, and randomly divided into a test group which was given KRG and a placebo control group. The calculation is carried out according to the standard of sub-high-intensity exercise test. Results: There was no adverse effect on safety index of subjects after taking red ginseng capsule. After KRG treatment, subjective strength grade is significant lower than placebo treatment. Blood lactic acid content is significantly get lower after trial in KRG group, and significant lower than placebo group. Creatine phosphokinase(CK) content is significantly get lower after trial in KRG group, and significant lower than placebo group. Conclusion: According to the criterion in the test scheme, the result shows that KRG is helpful on relieving physical fatigue.

Pharmacokinetics of thalidomide in dogs: can feeding affect it? A preliminary study

  • Pierini, Alessio;Sartini, Irene;Giorgi, Mario;Lebkowska-Wieruszewska, Beata;Lisowski, Andrzej;Poapolathep, Amnart;Marchetti, Veronica
    • Journal of Veterinary Science
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    • v.21 no.5
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    • pp.60.1-60.11
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    • 2020
  • Background: Tumor-associated neoangiogenesis is a crucial target for antitumor therapies. Thalidomide (TAL) is a promising anti-neoangiogenetic drug that has recently been used in the treatment of several malignancies in dogs. Objectives: The aim of the study was to assess the pharmacokinetics of TAL after single oral administration in dogs. Additionally, the influence of feeding on the pharmacokinetic profile of TAL in dogs has been preliminarily investigated. Methods: Six healthy adult female Labradors were enrolled according to a randomized single-dose, 2-treatment, 2-phase, paired 2 × 2 cross-over study design. The dogs were administered a single 400 mg capsule of TAL in fasted and fed conditions. Blood was collected from 15 min to 48 h after dosing, and TAL quantified in plasma by a validated high-performance liquid chromatography method. The pharmacokinetics of TAL were analyzed using a non-compartmental approach. Results: TAL concentration was quantifiable up to 10 h and 24 h after fasted and fed conditions, respectively. Cmax (fasted, 1.34 ± 0.12 ㎍/mL; fed, 2.47 ± 0.19 ㎍/mL) and Tmax (fasted, 3 h; fed, 10 h) differed substantially between the 2 groups. AUC and t1/2λz were significantly higher in fed (42.46 ± 6.64 mg × h/L; 17.14 ± 4.68 h) compared to fasted (12.38 ± 1.13 mg × h/L; 6.55 ± 1.25 h) dogs. The relative oral bioavailability of TAL for the fasted group was low (36.92% ± 3.28%). Conclusions: Feeding affects the pharmacokinetics of oral TAL in dogs, showing a delayed, but higher absorption with different rate of elimination. These findings are of importance in clinical veterinary settings, and represent a starting point for further related studies.

Chemosensitizing effect and mechanism of imperatorin on the anti-tumor activity of doxorubicin in tumor cells and transplantation tumor model

  • Liang, Xin-li;Ji, Miao-miao;Liao, Zheng-gen;Zhao, Guo-wei;Tang, Xi-lan;Dong, Wei
    • The Korean Journal of Physiology and Pharmacology
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    • v.26 no.3
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    • pp.145-155
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    • 2022
  • Multidrug resistance of tumors has been a severe obstacle to the success of cancer chemotherapy. The study wants to investigate the reversal effects of imperatorin (IMP) on doxorubicin (DOX) resistance in K562/DOX leukemia cells, A2780/Taxol cells and in NOD/SCID mice, to explore the possible molecular mechanisms. K562/DOX and A2780/Taxol cells were treated with various concentrations of DOX and Taol with or without different concentrations of IMP, respectively. K562/DOX xenograft model was used to assess anti-tumor effect of IMP combined with DOX. MTT assay, Rhodamine 123 efflux assay, RT-PCR, and Western blot analysis were determined in vivo and in vitro. Results showed that IMP significantly enhanced the cytotoxicity of DOX and Taxol toward corresponding resistance cells. In vivo results illustrated both the tumor volume and tumor weight were significantly decreased after 2-week treatment with IMP combined with DOX compared to the DOX alone group. Western blotting and RT-PCR analyses indicated that IMP downregulated the expression of P-gp in K562/DOX xenograft tumors in NOD/SCID mice. We also evaluated glycolysis and glutamine metabolism in K562/DOX cells by measuring glucose consumption and lactate production. The results revealed that IMP could significantly reduce the glucose consumption and lactate production of K562/DOX cells. Furthermore, IMP could also remarkably repress the glutamine consumption, α-KG and ATP production of K562/DOX cells. Thus, IMP may sensitize K562/DOX cells to DOX and enhance the antitumor effect of DOX in K562/DOX xenograft tumors in NOD/SCID mice. IMP may be an adjuvant therapy to mitigate the multidrug resistance in leukemia chemotherapy.

An Accurate Forward Head Posture Detection using Human Pose and Skeletal Data Learning

  • Jong-Hyun Kim
    • Journal of the Korea Society of Computer and Information
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    • v.28 no.8
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    • pp.87-93
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    • 2023
  • In this paper, we propose a system that accurately and efficiently determines forward head posture based on network learning by analyzing the user's skeletal posture. Forward head posture syndrome is a condition in which the forward head posture is changed by keeping the neck in a bent forward position for a long time, causing pain in the back, shoulders, and lower back, and it is known that daily posture habits are more effective than surgery or drug treatment. Existing methods use convolutional neural networks using webcams, and these approaches are affected by the brightness, lighting, skin color, etc. of the image, so there is a problem that they are only performed for a specific person. To alleviate this problem, this paper extracts the skeleton from the image and learns the data corresponding to the side rather than the frontal view to find the forward head posture more efficiently and accurately than the previous method. The results show that the accuracy is improved in various experimental scenes compared to the previous method.

A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus (전기식 온침기에 대한 안전성 및 성능평가 가이드라인 개발 연구)

  • Hansol Jang;U-Ryeong Chung;Jeong-Hyun Moon;Seong-Kyeong Choi;Won-Suk Sung;Min-Seop Hwang;Seung-Deok Lee;Kyung-Ho Kim;Jong-Hwa Yoon;Eun-Jung Kim
    • The Journal of Korean Medicine
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    • v.43 no.3
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    • pp.150-163
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    • 2022
  • Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

Chemoquiescence with Molecular Targeted Ablation of Cancer Stem Cells in Gastrointestinal Cancers

  • Jong-Min Park;Young-Min Han;Migyeong Jeong;Eun Jin Go;Napapan Kangwan;Woo Sung Kim;Ki Baik Hahm
    • Journal of Digestive Cancer Research
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    • v.4 no.1
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    • pp.1-9
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    • 2016
  • The abundance of multi-drug resistance ATPase binding cassette and deranged self-renewal pathways shown in cancer stem cells (CSCs) played a crucial role in tumorigenesis, tumor resistance, tumor recurrence, and tumor metastasis. Therefore, elucidation of CSCs biology can improve diagnosis, enable targeted treatment, and guide the follow up of GI cancer patients. In order to achieve chemoquiescence, seizing cancer through complete ablation of CSCs, CSCs are rational targets for the design of interventions that will enhance responsiveness to traditional therapeutic strategies and contribute in the prevention of local recurrence as well as metastasis. However, current cancer treatment strategies fail to either detect or differentiate the CSCs from their non-tumorigenic progenies mostly due to the absence of specific biomarkers and potent agents to kill CSCs. Recent advances in knowledge of CSCs enable to produce several candidates to ablate CSCs in gastrointestinal (GI) cancers, especially cancers originated from inflammation-driven mutagenesis such as Barrett's esophagus (BE), Helicobacter pylori-associated gastric cancer, and colitis-associated cancer (CAC). Our research teams elucidated through revisiting old drugs that proton pump inhibitor (PPI) and potassium competitive acid blocker (p-CAB) beyond authentic acid suppression, chloroquine for autophage inhibition, sonic hedgehog (SHH) inhibitors, and Wnt/β-catenin/NOTCH inhibitor can ablate CSCs specifically and efficiently. Furthermore, nanoformulations of these molecules could provide an additional advantage for more selective targeting of the pathways existing in CSCs just like current molecular targeted therapeutics and sustained action, while normal stem cells intact. In this review article, the novel approach specifically to ablate CSCs existing in GI cancers will be introduced with the introduction of explored mode of action.

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The Antifungal Efficacy of Extracts Derived from Kimchi Filtrates

  • JeungSun LEE;Seong-Soo CHA;Min-Kyu KWAK
    • The Korean Journal of Food & Health Convergence
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    • v.9 no.6
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    • pp.1-7
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    • 2023
  • Secondary metabolites in the culture filtrates of lactic acid bacteria offer varied chiral moieties, making them a valuable resource for drug design scaffolding. Our previous methodology included using a combination of anion exchange resins, Amberlite IRA-67 and Purolite A420S, to purify significant quantities of Lactobacillus plantarum LBP-K10 peptidyl compounds. However, current experimental evidence regarding the impact of native culture extracts and/or filtrates on pathogenic fungi in vivo/in vitro is insufficient. This study analyzed the antifungal properties of two different probiotic cultures: the CH2Cl2-extracted filtrate of Chinese cabbage kimchi (CH2Cl2-extracted CCKWLB and CH2Cl2-extracted CCKWOLB) and the non-extracted filtrate of Chinese cabbage kimchi (non-extracted CCKWLB and non-extracted CCKWOLB). The samples were divided into two groups: one group was inoculated with probiotics while the other group remained non-inoculated. Filtrates from both experimental groups were utilized for antifungal assays. The treatments employing CCKWLB, with an initial inoculation of Lb. plantarum LBP-K10 as a starter, demonstrated significant antifungal activity under various experimental conditions. Our study offers new perspectives on the antifungal properties of CH2Cl2-extracted kimchi filtrates, which are naturally produced by lactobacilli. The efficacy of antifungal compounds is supported by substantial evidence demonstrating their efficient uptake by cells and the antifungal properties exerted by metabolites.