With the increased use of cell therapy in the veterinary sector, there is a growing demand for the development of cell-based medicinal products and the determination of their safety. Currently, the Korean Animal and Plant Quarantine Agency has established a guideline for evaluating the safety of cell-based medicinal products for animal use. The guideline includes items related to definition, classification, management, manufacturing procedure and quality control (standard and test method), stability testing, toxicity testing, pharmacological testing, and performance of clinical trials. In addition, testing protocols related to safety assessment of animal cell-based products such as chromosome karyotyping, tumorigenicity testing, confirmatory testing of biodistribution and kinetics, and target animal safety testing are described in detail. Moreover, because cell-based medicinal products are novel therapies, deviations from traditional designs may be justified in order to obtain relevant safety information on the treatment. Additionally, this guideline can be amended on the basis of new scientific findings.
Animals ; Carcinogenicity Tests ; Cell- and Tissue-Based Therapy ; Classification ; Karyotyping ; Kinetics ; Plants ; Quality Control ; Quarantine ; Toxicity Tests

BACKGROUND/AIMS: Transradial intervention (TRI) is becoming the preferred method over transfemoral intervention (TFI) because TRI is associated with lower incidence of major bleeding and vascular complications. However, there has been limited published data regarding the clinical outcomes of TRI versus TFI in Korean patients with ST-elevation myocardial infarction (STEMI). METHODS: A total of 689 consecutive STEMI patients who underwent primary percutaneous coronary intervention (PCI) with drug-eluting stents (DESs) from January to December of 2009 at nine university hospitals were enrolled in this study. Mid-term angiographic and 12-month cumulative clinical outcomes of the TRI group (n = 220, 31.9%) were compared to those of the TFI group (n = 469, 28.1%). RESULTS: After propensity score matching, in-hospital complications and the 12-month major clinical outcomes during follow-up in the two groups were similar to each other. However, the incidence rates of repeat revascularization (6.4% vs. 0.5%, p = 0.003), target vessel revascularization (6.4% vs. 0.5%, p = 0.003), and major adverse cardiac events (MACE; 11.6% vs. 4.6%, p = 0.018) in the TFI group were higher than those in the TRI group during the 12-month of follow-up. CONCLUSIONS: In our study, TRI in STEMI patients undergoing primary PCI with DESs was associated with lower incidence of access site hematoma, 12-month repeat revascularization, and MACE compared to TFI. Therefore, TRI might play an important role in reducing bleeding complications while improving major clinical outcomes in STEMI patients undergoing primary PCI with DESs.
Drug-Eluting Stents ; Follow-Up Studies ; Hematoma ; Hemorrhage ; Hospitals, University ; Humans ; Incidence ; Methods ; Myocardial Infarction* ; Percutaneous Coronary Intervention ; Propensity Score

BACKGROUND/OBJECTIVES: Benign prostatic hypertrophy (BPH) is a major cause of abnormal overgrowth of the prostate mainly in the elderly. Corni Fructus has been reported to be effective in the prevention and treatment of various diseases because of its strong antioxidant effect, but its efficacy against BPH is not yet known. This study was designed to evaluate the therapeutic efficacy of Corni Fructus water extract (CF) in testosterone-induced BPH rats. MATERIALS/METHODS: To induce BPH, rats were intraperitoneal injected with testosterone propionate (TP). Rats in the treatment group were orally administered with CF with TP injection, and finasteride, which is a selective inhibitor of 5α-reductase type 2, was used as a positive control. RESULTS: Our results showed that the increased prostate weight and histopathological changes in BPH model rats were suppressed by CF treatment. CF, similar to the finasteride-treated group, decreased the levels of testosterone and dihydrotestosterone by TP treatment in the serum, and it also reduced 5α-reductase expression and concentration in prostate tissue and serum, respectively. In addition, CF significantly blocked the expression of the androgen receptor (AR), AR co-activators, and proliferating cell nuclear antigen in BPH rats, and this blocking was associated with a decrease in prostate-specific antigen levels in serum and prostate tissue. CONCLUSIONS: These results suggest that CF may weaken the BPH status through the inactivation of at least 5α-reductase and AR activity and may be useful for the clinical treatment of BPH.
Aged ; Animals ; Antioxidants ; Cornus* ; Dihydrotestosterone ; Finasteride ; Humans ; Proliferating Cell Nuclear Antigen ; Prostate ; Prostate-Specific Antigen ; Prostatic Hyperplasia* ; Rats* ; Receptors, Androgen* ; Testosterone ; Testosterone Propionate ; Water

BACKGROUND: Because conventional echocardiographic parameters have several limitations, strain echocardiography has often been introduced in clinical practice. However, there are also obstacles in using it in clinical practice. Therefore, we wanted to find the current status of awareness on using strain echocardiography in Korea. METHODS: We conducted a nationwide survey to evaluate current use and awareness of strain echocardiography from the members of the Korean Society of Echocardiography. RESULTS: We gathered total 321 questionnaires from 25 cardiology centers in Korea. All participants were able to perform or interpret echocardiographic examinations. All participating institutions performed strain echocardiography. Most of our study participants (97%) were aware of speckle tracking echocardiography and 185 (58%) performed it for clinical and research purposes. Two-dimensional strain echocardiography was the most commonly used modality and left ventricle (LV) was the most commonly used cardiac chamber (99%) for clinical purposes. Most of the participants (89%) did not think LV strain can replace LV ejection fraction (LVEF) in their clinical practice. The common reasons for not performing routine use of strain echocardiography was diversity of strain measurements and lack of normal reference value. Many participants had a favorable view of the future of strain echocardiography. CONCLUSION: Most of our study participants were aware of strain echocardiography, and all institutions performed strain echocardiography for clinical and research purposes. However, they did not think the LV strain values could replace LVEF. The diversity of strain measurements and lack of normal reference values were common reasons for not using strain echocardiography in clinical practice.
Cardiology ; Echocardiography* ; Heart Ventricles ; Korea* ; Reference Values

OBJECTIVE: To analyze the factors related to urinary tract infection (UTI) occurrence after an urodynamic study (UDS) in patients with spinal cord injury (SCI). METHODS: We retrospectively investigated the medical records of 387 patients with SCI who underwent UDS with prophylactic antibiotic therapy between January 2012 and December 2012. Among them, 140 patients met the inclusion criteria and were divided into two groups, UTI and non-UTI. We statistically analyzed the following factors between the two groups: age, sex, level of injury, SCI duration, spinal cord independence measure, non-steroidal anti-inflammatory drug use, diabetes mellitus, the American Spinal Injury Association impairment scale (AIS), lower extremity spasticity, a history of UTI within the past 4 weeks prior to the UDS, symptoms and signs of neurogenic bladder, urination methods, symptoms during the UDS and UDS results. RESULTS: Among the 140 study participants, the UTI group comprised 12 patients and the non-UTI group comprised 128 patients. On univariate analysis, a history of UTI within the past 4 weeks prior to the UDS was significant and previous autonomic dysreflexia before the UDS showed a greater tendency to influence the UTI group. Multivariable logistic regression analysis using these two variables showed that the former variable was significantly associated with UTI and the latter variable was not significantly associated with UTI. CONCLUSION: In patients with SCI, a history of UTI within the past 4 weeks prior to the UDS was a risk factor for UTI after the UDS accompanied by prophylactic antibiotic therapy. Therefore, more careful pre-treatment should be considered when these patients undergo a UDS.
Autonomic Dysreflexia ; Diabetes Mellitus ; Humans ; Logistic Models ; Lower Extremity ; Medical Records ; Muscle Spasticity ; Retrospective Studies ; Risk Factors ; Spinal Cord Injuries* ; Spinal Cord* ; Spinal Injuries ; Urinary Bladder, Neurogenic ; Urinary Tract Infections* ; Urinary Tract* ; Urination ; Urodynamics*

BACKGROUND: Hemodynamic and functional evaluation with Doppler and tissue Doppler study as a part of comprehensive echocardiography is essential but normal reference values have never been reported from Korean normal population especially according to age and sex. METHODS: Using Normal echOcaRdiographic Measurements in a KoreAn popuLation study subjects, we obtained normal reference values for Doppler and tissue Doppler echocardiography including tricuspid annular velocities according to current guidelines and compared values according to gender and age groups. RESULTS: Mitral early diastolic (E) and late diastolic (A) velocity as well as E/A ratio were significantly higher in women compared to those in men. Conversely, mitral peak systolic and late diastolic annular velocity in both septal and lateral mitral annulus were significantly lower in women compared to those in men. However, there were no significant differences in both septal and lateral mitral early diastolic annular (e') velocity between men and women. In both men and women, mitral E velocity and its deceleration time as well as both E/A and E/e' ratio considerably increased with age. There were no significant differences in tricuspid inflow velocities and tricuspid lateral annular velocities between men and women except e' velocity, which was significantly higher in women compared to that in men. However, changes in both tricuspid inflow and lateral annular velocities according to age were similar to those in mitral velocities. CONCLUSION: Since there were significant differences in Doppler and tissue Doppler echocardiographic variables between men and women and changes according to age were even more considerable in both gender groups, normal Doppler echocardiographic values should be differentially applied based on age and sex.
Deceleration ; Echocardiography* ; Echocardiography, Doppler ; Female ; Hemodynamics ; Humans ; Male ; Reference Values

PURPOSE: The purpose of this study is to assess the utility of positron emission tomography (PET) for predicting recurrence among patients with T1-T2/N1 breast cancer who were treated with mastectomy. MATERIALS AND METHODS: Of 712 consecutive patients with T1-T2/N1 breast cancer treated during 2003-2012, 109 had undergone preoperative 18F-fluorodeoxyglucose/PET and were included. Metabolic (maximum standardized uptake value [SUVmax]), volumetric (metabolic tumor volume [MTV]), and combined (total lesion glycolysis [TLG]) indices were measured. The resulting values were analyzed and compared with clinical outcome. RESULTS: At the median follow-up of 46.7 months, the 3-year relapse-free survival (RFS) rate was 95.2%. SUVmax (area under curve, 0.824) was more useful than MTV or TLG as a means of identifying patients at high risk for any recurrence. In multivariate analysis, SUVmax remained an independent risk factor for RFS (p=0.006). Using the method of Contal and O'Quigley, a SUVmax threshold of 5.36 showed the best predictive performance. The PET-based high-risk group (≥ 5.36 in either breast or nodes) had more T1c-T2, high-grade, hormone-receptor negative, and invasive ductal carcinoma tumors than the low-risk group (< 5.36 in both breast and nodes). The prognosis was much worse when high SUVmax (≥ 5.36) was detected in nodes (p < 0.001). In the no-radiotherapy cohort, the PET-based high-risk group had increased risk of locoregional recurrence when compared to the low-risk group (p=0.037). CONCLUSION: High SUVmax on preoperative PET showed association with elevated risk of locoregional recurrence and any recurrence. Pre-treatment PET may improve assessments of recurrence risk and clarify indications for post-mastectomy radiotherapy in this subset of patients.
Breast Neoplasms* ; Breast* ; Carcinoma, Ductal ; Cohort Studies ; Follow-Up Studies ; Glycolysis ; Humans ; Lymph Nodes* ; Mastectomy* ; Multivariate Analysis ; Positron-Emission Tomography ; Prognosis ; Radiotherapy ; Recurrence* ; Risk Factors ; Tumor Burden

BACKGROUND: It is important to understand the distribution of 2-dimensional strain values in normal population. We performed a multicenter trial to measure normal echocardiographic values in the Korean population. METHODS: This was a substudy of the Normal echOcardiogRaphic Measurements in KoreAn popuLation (NORMAL) study. Echocardiographic specialists measured frequently used echocardiographic indices in healthy people according to a standardized method at 23 different university hospitals. The strain values were analyzed from digitally stored images. RESULTS: Of a total of 1003 healthy participants in NORMAL study, 2-dimensional strain values were measured in 501 subjects (265 females, mean age 47 ± 15 years old) with echocardiographic images only by GE echocardiographic machines. Interventricular septal thickness, left ventricular (LV) posterior wall thickness, systolic and diastolic LV dimensions, and LV ejection fraction were 7.5 ± 1.0 mm, 7.4 ± 1.0 mm, 29.9 ± 2.8 mm, 48.9 ± 3.6 mm, and 62 ± 4%, respectively. LV longitudinal systolic strain (LS) values of apical 4-chamber (A4C) view, apical 3-chamber (A3C) view, apical 2-chamber (A2C) view, and LV global LS (LVGLS) were −20.1 ± 2.3, −19.9 ± 2.7, −21.2 ± 2.6, and −20.4 ± 2.2%, respectively. LV longitudinal systolic strain rate (LVLSR) values of the A4C view, A3C view, A2C view, and LV global LSR (LVGLSR) were −1.18 ± 0.18, −1.20 ± 0.21, −1.25 ± 0.21, and −1.21 ± 0.21(−s), respectively. Females had lower LVGLS (−21.2 ± 2.2% vs. −19.5 ± 1.9%, p < 0.001) and LVGLSR (−1.25 ± 0.18(−s) vs. −1.17 ± 0.15(−s), p < 0.001) values than males. CONCLUSION: We measured LV longitudinal strain and strain rate values in the normal Korean population. Since considerable gender differences were observed, normal echocardiographic cutoff values should be differentially applied based on sex.
Echocardiography* ; Female ; Healthy Volunteers ; Heart Ventricles* ; Hospitals, University ; Humans ; Male ; Methods ; Multicenter Studies as Topic ; Reference Values ; Specialization

We experienced anaphylaxis during general anesthesia twice in the same patient. After the first incidence of anaphylaxis at the induction of anesthesia, we speculated that the allergen was rocuronium. Thus, we administered sugammadex as well as a vasopressor to treat the anaphylaxis and the vital signs gradually recovered to nearly normal. Thereafter, we could not avoid the administration of another muscle relaxant, cisatracurium, since the patient moved uncontrollably after the surgery was restarted. A second anaphylactic event then occurred. We speculated that the second allergen was cisatracurium and stopped using it. The results of the investigation after the surgery showed that the allergens were indeed rocuronium and cisatracurium. When we encounter anaphylaxis during general anesthesia, it is necessary to suspect all administered medicines as the cause, with the potential of two or more causes, especially with muscle relaxants.
Allergens ; Anaphylaxis* ; Anesthesia ; Anesthesia, General* ; Humans ; Incidence ; Intradermal Tests ; Vital Signs

For patients refusing surgical treatment for deep early gastric cancer, hybrid natural orifice transluminal endoscopic surgery with sentinel lymph node navigation is a potential treatment option, particularly when the anatomic location of the cancer has low probability of lymph node metastasis. We report a case of deep early gastric cancer of the fundus beyond the endoscopic submucosal dissection indication that was treated by hybrid natural orifice transluminal endoscopic surgery with sentinel lymph node navigation. In a conventional approach, a total gastrectomy would have been needed; however, the patient refused surgical intervention. In this case, since the patient showed no positivity of the sentinel lymph node on intraoperative navigation, laparoscopic basin lymph node dissection was not performed. Hybrid natural orifice transluminal endoscopic surgery might be considered for specific regions such as the safety zone where lymph node metastases are less likely to occur.
Gastrectomy ; Humans ; Lymph Node Excision ; Lymph Nodes* ; Lymphatic Metastasis ; Natural Orifice Endoscopic Surgery* ; Neoplasm Metastasis ; Stomach Neoplasms*