• Title/Summary/Keyword: Treatment Efficacy

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Characteristics of Clinical Trials in Korea for Atopic Dermatitis - Focus on ClinicalTrials.gov Registered Clinical Trials - (식약처 승인 아토피 피부염 의약품 국내 임상 시험의 특성 - ClinicalTrials.gov 등록 임상시험을 중심으로-)

  • Hwang, Mi-Lee;Ahn, Jae-Hyun;Jea, Ha-Kyung;Kim, Soo-Young;Jung, Hyun-A
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.2
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    • pp.68-93
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    • 2019
  • Objective : This study summarized the characteristics of clinical trials for atopic dermatitis medicines approved by the Ministry of Food and Drug Safety(MFDS). This study may be a reference for the design of clinical trials of atopic dermatitis herbal medicine treatment which may be carried out later. Method : The characteristics of the clinical trial were analyzed for clinical trials registered with ClinicalTrials.gov, CRIS, and the Korea Health Industry Development Institute among the clinical trial approval statuses posted on the website of the MFDS. Result : 1. Clinical trial drugs were developed in various formulations such as oral medicines, injections, dermatologic agents, and similar proportions. Relatively little clinical trials were found for herbal medicine. 2. In the control evaluation test, most of the treatments for the control group were performed with placebo using Vehicle. 3. In most clinical trials, one intervention group was in the form of a parallel assignment with only one treatment. 4. The age of the subjects was 11 out of 28 studies including minors, and clinical trials targeting minors were also found to be significant. 5. In the case of atopic dermatitis, the cases of subacute chronic or atopic dermatitis more than 6 months or more than 1 year were often used. 6. Most clinical trials were divided into mild to moderate atopic dermatitis or moderate to severe atopic dermatitis. The SCORAD index, EASI, IGA, BSA, and NRS were used as the evaluation criteria. 7. Regulations for the drugs used prior to the trial period for the treatment of atopic dermatitis vary somewhat from one clinical trial to another. 8. IGA was used most often as a primary efficacy tool, and SCORAD index, EASI, and NRS were also used.

Long-Term Durability of Infliximab for Pediatric Ulcerative Colitis: A Retrospective Data Review in a Tertiary Children's Hospital in Japan

  • Shimizu, Hirotaka;Arai, Katsuhiro;Takeuchi, Ichiro;Minowa, Kei;Hosoi, Kenji;Sato, Masamichi;Oka, Itsuhiro;Kaburaki, Yoichiro;Shimizu, Toshiaki
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.24 no.1
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    • pp.7-18
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    • 2021
  • Purpose: The long-term efficacy and safety of infliximab (IFX) in children with ulcerative colitis (UC) have not been well-evaluated. Here, we reviewed the long-term durability and safety of IFX in our single center pediatric cohort with UC. Methods: This retrospective study included 20 children with UC who were administered IFX. Results: For induction, 5 mg/kg IFX was administered at weeks 0, 2, and 6, followed by every 8 weeks for maintenance. The dose and interval of IFX were adjusted depending on clinical decisions. Corticosteroid (CS)-free remission without dose escalation (DE) occurred in 30% and 25% of patients at weeks 30 and 54, respectively. Patients who achieved CS-free remission without DE at week 30 sustained long-term IFX treatment without colectomy. However, one-third of the patients discontinued IFX treatment because of a primary nonresponse, and one-third experienced secondary loss of response (sLOR). IFX durability was higher in patients administered IFX plus azathioprine for >6 months. Four of five patients with very early onset UC had a primary nonresponse. Infusion reactions (IRs) occurred in 10 patients, resulting in discontinuation of IFX in four of these patients. No severe opportunistic infections occurred, except in one patient who developed acute focal bacterial nephritis. Three patients developed psoriasis-like lesions. Conclusion: IFX is relatively safe and effective for children with UC. Clinical remission at week 30 was associated with long-term durability of colectomy-free IFX treatment. However, approximately two-thirds of the patients were unable to continue IFX therapy because of primary nonresponse, sLOR, IRs, and other side effects.

Second Asian Consensus on Irritable Bowel Syndrome

  • Gwee, Kok Ann;Gonlachanvit, Sutep;Ghoshal, Uday C;Chua, Andrew SB;Miwa, Hiroto;Wu, Justin;Bak, Young-Tae;Lee, Oh Young;Lu, Ching-Liang;Park, Hyojin;Chen, Minhu;Syam, Ari F;Abraham, Philip;Sollano, Jose;Chang, Chi-Sen;Suzuki, Hidekazu;Fang, Xiucai;Fukudo, Shin;Choi, Myung-Gyu;Hou, Xiaohua;Hongo, Michio
    • Journal of Neurogastroenterology and Motility
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    • v.25 no.3
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    • pp.343-362
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    • 2019
  • Background/Aims There has been major progress in our understanding of the irritable bowel syndrome (IBS), and novel treatment classes have emerged. The Rome IV guidelines were published in 2016 and together with the growing body of Asian data on IBS, we felt it is timely to update the Asian IBS Consensus. Methods Key opinion leaders from Asian countries were organized into 4 teams to review 4 themes: symptoms and epidemiology, pathophysiology, diagnosis and investigations, and lifestyle modifications and treatments. The consensus development process was carried out by using a modified Delphi method. Results Thirty-seven statements were developed. Asian data substantiate the current global viewpoint that IBS is a disorder of gut-brain interaction. Socio-cultural and environmental factors in Asia appear to influence the greater overlap between IBS and upper gastrointestinal symptoms. New classes of treatments comprising low fermentable oligo-, di-, monosacharides, and polyols diet, probiotics, non-absorbable antibiotics, and secretagogues have good evidence base for their efficacy. Conclusions Our consensus is that all patients with functional gastrointestinal disorders should be evaluated comprehensively with a view to holistic management. Physicians should be encouraged to take a positive attitude to the treatment outcomes for IBS patients.

Comparative Responses of Sugar Beet Cyst Nematode, Heterodera schachtii and Clover Cyst Nematode, H. trifolii to Different Nematicides (클로버씨스트선충과 사탕무씨스트선충 알과 유충에 대한 약제 반응 비교)

  • Jeong, Mungi;Lee, Dong Woon
    • Korean journal of applied entomology
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    • v.59 no.4
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    • pp.361-369
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    • 2020
  • This study aimed to investigate the differences in the effects of nematicidal materials (Burkholderia rinojensis, fluazaindolizine, fluopyram, fosthiazate, hydrogen peroxide, and imicyafos) on eggs and larvae of the sugar beet cyst nematode, Heterodera schachtii and clover cyst nematode, H. trifolii, which have recently become problematic in highland Chinese cabbage cultivation areas in Korea. Comparison of the hatching rates according to the test materials showed differences between treatments. In the treatment with fluopyram, fosthiazate, and imicyafos, a very high hatching inhibitory effect of 99% was observed in both nematodes, and there was no difference in the efficacy of treatments between nematode species except for that with hydrogen peroxide. Regarding the nematocidal activity of treatments against hatched larvae, only the fluazaindolizine treatment, despite showing a high hatching inhibitory effect, showed a low nematicidal effect of less than 30% against both nematodes, whereas a mortality rate of more than 90% was observed in the other treatments. There was no difference between nematode species in the reactions of the 2nd instar juveniles to all nematicidal test materials after 24 and 48 h of treatment. Although there are limitations to the laboratory experiment, the reaction to the nematicidal materials of the two cyst nematodes that damage the same host was similar, and simultaneous control is suggested in the areas where the two nematodes occur together.

Development of Cell Therapeutics against Ischemic Vascular Diseases Using Mesenchymal Stem Cells: From Bench to Bed (중간엽줄기세포(MSC)를 이용한 허혈성 혈관질환 치료를 위한 세포치료제 개발: 기초연구에서 임상연구)

  • Lee, Eun Ji;Park, Shin Hu;Seo, Jeong Ho;An, Hyo Gyung;Nam, Si Hyun;Kwon, Sang-Mo
    • Journal of Life Science
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    • v.32 no.7
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    • pp.567-577
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    • 2022
  • Recently, the prevalence of ischemic diseases, such as ischemic heart disease, cerebral ischemia, and peripheral arterial disease, has been continuously increasing due to the aging population. The current standardized treatment for ischemic diseases is reperfusion therapy through pharmacotherapy and surgical approaches. Although reperfusion therapy may restore the function of damaged arteries, it is not effective at restoring the function of the surrounding tissues that have been damaged due to ischemia. Therefore, it is necessary to develop a new treatment strategy that can safely and effectively treat ischemic damage and restore the function of surrounding tissues. To overcome these limitations, stem cell-based therapy to regenerate the damaged region has been studied as a promising strategy for ischemic vascular diseases. Mesenchymal stem cells (MSCs) can be isolated from diverse tissues and have been shown to be promising for the treatment of ischemic disease by regenerating damaged tissues through immunomodulation, the promotion of angiogenesis, and the secretion of various relevant factors. Moreover, new approaches to enhancing MSC function, such as cell priming or enhancing transplantation efficiency using a 3D culture method, have been studied to increase stem cell therapeutic efficacy. In this review, we provide various strategies by which MSCs are used to treat ischemic diseases, and we discuss the challenges of MSC transplantation, such as the differentiation, proliferation, and engraftment of MSCs at the ischemic site.

Evaluation of Anti-Stain Efficacy of Myoung-oil, Traditional Coating Agent (전통 마감제인 명유의 방미효력 평가)

  • Yoon, Sae-Min;Park, Yonggun;Jeon, Woo-Seok;Lee, Hyun-Mi;Hwang, Wonjoung;Nam, Kee Dal;Park, Jae-Gwan
    • Journal of Conservation Science
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    • v.36 no.6
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    • pp.505-510
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    • 2020
  • In this study, the anti-stain effect of the Traditional Myoung-oil, which has been reproduced through traditional method, the Clean Myoung-oil, which was developed in an eco-friendly method through scientific analysis of Traditional Myoung-oil, and the perilla oil, which is the raw material of Myoung-oil and is currently used as a finishing agent when repairing wooden cultural properties was evaluated. As a result of the evaluation, perilla oil showed almost no anti-stain effect, whereas both types of Myoung-oil showed high anti-stain effect. However, it was confirmed that the anti-stain effect was significantly reduced after 4 weeks of exposure to the strain when Myoung-oil was diluted with terpene oil, a natural solvent. Thus, it was considered that the amount of treatment in the wood affected the anti-stain effect of Myoung-oil. In other words, in constructing wooden buildings, Myoung-o il is more suitable as a finishing agent to suppress mold growth than perilla oil. And, in order to increase the applicability of Myoung-oil, it is suggested that additional research on the optimal treatment amount and treatment method that can inhibit mold growth inhibition in outdoor environments is necessary.

Effects for the New Formulation of Daesiho-tang on adipocyte development and differentiation in 3T3-L1 (대시호탕의 새로운 제형이 3T3-L1에서 지방세포 증식과 분화 과정에 미치는 영향)

  • Choi, Hye-Min;Kim, Se-Jin;Moon, Sung-Ok;Lee, Ji-Beom;Lee, Ha-young;Kim, Jong-Beom;Lee, Hwa-Dong
    • The Korea Journal of Herbology
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    • v.33 no.2
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    • pp.69-77
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    • 2018
  • Objectives : Daesiho-tang (DSHT) has been widely used in the treatment of cerebral infarct in traditional medicine. However, there was not report on the anti-obesity-related diseases efficacy of DSHT. In this study, we investigated the effects for the new formulation of DSHT, on the adipocyte differentiation cycle in 3T3-L1 cells. Methods : 3T3-L1 cells were treated with DSHT (50, 100, $200{\mu}g/m{\ell}$) during differentiation for 6 days. Also, the inhibitory effect of DSHT against 3T3-L1 adipogenesis was evaluated in various stage of adipogenesis such as early (0-2day), intermediate (2-4day), and terminal stage (4-6day). The accumulation of lipid droplets was determined by Oil Red O staining. and, the expressions of genes related to adipogenesis were measured by RT-PCR and Western blot analyses. Results : DSHT showed inhibitory activity on adipocyte differentiation at 3T3-L1 preadipocytes without affect cell toxicity as assessed by measuring fat accumulation and adipogenesis. In addition, DSHT significantly reduced the expression levels of several adipocyte marker genes including proliferator activated $receptor-{\gamma}$ ($PPAR-{\gamma}$) and CCAAT/ enhancer-binding $protein-{\alpha}$ ($C/EBP-{\alpha}$). Also, the anti-adipogenic effect of DSHT was strongly limited in the intermediate (2-4 day), terminal stage (4-6 day) of 3T3-L1 adipogenesis. In addition, the DSHT treatment down- regulated mRNA expression levels of $PPAR-{\gamma}$,, $C/EBP-{\alpha}$ in mature 3T3-L1 adipocytes. Conclusions : These results suggest that, the ability of DSHT has inhibited overall adipogenesis and lipid accumulation in the 3T3-L1 cells. The new formulation of DSHT may be a promising medicine for the treatment of obesity and related metabolic disorders.

Phosphodiesterase-5 Inhibitor Attenuates Anxious Phenotypes and Movement Disorder Induced by Mild Ischemic Stroke in Rats

  • Yu, Yeon Hee;Kim, Seong-Wook;Kang, Juhyeon;Song, Yejin;Im, yHyuna;Kim, Seo Jeong;Yoo, Dae Young;Lee, Man-Ryul;Park, Dae-Kyoon;Oh, Jae Sang;Kim, Duk-Soo
    • Journal of Korean Neurosurgical Society
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    • v.65 no.5
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    • pp.665-679
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    • 2022
  • Objective : Patients with mild ischemic stroke experience various sequela and residual symptoms, such as anxious behavior and deficits in movement. Few approaches have been proved to be effective and safe therapeutic approaches for patients with mild ischemic stroke by acute stroke. Sildenafil (SIL), a phosphodiesterase-5 inhibitor (PDE5i), is a known remedy for neurodegenerative disorders and vascular dementia through its angiogenesis and neurogenesis effects. In this study, we investigated the efficacy of PDE5i in the emotional and behavioral abnormalities in rats with mild ischemic stroke. Methods : We divided the rats into four groups as follows (n=20, respectively) : group 1, naïve; group 2, middle cerebral artery occlusion (MCAo30); group 3, MCAo30+SIL-pre; and group 4, MCAo30+SIL-post. In the case of drug administration groups, single dose of PDE5i (sildenafil citrate, 20 mg/kg) was given at 30-minute before and after reperfusion of MCAo in rats. After surgery, we investigated and confirmed the therapeutic effect of sildenafil on histology, immunofluorescence, behavioral assays and neural oscillations. Results : Sildenafil alleviated a neuronal loss and reduced the infarction volume. And results of behavior task and immunofluorescence shown possibility that anti-inflammation process and improve motor deficits sildenafil treatment after mild ischemic stroke. Furthermore, sildenafil treatment attenuated the alteration of theta-frequency rhythm in the CA1 region of the hippocampus, a known neural oscillatory marker for anxiety disorder in rodents, induced by mild ischemic stroke. Conclusion : PDE5i as effective therapeutic agents for anxiety and movement disorders and provide robust preclinical evidence to support the development and use of PDE5i for the treatment of mild ischemic stroke residual disorders.

Application of Primary Rat Corneal Epithelial Cells to Evaluate Toxicity of Particulate Matter 2.5 to the Eyes (눈에 대한 미세먼지의 독성 평가를 위한 쥐 각막 상피 세포의 적용)

  • Kim, Da Hye;Hwangbo, Hyun;Lee, Hyesook;Cheong, Jaehun;Choi, Yung Hyun
    • Journal of Life Science
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    • v.32 no.9
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    • pp.712-720
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    • 2022
  • The purpose of this study was to investigate the efficacy of rat corneal-derived epithelial cells as an in vitro model to evaluate the harmfulness of the cornea caused by particulate matter 2.5 (PM2.5). To establish an experimental model for the effect of PM2.5 on corneal epithelial cells, it was confirmed that primary cultured cells isolated from rat eyes were corneal epithelial cells through pan-cytokeratin staining. Our results showed that PM2.5 treatment reduced cell viability of primary rat corneal epithelial (RCE) cells, which was associated with the induction of apoptosis. PM2.5 treatment also increased the generation of reactive oxygen species due to mitochondrial dysfunction. In addition, the production of nitric oxide and inflammatory cytokines was increased in PM2.5-treated RCE cells. Furthermore, through heatmap analysis showing various expression profiling between PM2.5-exposed and unexposed RCE cells, we proposed five genes, including BLNK, IL-1RA, Itga2b, ABCb1a and Ptgs2, as potential targets for clinical treatment of PM-related ocular diseases. These findings indicate that the primary RCE cell line is a useful in vitro model system for the study of PM2.5-mediated pathological mechanisms and that PM2.5-induced oxidative and inflammatory responses are key factors in PM2.5-induced ocular surface disorders.

Cardioprotective Potential of Gracilaria Verrucosa Extract in Myocardial Infarction-Induced Heart Failure Model (심근 경색 유발 심부전 모델에서 강리 추출물의 심장 보호 가능성)

  • Youn Jae Jang;Hye Yoom Kim;Jung Joo Yoon;Byung Hyuk Han;Je Kuk Yu;Nam Geun Cho;Ho Sub Lee;Dae Gill Kang
    • Herbal Formula Science
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    • v.31 no.3
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    • pp.157-169
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    • 2023
  • Gracilaria Verrucosa (GV), a seaweed used in traditional Korean medicine, was studied for its effects on MI-induced heart failure in rats. MI is caused by a blocked coronary artery, leading to severe cardiac dysfunction. The study used a rat model to assess cardiac changes over time and evaluate the impact of GV on heart failure. Ischemia was induced through LAD ligation surgery, and the extent of ischemic area was measured as a prognostic factor. GV extract administration significantly improved cardiac morphology and reduced cardiac weight compared to the MI group. GV treatment also improved cardiac function, as evidenced by positive effects on chamber dilation during MI-induced heart failure. Parameters such as ejection fraction (EF) and fractional shortening (FS) were measured. The MI group showed decreased EF and FS compared to the sham group, while these parameters improved in the GV group. GV treatment also reduced levels of LDH, CPK, and CK-MB in the serum, indicating reduced myocardial damage. Histological analysis revealed that GV treatment attenuated cardiac hypertrophy and fibrosis, with reduced collagen deposition in the myocardium. Immunohistochemistry analysis showed suppressed expression of TGF-β1 and collagen 1, involved in fibrosis. In conclusion, GV showed potential in improving cardiac function in a rat model of MI-induced heart failure. It alleviated myocardial damage, attenuated cardiac hypertrophy and fibrosis, and suppressed fibrotic markers. Further studies are needed to explore its clinical efficacy and underlying mechanisms in cardiac diseases beyond animal models.