• Journal of Trauma and Injury
• /
• 제33권3호
• /
• pp.144-152
• /
• 2020

Purpose: This retrospective multicenter study analyzed trauma patients who underwent resuscitative endovascular balloon occlusion of the aorta (REBOA) in the Republic of Korea. Methods: This study was conducted from February 2017 to May 2018 at three regional trauma centers in the Republic of Korea. The patients were divided into two groups (cardiopulmonary resuscitation [CPR] and No-CPR) for comparative analysis based on two criteria (complication and mortality) for logistic regression analysis (LRA). Results: There were significant differences between the CPR and No-CPR groups in mortality (p=0.003) and treatment administered (p=0.016). By LRA for complications, total occlusion has significantly lesser risk than intermittent or partial occlusion in both univariate (odds ratio [OR] 0.06, 95% confidence interval [CI] 0.00-0.36, p=0.01) and multivariate (OR 0.05, 95% CI 0.00-0.38, p=0.01) analyses. The Rescue had a higher risk than the Coda or Reliant in univariate analysis (OR 4.91, 95% CI 1.14-34.25, p=0.05); however, it was not statistically significant in multivariate analysis (OR 6.98, 95% CI 1.03-74.52, p=0.07). By LRA for mortality, the CPR group was the only variable that had a significantly higher risk of mortality than the No-CPR group in both univariate (OR 17.59, 95% CI 3.05-335.25, p=0.01), and multivariate (OR 24.92, 95% CI 3.77-520.51, p=0.01) analyses. Conclusions: This study was conducted in the early stages of REBOA implementation in the Republic of Korea and showed conflicting results from studies conducted by multiple institutions. Therefore, additional research with more accumulated data is needed.

• 대한기관윤리심의기구협의회지
• /
• 제5권1호
• /
• pp.14-20
• /
• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Childhood Kidney Diseases
• /
• 제27권2호
• /
• pp.97-104
• /
• 2023

Purpose: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers (ARBs) are frequently employed to counteract the detrimental effects of proteinuria on glomerular diseases. However, the effects of ARBs remain poorly examined in pediatric patients with immunoglobulin A (IgA) nephropathy. Herein, we evaluated the efficacy and safety of losartan, an ARB, in pediatric IgA nephropathy with proteinuria. Methods: This prospective, single-arm, multicenter study included children with IgA nephropathy exhibiting proteinuria. Changes in proteinuria, blood pressure, and kidney function were prospectively evaluated before and 4 and 24 weeks after losartan administration. The primary endpoint was the difference in proteinuria between baseline and 24 weeks. Results: In total, 29 patients were enrolled and received losartan treatment. The full analysis set included 28 patients who received losartan at least once and had pre- and post-urinary protein to creatinine ratio measurements (n=28). The per-protocol analysis group included 22 patients who completed all scheduled visits without any serious violations during the study period. In both groups, the mean log (urine protein to creatinine ratio) value decreased significantly at 6 months. After 24 weeks, the urinary protein to creatinine ratio decreased by more than 50% in approximately 40% of the patients. The glomerular filtration rate was not significantly altered during the observation period. Conclusions: Losartan decreased proteinuria without decreasing kidney function in patients with IgA nephropathy over 24 weeks. Losartan could be safely employed to reduce proteinuria in this patient population. ClinicalTrials.gov trial registration (NCT0223277)

• Korean Journal of Radiology
• /
• 제25권6호
• /
• pp.565-574
• /
• 2024

Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

• Journal of Chest Surgery
• /
• 제44권2호
• /
• pp.123-130
• /
• 2011

Background: The aim of the present study was to identify chromosomal loci that contribute to the pathogenesis of aortic dissection (AD) in a Korean population using array comparative genomic hybridization (CGH) and to confirm the results using real-time polymerase chain reaction (PCR). Materials and Methods: Eighteen patients with ADs were enrolled in this study. Genomic DNA was extracted from individual blood samples, and array CGH analyses were performed. Four corresponding genes with obvious genomic changes were analyzed using real-time PCR in order to assess the level of genomic imbalance identified by array CGH. Results: Genomic gains were most frequently detected at 8q24.3 (56%), followed by regions 7q35, 11q12.2, and 15q25.2 (50%). Genomic losses were most frequently observed at 4q35.2 (56%). Real-time PCR confirmed the results of the array CGH studies of the COL6A2, DGCR14, PCSK6, and SDHA genes. Conclusion: This is the first study to identify candidate regions by array CGH in patients with ADs. The identification of genes that may predispose an individual to AD may lead to a better understanding of the mechanism of AD formation. Further multicenter studies comparing cohorts of patients of different ethnicities are warranted.

• Integrative Medicine Research
• /
• 제7권4호
• /
• pp.333-340
• /
• 2018

Background: Traditional Korean medicine (TKM) is widely used to treat children with cerebral palsy (CP) in Korea; however, studies investigating factors that influence the use of TKM are scarce. Thus, we investigated the clinical factors that might influence the use of TKM. Methods: A population-based, cross-sectional, multicenter survey was performed from August 2014 to May 2016. The history of TKM use, type and severity of CP, current treatment characteristics, presence of accompanying disabilities or other health problems not directly related to CP, and monthly cost for the treatment of CP were surveyed. Results: In total, 182 children were recruited, and 78 children (42.9%) had used TKM. Among these 78 children, 50 (64.1% of the TKM-use group) had used both acupuncture and herbal medication, 15 (19.2%) had used acupuncture only, and 13 (16.7%) had used herbal medication only. Children with non-typical CP, accompanying disabilities and general health problems tended to use TKM. The monthly cost of treatment for CP was significantly higher in the TKM-use group than that in the no-TKM-use group, suggesting that economically disadvantaged children may have difficulty in accessing TKM. Dietary supplements, conventional pharmacological treatments, and rehabilitation therapies did not affect TKM use. Conclusion: Children with non-typical symptoms or those with poor overall health status are likely to use TKM. Additionally, TKM use leads to increased treatment costs. Studies investigating the motivation for starting or ceasing TKM therapy, socioeconomic factors and the attitude of parents towards complementary and alternative medicine should be performed.

• 중환자간호학회지
• /
• 제16권3호
• /
• pp.24-33
• /
• 2023

Purpose : This study aims to establish an optimal cut-off score on the Braden scale for the assessment of pressure injury to detect pressure injury risks among inpatients in a South Korean tertiary hospital. Methods : This retrospective study used electronic medical records, from January to December 2022. A total of 654 patients were included in the study. Of these, 218 inpatients with pressure injuries and 436 without pressure injuries were classified and analyzed using 1:2 Propensity Score Matching (PSM), and the generalized estimating equation was performed using SPSS Version 26 and the R Machlt package program. Results : The cut-off value on the Braden scale for distinguishing pressure injury was 17 points, and the AUC (area under the ROC curve) was 0.531 (0.484-0.579). The sensitivity was 56.6% (45.5-67.7%) and the specificity was 69.7% (66.0-73.4%). With 17 points, the Braden scale cut-off distinguished those who had pressure injuries from those who did not at the time of admission (p < .03). In the pressure injury group, the Braden score on the day of the pressure injury was 14, with significant results in all subcategories except the moisture category. Conclusion : Our findings revealed that a cut-off value of 17 was optimal for predicting the risk of pressure injuries among tertiary hospital inpatients. Future studies should evaluate the optimal cut-off values in different clinical environments. Additionally, it is necessary to conduct multicenter large sample studies to verify the effectiveness of a 17 value in PI risk assessments.

• Asian Pacific Journal of Cancer Prevention
• /
• 제15권9호
• /
• pp.3993-3996
• /
• 2014

Background: Diabetes is a chronic disease characterized by impaired fasting blood glucose that leads to disturbances in various organs. In this study, we evaluated relationships between tumor size and grade in a population of diabetic and non-diabetic patients with renal cell carcinoma. Materials and Methods: Between 2007-2013, in our clinic radical nephrectomy performed to 310 patients for renal tumors and pathology reported renal cell carcinoma cases were enrolled in the study. Patients with and without a history of diabetes regarding fasting glucose and HgA1c levels were evaluated during surgery for tumor size and Fuhrman grade. Results: Diabetes was found in 95 patients. The mean age of the patients with and without diabetes mellitus was 64.3 (40-79) and 58.4 (31-87) years, respectively. In the diabetes group 51% of patients had a tumor size over 7 cm and 54% a tumor grade over Fuhrman 3. The respective figures in the non-diabetes group were 35% and 30% (p<0.05 in both cases). Conclusions: Renal cancer appears more aggressive in patients with diabetes. In this study lifestyle and risk factors with diabetes regulation were observed to be important for renal cancer patients. Multicenter studies are needed in larger series for more accurate results.

• 대한임상독성학회지
• /
• 제14권2호
• /
• pp.92-99
• /
• 2016

Purpose: The use of flumazenil administration in the emergency department is still controversial because of concerns about adverse effects. The present study was conducted to re-evaluate the risk-benefit ratio associated with flumazenil administration to patients suspected of having acute hypnotics and sedatives poisoning in the emergency department. Methods: A retrospective chart review study was conducted for patients whose final diagnoses were "poisoning" and "benzodiazepine" or "sedatives-hypnotics" from Mar. 2006 to Feb. 2015. The basal characteristics of the patients, including past medical history, ingredients and dose of ingested drug and co-ingested drugs were investigated. For patients administered flumazenil, responsiveness and time from admission to flumazenil administration were investigated with supplement. All collected data were analyzed in aspect terms of risk/benefit. Results: A total of 678 patients were included in our study. Benzodiazepine was the most common sedative/hypnotic drug prescribed, and the frequency of prescription continuously increased. The proportion of TCA as co-ingestion decreased from 13.1% to 3.9% in patients with acute sedative/hypnotic poisoning. Flumazenil was administered to 55 patients (8.1%), of which 29 patients (52.7%) were applied to contraindications. Fifty-three patients (96.4%) showed positive responsiveness, including partial responsiveness after flumazenil administration. No severe adverse events were identified. Conclusion: Based on the current trends in prescription patterns for sedative/hypnotic drugs, increased use of non-TCA antidepressants, and responsiveness to administration of flumazenil, benefit seemed weighted more in this study, although the observed benefits were based on limited results. Further prospective multicenter studies will be needed to optimize benefit-risk ratio.

• 동의생리병리학회지
• /
• 제22권6호
• /
• pp.1378-1382
• /
• 2008

This study is aim to evaluate pulse diagnosis as indicators for classification of the pattern identifications in stroke patients. To get the clinical information, we recruited the onset 1 month stroke patients through the multicenter network which consists of 13 oriental hospitals. The clinical informations about three pairs of pulse wave form and levels of their significancy based on the case report form (CRF) were collected and their distribution in each pattern identification were analyzed. The results are as follows Fire-Heat group shows high portions of floating pulse, rapid pulse and solid pulse. Qi Defficiency group has a greater portion of deep pulse, slow pulse, deficient pulse. The well-defined character of Phlegm-Retained Fluid, Yin Defficiency, Static Blood groups cannot be explained by pulse wave form. These results show a rough relationship between the pulse diagnosis and pattern identifications of stroke therefore, further studies are required to determine the pulse diagnosis as significant indicators of stroke pattern identification.