• Title/Summary/Keyword: Healthy Volunteers

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Significance Test for Electric Potential of Meridian System - Between hand and foot meridian, yin and yang meridian, exterior and interior of the body, and among the five elements - (정상인의 12경맥 측정전위에 대한 유의성 분석 - 고전경락이론의 수족 . 음양 . 장부의 표리와 오행 . 육기의 표리와 오행을 중심으로 -)

  • Choi, Hwan-Soo;Nam, Bong-Hyun
    • Korean Journal of Oriental Medicine
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    • v.6 no.1
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    • pp.69-80
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    • 2000
  • Objectives : Assuming that the characteristic of meridian system has been similar to this of electric potentials in human body and that measurements of electric potential at well(井穴) and sea(合穴) points in branches of the twelves meridians will be representative of measurements of the twelve meridians, to measure the electric potentials in twenty healthy volunteers when they were sleeping or waking respectively, to do significance test for electric potential of meridian system between hand and foot meridian, yin and yang meridian, exterior and interior of the body, and among the five elements. Methods : When twenty healthy volunteers were sleeping, their electric potentials of well and sea points in branches of the twelve meridians were simultaneously measured by physiograph. After a minute we measured them again, totally 5 times. And then when they were waking, their electric potentials were measured 5 times by the above method. Results : Measurements were analyzed by statistical t-test, we obtained that the left side electric potential of hand or yin meridian was significantly different from that of foot or yang meridian both sleeping and waking. The right side of electric potential was the same result as the left side's. Most of the t-test was significant between exterior and interior of the body, and among the five elements. That meaned that it was partly possible to apply the ancient theory of meridians to the study of electric potential at well and sea points in branches of the twelves meridians.

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Pharmacokinetic Comparison of Lamisil Tablet and Muzonal Tablet Containing Terbinafine HCl in Healthy Volunteers (건강한 지원자에 있어서 염산테르비나핀 함유 라미실정과 무조날정의 약물동력학적 비교)

  • Choi Han-Gon;Yong Chul Soon;Rhee Jong-Dhal;Woo Jong-Soo;Lee Kyung Hee;Yoo Bong Kyu
    • YAKHAK HOEJI
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    • v.49 no.4
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    • pp.255-259
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    • 2005
  • Financial standing of National Health Insurance has been experiencing a grave deterioration during the last 4-5 years, and the yearly amount paid by the insurance for drug expense rose up to 4 trillion won recently. Furthermore, the ratio of drug expenses in the total expenditure of the insurance reached about $25\%$, showing the tendency to be levelled off. As a measure to improve the financial deterioration of the insurance and to encourage generic substitution among the health professionals, we compared pharmacokinetic parameters of brand name drug (Lamisil) and generic drug (Muzonal) containing terbinafine HCl in healthy volunteers. The area under the curve (AUC) of the two drugs showed $2220.4\pm784.7\;and\;2143.1\pm861.6hr{\cdot}ng/ml$ in the corresponding order and no statistically significant difference was identified. The peak concentration $(C_{max})$ of the generic drug demonstrated $566.6\pm246.2 ng/ml$ compared to $550.8\pm204.0$ of brand name drug, which was not significantly different either. Time to reach peak concentration showed about 6 minutes difference between the drugs, which has no clinical significance to the treatment of dermatomycosis and dermatophytosis.

A fMRI study on the cerebral activity induced by Electro-acupuncture on Sp9(Yinlingquan) (음릉천(陰陵泉)(Sp9)의 전침자극(電鍼刺戟)이 functional MRI상 뇌활성(腦活性) 변화(變化)에 미치는 영향(影響))

  • Kim, Jeong-ho;Lee, Hyun;Lim, Yun-kyoung;Hong, Kwon-eui;Lee, Byung-ryul;Kim, Yeon-jin
    • Journal of Acupuncture Research
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    • v.20 no.4
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    • pp.114-133
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    • 2003
  • Objective : The meridian theory in oriental medicine explains that Sp9(Yinlingquan) has been considered very important for gynecological disorders, spleen and stomach disorders, and water metabolic disorders. Functional MRI is the best method of showing the evidences of the effect of the Electro-acupuncture treatment through scientific methods. On this supposition, Electro-acupuncture stimulation on Sp9(Yinlingquan) was carried out on six healthy volunteers, using the gradient echo sequence with the 3.0T whole-body MRI system(ISOL). Methods : Electro-acupuncture stimulation on Sp9(Yinlingquan), the experiment was carried out on six healthy volunteers, using the gradient echo sequence with the 3.0T whole-body MRI system(ISOL). After the needle insertion on right Sp9(Yinlingquan), 2Hz of electric stimulation was given for 30 seconds, repeated five times, with 30 seconds' intervals. The Image analysis including motion correction, talairach transformation, and smoothing was done using SPM99. Results : The electro-acupuncture stimulation on Sp9(Yinlingquan) activates Brodmann Area 13, 19, 22, 39, 40, 47 which may be the central pathways of the electro-acupuncture stimulation on Sp9(Yinlingquan). We also hypothesize that those brain areas may be directly or indirectly related with the mechanism of the effect of electro-acupuncture stimulation on Sp9(Yinlingquan).

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Plasma Lipidomics as a Tool for Diagnosis of Extrahepatic Cholangiocarcinoma in Biliary Strictures: a Pilot Study

  • Prachayakul, Varayu;Thearavathanasingha, Phataraphong;Thuwajit, Chanitra;Roytrakul, Sittiruk;Jaresitthikunchai, Janthima;Thuwajit, Peti
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.8
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    • pp.4155-4161
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    • 2016
  • Biliary obstruction is a common clinical manifestation of various conditions, including extrahepatic cholangiocarcinoma. However, a screening test for diagnosis of extrahepatic cholangiocarcinoma in patients with biliary obstruction is not yet available. According to the rationale that the biliary system plays a major role in lipid metabolism, biliary obstruction may interfere with lipid profiles in the body. Therefore, plasma lipidomics may help indicate the presence or status of disease in biliary obstruction suspected extrahepatic cholangiocarcinoma. This study aimed to use plasma lipidomics for diagnosis of extrahepatic cholangiocarcinoma in patients with biliary obstruction. Plasma from healthy volunteers, patients with benign biliary obstruction extrahepatic cholangiocarcinoma, and other related cancers were used in this study. Plasma lipids were extracted and lipidomic analysis was performed using matrix-assisted laser desorption ionization time-of-flight mass spectrometry. Lipid profiles from extrahepatic cholangiocarcinoma patients showed significant differences from both normal and benign biliary obstruction conditions, with no distinction between the latter two. Relative intensity of the selected lipid mass was able to successfully differentiate all extrahepatic cholangiocarcinoma samples from patient samples taken from healthy volunteers, patients with benign biliary obstruction, and patients with other related cancers. In conclusion, lipidomics is a non-invasive method with high sensitivity and specificity for identification of extrahepatic cholangiocarcinoma in patients with biliary obstruction.

Bioequivalence of Cefaclor 375 mg SR Tablet (세파클러 375 mg서방정의 생물학적 동등성)

  • Lee, Shin Hwa;Yun, Min Hyuk;Choi, Kyung Eob;Kwon, Kwang Il
    • Korean Journal of Clinical Pharmacy
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    • v.13 no.1
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    • pp.13-17
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    • 2003
  • This study was carried out to compare the bioavailability of $Ceclex^{(R)}$ SR TAB (test drug, cefaclor 375 mg/Tablet) with that of Ceclor $MR^{(R)}$ SR IAB (reference drug) and to estimate the pharmacokinetic parameters of cefaclor in healthy Korean volunteers. The bioavailability was examined on 24 healthy volunteers who received a single dose (375 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 7 hours. Plasma concentrations of cefaclor were determined using HPLC with UV detection. The pharmacokinetic parameters $(AUC_{0-7h},\;C_{max},\;T_{max},\;AUC_{inf},\;K_e,\;t_{1/2},\;V_d/F,\;and\;CL/F)$ were calculated with non-compartmental pharmacokinetic analysis. The ANOVA test was utilized for the statistical analysis of the $T_{max}$, log-transformed $AUC_{0-7h$}$, log-transformed $C_{max},\;t_{1/2},\;V_d/F$, and $CL/F$. The ratios of geometric means of $AUC_{0-7h}\;and\;C_{max}$ between test drug End reference drug were $95.67\%\;(8.55\;vs\;8.18{\mu}g{\cdot}hr/ml)\;and\;103.86\%\;(2.85\;vs\;2.96{\mu}g/ml)$, respectively. The $T_{max}$ of test drug and reference drug was $2.56\pm0.15\;and\;2.23\pm0.13\;hrs,\;respectively.\;The\;90\%$ confidence intervals of mean difference of logarithmic transformed $AUC_{0-7h}\;and\;C_{max}$ were log0.90-log1.04 and log0.91-log1.13, respectively. It shows that the bioavailability of test drug is equivalent with that of reference drug.

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Incremental Expression of 14-3-3 Protein Beta/Alpha in Urine Correlates with Advanced Stage and Poor Survival in Patients with Clear Cell Renal Cell Carcinoma

  • Kaneko, Shiho;Matsumoto, Kazumasa;Minamida, Satoru;Hirayama, Takahiro;Fujita, Tetsuo;Kodera, Yoshio;Iwamura, Masatsugu
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.3
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    • pp.1399-1404
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    • 2016
  • We investigated the urinary levels of 14-3-3 protein beta/alpha to evaluate their diagnostic significance with regard to clear cell renal cell carcinoma (ccRCC) and angiomyolipoma (AML). Urine samples from 91 patients with ccRCC, 16 patients with AML and 24 healthy volunteers were assessed. We used an enzyme-linked immunosorbent assay (ELISA) to quantify 14-3-3 protein beta/alpha levels in urine. Values were higher in patients with ccRCC than in those with AML and in healthy volunteers. High levels were associated with pathologic stage, lymph node status, distant metastasis and poor survival. Urinary levels of 14-3-3 protein beta/alpha were significantly increased in patients with small-sized carcinoma, irrespective of being less than 4.0 cm and 2.0 cm, compared with levels in patients with AML. This study is the first to report that increased expression of 14-3-3 protein beta/alpha in urine is associated with advanced stage and poor survival in patients with ccRCC. In addition, urinary 14-3-3 protein beta/alpha may differentiate AML from RCC, even when small sized. These results suggest that examination of urinary 14-3-3 protein beta/alpha could serve as a diagnostic and prognostic marker in patients with ccRCC.

Radial displacement of clinical target volume in node negative head and neck cancer

  • Jeon, Wan;Wu, Hong-Gyun;Song, Sang-Hyuk;Kim, Jung-In
    • Radiation Oncology Journal
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    • v.30 no.1
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    • pp.36-42
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    • 2012
  • Purpose: To evaluate the radial displacement of clinical target volume in the patients with node negative head and neck (H&N) cancer and to quantify the relative positional changes compared to that of normal healthy volunteers. Materials and Methods: Three node-negative H&N cancer patients and five healthy volunteers were enrolled in this study. For setup accuracy, neck thermoplastic masks and laser alignment were used in each of the acquired computed tomography (CT) images. Both groups had total three sequential CT images in every two weeks. The lymph node (LN) level of the neck was delineated based on the Radiation Therapy Oncology Group (RTOG) consensus guideline by one physician. We use the second cervical vertebra body as a reference point to match each CT image set. Each of the sequential CT images and delineated neck LN levels were fused with the primary image, then maximal radial displacement was measured at 1.5 cm intervals from skull base (SB) to caudal margin of LN level V, and the volume differences at each node level were quantified. Results: The mean radial displacements were 2.26 (${\pm}1.03$) mm in the control group and 3.05 (${\pm}1.97$) in the H&N cancer patients. There was a statistically significant difference between the groups in terms of the mean radial displacement (p = 0.03). In addition, the mean radial displacement increased with the distance from SB. As for the mean volume differences, there was no statistical significance between the two groups. Conclusion: This study suggests that a more generous radial margin should be applied to the lower part of the neck LN for better clinical target coverage and dose delivery.

A Study on Effects of incense smokes of 'Cheung-Woon' on Concentration (한방(韓方) 훈법(熏法)을 이용한 '청운(淸雲)'의 집중력 효과에 관한 연구)

  • Uhm, Ji-Tae;Kim, Byoung-Soo;Kim, Kyoung-Shin
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.2
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    • pp.33-48
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    • 2012
  • Objectives : This study aimed to assess the effects of incense smokes of 'Cheung-Woon' on the concentration and EEG in healthy individuals. Methods : A total of 48 healthy volunteers participated in this study. The volunteers were examined with K-MAS, CBT(Corsi block tapping task), and EEG before and after smelling the incense smokes of 'Cheung-Woon'. K-MAS measured the recalled words, and CBT measured the recalled positions and orders of the color boxes. EEG measured the relative power of ${\theta}$ wave, ${\alpha}$ wave, SMR wave, mid-${\beta}$ wave, high-${\beta}$ wave, ${\gamma}$ wave and T(concentraion index T = (SMR wave + mid-${\beta}$ wave) / ${\theta}$ wave). 'Cheung-Woon' consists of 7 herbal powder, known as a useful effect on the concentration and memory. Results : After smelling 'Cheung-Woon', K-MAS were increased significantly(p<0.05). In relative power of ${\theta}$ wave, F4, T3, and P4 were decreased significantly(p<0.05) and P3 was also decreased significantly(p<0.01). In the relative power of ${\alpha}$ wave, SMR wave, and mid-${\beta}$ wave, the values were not significant. In the relative power of high-${\beta}$ wave, Fp1, and P4 were increased significantly(p<0.05). In relative power of ${\gamma}$ wave, T3 were increased significantly (p<0.05). In T value, F4, T3, T4, and P4 were increased significantly(p<0.05) and P3 were also increased significantly(p<0.01). Conclusions : This results show that smelling incense smokes of 'Cheung-Woon' is an effective way of increasing concentration and memory.

Bioequivalence Assessment of Roxithromycin Tablets in Healthy Korean Volunteers

  • Kwon Oh-Seung;Kim Hye-Jung;Pyo Hee-Soo;Chung Youn-Bok
    • Biomolecules & Therapeutics
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    • v.14 no.1
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    • pp.50-55
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    • 2006
  • The objective of the study was to evaluate the bioequivalency between the $Rozid^{TM}$ Tablet (Ilhwa Pharm. Co., Ltd.) as a test formulation and the $Rulid^{TM}$ Tablet (Handok Pharm. Co., Ltd) as a reference formulation. Twenty-four healthy male volunteers were administered the formulations by the randomized Latin square crossover design, and the plasma samples were determined by a high performance liquid chromatography (HPLC) with fluorescence detector. $AUC_t,\;C_{max}\;and\;T_{max}$ were obtained from the time-plasma concentration curves, and log-transformed $AUC_t\;and\;C_{max}$ and log-untransformed $T_{max}$ values for two formulations were compared by statistical tests and analysis of variation. $AUC_t$ was determined to be $63.30{\pm}25.57{\mu}g.hr/ml$ for the test formulation and $64.02{\pm}29.27mg.hr/ml$ for the reference formulation. The mean values of $C_{max}$ for the test and reference formulations were $5.07{\pm}2.14\;and\;5.53{\pm}2.60{\mu}g/ml$, respectively. The $AUC_t,\;and\;C_{max}$ ratios of the test $Rozid^{TM}$ Tablet to the reference $Rulid^{TM}$ Tablet were -1.12% and -8.32%, respectively, showing that the mean differences were satisfied the acceptance criteria within 20%. The results from analysis of variance for log-transformed $AUC_t,\;and\;C_{max}$ indicated that sequence effects between groups were not exerted and 90% confidence limits of the mean differences for $AUC_t,\;and\;C_{max}$ were located in ranges from log 0.80 and log 1.25, satisfying the acceptance criteria of the KFDA bioequivalence. The RozidTM Tablet as the test formulation was considered to be bioequivalent to the RulidTM Tablet used as its reference formulation, based on $AUC_t,\;and\;C_{max}$ values.

Changes in Sensory Function After Transcranial Direct Current Stimulation on Primary Motor Cortex Area

  • Min, Dong-Ki
    • Physical Therapy Korea
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    • v.21 no.4
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    • pp.1-8
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    • 2014
  • Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity direct current to cortical areas, thereby facilitating or inhibiting spontaneous neuronal activity. This study was designed to investigate changes in various sensory functions after tDCS. We conducted a single-center, single-blinded, randomized trial to determine the effect of a single session of tDCS with the current perception threshold (CPT) in 50 healthy volunteers. Nerve conduction studies were performed in relation to the median sensory and motor nerves on the dominant hand to discriminate peripheral nerve lesions. The subjects received anodal tDCS with 1 mA for 15 minutes under two different conditions, with 25 subjects in each groups: the conditions were as follows tDCS on the primary motor cortex (M1) and sham tDCS on M1. We recorded the parameters of the CPT a with Neurometer$^{(R)}$ at frequencies of 2000, 250, and 5 Hz in the dominant index finger to assess the tactile sense, fast pain and slow pain, respectively. In the test to measure CPT values of the M1 in the tDCS group, the values of the distal part of the distal interphalangeal joint of the second finger statistically increased in all of 2000 Hz (p=.000), 250 Hz (p=.002), and 5 Hz (p=.008). However, the values of the sham tDCS group decreased in all of 2000 Hz (p=.285), 250 Hz (p=.552), and 5 Hz (p=.062), and were not statistically significant. These results show that M1 anodal tDCS can modulate sensory perception and pain thresholds in healthy adult volunteers. The study suggests that tDCS may be a useful strategy for treating central neurogenic pain in rehabilitation medicine.