• Title/Summary/Keyword: Healthy volunteers

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Preliminary Study for the Comparison of the Skin Temperature Changes by the Combustible Moxibustion and the Electronic Moxibustion Device (연소식 뜸과 전자식 뜸치료 시스템에 의한 체표 온도변화 비교를 위한 사전연구)

  • Chae, Han;Noh, Seung-Hee;Kim, Yu-Ri;Jung, Hae-Ree;Ha, Hyun-Yee;Kim, Kun-Hyung;Yang, Gi-Young;Kim, Jae-Kyu;Lee, Byung-Ryul
    • Journal of Acupuncture Research
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    • v.29 no.3
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    • pp.1-8
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    • 2012
  • Objectives : The purpose of this study was to compare the skin temperature changes by the rechargeable and programmable electronic moxibustion device(EMD) with the traditional combustible moxibustion device(CMD). Methods : Skin temperature changes in six healthy volunteers induced by CMD and EMD were measured with digital infrared thermal imaging(DITI). Heat stimulation was applied on $LI_4$ and $TE_5$, and skin temperature changes on each point were measured at baseline and per minute for total 7 minutes, 2 minutes of heat stimulation and 5 minutes of observation. Results : There was no significant difference in the skin temperature changes between CMD and EMD. The temperature on $LI_4$ with EMD was $32.3{\pm}1.3^{\circ}C$ at baseline, $34.0{\pm}1.3^{\circ}C$ at 1 minute after heat stimulation start, $34.6{\pm}1.2^{\circ}C$ at 2 minutes after, and from 3 minutes after heat stimulation, it maintained $32.6{\sim}32.8^{\circ}C$. Conclusions : Methods for measuring skin temperature changes induced by heat stimulation of moxibustion were established, and the possibility of effectiveness of the newly developed electronic moxibustion device was raised with this preliminary study. This study can contribute to the development of clinical research methodology for traditional Korean medicine.

Bioequivalence Evaluation of Lovastatin Tablets (로바스타틴 정제의 생물학적 동등성 평가)

  • Bok, Hae Sook;Kim, Myoung Min;Choi, Kyung Eob
    • Korean Journal of Clinical Pharmacy
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    • v.8 no.2
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    • pp.107-112
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    • 1998
  • Lovastatin is a lipid lowering agent for the treatment of hypercholesterolemia and belongs to a new class of pharmacologic compounds called the 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors. By competitively inhibiting HMG CoA reductase, lovastatin disrupts the biosynthesis of cholesterol in hepatic and peripheral cells and increases the synthesis of high-density-lipoprotein HDL) receptors. Following oral administration, the lactone ring of lovastatin is hydrolysed to the active inhibitor of HMG CoA reductase, lovastatin acid. Lovastatin is known to have poor oral absorption and wide individual variation. In this study, bioequivalence test of two lovastatin formulations, the test drug ($Lovaload^{TM}$, Chong Kun Dang Pharmaceutical Co.) and the reference drug ($Mevacor^{TM}$, Chung Wae Pharmaceutical Co.) were conducted according to the guidelines of Korea Food and Drug Administration (KFDA). A total of 18 healthy male volunteers, $31.90\pm3.60$ years old and $72.17\;7.88$ kg of body weight in average, were evaluated in a randomized crossover manner with a 2-week washout period. Concentrations of lovastatin acid in plasma were measured upto 12 hours following a single oral administration of eight tablets (20 mg of lovastatin per tablet) by high-performance liquid chromatography with UV detection at 238 nm. The area under the concentration-vs-time curve from 0 to 12 hours $(AUC_{0-12h})$ was calculated by the trapezoidal summation method. The statistical analysis showed that there are no significant differences in $AUC_{0-12h),\;C_{max}\;and\;T_{max}$ between the two formulations ($6.72\%,\;1.52\%,\;and\;0.88\$, respectively). The least significant differences between the formulations at $\alpha$=0.05 were less than $20\%\;(11.65\%,\;19.73\%,\;and\;14.81\%\;for\;AUC_{0-12h},\;C_{max}\;and\;T_{max}$, respectively). The $90\%$ confidence intervals for these parameters were also within $\pm20\%\;(-1.50{\leq}{\delta}{\leq}15.00$, $-12.50{\leq}{\delta}{\leq}15.50,\;and\;-9.64{\leq}{\delta]{\leq}11.40{\leq}\;for\;\;AUC_{0-12h}$ ,$C_{max}\;and\;T_{max}$, respectively). In conclusion, the new generic product $Lovaload^{TM}$ was proven to be bioequivalent with the reference drug.

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Bioequivalence Evaluation of Pylocin Tablet to Klaricid Tablet (Clarithyomycin, 250 mg) (클래리시드 정(클래리스로마이신 250 mg)에 대한 파이로신 정의 생물학적 동등성)

  • Cho, Hea Young;Kim, Soo Jin;Sim, Young Sun;Lim, Dong Koo;Oh, In Joon;Lee, Yong Bok;Moon, Jai Dong
    • Korean Journal of Clinical Pharmacy
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    • v.10 no.1
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    • pp.13-18
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    • 2000
  • The bioequivalence of two clarithromycin tablets, the $Klaricid^{TM}$ (Ciba-Geigy Korea Ltd.) and the $Pylocin^{TM}$ (Kyungdong Pharmaceutical Co., Ltd.), was evaluated according to the Korean Guidelines for Bioequivalence Test (KGBT 1998). Sixteen healthy male volunteers ($20\sim26$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After one tablet containing 250 mg of clarithromycin was orally administered, blood sample was taken at predetermined time intervals, and the concentrations of clarithromycin in serum were determined using high-performance liquid chromatographic method with electrochemical detector. The pharmaco-kinetic parameters (area under the concentration-time curve: $AUC_t$, maximum concentration; $C_{max}$ and time to maximum concentration; $T_{max}$) were calculated and analysis of variance (ANOVA) was utilized for the statistical analysis of parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on $Klaricid^{TM}$ tablet were $-0.22\%,\;-0.48\%\;and\;-1.63\%$, respectively. The powers $(1-\beta)\;for\;AUC_t,\;C_{max}\;and\;T_{max}\;were\;99.07\%,\;88.15\%\;and\;99.99\%$, respectively. Detectable differences $(\Delta)\;and\;90\%$ confidence intervals ($\alpha$=0.10) were all less than $\pm20\%$ All the parameters above met the criteria of KGBT 1998, indicating that $Pylocin^{TM}$ tablet is bioequivalent to $Klaricid^{TM}$ tablet.

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Muscle Stiffness and Elasticity Related to Physical Therapeutic Modalities (물리치료에 따른 근육의 경도와 탄성도 비교)

  • Kim, Sung-Hwan;Kim, Mee-Eun
    • Journal of Oral Medicine and Pain
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    • v.32 no.3
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    • pp.319-328
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    • 2007
  • The purpose of this study was to quantitatively assess treatment effect of physical therapy on experimentally-induced masseter muscle fatigue by two parameters of muscle stiffness and elasticity. Three physical therapeutic modalities inducing electroacupunture stimulation therapy(EAST), Microwave diathermy and low-level laser therapy(LLLT) were compared. 10 healthy volunteers with normal occlusion (mean age of $26.3{\pm}1.16$ years, M:F=1:1) were participated in this study. All subjects were asked to chew gum on the right side until they felt pain(more and VAS 5 (0 to 10)) and their masseter muscles were examined with a tactile sensor in order to evaluate changes of stiffness and elasticity according to gum chewing and three physical therapeutic modalities. Subjective discomfort or pain was self-estimated by VAS as well. Unilateral gum chewing increased stiffness and decreased elasticity only on the chewing side but VAS increased on the both sides(p<0.05). EAST or Microwave diathermy greatly decreased stiffness and VAS and increased elasticity(p<0.05) but LLLT did not exhibit significant difference. From the results of this study, it is concluded that both EAST and Microwave diathermy have favorable effect on stiffness and elasticity of muscles and pain relief while effect of LLLT is not reliable. In addition, experimental unilateral gum chewing compromises stiffness and elasticity of masseter muscles only the chewing side while subjective discomfort or pain can be felt on the both sides.

Overexpression of Neuron-Specific Enolase as a Prognostic Factor in Patients with Gastric Cancer

  • Park, Taejin;Lee, Young-Joon;Jeong, Sang-Ho;Choi, Sang-Kyung;Jung, Eun-Jung;Ju, Young-tae;Jeong, Chi-Young;Park, Miyeong;Hah, Young-Sool;Yoo, Jiyun;Ha, Woo-Song;Hong, Soon-Chan;Ko, Gyung Hyuck
    • Journal of Gastric Cancer
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    • v.17 no.3
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    • pp.228-236
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    • 2017
  • Purpose: Enolase is a cytoplasmic enzyme that catalyzes the conversion of 2-phosphoglycerate to phosphoenolpyruvate in the glycolytic pathway. The aim of this study was to investigate whether the overexpression of neuron-specific enolase (NSE) can serve as a prognostic factor in patients with gastric cancer (GC). Materials and Methods: To assess its prognostic value in GC, NSE expression was measured by immunohistochemistry in a clinically annotated tissue microarray comprising of 327 human GC specimens. Cytoplasmic NSE expression was scored from 0 to 4, reflecting the percentage of NSE-positive cells. Results: In terms of histology as per the World Health Organization criteria (P=0.34), there were no differences between the NSE overexpression (NSE-OE) and NSE underexpression (NSE-UE) groups. The NSE-OE group showed a significantly lower rate of advanced GC (P<0.01), lymph node metastasis (P=0.01), advanced stage group (P<0.01), cancer-related death (P<0.01), and cancer recurrence (P<0.01). Additionally, a Kaplan-Meier survival analysis revealed that the NSE-OE group had longer cumulative survival times than the NSE-UE group (log-rank test, P<0.01). However, there were no significant differences in the serum levels of NSE expression in patients with GC and healthy volunteers (P=0.28). Conclusions: Patients with NSE overexpressing GC tissues showed better prognostic results, implying that NSE could be a candidate biomarker of GC.

The Study of Vascular Dynamics for the Effect of a Compress Pack on Pain Relief using Magnetic Resonance Angiography (자기공명영상을 이용한 찜질 자극에 의한 통증 완화 효과에 대한 혈류 영상학적 고찰)

  • Baek, Ji-Won;Lim, Young-Khi
    • Journal of Radiation Protection and Research
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    • v.40 no.4
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    • pp.277-282
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    • 2015
  • This study was to investigate the effects of the hot compress pack on alleviating local muscular discomfort, stiffness in limbs as well as the chronic pains such as migraine in terms of hemodynamics. In this study, the hot compress band was put on the neck and the local physiological change on the stimulation site and the cranial blood circulation change were examined. We recruited healthy volunteers (n=8, mean age: 32.13 (4.61)), who participated in the magnetic resonance imaging (MRI) study. Local skin color and temperature were measured for the local effect of the hot compress band and the changes of intra-cranial and extra-cranial blood vessels were examined with MR angiography (MRA) images. The skin temperature increased from $36.4^{\circ}C$ at the rest condition to $36.7^{\circ}C$ and $37.1^{\circ}C$ after 15 min and 30 min stimulation, respectively. The change of the extra-cranial blood vessels between pre-stimulation and post-stimulation of 30 min was significantly increased (+38.8%), while the change of the intra-cranial blood vessels was negligible. In this study, we demonstrated that the hot compress band on the neck yielded the increase of local skin temperature on the stimulation site and it made an effect on the extracranial circulation. In conclusion, the stimulation with a hot compress could facilitate the blood circulation, causing to relieve the muscular discomfort, stiffness in limbs as well as the chronic pains such as migraine.

The Relationship between Insomnia Severity and Depression, Anxiety and Anxiety Sensitivity in General Population (불면증의 심각도와 우울, 불안 및 불안 민감성의 관계)

  • Kim, Na-Hyun;Choi, Hong-Min;Lim, Se-Won;Oh, Kang-Seob
    • Sleep Medicine and Psychophysiology
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    • v.13 no.2
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    • pp.59-66
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    • 2006
  • The objective of this study was to investigate the relationship between insomnia severity, depression, anxiety, and anxiety sensitivity and to find out the explanatory variables that account for the insomnia severity among depression, anxiety, and anxiety sensitivity in general population. 95 mentally healthy volunteers who visit health promotion center of Kangbuk Samsung hospital for their regular medical examination were requested to complete Athens Insomnia Scale, Beck Depression Inventory, State-Trait Anxiety Inventory, and Anxiety Sensitivity Index. Association between total scores of Athens Insomnia Scale and other variables (total scores of Beck Depression Inventory excluded item 16, total scores of State Anxiety, total scores of Trait Anxiety, and total scores of Anxiety Sensitivity Scale) was assessed individually with partial correlations adjusted by age and then together using multiple regression analysis. The total scores of Athens Insomnia Scale were significantly associated with total scores of Beck Depression Inventory excluded item 16 (r=0.541, p<0.001), total scores of Trait Anxiety (r=0.642, p<0.001), total scores of State Anxiety (r=0.267, p<0.05), and total scores of Anxiety Sensitivity Index (r=0.312, p<0.01). Total scores of trait anxiety showed the highest correlation with the total scores of Athens Insomnia Scale and was the significant predictor to total scores of Athens Insomnia Scale among the other predictor variables (p<0.001). These results show that insomnia severity is positively correlated with depression, anxiety, and anxiety sensitivity. The correlation was strongest with trait anxiety. In addition, our results suggest that trait anxiety is associated with insomnia severity in general populations.

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The Role of Protein Kinase C and Protein Tyrosine Kinase in the Signal Transduction Pathway of Stimulus Induced by Endotoxin in Peripheral Blood Monocyte (말초혈액 단핵구에 대한 내독소 자극의 신호 전달에서 Protein Kinase C와 Protein Tyrosine Kinase의 역할)

  • Kim, Jae-Yeol;Park, Jae-Suk;Lee, Gwi-Lae;Yoo, Chul-Gyu;Kim, Young-Whan;Han, Sung-Koo;Shim, Young-Soo
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.2
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    • pp.338-348
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    • 1997
  • Background : Endotoxin, the component of outermembrane of gram negative organism, plays an important role in the initiation and amplification of inflammatory reaction by its effects on inflammatory cells. Until recently, there have been continuing efforts to delinate the mechanisms of the signal trasduction pathway of endotoxin stimuli on inflammatory cells. By uncovering the mechanisms of signal transduction pathway of endotoxin stimuli, we can expect to have tools to control the excessive inflammatory responses which sometimes may be fatal to the involved host. It was generally accepted that endotoxin exerts its inflammatory effects through inflammatory cytokines that are produced by endotoxin-stimulated inflammatory cells and there were some reports on the importance of protein kinase C and protein tyrosine kinase activation in the production of inflammatory cytokines by endotoxin So we evaluated the effect of pretreatment of protein kinase C inhibitors (H7, Staurosporin) and protein tyrosine kinase inhibitors(Herbimycin, Genistein) on the endotoxin-stimulated cytokines(IL-8 & TNF-$\alpha$) mRNA expression. Method : Peripheral blood monocytes were isolated from healthy volunteers by Ficoll-Hypaque density gradient method and purified by adhesion to 60mm Petri dishes. Endotoxin(LPS 100ng/ml) was added to each dishes except one control dish, and each endotoxin-stimulated dishes was preincubated with H7, Staurosporin(protein kinase C inhibitor), Herbimycin or Genistein(protein tyrosine kinase inhibitor) respectively except one dish. Four hours later the endotoxin stimulation, total RNA was extracted and Northern blot analysis for IL-8 mRNA and TNF-$\alpha$ mRNA was done. Result : Endotoxin stimulation increased the expression of IL-8 mRNA and TNF-$\alpha$ mRNA expression in human peripheral blood monocyte as expected and the stimulatory effect of endotoxin on TNF-$\alpha$ mRNA expression was inhibited by protein kinase C inhibitors(H7, Staurosporin) and protein tyrosine kinase inhibitors (Herbimycin, Genistein). The inhibitory effect of each drugs was increased with increasing concentration. The stimulatory effect of endotoxin on IL-8 mRNA was also inhibited by H7 and protein tyrosine kinase inhibitors (Herbimycin, Genistein) dose-dependently but not by Staurosporin. Conclusion : Protein kinase C and protein tyrosine kinase are involved in the endotoxin induced signal transduction pathway in human peripheral blood monocyte.

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Quantification of Entacapone in Human Plasma by HPLC Coupled to ESI-MS/MS Detection: Application to Bioequavalence Study (체외에서 ESI-MS/MS 탐지에 연결된 HPLC에 의한 Entacapon의 수량화: 생물학적 동등성 연구에 적용)

  • Balasekhara Reddy., Ch.;Baburao., Ch.;Chandrasekhar., K.B.;Kanchanamala., K.;RihanaParveen., S.K.;Ravikumar., Konda
    • Journal of the Korean Chemical Society
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    • v.54 no.5
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    • pp.523-532
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    • 2010
  • The proposed method is simple, sensitive and specific Liquid chromatography-tandem mass spectrometry (LCESI-MS/MS) method for the quantification of Entacapone (EA) in human plasma using Entacapone-d10 (EAD10) as an internal standard (IS). Chromatographic separation was performed on Zorbax SB-C18, $2.1{\times}50\;mm$, $5\;{\mu}m$ column, mobile phase composed of 10 mM Ammonium formate (pH 3.0): Acetonitrile (60:40 v/v), with a flow-rate of 0.7 mL/min, followed by Liquid-liquid extraction. EA and EAD10 were detected with proton adducts at m/z $306.1{\rightarrow}233.1$ and $316.3{\rightarrow}233.0$ in multiple reaction monitoring (MRM) positive mode respectively. The method was validated over a linear concentration range of 1.00 - 2000.00 ng/mL with correlation coefficient ($r^2$) $\geq$ 0.9993. Intra and inter-day Precision within 3.60 to 7.30 and 4.20 to 5.50% and Accuracy within 97.30 to 104.20 and 98.30 to 105.80% proved for EA. This method is successfully applied in the bioequivalence study of healthy Indian human volunteers.

The Dose-Dependent Effects of Nitric Oxide on Human Sperm Cell Function (Nitric Oxide가 인간 정자세포의 기능에 미치는 효과에 대한 연구)

  • Joo, Bo-Sun;Moon, Hwa-Sook;Park, Sue-Jin;Moon, Jae-Yeoun; Cho, Jae-Dong;Kim, Han-Do
    • Clinical and Experimental Reproductive Medicine
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    • v.25 no.1
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    • pp.43-50
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    • 1998
  • This study was performed to determine the effects of nitric oxide on human sperm cell function. Semen samples were obtained from normal healthy volunteers. Motile spermatozoas collected by swim-up method were incubated up to 24 hours in Ham's F-10 medium supplemented with a various concentration of sodium nitroprusside (nitric oxide releasing agent). Sperm motility, hyperactivation, acrosome reaction rate, and acrosin activity were determined. The results are as follows; 1. 1mM of SNP resulted in a significant decrease in sperm motility ($44.8%{\pm}8.9%:78.1%{\pm}6.3%$, and hyperactivation $(10.4%{\pm}6.4%:47.7%:{\pm}9.5%)$ after incubation for 3 hours compared with the control group (Ham's F-10 alone), but had no effect on acrosome reaction. 2. At $100{\mu}M$ SNP, sperm motility was reduced after incubation for 6 hours $(54.8%{\pm}3.2%)$ compared with that of the control group $(82.7%{\pm}8.9%)$, but hyperactivation and acrosome reaction were not affected. 3. However, a lower concentration (less than $10{\mu}M$) of SNP had no effect on sperm motility and hyperactivation for 8 hours of incubation but significantly decreased them when incubation periods were increased up to 24 hours compared with the control group. On the other hand, $1{\mu}M$ and $10{\mu}M$ SNP significantly increased the acrosome reaction rate in both acrosomal status ($17.3%{\pm}5.2%$, $23.5%{\pm}4.7%$, respectively) and acrosin activity ($34.3{\mu}IU{\pm}10.5{\mu}IU,\;45.6{\mu}IU{\pm}5.6{\mu}IU$, respectively) as compared with the control group $(7.0%{\pm}4.0%,\;9.5{\mu}IU{\pm}3.4{\mu}IU)$. These results indicate that SNP, NO releasing agent, has a dose-dependent effects on the sperm cell function. Therefore it may positively affect the fertilization by promoting acrosomal reaction at a lower concentration (less than $10{\mu}M$).

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