• Journal of East-West Nursing Research
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• v.15 no.2
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• pp.82-90
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• 2009

Purpose: The purpose of this study was to compare the degree of preoperative anxiety and postoperative pain among volunteer and non-volunteer donors in living liver transplantation. Methods: The 32 volunteer and 32 non-volunteer donors were recruited from a university hospital after obtaining research approval. The data were analyzed by $x^2$, t, ANOVA tests and Pearson's correlation coefficients using SPSS 12.0 program. Results: There were no significant differences in pre-operative anxiety between the two groups. However, the non-volunteer donors had significantly more severe pain for 3 post-operative days, measured by visual analogue scale (VAS) and non-verbal pain behavior scale (non-VPBS), compared to that of the volunteer donors. There was a significant correlation between preoperative state anxiety and postoperative non-VPBS score. Conclusions: These results showed that liver donors who belonged to the non-volunteer group needed much more active postoperative pain management and psychological support than the volunteer group.

• The Journal of Korean Obstetrics and Gynecology
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• v.32 no.2
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• pp.29-49
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• 2019

Objectives: This study was a methodological study to verify the reliability and validity and to make a diagnosis of a diagnostic tool for climacteric and postmenopausal syndrome pattern identification (CaPSPI). Methods: This study was conducted from June 1, 2018 to October 18, 2018 with ${{\bigcirc}{\bigcirc}}$ University Korean Medicine Hospital IRB's approval (2018-3). To make a diagnosis using CaPSPI, we decided the cut-points for the tool. Three professors of ${{\bigcirc}{\bigcirc}}$Korean Medical University conducted pattern identification diagnosis. The result is marked from 0 to 3, 0 is 'No', 1 is 'Slightly Yes', 2 is 'Yes' and 3 is 'Very Yes'. And if two or more professors' diagnoses are the same, we took the diagnoses as a diagnostic criteria. The decision of pattern by three experts converted to 0-1 scores in two ways. In "method 1", if the diagnosis was zero points, the score was 0 (have no such identification), and the rest was 1 (have such identification). In "method 2", if the diagnosis was zero or 1 point, the score was 0, and the rest was 1. After that, intraclass correlation was calculated for experts agreement. And logistic regression was conducted. A response variable was the results of the experts' diagnosis and an explanatory variable was the results of the pattern identification diagnostic tool. Results: The diagnosis of the three experts showed excellent concordance of more than 0.794 and showed a significant correlation with the diagnostic tool. Both 'Method 1' and 'Method 2' showed statistically significant effects with the diagnosis of 3 experts and the results of the diagnostic tool. The frequency of cumulative pattern identification diagnosis in 'Method 1' and 'Method 2' were found to be 578 occasions and 203 occasions, respectively. The average number of pattern held by participants in 'Method 1' and 'Method 2' were found to be 5.26 and 1.85, respectively. In both "Method 1" and "Method 2," the yield frequency of liver qi depression was the highest, and the frequency of kidney yin deficiency and liver-kidney yin deficiency was relatively high. Conclusions: Based on the above results, it is thought that, in diagnosis using CaPSPI of menopausal women, 'method 1' could be used for the health diagnosis and prevention, 'method 2' could be used for the pattern diagnosis. On the conclusion, CaPSPI is thought to be available for pattern diagnosis of menopause women.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.33 no.3
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• pp.27-44
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• 2020

Objectives : The authors conducted randomized, Double-blinded, and placebo-controlled parallel-group clinical experiment study to evaluate efficacy of fermented soybean(Bio-Peptone)cream in pruritus. Methods : The research had been conducted for 4 months from the date of IRB approval(May 26 in 2017) to Sept 2017. The experiment started by randomly distributing 25 subjects with pruritus into experimental group and control group, respectively. The experimental group applied fermented soybean(Bio-Peptone)cream twice a day, in the morning and evening, for one week on itchy area. The effect of the product was evaluated by comparing the PSS(Patient subjective score), moisture level by measuring skin moisture content(Corneometer) and transepidermal water loss(Tewameter), and the Korean version of Skindex-29(index of quality of life improvement) before applying the cream, after applying the cream for one week and after stop applying the cream for one week. The control group conducted identical experiment with the experimental group, except the control group applied placebo instead of the fermented soybean(Bio-Peptone)cream. Results : Pruritus, criterion of the first validation testing, indicates fermented soybean(Bio-Peptone)cream tend to reduce pruritus compare to placebo, although the result is not statistically noticeable. Significant difference in reduction of prutitus, the second validation test was not discovered in both groups. Corneometer and life quality tend to be improved with soy cream than placebo, but not statistically effective and both groups did not show any difference in terms of Tewameter measurement. Conclusions : The result of clinical experiment didn't prove that the fermented soybean(Bio-Peptone)cream is more effective in reducing pruritus than placebo, statistically. The clinical use of soybean product for pruritus requires further studies to be verified.

• Journal of Pharmacopuncture
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• v.19 no.4
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• pp.350-358
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• 2016

Objectives: This study was carried out to analyze the single dose toxicity of ShinEumHur (SEH) pharmacopuncture injected into the muscles of Sprague-Dawley rats. Methods: The SEH pharmacopuncture was made in a clean room at the Korean Pharmacopuncture Institute (K-GMP). After the mixing process with sterile distilled water had been completed, the pH was controlled to between 7.0 and 7.5. All experiments were conducted at Biotoxtech, an institution authorized to perform non-clinical studies under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen for the pilot study. Doses of SEH pharmacopuncture, 0.25, 0.5 and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. We examined the survival rate, weights, clinical signs, mean hematology parameters, mean clinical chemistry, necropsy and histopathological findings. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The above findings suggest that treatment with SEH pharmacopuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

• Journal of Pharmacopuncture
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• v.18 no.1
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• pp.63-71
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• 2015

Objectives: This study was carried out to analyze the single-dose toxicity of Eun-Bi San pharmacopuncture injected into the muscle of Sprague-Dawley (SD) rats. Methods: All experiments were performed at Biotoxtech, an institution certified to conduct non-clinical studies under the Good Laboratory Practice (GLP) regulations. Six week old SD rats reared by ORIENTBIO were chosen for this pilot study. The reason SD rats were chosen is that they have been widely used in safety tests in the field of medicine, so the results can be easily compared with many other databases. The Eun-Bi San pharmacopuncture was made in a clean room at the Korean Pharmacopuncture Institute (KPI, K-GMP). The constituents of the Eun-Bi San pharmacopuncture are Angelicae gigantis radix, Strychni semen and Glycyrrhizae radix. These were extracted at low temperature and low pressure in an aseptic room at the KPI. Doses of Eun-Bi San pharmacopuncture, 0.25, 0.5 and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was performed under the approval of the Institutional Animal Ethics Committee of Biotoxtech Co., Ltd. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To determine if abnormalities existed in any organs and tissues, we used microscopy to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The results of this study suggest that treatment with Eun-Bi San pharmacopuncture is relatively safe and that its clinical use may be beneficial. Further evaluations and studies on this subject will be needed to provide more concrete evidence in support of these conclusions.

• Journal of Acupuncture Research
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• v.33 no.1
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• pp.1-7
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• 2016

Objectives : This study was conducted to analyze the single dose toxicity of Mecasin (Gami-Jakyak Gamcho buja Decoction) herbal acupuncture administered in the vein of Sprague-Dawley rats. Methods : All experiments were performed at the Medvill, an institution licensed to conduct nonclinical studies, under the Good Laboratory Practice (GLP) regulations. Sprague-Dawley rats were chosen in this pilot study. In the experiment, Sprague-Dawley rats were divided into four groups of five male and five female animals per group. Doses of Mecasin herbal acupuncture, at 0, 500, 1,000, and 2,000 mg/kg, were given to the experimental groups, and a dose of normal saline solution, at 2 ml/kg, was administered to the control group. Mecasin herb acupuncture and normal saline were injected into the vein at once, and we observed mortality, clinical signs, weights, and gross findings for 14 days after injection. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results : There is no death or abnormality in any of the four groups. All groups put on weights favorably. There are no significant gross findings in necropsy examinations. Conclusions : The above results showed that intravenous injection of 500-2,000 mg/kg of Mecasin herb acupuncture did not cause any changes in weight or, in the results of necropsy examinations, in mortalities. Therefore, the toxicity of Mecasin herb acupuncture was not confirmed, and the presumptive lethal dose of Mecasin herb acupuncture was higher than 2,000 mg/kg. The outcomes suggest that treatment with Mecasin herbal acupuncture is relatively safe. Further evaluations on this subject are needed to yield more concrete evidence.

• The Journal of Korean Medicine
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• v.44 no.1
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• pp.128-128
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• 2023

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• The Journal of Korean Obstetrics and Gynecology
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• v.32 no.1
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• pp.73-84
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• 2019

Objectives: The purpose of this study is to collect and analyze the KCD codes applied to the treatment of 27 postpartum women who had been treated with Korean traditional medicine in a Korean medicine hospital, so that this study may be used as a basic data for setting the direction of postpartum Korean medical treatment research. Methods: It was approved by the Institutional Review Board (IRB) of ${\bigcirc}{\bigcirc}$ University medical center (IRB approval number : WSOH IRB H1708-02-01). Twenty-seven postpartum women who had been treated at ${\bigcirc}{\bigcirc}$ University medical center were received outpatient treatment for two weeks (from September 27, 2017 to January 5, 2018), and the KCD codes applied to the mothers were collected after obtaining the consent. On the day of registration of the study, the fertility, obstetric history and high-risk pregnancies were identified through an interview. Results: 1. The mean age of the 27 subjects was $33.33{\pm}3.99\;years$ old. Among the subjects, 17 mothers (63.0%) were high-risk pregnancy and 10 mothers (37.0%) were normal. 2. Among the 22 major disease categories, 8 categories were used. M code (musculoskeletal system) was used 243 times (70.85%), followed by R code (unclassified symptom) of 51 times (14.87%) and U code (special purpose code) of 23 times (6.71%). 3. The most commonly used code among the ten frequently used codes was M25.57 (joint pain, ankle and foot), a total of 47 times. Of the remaining nine codes, except for R60.1 (systemic edema) and U68.4 (The deficiency of yang in Bi), all codes were M codes (musculoskeletal system). 4. The M code (musculoskeletal system) was the most used major disease category in high-risk group, a total of 159 times. But in specific categories, the most commonly used code was R60.1 (systemic edema), a total of 28 times. 5. In normal group, the M code (musculoskeletal system) was the most used major disease category, a total of 84 times. Also, in specific categories, the most commonly used code was M25.57 (joint pain, ankle and foot), total 29 times. 6. The U code, corresponding to 'the diagnosis of childbirth and other obstetrical medical use', was used 23 times (6.71%), O code three times (0.87%) and Z code two times (0.58%), which was less than 10% of the total number of codes used. Conclusion: When analyzing KCD codes related to Korean medicine treatment for postpartum diseases, it is important to select the KCD codes that reflect the actual clinical state.

• Asian Pacific Journal of Cancer Prevention
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• v.15 no.21
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• pp.9101-9105
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• 2014

Background: The purpose of this study was to compare the accuracy and effectiveness of automated breast volume scanning (ABVS) and hand-held ultrasound (HHUS) in the detection of breast cancer in a large population group with a long-term follow-up, and to investigate whether different ultrasound systems may influence the estimation of cancer detection. Materials and Methods: Institutional review board approval was obtained for this retrospective study, and informed consent was waived. From September 2010 to August 2011, a total of 1,866 ABVS and 3,700 HHUS participants, who underwent these procedures at our institute, were included in this study. Cancers occurring during the study and subsequent follow-up were evaluated. The reference standard was a combination of histology and follow-up imaging (${\geq}12months$). The recall rate, cancer detection yield, diagnostic accuracy, sensitivity, specificity, and positive (PPV) and negative (NPV) predictive values were calculated with exact 95% confidence intervals. Results: The recall rate was 2.57 per 1,000 (48/1,866) for ABVS and 3.57 per 1,000 (132/3,700) for HHUS, with a significant difference (p=0.048). The cancer detection yield was 3.8 per 1,000 for ABVS and 2.7 per 1,000 for HHUS. The diagnostic accuracy was 97.7% for ABVS and 96.5% for HHUS with statistical significance (p=0.018). The specificity of ABVS and HHUS were 97.8%, 96.7%, respectively (p=0.022). Conclusions: ABVS shows a comparable diagnostic performance to HHUS. ABVS is an effective supplemental tool for mammography in breast cancer detection in a large population.

• The Journal of the Acoustical Society of Korea
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• v.41 no.5
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• pp.570-588
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• 2022

We scrutinized the acoustic outputs from the 70 shock wave generators of the 15 product models whose technical documents were available, among the 46 ballistic extracorporeal shock wave therapeutic devices of 11 domestic and 6 foreign manufacturers, approved by the Minster of Food & Drug Safety (Rep. Korea). We found that the acoustic Energy Flux Density (EFD), the most popular exposure parameter, was different by up to 563.64 times among shock wave generators at their minimum output settings and by up to 74.62 times at their maximum settings. In the same product model, the EFD was shown to vary depending on shock wave transmitters by up to 81.82 times at its minimum output setting and by up to 46.15 times at its maximum setting. The lowest EFD 0.013 mJ/mm² at the maximum output settings was much lower (2.1 %) than the maximum value 0.62 mJ/mm² at the minimum settings. The Large acoustic output differences (tens to hundreds of times)from the therapeutic devices approved for the same clinical indications imply that their therapeutic efficacy & safety may not be assured. The findings suggest the regulatory authority to revise her guideline to give clearer criteria for clinical approval and equality in performance, and recommend the authority to initiate a post-approval surveillance as well as a test in conformance between the data in technical documents and the real acoustic outputs clinically used.