• Title/Summary/Keyword: Healthy volunteers

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Comparative Serum Proteomic Analysis of Serum Diagnosis Proteins of Colorectal Cancer Based on Magnetic Bead Separation and MALDI-TOF Mass Spectrometry

  • Deng, Bao-Guo;Yao, Jin-Hua;Liu, Qing-Yin;Feng, Xian-Jun;Liu, Dong;Zhao, Li;Tu, Bin;Yang, Fan
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.10
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    • pp.6069-6075
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    • 2013
  • Background: At present, the diagnosis of colorectal cancer (CRC) requires a colorectal biopsy which is an invasive procedure. We undertook this pilot study to develop an alternative method and potential new biomarkers for diagnosis, and validated a set of well-integrated tools called ClinProt to investigate the serum peptidome in CRC patients. Methods: Fasting blood samples from 67 patients diagnosed with CRC by histological diagnosis, 55 patients diagnosed with colorectal adenoma by biopsy, and 65 healthy volunteers were collected. Division was into a model construction group and an external validation group randomly. The present work focused on serum proteomic analysis of model construction group by ClinProt Kit combined with mass spectrometry. This approach allowed construction of a peptide pattern able to differentiate the studied populations. An external validation group was used to verify the diagnostic capability of the peptidome pattern blindly. An immunoassay method was used to determine serum CEA of CRC and controls. Results: The results showed 59 differential peptide peaks in CRC, colorectal adenoma and health volunteers. A genetic algorithm was used to set up the classification models. Four of the identified peaks at m/z 797, 810, 4078 and 5343 were used to construct peptidome patterns, achieving an accuracy of 100% (> CEA, P<0.05). Furthermore, the peptidome patterns could differentiate the validation group with high accuracy close to 100%. Conclusions: Our results showed that proteomic analysis of serum with MALDI-TOF MS is a fast and reproducible approach, which may provide a novel approach to screening for CRC.

Effects of Oriental Medicine Music Therapy for Mental Stress on Short-term Analysis of Heart Rate Variability (한방음악치료가 정신적 스트레스를 가한 정상 성인의 심박변이도에 미치는 영향)

  • Kim, Jin-Yi;Kim, Soo-Jung;Seo, Joo-Hee;Ryu, Chun-Gil;Yoon, In-Ae;Park, Eun-Young;Sung, Woo-Yong
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.1
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    • pp.1-12
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    • 2011
  • Objectives : This study was conducted to assess effects of oriental medicine music therapy on heart rate variability(HRV) in normal subjects under mental stress. Methods : 34 healthy volunteers(control group:17, experimental group:17) participate in this study. The volunteers were randomly allocated into two groups. After 10-minutes rest period and instrumentation, both groups performed a mental stress test for 12-minutes. HRV was recorded before and after the mental stress. And then the experimental group applied oriental medicine music therapy for 10-minutes. In the control group, they rested for 10-minutes. And HRV was recorded. Results : After giving mental stress stimulation to both groups, LF and LF/HF ratio were significantly increased and HF, mean HRV were decreased. In experimental group, LF, LF/HF ratio were significantly decreased and HF, SDNN were significantly increased after applying oriental medicine music therapy. In control group, LF was significantly decreased. And LF/HF ratio was decreased and HF, SDNN were increased, but it was not significant. Conclusions : This results show that oriental medicine music therapy could be relatively useful to decrease sympathetic activity and prevent the alteration of autonomic nervous system due to mental stress.

Changes of HRV according to Emotional Stimulus in Sasang Constitutional Groups (정서유발 자극에 따른 사상인(四象人)의 심박변이도 변화 연구)

  • Lee, Gyung-Ro;Shin, Dong-Yun;Kim, Young-Won;Yi, Ja-Hyeong;Song, Jung-Mo;Kim, Lak-Hyung
    • Journal of Oriental Neuropsychiatry
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    • v.18 no.2
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    • pp.25-34
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    • 2007
  • Objective : This study was done to investigate the differences of HRV(Heart Rate Variability) change as the response to the emotional stimulus in each Sasang constitutions. Method : We investigated 44 healthy volunteers consisted of 10 Soyangin, 14 Soeumin and 20 Taeumin. After diagnosing the Sasang constitution by specialist of Sasang medicine, we measured the baseline emotional state(100 sec) before the stimulus, the changing emotional state(100 sec) while fearful film was being played. And we rechecked the emotional state(100 sec) while taking a rest. At last, volunteers checked the questionnaire for emotional response. We analysed ECG data with HRV-time domain and frequency domain analysis. Results : (1) There were no significant difference in Mean-RR , SDNN between each groups. (2) LF of Taeumin group significantly increased by the emotional stimulation compared with other groups. (3) There was no significant difference in TP, HF, normalized LF, normalized HF, but the variation of each period in Taeumin group was bigger than those of other groups. (4) Soeumin group reported that they felt significant disgust-emotion in the questionnaire compared with other groups. Conclusion : Taeumin group showed significant emotional changes on HRV by fear stimulus film.

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Effects of HP228 on Analgesia Alone or in Combination with Morphine (새로운 해열, 진통, 소염제인 HP228의 단독 또는 Morphine과의 병용투여가 제통효과에 미치는 영향)

  • Lee, Seung-Gu;Lee, Seung-Hoon;Kim, Tae-Sung;Kim, Hyun-Soo;Kim, Kwang-Min
    • The Korean Journal of Pain
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    • v.12 no.1
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    • pp.64-69
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    • 1999
  • Background: The new drug HP228 is a cytokine restraining agent with a broad spectrum of anti-inflammatory, analgesic, and antipyretic activity. Six healthy, adult, male volunteers were studied to determine the independent and interactive effects of HP228 and morphine on pain perception. Methods: Two groups of stimuli were applied to each volunteers before drug administration as control, 20 min after morphine and HP228 administration, and 20 min after combined administration of these two drugs. Two adhesive electrically-conducting pads were applied on opposite sides of the arm approximately 8 cm apart. The electrode were connected to an electrical impulse generator and 50 Hz 1 msec pulses of incrementally increasing intensity were delivered at 1 sec intervals. The analgesic endpoints were the current intensity (mA) at which the subject first detected the stimulus (THRESH), the intensity at which the stimulus was first idenfied as being painful (PAIN), and the intensity at which the subject requested that the stimulus be terminated due to discomfort (LIMIT). A second series of stimuli were applied immediately thereafter using 1-sec duration 50 Hz tetanus pulses with increasing intensities at 2~5 sec intervals. Results: There were significant differences between drug treatments (Morphine, HP228, HP228/Morphine) and control (No drugs) in any of the measurements (PAIN, LIMIT) except THRESH with the twitch and tetanus test. Conclusions: The data suggests that HP228 is an analgesic, but it does not appear to interact with morphine in an additive manner.

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Usefulness of shear wave elastography in the diagnosis of oral and maxillofacial diseases

  • Ogura, Ichiro;Nakahara, Ken;Sasaki, Yoshihiko;Sue, Mikiko;Oda, Takaaki
    • Imaging Science in Dentistry
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    • v.48 no.3
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    • pp.161-165
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    • 2018
  • Purpose: To evaluate the usefulness of shear wave elastography in the diagnosis of oral and maxillofacial diseases. Materials and Methods: Ten patients with oral and maxillofacial diseases and 28 volunteers drawn from our student doctors were examined by shear wave elastography with a 14-MHz linear transducer using an Aplio 300 apparatus (Canon Medical Systems, Otawara, Japan). A statistical analysis of the shear elastic modulus(kPa) of healthy tissue (the sublingual gland, submandibular gland, anterior belly of the digastric muscle, and geniohyoid muscle) in the 28 volunteers was performed using 1-way repeated measures analysis of variance with the Tukey honest significant difference test. The maximum shear elastic modulus(kPa) of 8 patients with squamous cell carcinoma (SCC) and 2 patients with benign lesions was evaluated with the Mann-Whitney U test. The analysis used a 5% significance level. Results: The mean shear elastic modulus of the sublingual gland ($9.4{\pm}3.7kPa$) was lower than that of the geniohyoid muscle ($19.2{\pm}9.2kPa$, P=.000) and the anterior belly of the digastric muscle ($15.3{\pm}6.1kPa$, P=.004). The maximum shear elastic modulus of the SCCs($109.6{\pm}14.4kPa$) was higher than that of the benign lesions($46.4{\pm}26.8kPa$, P=.044). Conclusion: Our results demonstrated the usefulness of shear wave elastography in the diagnosis of oral and maxillofacial diseases. Shear wave elastography has the potential to be an effective technique for the objective and quantitative diagnosis of oral and maxillofacial diseases.

The Changes of Electroencephalography According to Emotional Stimulus in Sasangin (정서자극이 사상인(四象人)의 뇌파 변화에 미치는 영향)

  • Lee, Sang-Gi;Kim, Young-Won;Shin, Dong-Yun;Lim, Mi-Kyoung;Yi, Ja-Hyeong;Song, Jung-Mo;Kim, Lak-Hyung
    • Journal of Sasang Constitutional Medicine
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    • v.19 no.2
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    • pp.113-126
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    • 2007
  • 1. Objectives The objective of this study was to measure the differences of EEG changes accoring to emotional stimulus in Sasangin. 2. Methods 44 healthy volunteers(Soyangin 10, Soeumin 14, Taeumin 20) were participated. Sasang Constitution was diagnosed by Sasang specialist. Volunteers watched horror movie as the emotional stimulus. We recorded EEG data during pre-stimulus rest(120sec), during-stimulus(197sec), rest-stimulus(120sec). Power spectral analysis was done and relitive power and ${\alpha}/{\beta}$ ratio were compared among each groups. 3. Results (1) The mean of relative ${\alpha}$ of Taeumin was significantly decreased according to stimulus compared with Soyagnin. (2) Relative ${\alpha}$ of Soeumin was significantly decreased in T3 area according to stimulus compared with Taeumin. (3) Relative ${\beta}$ of Taeumin group was significantly increased in Fp2 area according to stimulus compared with Soeumin. 4) Relative $high-{\beta}$ of Soyangin group was significantly decreased in F3 by the post-stimulus rest compared with Soeumin. (5) ${\alpha}/{\beta}$ ratio of Soeumin was significantly increased according to stimulus compared with other groups. 4. Conclusions Soyangin showed sensitive changes according to the emotional simulus compared with Soeumin and Taeumin. Above results suggest that the emotional characteristics of Sasangin can be measured by objective methods as by EEG.

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Bioequivalence and Pharmacokinetics of Carvedilol (25mg) Tablets in Volunteers (카베딜롤(25mg)정제의 생물학적 동등성 및 약물동태연구)

  • 우수경;김호순;강종성;권광일
    • YAKHAK HOEJI
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    • v.45 no.6
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    • pp.650-655
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    • 2001
  • Carvedilol is a nonselective $\beta$-blocking agent with vasodilating properties that are attributed mainly to its blocking activity at $\alpha$$^{1}$-receptors. Carvedilol is used in the treatment of mild to moderate hypertention and angina pectoris and is often used in combination with other drugs. This study was carried out to evaluate the bioequivalence and pharmacokinetics of two carvedilol 25mg tablet formulations according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty healthy volunteers are enrolled and received a single dose (25mg as carvedilol) of each drug in the fasting state, in a randomized 2-way crossover design. After oral administration, blond samples were collected for a period of 30 hours. Plasma concentrations of carvedilol were determined by a rapid and sensitive HPLC method with spectrofluorometric detection. The major pharmacokinetic parameters such as AU $C_{0-}$30hr/, AU $C_{inf}$ , $C_{max}$, $T_{max}$, $t_{1}$2 / Cl/F and V $_{\beta}$//F were calculated. ANOVA test and t-test were utilized for the statistical analysis of each parameter. The results showed that the differences in AU $C_{0-}$30hr/, $C_{max}$ and $T_{max}$ between two were ~5.66, 1.74 and 0.00%, respectively. Minimum detectable differences ($\Delta$) at $\alpha$=0.05 were less than$\pm$ 20% except $T_{max}$ (8.44, 18.36, and 33.86%, respectively). The 90% confidence intervals of all parameters were within $\pm$20% (-10.60~ -0.72, -9.00~12.49 and -19.81~19.81%, respectively). Therefore, it is concluded that the two formulations are bioequivalent for both the extent and the rate of absorption after single dose administration.ation.ion.ion.ation.ion.n.

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Studies on the potential hazard of dichlorvos-resin vaporizing insecticide in human and domestic fowl (Dichlorvos 증기(蒸氣)의 지속적(持續的) 흡입(吸入)이 인체(人體) 및 가계(家鷄)에 미치는 영향)

  • Oh, J.S.;Hong, S.A.;Lim, J.K.;Kim, M.S.;Shin, S.G.;Yoon, H.I.
    • The Korean Journal of Pharmacology
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    • v.11 no.2
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    • pp.55-59
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    • 1975
  • Safety study of the continuous releasing dichlorvos-resin insecticide $(Mopari^{\circledR})$ was conducted in human volunteers and domestic fowls. For the purpose, the potential hazards in using the insecticide were observed in terms of the inhibition of plasma cholinesterase activity and the changes in the liver function (GOT, GPT, Alkaline phosphatase, Bilirubin, Thymol turbidity), the blood picture (RBC, WBC with differential count, Hemoglobin, Hematocrit and ESR) and the urine picture (sugar, albumin, pH and microscopic findings) in 40 healthy adult volunteers and 60 leghorn domestic fowls. In case of the human study the observation was continued for 2 months during the application of the insectiside ($1{\sim}3$ solid formulations/$30m^3$) in the living rooms of ordinary Korean dwelling houses or in the office. In the animal test, however, 1 to 5 solid formulations of the insecticide were applied in the fowl cage of $9.2m^3$ for 5 weeks. Any significant inhibition of the plasma cholinesterase activity was not observed in both the human volunteer and the fowl throughout the experimental period. And the liver function as well as the blood and urine pictures were also not changed after exposure to the vaporizing insecticide. It is considered from the result that the amount of dichlorvos released into the air by the continuous vaporizing dichlorvos-resin insecticide presents no significant hazardous effect on humans or animals in the present experimental condition.

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Comparative Bioavailability and Metabolism of Two Capsule Formulations of Fluoxetine in Human Volunteers (플루옥세틴 캅셀제의 지원자에 대한 생체이용율 및 대사율 비교)

  • Kang, Won-Ku;Park, Yong-Soon;Cho, Gyu-Haeng;Choi, Jun-Sik;Kwon, Kwang-Il
    • YAKHAK HOEJI
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    • v.42 no.5
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    • pp.513-518
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    • 1998
  • Fluoxetine is a nontricyclic antidepressant which blocks serotonin reuptake selectively. Its N-demethyl metabolite, norfluoxetine is also selective inhibitor of serotonin uptake . This study was carried out to compare the bioavailability of Myung-in fluoxetine (20mg/cap.) with that of Prozac$^{\circde{R}}$. The bioavailability was conducted on 24 healthy volunteers who received a single dose (80mg) of each drug in the fasting state, in a randomized balanced 2-way crossover design. After closing, serial blood samples were collected for a period of 48 hours, Plasma was analyzed for fluoxetine and norfluoxetine by a sensitive and validated HPLC assay. The major pharmacokinetic parameters ($AUC_{0-48\;hr}$, Cmax, Tmax , $AUC_{inf.}$, MRT. $T_{1/2}$, Vd and Cl) were, calculated from the plasma fluoxetine concentration-time data of each volunteer. The microcomputer program, 'WinNonlin' was used for compartmental analysis. A two-compartment model with first-order input, first-order output and no lag time was chosen as the most appropriate pharmacokinetic model. The data were best described by using a weighting factor of $1/y^2$. Though the plasma fluoxetine concentrations of Myung-in fluoxetine were higher than those of Prozac$^{\circde{R}}$ at all observed time from 7.9% to 16.9% (P<0.05 at 6.7 and 10 hr), the bioavailability of Myung-in fluoxetine appeared to be bioequivalent with that of Prozac$^{\circde{R}}$. There were no statistical significant differences between the two drugs in all pharmacokinetic parameters including $AUC_{0-48\;hr}$ of norfluoxetine.

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Methods for Pharmacodynamic Analysis and Proposed Protocols for Bioequivalence Study of Acarbose (Acarbose 제제의 약력학적 평가 및 생물학적동등성 시험법에 대한 연구)

  • Bae, Jung-Woo;Jang, Choon-Gon;Lee, Seok-Yong
    • YAKHAK HOEJI
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    • v.51 no.6
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    • pp.440-446
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    • 2007
  • Arcabose is a competitive inhibitor of the intestinal ${\alpha}$-glucosidases and reduces the postprandial digestion and absorption of carbohydrate and disaccharides. Due to its negligible oral absorption, measuring drug concentration in the plasma is impractical. Thus, the common pharmacokinetic study is not available to determine the bioequivalence of the generic acarbose preparations. The aim of this study is the establishment of pharmacodynamic assessment method for the bioequivalence test of the generic acarbose preparations. Placebo-controlled cross-over ($3{\times}3$) clinical study was conducted in 23 healthy volunteers. Volunteers received a single oral dose of placebo, reference drug ($Glucoby^{(R)}$ 100 mg, Lot # D043) or test drug ($Glucoby^{(R)}$ 100 mg, Lot # E005) just before breakfast, then blood samples for evaluation of serum glucose and insulin levels were taken during for 4 hours. $C_{max},\;AUC_{0-2},\;AUC_{0-4},\;{\Delta}C_{max},\;{\Delta}AUC_{0-2}\;and\;{\Delta}AUC_{0-4}$ of the postprandial plasma glucose level significantly decreased when a single dose of acarbose 100 mg preparations was administered. However, any significant difference was not detected between the groups taken the reference drug and the test drug. These results proposed that the pharmacodynamic protocols of this study is suitable to use for bioequivalence test of acarbose preparations. On the basis of the results of this study and the data of literature on this subject, the standard protocols of bioequivalence study of acarbose preparation are proposed.