• Title/Summary/Keyword: Trial drug

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A Preliminary Study on the Inhibitory Effect of Chunghyul-dan on Stroke Recurrence on Patients with Small Vessel Disease

  • Cho, Ki-Ho;Jee, Nam-gue;Jung, Woo-Sang;Park, Seong-Uk;Moon, Sang-Kwan;Ko, Chang-Nam;Kim, Young-Suk;Jung, Woo-Sang
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.224-236
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    • 2007
  • Background : Chunghyul-dan is a combinatorial herbal medicine; previous studies reported it had therapeutic effects for microangiopathy, a major part in the progression of small vessel disease, as well as having anti-hypertensive, anti-hyperlipidemic, anti-apoptotic, anti-oxidative, and anti-inflammatory activities. Therefor, we examined the inhibitory effect of Chunghyul-dan on stroke recurrence in patients with small vessel disease. Methods : We prescribed Chunghyul-dan at 600 mg a day to patients with small vessel disease, and monitored stroke recurrence, drug compliances, and adverse effect for 1 year. We then performed follow-up brain MRI to find new vascular lesions after 1 year of Chunghyul-dan medication. For the subjects lost to follow-up, we assessed their prognosis after 1 year by telephone. Results : There were 73 subjects treated with Chunghyul-dan for 1 year; new vascular events were found in 3. Of the 85 subjects lost to follow-up, fifty four could be contacted, and eight of them had stroke recurrence. One year of Chunghyul-dan medication reduced the odds ratio of stroke recurrence by 75% compared to the subjects lost to follow-up and the rate increased to 88%, when adjusted for other relevant risk factors for stroke recurrence. These reductions were much higher than those of aspirin and other kinds of conventional anti-platelets. There was no adverse effect in any of the study subjects. Conclusions : We suggest Chunghyul-dan could be useful for inhibition of stroke recurrence. Further study with a randomized controlled trial is needed to confirm this suggestion.

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The Detection of Irradiated Composite Seasoning Foods by Analyzing Photostimulated Luminescence (PSL), Electron Spin Resonance (ESR) and Thermoluminescence (TL) (PSL, ESR 및 TL 측정에 의한 복합조미식품의 방사선 조사여부 검지)

  • Kwon Joong-Ho;Kim Mi-Yeung;Kim Byeong-Keun;Chung Hyung-Wook;Kim Tae-Cheol;Kim Soo-Jin
    • Food Science and Preservation
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    • v.13 no.1
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    • pp.55-60
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    • 2006
  • Two kinds of composite seasoning products (beef broth powder, polk bone extract powder) were used for a detection trial of gamma irradiation treatment up to 10 kGy by analyzing photostimulated luminescence (PSL), electron spin resonance (ESR) and thermoluminescence(TL). PSL results showed that the photon counts of non-irradiated samples were lower than 700, while those of irradiated samples were higher than 5000, which makes it possible to screen irradiated composite seasoning products at 1 kGy or over from the non-irradiated control. ESR signals measured for both irradiated samples were not irradiation-specific, even though they were dose dependent in the signal intensity. Radiation-induced TL glow curves were found in irradiated beef broth powder and furthernmore, TL ratio $(TL_4/TL_2)$ obtained by a re-irradiation step could verify the detection result of TL1 glow curves, showing ratios lower than 0.05 in the non-irradiated sample and higher than 1.00 in irradiated ones.

An Analysis of Domestic Medicine Study Tendency on Obesity -Focused on The Korean Journal of Obesity- (비만에 대한 국내 의학계의 최근 연구 동향 분석 -대한비만학회지를 중심으로-)

  • Kim, Doo Hee;Shin, Woo Suk;Kim, Dong Hwan;Jeong, Yeon Jae;Im, Han Bit;Park, Won Hyung;Cha, Yun Yeop
    • Journal of Korean Medicine for Obesity Research
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    • v.13 no.1
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    • pp.1-9
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    • 2013
  • Objectives: This study was performed to analyze the recent trend of the studies about obesity in medicine and to provide background for futher studies. Methods: All of the article were selected in "The Korean Journal of Obesity". Search were conducted through "http://kosso.or.kr" with the search word "obesity". Collected articles were classified into clinical study, experimental study, literary study, case report. Results: One hundred eighty four studies were included and analyzed in terms of study design, subject, intervention, period, obesity index and so on. The numbers of clinical studies, literary studies, experimental studies, case reports were respectively 143 (77.7%), 26 (14.1%), 2 (1.1%) and 7 (3.8%). In clinical studies, observational studies were 112 (78.3%) and intervention studies were 31 (21.7%). And most of sample sizes were more than 100 and less than 499. Body mass index, waist circumstance, body fat percent were major criteria of clinical study. Most of the subjects on obesity were about relation with another disease or experimental results and diagnosis. According to classification by the kinds of intervention, diet, exercise, drug, behavior were respectively 22, 18, 8, and 8. More than fourty percent of intervention studies were studied for 12 weeks. Conclusions: To improve the quality of Korean Medicine study for obesity, we need to recruiting big sample size and activate randomized clinical trial.

Melatonin for Treatment of Delirium in Hospitalized Patients : Retrospective Trial (입원 환자의 섬망 치료에서 멜라토닌의 효과에 관한 후향적 연구)

  • Yang, Jung Woo;Kim, Jong Woo;Kang, Won Sub;Lee, Sang Min;Kim, Young Jong;Paik, Jong-Woo
    • Korean Journal of Psychosomatic Medicine
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    • v.26 no.2
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    • pp.112-118
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    • 2018
  • Objectives : Delirium is one of the most common mental illnesses that can affect cognitive function. Melatonin has been shown to be effective in the treatment of insomnia, and recent studies have shown a protective effect to prevent delirium. This study was conducted to investigate the efficacy of melatonin in delirium patients. Methods : All patients were referred to psychiatric department for insomnia and symptoms of delirium, and were diagnosed delirium by the DSM-5 diagnostic criteria. We compared base line severity of delirium with K-DRS-R-98-R (Korean version of Delirium Rating Scale revised 98) and after taking 2mg of melatonin, retrospectively. The side effects were also identified by referring to the medical records. Results : A total 21 patients had taken melatonin for insomnia and delirious symptoms. The K-DRS-R-98 scores were decreased from $15.24{\pm}2.64$ before treatment to $6.57{\pm}5.42$ after treatment. And CGI-S scores were also decreased from $4.14{\pm}0.48$ before treatment to $2.81{\pm}0.93$ after treatment (p<0.05). Conclusions : This study illustrates the possibility of melatonin as an effective treatment option for delirious symptoms such as disorientation, motor agitation, lability of affect and hallucinations as well as insomnia, with less concerns of drug side effect. Further study with a larger sample and prospective design will be required to confirm these results.

FOLFIRI Regimen as a Second-line Chemotherapy after Failure of First-line Chemotherapy in Advanced Gastric Cancer (진행성 위암에서 1차 항암화학요법에 실패한 환자에서 2차 항암화학요법으로 FOLFIRI요법의 효용성에 대한 연구)

  • Yong Kang Lee;Jae Hyun Kim;Jun Chul Park;Hee Seok Moon;Sung Eun Kim;Jin Seok Jang;Joo Young Cho;Eun Sun Kim;Si Hyung Lee;Sang Kil Lee
    • Journal of Digestive Cancer Research
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    • v.5 no.2
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    • pp.113-119
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    • 2017
  • Background: Second line chemotherapy is often considered in advanced gastric cancers. We assessed irinotecan in combination with fluorouracil in patients experienced diseases progression after first line chemotherapy. Methods: Prospective trial was done at 7 centers in republic of Korea. Patients aged 18 years or older with advanced gastric adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy were assigned to receive irinotecan 180 mg/m2 and 5-fluorouraicl 400 mg/m2 intravenously bolus injection on days 1 and leucovorin 200 mg/m2 for 2 hours and 5-fluorouracil 600 mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle (FOLFIRI group). The primary endpoint was objective tumor response (OR). Efficacy analysis was by per-protocol, and safety analysis included all patients who received at least one treatment with study drug. Results: Between January 1, 2014 and December 31, 2016, 28 patients were assigned to FOLFIRI treatment. Of those 20 patients were completed the study protocol. Per-protocol analysis, two patients among 20 subjects (10.0%) showed partial response. Overall survivals of FOLFIRI group; median 10.1 months [95% CI 4.9-15.3] Grade 3 and higher adverse event that occurred about 5%, but grade 3 or higher febrile neutropenia or life threatening complication was not reported. Conclusion: Combination chemotherapy with irinotecan, 5-FU, and LV is feasible in gastric cancer patients previously treated with platinum-based chemotherapy

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Research on the Development of Microneedle Arrays Based on Micromachining Technology and the Applicability of Parylene-C (미세가공 기술 기반의 마이크로니들 어레이 개발 및 패럴린 적용 가능성에 관한 연구)

  • Dong-Guk Kim;Deok-kyu Yoon;Yongchan Lee;Min-Uk Kim;Jihyoung Roh;Yohan Seo;Kwan-Su Kang;Young Hun Jeong;Kyung-Ah Kim;Tae-Ha Song
    • Journal of Biomedical Engineering Research
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    • v.44 no.6
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    • pp.404-413
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    • 2023
  • In this research, we studied the development of a SUS304 microneedle array based on microfabrication technology and the applicability of Parylene-C thin film, a medical polymer material. First of all, four materials commonly used in the field of medical engineering (SUS304, Ti, PMMA, and PEEK) were selected and a 5 ㎛ Parylene-C thin film was deposited. The applicability of Parylene-C coating to each material was confirmed through SEM analysis, contact angle measurement, surface roughness(Ra) measurement, and adhesion test according to ASTM standards for each specimen. Parylene-C thin film was deposited based on chemical vapor deposition (CVD), and a 5 ㎛ Parylene-C deposition process was established through trial and error. Through characteristic experiments to confirm the applicability of Parylene-C, SUS304 material, which is the easiest to apply Parylene-C coating without pretreatment was selected to develop a microneedle array based on CNC micromachining technology. The CNC micromachining process was divided into a total of 5 steps, and a microneedle array consisting of 19 needles with an inner diameter of 200 ㎛, an outer diameter of 400 ㎛, and a height of 1.4 mm was designed and manufactured. Finally, a 5 ㎛ Parylene-C coated microneedle array was developed, which presented future research directions in the field of microneedle-based drug delivery systems.

AN OBSERVATIONAL MULTI-CENTER STUDY FOR EVALUATION OF EFFICACY, SAFETY AND PARENTAL SATISFACTION OF METHYLPHENIDATE-OROS IN CHILDREN WITH ADHD (주의력결핍과잉운동장애 아동에게 Methylphenidate-OROS 투여시 효용성과 안전성 및 부모 만족도를 평가하기 위한 다기관관찰연구)

  • Kim, Bong-Seog;Park, Eun-Jin
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.16 no.2
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    • pp.279-285
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    • 2005
  • Objectives : This study was performed to evaluate the efficacy and safety of MPH-OROS and parental satisfaction for treatment of children with ADHD Method : The 569 participants were clinically diagnosed for ADHD using DSM-IV criteria. We switched current medication to MPH-OROS or introduced MPH-OROS for treatment of ADHD. We assessed the clinical global impression severity of illness (CGI-S), the clinical global impression severity of improvement(CGI-I). And the parents of participants measured the Korean version of Conners rating scale at baseline, the 1 st week and the 3rd week after MPH-OROS trial. At the 3rd week, the parents measured the parent satisfaction questionnaire. Results : $13\%$ of participants dropped out because of several causes including side effects. The change of CGI-S was significantly decreased. Using CGI-I, the improvement was $72.3\%$ at the 1st week and $87.4\%$ at the 3rd week. The total score of the Korean version of Conners parent rating scale was significantly decreased. The participants complaining one or more of side effects were 119$(20.7\%)$, and the most common side effect was anorexia. The $94\%$ of parents replied that they were overall satisfied with MPH-OROS trial. Also the advantages of MPH-OROS of parental report were the long duration of the drug, the improvement of schoolwork and attitude, the improvement of home behavior and homework and the improvement of overactivity. Conclusion : MPH-OROS is effective and well-tolerated in actual clinical use for ADHD.

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An Open-label, Randomized, Comparative Assessment of the Efficacy and Safety between Tofisopam and Lorazepam in Anxiety Disorder (Tofisopam과 lorazepam의 항불안효과와 안전성에 대한 비교 연구)

  • Lee, Min Soo;Kim, Yong-Ku;Kwak, Dong-Il
    • Korean Journal of Biological Psychiatry
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    • v.4 no.2
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    • pp.265-271
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    • 1997
  • Objective : A 4-week, single-blind, parallel group study was conducted to evaluate the efficacy and safety of tofisopam and lorazepam in 32 outpatients with anxiety disorder. Methods : Patients were randomized to receive either tofisopam(N=17) or lorazepam(N=15). The starting dose of tofisopam was 50mg t.i.d. daily, which could be increased to a maximum of 100mg t.i.d. according to the patient's clinical response and side effect. The starting dose of lorazepam was 0.75mg b.i.d. daily, which could be increased to a maximum of 1.5mg b.i.d. depending on the patient's clinical response and side effect. Efficacy evaluations at baseline, week 1, 2, and 4 used the 14-item Hamilton Rating Scale for Anxiety(HAM-A) and Clinical Global Impression(CGI). Tolerability was assessed by response to a nonleading question concerning adverse events. Laboratory parameters including vital sign, EKG, hematological, and biochemical values were measured during trial. Results : No significant differences between HAM-A total scores, two HAM-A factors(psychic, somatic) and CGI severity scores were recorded at any point during tofisopam and lorazepam treatments. However, in each group there was a significant decrease in HAM-A total scores, two HAM-A factor s(psychic, somatic), CGI severity scores over time. The pecentages of patients with tofisopam who at least minimally improved increased from 64.7% at week 1 to 94.1% at week 4. The pecentages of patients with lorazepam who at least minimally improved increased from 40.0% at week 1 to 66.7% at week 4. The pecentages of patients with tofisopam who had not any adverse event increased from 58.8% at week 1 to 87.9% at week 4. The pecentages of patients with lorazepam who had not any adverse event were not changed from 46.7% at week 1 to 46.7% at week 4. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial in both groups. Conclusion : These data suggest that tofisopam may be effective in reducing anxiety and is a anti-anxiety drug of identical potency with lorazepam. Tolerability of tofisopam was superior to lorazepam. These findings should be confirmed by using double-blind crossover study with a large member of patients.

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Clinical Trial of Nasal Flumazenil Administration (플루마제닐의 경비 투여)

  • Hong, Soo-Jin;Kim, Hyun-Jung;Yum, Kwang-Won
    • Journal of the korean academy of Pediatric Dentistry
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    • v.28 no.3
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    • pp.441-446
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    • 2001
  • Flumazenil is a competitive antagonist of benzodiazepines. It is usually administered intravenously. However, if the intravenous route is not available then other routes of drug administration should be considered. This study was designed to evaluate the reversal effects of flumazenil after nasal administration. Twenty-five young, healthy adult volunteers participated in this clinical trial. The dosage of 0.08mg/kg midazolam was administered intravenously to induce deep sedation. Ten minutes after midazolam administration, 0.5mg of flumazenil was dropped nasally, over a period of one minute. Blood samples were taken to measure the concentration of midazolam and flumazenil at 0, 5, 10, and 20min after nasal administration of flumazenil, using High Performance Liquid Chromatography. The degree of sedation was evaluated with sedation score and bispectral index (BIS), Statistical analysis was performed by multivariate ANOVA and correlation analysis (P<0.05). Peak serum flumazenil concentration was reached in 10min. Sedation score decreased after midazolam administration and showed a significant increase after flumazenil administration. However, BIS decreased during the first 10min after midazolam administration and then no significant changes after flumazenil administration. There were two instances representing rapid and complete reversal of midazolam after intranasal administration of flumazenil. In conclusion, intranasal flumazenil administration may be effective in some patients when intravenous route is not available in condition of benzodiazepine overdose.

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$H_2$ Receptor Antagonists and Gastric Cancer in the Elderly: A Nested Case-Control Study (노인 인구에서 $H_2$ Receptor Antagonist와 위암과의 관련성: 코호트 내 환자-대조군 연구)

  • Kim, Yoon-I;Heo, Dae-Seog;Lee, Seung-Mi;Youn, Kyoung-Eun;Koo, Hye-Won;Bae, Jong-Myon;Park, Byoung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.35 no.3
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    • pp.245-254
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    • 2002
  • Objective : To test if the intake of $H_2$ receptor antagonists ($H_2$-RAs) increases the risk of gastric cancer in the elderly. Methods : The source population for this study was drawn from the responders to a questionnaire survey administered to the Korea Elderly Pharmacoepidemiological Cohort (KEPEC), who were beneficiaries of the Korean Medical Insurance Corporation, were at least 65 years old, and residing in Busan in 1999. The information on $H_2$-RAs exposure was obtained from a drug prescription database compiled between inn. 1993 and Dec. 1994. The cases consisted of 76 gastric cancer patients, as confirmed from the KMIC claims data, the National Cancer Registry and the Busan Cancer Registry. The follow-up period was from Jan. 1993 to Dec. 1998. Cancer free controls were randomly selected by 1:4 individual matching, which took in to consideration the year of birth and gender. Information on confounders was collected by a mail questionnaire survey. The odds ratios, and their 95% confidence intervals, were calculated using a conditional logistic regression model. Results : After adjusting for a history of gastric ulcer symptoms, medication history, and body mass index, the adjusted OR (aOR) was 4.6 (95% CI=1.72-12.49). The odds ratio of long term use (more than 7 days) was 2.3 (95% CI=1.07-4.82). The odds ratio of short term use was 4.6 (95% CI=1.26-16.50). The odds ratio of parenteral use was 4.4 195% CI=1.16-17.05) and combination use between the oral and parenteral routes (aOR, 16.8; 95% CI=1.21-233.24) had the high risk of gastric cancer. The aOR of cimetidine was 1.7 (95% CI=1.04-2.95). The aOR of ranitidine was 2.0 (95% CI=1.21-3.40). The aOR of famotidine was 1.7 (95% CI=0.98-2.80). Conclusion : The intake of $H_2$-RAs might increase the risk of gastric cancer through achlorhydria in the elderly.