• Journal of Pharmaceutical Investigation
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• v.40 no.2
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• pp.117-123
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• 2010

Ibudilast, 3-isobutyryl-2-isopropyrazolo[1,5-a]pyridine, is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE). It preferentially inhibits PDE 3A, PDE4, PDE10 and PDE11 as well as a number of the other PDE families, albeit to a lesser extent. Ibudilast is used clinically to treat bronchial asthma and cerebrovascular disorders. Thes e clinical uses are based on the ability of ibudilast to inhibit platelet aggregation, improve cerebral blood flow and attenuate allergic reactions. The purpose of the present study was to evaluate the bioequivalence of two ibudilast capsules, Ketas capsule (Handok Pharmaceuticals Co., Ltd.) and Pinatos capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of ibudilast from the two ibudilast formulations was tested using KP Apparatus method with various dissolution media. Twenty six healthy male subjects, 23.31${\pm}$1.09 years in age and 70.45${\pm}$8.51 kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 10 mg as ibudilast was orally administered, blood samples were taken at predetermined time intervals and the concentrations of ibudilast in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Ketas, were 6.99%, -2.48% and 9.93% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.8791~log 1.1861 and log 0.8347~log 1.1199 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Pinatos capsule was bioequivalent to Ketas capsule.

• Clinics in Shoulder and Elbow
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• v.8 no.2
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• pp.141-147
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• 2005

Purpose: The purpose of this study was to compare the effectiveness of postoperative pain control by intravenous patient-controlled analgesia (IV) to the effectiveness of postoperative pain control by continuous intra-lesional infusion of local anesthetics (IL) with or without an interscalene brachial plexus block (ISB) after arthroscopic shoulder surgery. Materials and Methods: We designed this prospective randomized case-controlled double-blind study, and allocated 84 consecutive patients to four groups according to postoperative analgesic method, i.e., Group IV, Group ISBIV, Group IL, and Group ISB-IL after arthroscopic shoulder surgery. Postoperative pain, side effects and supplemental analgesics were recorded at 1 hour and then at every 8 hours for 2 days. Result: The demographic and clinical characteristics of four groups were identical statistically. Interscalene block (Group ISB-IV, Group ISB-IL) was found to be effective at relieving pain and at reducing supplemental analgesic amounts at 1 and 8 hours postoperatively (p<0.05). Patients in the Group ISB-IL had less pain at 16 and 48 hours postoperatively than the other groups (p<0.05). Continuous intra-lesional infusion (Group IL, Group ISB-IL) was superior in reducing analgesic-related side effects (p<0.05). Conclusion: This study suggests that a combination of an interscalene brachial plexus block and continuous intralesional infusion of ropivacaine is an effective and safe method of postoperative pain control in patients after arthroscopic shoulder surgery.

• Journal of Pharmacopuncture
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• v.11 no.1
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• pp.83-97
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• 2008

Objectives : We investigated the effects of distilled Rehmannia glutinosa Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Rehmannia glutinosa Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 58 healthy volunteers consisted of 28 subjects in experiment(distilled Rehmannia glutinosa Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 28 subjects in experiment group were injected distilled Rehmannia glutinosa Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $G_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 6 subjects(2 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 26 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t-test(in group) and Student t-test(between two groups) were used to verify the result. Results : 1. After distilled Rehmannia glutinosa Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low only from 20 minute to 25 minute. HRV index is significantly high for first 5minute and from 10 minute to after 10 minute. 2. HRV index of distilled Rehmannia glutinosa Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, and pNN50 of Rehmannia glutinosa Herbal Acupuncture Group significantly decreased from 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Rehmannia glutinosa Herbal Acupuncture injection, Ln(TP) and Ln(VLF) are significantly high after injection. Normalized LF is significantly high from 5 minute to 20 minute and from 25 minute and 30 minute. Normalized HF is significantly low from 5minute to 20 minute and from 25 minute and 30 minute. 4. Ln(TP) and Ln(VLF) of distilled Rehmannia glutinosa Herbal Acupuncture Group significantly increased from 20 minute to 25 minute compared with those of Normal Saline group. Conclusions : The results suggest that Rehmannia glutinosa Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and parasympathetic nervous system compared to Normal Saline within normal range.

• The Journal of Korean Medicine
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• v.33 no.3
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• pp.1-9
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• 2012

Objectives: This research was aimed 1) to find out various subjective symptoms cancer patients had, 2) to find out the quantitative difference of symptoms occurring according to the area of cancer, current treatment methods, and relapse of the cancer and 3) to analyze the relationship between the occurrence of symptoms. Methods: This study was a survey about the various subjective symptoms cancer patients had. The subjects were 48 cancer patients in a double-blinded randomized controlled trial about the effectiveness of Korean Red Ginseng (KRG) treatments. Surveys were examined before Korean Red Ginseng (KRG) treatments. The questionnaire consisted of demographic research, patient history and accompanying symptoms. The symptoms part consisted of 4 questions on general symptoms (vertigo, hot flush, rash, insomnia), 2 questions on digestion symptoms (anorexia, dyspepsia), 2 questions on excretions (diarrhea, constipation), and 5 questions on symptoms in different body parts (headache, dryness of lips, chest pain, aphthous ulcer, nose bleeding). The questionnaire was used to research presence of symptoms and relationships between the occurrence of symptoms. Results: A total of 48 patients took part in this survey. Dizziness was the most frequent subjective symptom patients had (64.58%), followed by dry mouth (43.75%), headache (43.75%), insomnia (41.67%), anorexia (37.5%) and chest discomfort (37.5%). The presence of these subjective symptoms was partially related to the patient's history details - type of cancer, method of cancer treatment (chemotherapy, radiotherapy), termination of treatment, presence of pain, fatigue and recurrence, etc. Factor analysis was conducted to analyze the relationship between the occurrence of symptoms. It suggested 5 factors as a result, but there was a limitation that only a low level of correlation was shown among them. Conclusions: We were able to analyze the occurrences and the relationships among them for accompanying subjective symptoms in cancer patients. However the results of the study are limited in that only 48 patients participated. The symptoms in cancer patients showed a tendency for clustering, occurring simultaneously or continuously rather than occurring alone. The study of these symptom clusters is worth further study, for it is similar to the Symptom Differentiation System in Traditional Korean Medicine. For effective approach to the treatment of cancer in Traditional Korean Medicine, further research on the Korean traditional view of cancer patients should be done based on this research, regarding various symptoms and those relationships on a larger scale.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.46 no.4
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• pp.240-249
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• 2020

Objectives: Although the side effects of radiation therapy vary from mucositis to osteomyelitis depending on the dose of radiation therapy, to date, an experimental animal model has not yet been proposed. The aim of this study was to develop an animal model for assessing complications of irradiated bone, especially to quantify the dose of radiation needed to develop a rat model. Materials and Methods: Sixteen Sprague-Dawley rats aged seven weeks with a mean weight of 267.59 g were used. Atraumatic extraction of a right mandibular first molar was performed. At one week after the extraction, the rats were randomized into four groups and received a single dose of external radiation administered to the right lower jaw at a level of 14, 16, 18, or 20 Gy, respectively. Clinical alopecia with body weight changes were compared and bony volumetric analysis with micro-computed tomography (CT), histologic analysis with H&E were performed. Results: The progression of the skin alopecia was different depending on the irradiation dose. Micro-CT parameters including bone volume, bone volume/tissue volume, bone mineral density, and trabecular spaces, showed no significant differences. The progression of osteoradionecrosis (ORN) along with that of inflammation, fibrosis, and bone resorption, was found with increased osteoclast or fibrosis in the radiated group. As the radiation dose increases, osteoclast numbers begin to decrease and osteoclast tends to increase. Osteoclasts respond more sensitively to the radiation dose, and osteoblasts are degraded at doses above 18 Gy. Conclusion: A standardized animal model clinically comparable to ORN of the jaw is a valuable tool that can be used to examine the pathophysiology of the disease and trial any potential treatment modalities. We present a methodology for the use of an experimental rat model that incorporates a guideline regarding radiation dose.

• Journal of Korean Medicine for Obesity Research
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• v.4 no.1
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• pp.45-54
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• 2004

Objective: To evaluate the effect of Ephedra Sinica and Evodia Rutaecarpa on resting metabolic rate(RMR), weight and body composition in obese women during low-calorie diet. Methods: We recruited 90 healthy premenopausal women$(body\;mass\;index{\geq}25kg/m^2)$ and randomly assigned to three groups(ephedra group, evodia group and placebo group). Subjects were administered Ephedra Sinica(6g twice a day) or Evodia Rutaecarpa(6g twice a day) or placebo in a double-blind fashion and participated in low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Results: RMR change for 4 weeks was significantly higher in the ephedra group compared with the placebo group(p<.05). But the change for 8 weeks was not significant and the Evodia group showed no significant RMR change. Weight and percent body fat changes for 4 weeks and 8 weeks were significantly higher than the placebo group in the ephedra group(p<.05), but the Evodia group didn't show significant level. Conclusions: This study supports and emphasizes the benefits of herbal medicine in maintaining or increasing RMR during low-calorie diet. Especially Ephedra treatment was effective on significant maintainment of RMR, loss of weight and percent body fat(P<.05).

• YAKHAK HOEJI
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• v.49 no.6
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• pp.518-526
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• 2005

Hwanggumgung (HGG) is a hair-care product which is composed of several plant extracts used in oriental medicine. This study was carried out to investigate effect of HGG on hair regrowth in a shaving model of C57BL6 mice. Five-week-old mice were acclimated for 1 week under 23$\pm$3$^{\circ}C$, 50$\pm10\%$ relative humidity and 12 h of a light/dark cycle before beginning experiment. There were four experimental groups including distilled water (D.W., control), 10$\%$ ethanol (EtOH, vehicle control), a positive control of 3$\%$ minoxidil (MXD), and HGG for female and male mice, respectively; Six-weeks old mice were trimmed by electric clippers so as not to damage the skin. The next day; mice without visible scraches were selected, randomized and separated in groups of 11 mice. The test compounds were topically treated with 0.15ml per mouse per day for 21 days. The hair regrowth was photographically and histologically determined during the experimental period of 21 days. Enzyme activities of $\gamma$-glutamyl transpeptidase and alkaline phosphatase were also determined using a rate assay method. There were no clinical signs in all experimental groups. The topical application of 3$\%$ MXD and HGG in female mice promoted hair regrowth earlier and faster than the control groups. In male mice, the topical application of 3$\%$ MXD and HGG also accelerated hair growth compared with the controls. Ten percent ethanol also promoted hair growth faster than D.W group. The histology of hair growth in experimental groups was strongly associated with the hair regrowth. 3$\%$ MXD and HGG promoted elongation of hair follicles compared with the controls in both female and male mice. Activities of alkaline phosphatase and $\gamma$-glutamyl transpeptidase, enzymes related to hair growth, significantly increased after treatments of 3$\%$ MXD and HGG for 2 weeks in both female and male mice (p < 0.05). These results suggest that HGG has hair growth promoting activities and it can be for treatment for alopecia.

• Journal of the Korean Data and Information Science Society
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• v.27 no.1
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• pp.203-215
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• 2016

This study was performed in order to investigate the effect of breast milk on pain relief in newborn during heel lancing. Nonequivalent control group pretest-posttest design by double blinded experiment was used. 50 neonates were randomized to receive breast milk (experimental group, n=25) or no treatment (control group, n=25) before undergoing heel lancing. Informed consent was obtained from parents of 50 neonates. Neonatal infant pain scale (NIPS), respiration rate, heart rate, oxygen saturation, and crying duration were used to assess subjects' pain reaction. Data were analyzed using SPSS 18.0. The experimental and control group showed a statistically significant differences in NIPS score (F=28.89, p<.001), heart rate (F=14.03, p<.001), respiration rate (F=4.79, p=.001), oxygen saturation (F=2.69, p=.027), and crying duration (t=-8.78, p <.001) at each time points (during heel lancing, right after heel lancing, 1, 2, 3 minutes after heel lancing). The result suggest that oral administration of expressed breast milk is safe and natural agents for reducing procedural pain of neonates. Another clinical trial study with more samples is recommended.

• The Journal of Korean Academy of Sensory Integration
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• v.15 no.2
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• pp.93-106
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• 2017

Objective : The purpose of this study is to provide an evidence for clinical practice by systemic analysis on occupational therapy interventions for improvement of children's play. Methods : Articles used in this study were collected from database of Pubmed, ProQuest, EBSCOhost, Scopus, RISS, KISS, and National Library of Korea. The key words used in the search were "Play AND Occupational Therapy AND (Intervention OR Treatment)" and the publication period was limited from January 2007 to April 2017. 11 articles in total were selected for the systematic review analysis. Results : The results revealed that the majority of studies was one-group non-randomized study and the majority of intervention used was play-based intervention in case of that play itself was the intervention goal. The most frequently used environment for the intervention was parallel setting of home and treatment room. The majority of studies was for children with ADHD and the most commonly used assessment tool was Test of Playfulness (ToP). Dependent variables measured along with play were language skills, social interactive skills, communication and pragmatic skills, problem-solving skills, caregiver responsiveness, and parent-child interaction. Conclusion : This study help to understand the current state of occupational therapy intervention for improvement of children's play. Starting with the understanding, it is expected that various studies on play of children will be done in the future.

• Clinical and Experimental Reproductive Medicine
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• v.26 no.1
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• pp.75-81
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• 1999

The beneficial effect of glucose and phosphate ions in culture medium on the development of human embryos in vitro has not been fully elucidated. The purpose of this study was to evaluate the influence of fertilization and culture of embryos in glucose/phosphate-free m-TALP medium on pregnancy rates in IVF-ET program. The patients in 244 IVF-ET cycles received GnRH agonist + HMG regimens. A does of 10,000 IU HCG was administered when two or more dominent follicles reached 18mm in diameter. Thirty-six hours after HCG, oocytes were recovered transvaginally using ultrasound guidance. Aspirated oocytes were matured for 4 to 6 h in TCM-199 supplemented with 10% follicular fluid (FF). Insemination was carried out with 50,000 motile spermatozoa in TCM-199 + 10% FF or m-TALP + 5% FF + 5% fetal cord serum (FCS) according to experimental design. After 6 h, oocytes were washed 3 to 4 times and cultured in each fresh medium. After 20 h, oocytes were freed from cumulus/corona cells and examined for the presence of pronuclei. Fertilized oocytes were transferred into each co-culture drops and cultured for further incubation. On day 3, embryo transfer was performed with grade 1 and 2 embryos. Monolayers for co-culture of embryos were prepared by plating $1{\times}10^5$ cumulus cells/ml in 10ul drop of TCM-199 + 10% FF or m-TALP + 5% FF + 5% FCS media 24 h prior to the onset of co-culture. Development to 4 to 16 cell stage was observed at 70x magnification following two days of incubation. Pregnancy was confirmed by detecting increasing serum ${\beta}$-hCG concentrations for 11 days following embryo transfer. Data were analyzed by ${\chi}^2$-test. Oocytes from 244 IVF-ET cycles were randomized. The number of cycles and mean age of patients were 97 and 147, 31.3 yrs and 31.2 yrs for TCM-199 (control) and m-TALP groups, respectively. The mean number of retrieved oocytes/cycle, fertilization rates, number of embryos transferred/ET and pregnancy rates were 11.1 and 10.3, 65.1% and 67.3%, 4.1 and 4.7, 28.9% and 43.8% for TCM-199 and m-TALP groups, respectively. Differences in the pregnancy rates were found between control and m-TALP groups (p<0.05). The pregnancy rate of patients divided according to maternal age groups of ${\leq}30$, 31-35, $36{\leq}$ were 44.4% and 49.0%, 26.1% and 41.3%, 29.2% and 41.2% for control and m-TALP groups, respectively. These data indicate that culture of human embryos in glucose/phosphate-free m-TALP medium improves pregnancy rates.