• Clinical and Experimental Pediatrics
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• v.58 no.9
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• pp.347-353
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• 2015

Purpose: The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD). Methods: The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study. Results: The incidence of moderate to severe BPD was not different between the groups (case group: 13 of 30 [43.3%] vs. control group: 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group: 10 of 42 [23.8%] vs. control group: 6 of 48 (15.8%), P=0.414). Conclusion: Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.

• The Journal of Internal Korean Medicine
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• v.27 no.2
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• pp.480-487
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• 2006

Objectives : In this study we investigated BDI(Beck Depression Inventory) improvement of poststroke depression Patients who took the acupuncture with aromatherapy, in order to examine its capacity as a new treatment and to establish a primary data for further studies of developments of diverse Practical acupunctures. Methods : Physicians applied the acupuncture with aromatherapy every day for two weeks. We had evaluated baseline characteristics and BDI of all Patients, and revaluated BDI and examined the side effects two weeks later. The qualified Patients were classified into two groups, depression group (more than 10 points and 10 in BDI) and non-depression group (less than 10 points in BDI) according to the baseline BDI. Results : The study was completed with 27stroke patients. The acupuncture with aroma therapy was applied in 18 post-stroke depression patients and 9 non-depression patients for 2 weeks. And the result showed that the BDI scores in the depression group decreased to $16.5{\pm}11.1$ after the treatment (compared to $24.4{\pm}11.5$ before the treatment). so proved the significant effect on post-stroke depression of the acupuncture. On the other hand. the scores in the non-depression group increased to $9.2{\pm}9.5$ (compared to $3.3{\pm}3.0$). Conclusions : The acupuncture with aromatherapy applied on post-stroke depression patients showed the effect of BDI improvement. Further researches are needed to evaluate the distinct functional mechanism of acupuncture with aromatherapy, and to estimate its effectiveness by well-designed randomized controlled trial.

• Archives of Plastic Surgery
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• v.44 no.6
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• pp.482-489
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• 2017

Background Polydeoxyribonucleotide (PDRN) is known to have anti-inflammatory and angiogenic effects and to accelerate wound healing. The aim of this study was to investigate whether PDRN could improve peripheral tissue oxygenation and angiogenesis in diabetic foot ulcers. Methods This was a prospective randomized controlled clinical trial. Twenty patients with a non-healing diabetic foot ulcer were randomly distributed into a control group (n=10) and a PDRN group (n=10). Initial surgical debridement and secondary surgical procedures such as a split-thickness skin graft, primary closure, or local flap were performed. Between the initial surgical debridement and secondary surgical procedures, 0.9% normal saline (3 mL) or PDRN was injected for 2 weeks by the intramuscular (1 ampule, 3 mL, 5.625 mg, 5 days per week) and perilesional routes (1 ampule, 3 mL, 5.625 mg, 2 days per week). Transcutaneous oxygen tension ($TcPO_2$) was evaluated using the Periflux System 5000 with $TcPO_2/CO_2$ unit 5040 before the injections and on days 1, 3, 7, 14, and 28 after the start of the injections. A pathologic review (hematoxylin and eosin stain) of the debrided specimens was conducted by a pathologist, and vessel density (average number of vessels per visual field) was calculated. Results Compared with the control group, the PDRN-treated group showed improvements in peripheral tissue oxygenation on day 7 (P<0.01), day 14 (P<0.001), and day 28 (P<0.001). The pathologic review of the specimens from the PDRN group showed increased angiogenesis and improved inflammation compared with the control group. No statistically significant difference was found between the control group and the PDRN group in terms of vessel density (P=0.094). Complete healing was achieved in every patient. Conclusions In this study, PDRN improved peripheral tissue oxygenation. Moreover, PDRN is thought to be effective in improving inflammation and angiogenesis in diabetic foot ulcers.

• The Journal of Korean Physical Therapy
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• v.23 no.2
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• pp.37-43
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• 2011

Purpose: The purpose of this study was to determine the effects of chest resistance exercise on Forced Expiratory Volume per second and on fatigue in patients with chronic obstructive pulmonary disease (COPD). Methods: In all, 62 male patients with COPD were included in this study. The experimental group included 32 patients who were treated with chest resistance exercise using the PNF technique with medication. The control group included 30 patients who were treated only with medication. Subjects were stratified into the 2 groups by randomized clinical sampling. Before the start of the experiment, forced expiratory volume at the first second (FEV1) and lactic acid were tested in both experimental and control groups. The experimental group did chest resistance exercise for 6 weeks, 4 times per week, 30 min per day, and the effects of this exercise in patients with COPD was determined by comparing the results of FEV1 and lactic acid tests before and after the experiment between and within the experimental and control groups. Results: There was a statistically significant within group difference for FEV1 MEAS and FEV1 %PRED. There was statistically significant control group of FEV1 MEAS and FEV1 %PRED There was a statistically significant difference in the experimental group for fatigue, comparing scores before and after the test. There was a statistically significant control group of fatigue, in comparison of between the groups of FEV1 MEAS, FEV1 %PRED, fatigue(p<0.01)(p<0.05). Conclusion: More research on COPD will be necessary for improving pulmonary function and reducing fatigue. Further studies on COPD will be required for improving pulmonary function and reducing of fatigue.

• 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).