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A Prospective, Multi-Center, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of the Synthetic Bone Graft Material DBM Gel with rhBMP-2 versus DBM Gel Used during the TLIF Procedure in Patients with Lumbar Disc Disease

  • Hyun, Seung-Jae;Yoon, Seung Hwan;Kim, Joo Han;Oh, Jae Keun;Lee, Chang-Hyun;Shin, Jun Jae;Kang, Jiin;Ha, Yoon
    • Journal of Korean Neurosurgical Society
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    • v.64 no.4
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    • pp.562-574
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    • 2021
  • Objective : This study is to evaluate the efficacy and safety of demineralized bone matrix (DBM) gel versus DBM gel with recombinant human bone morphogenetic protein-2 (rhBMP-2) used in transforaminal lumbar interbody fusion (TLIF). Methods : This study was designed as a prospective, multi-center, double-blind method, randomized study. All randomized subjects underwent TLIF with DBM gel with rhBMP-2 group (40 patients) as an experimental group or DBM gel group (36 patients) as a control group. Post-operative observations were performed at 12, 24, and 48 weeks. The spinal fusion rate on computed tomography scans and X-rays films, Visual analog scale pain scores, Oswestry disability index and SF-36 quality of life (QOL) scores were used for the efficacy evaluation. The incidence rate of adverse device effects (ADEs) and serious adverse device effects (SADEs) were used for safety evaluation. Results : The spinal fusion rate at 12 weeks for the DBM gel with rhBMP-2 group was higher with 73.68% compared to 58.82% for the DBM gel group. The 24 and 48 weeks were 72.22% and 82.86% for the DBM gel with rhBMP-2 group and 78.79% and 78.13%, respectively, for the DBM gel group. However, there were no significant differences between two groups in the spinal fusion rate at 12, 24, and 48 weeks post-treatment (p=0.1817, p=0.5272, p=0.6247). There was no significant difference between the two groups in the incidence rate of ADEs (p=0.3836). For ADEs in the experimental group, 'Pyrexia' (5.00%) was the most common ADE, followed by 'Hypesthesia', 'Paresthesia', 'Transient peripheral paralysis', 'Spondylitis' and 'Insomnia' (2.50%, respectively). ADEs reported in control group included 'Pyrexia', 'Chest discomfort', 'Pain', 'Osteoarthritis', 'Nephropathy toxic', 'Neurogenic bladder', 'Liver function analyses' and 'Urticaria' (2.86%, respectively). There was no significant difference between the two groups in the incidence rate of SADEs (p=0.6594). For SADE in the experimental group, ''Pyrexia' and 'Spondylitis' were 2.50%. SADE reported in the control group included 'Chest discomfort', 'Osteoarthritis' and 'Neurogenic bladder'. All SADEs described above were resolved after medical treatment. Conclusion : This study demonstrated that the spinal fusion rates of DBM gel group and DBM gel with rhBMP-2 group were not significantly different. But, this study provides knowledge regarding the earlier postoperative effect of rhBMP-2 containing DBM gel and also supports the idea that the longer term follow-up results are essential to confirm the safety and effectiveness.

Clinical Results of Cardiovascular Surgery in the Patients Older than 75 Years

  • Kim, Dong Jin;Park, Kay-Hyun;Isamukhamedov, Shukurjon S.;Lim, Cheong;Shin, Yoon Cheol;Kim, Jun Sung
    • Journal of Chest Surgery
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    • v.47 no.5
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    • pp.451-457
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    • 2014
  • Background: The balance of the risks and the benefits of cardiac surgery in the elderly remains a major concern. We evaluated the early and mid-term clinical results of patients aged over 75 years who underwent major cardiovascular surgery. Methods: Two hundred and fifty-one consecutive patients, who underwent cardiac surgery at Seoul National University Bundang Hospital between July 2003 and June 2011, were included in this study (mean age, $78.7{\pm}3.4$ years; male:female=130:121). Elective surgery was performed in 112 patients, urgent in 90, and emergency in 49. Results: Early mortality was 12.7% (32/251). Follow-up completion was 100%, and the mean follow-up duration was $2.8{\pm}2.2$ years. Late mortality was 24.2% (53/219). There were 283 readmissions in a total of 109 patients after discharge. However, the reason for readmission was related more to non-cardiac factors (71.3%) than to cardiac factors. The overall survival estimates were 79.2% at the 1-year follow-up and 58.4% at the 5-year follow-up. Patients who underwent elective surgery had a lower early mortality rate (elective, 4.5%; urgent, 13.3%; emergency, 30.6%) and better overall survival rate than those that underwent urgent or emergency surgery (p<0.001). Conclusion: The timing of cardiac surgery was found to be an independent risk factor for early and late mortality. Thus, earlier referral and intervention may improve operative results. Further, comprehensive coordinated postoperative care is needed for other comorbid problems in aged patients.

Development of the Atomated Prediction System for Seasonal Tropical Cyclone Activity over the Western North Pacific and its Evaluation for Early Predictability (북서태평양 태풍 진로의 계절예측시스템 자동화 구축 및 조기 예측성의 검증)

  • Jin, Chun-Sil;Ho, Chang-Hoi;Park, Doo-Sun R.;Choi, Woosuk;Kim, Dasol;Lee, Jong-Ho;Chang, Ki-Ho;Kang, Ki-Ryong
    • Atmosphere
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    • v.24 no.1
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    • pp.123-130
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    • 2014
  • The automated prediction system for seasonal tropical cyclone (TC) activity is established at the National Typhoon Center of the Korea Meteorological Administration (KMA) to provide effective operation and control of the system for user who lacks knowledge of the system. For automation of the system, two procedures which include subjective decisions by user are performed in advance, and their output data are provided as input data. To provide the capability to understand the operational processes for operational user, the input and output data are summarized with each process, and the directory structure is reconstructed following KMA's standard. We introduce a user interface using namelist input parameters to effectively control operational conditions which is fixed or should be manually set in the previous version of the prediction system. To operationally use early prediction which become available through the automation, its performances are evaluated according to initial condition dates. As a result, high correlations between the observed and predicted TC counts are kept for all track clusters even though advancing the initial condition date from May to January.

Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C

  • Ryu, Ji Hyeong;Kwon, Minsuk;Moon, Joung-Dae;Hwang, Min-Woong;Lee, Jeong-Min;Park, Ki-Hyun;Yun, So Jeong;Bae, Hyun Jin;Choi, Aeran;Lee, Hyeyoung;Jung, Bongsu;Jeong, Juhee;Han, Kyungja;Kim, Yonggoo;Oh, Eun-Jee
    • Annals of Laboratory Medicine
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    • v.38 no.6
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    • pp.578-584
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    • 2018
  • Background: Accurate, rapid, and cost-effective screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection may be useful in laboratories that cannot afford automated chemiluminescent immunoassays (CLIAs). We evaluated the diagnostic performance of a novel rapid automated fluorescent lateral flow immunoassay (LFIA). Methods: A fluorescent LFIA using a small bench-top fluorescence reader, Automated Fluorescent Immunoassay System (AFIAS; Boditech Med Inc., Chuncheon, Korea), was developed for qualitative detection of hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to HCV (anti-HCV) within 20 minutes. We compared the diagnostic performance of AFIAS with that of automated CLIAs-Elecsys (Roche Diagnostics GmbH, Penzberg, Germany) and ARCHITECT (Abbott Laboratories, Abbott Park, IL, USA)-using 20 seroconversion panels and 3,500 clinical serum samples. Results: Evaluation with the seroconversion panels demonstrated that AFIAS had adequate sensitivity for HBsAg and anti-HCV detection. From the clinical samples, AFIAS sensitivity and specificity were 99.8% and 99.3% for the HBsAg test, 100.0% and 100.0% for the anti-HBs test, and 98.8% and 99.1% for the anti-HCV test, respectively. Its agreement rates with the Elecsys HBsAg, anti-HBs, and anti-HCV detection assays were 99.4%, 100.0%, and 99.0%, respectively. AFIAS detected all samples with HBsAg genotypes A-F and H and anti-HCV genotypes 1, 1a, 1b, 2a, 2b, 4, and 6. Cross-reactivity with other infections was not observed. Conclusions: The AFIAS HBsAg, anti-HBs, and anti-HCV tests demonstrated diagnostic performance equivalent to current automated CLIAs. AFIAS could be used for a large-scale HBV or HCV screening in low-resource laboratories or low-to middle-income areas.

Changes in the Prosthesis Types Used for Aortic Valve Replacement after the Introduction of Sutureless and Rapid Deployment Valves in Korea: A Nationwide Population-Based Cohort Study

  • Woo, Hyeok Sang;Hwang, Ho Young;Kim, Ho Jin;Kim, Joon Bum;Lee, Sak;Lim, Cheong;Chang, Byung-Cheul;Lee, Na Rae;Suh, Youshin;Choi, Jae Woong
    • Journal of Chest Surgery
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    • v.54 no.5
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    • pp.369-376
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    • 2021
  • Background: Sutureless and rapid deployment valves for aortic valve replacement (AVR) were introduced in Korea in December 2016. This study evaluated changing trends in the prosthetic valves used for AVR in Korea after the introduction of sutureless and rapid deployment valves. Methods: From December 2016 to December 2018, 4,899 patients underwent AVR in Korea. After applying the exclusion criteria, 4,872 patients were analyzed to determine changes in the type of prosthetic valve used for AVR. The study period was divided into 5 groups corresponding to 5-month intervals. Results: The total number of AVR cases was 194.88±28.78 per month during the study period. Mechanical valves were used in approximately 27% to 33% of cases, and the proportion of mechanical valve use showed a tendency to decrease, with marginal significance overall (p=0.078) and significant decreases in patients less than 60 years of age and in men (p=0.013 and p=0.023, respectively). The use of sutureless valves increased from 13.4% to 25.8% of cases (p<0.001), especially in elderly patients (>70 years) and those requiring concomitant surgery. In a comparison between sutureless and rapid deployment valves, the use of Perceval S valves (a type of sutureless valve), gradually increased (p<0.001). Conclusion: After the introduction of sutureless and rapid deployment valves in Korea, the rate of use of these new valves remarkably increased, especially in elderly patients and those requiring concomitant surgery. Further studies should investigate the clinical outcomes of these new prostheses.

Intestinal histopathology and in situ postures of Gymnophalloides seoi in experimentally infected mice

  • Jong-Yil CHAI;Hong-Soon LEE;Sung-Jong HONG;Jae-Hyung YOO;Sang-Mee GUK
    • Parasites, Hosts and Diseases
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    • v.39 no.1
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    • pp.31-41
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    • 2001
  • The intestinal histopathology and in situ postures of Gymnophalloides seoi (Digenea: Gymnophallidae) were studied using C3H/HeN and C57BL/6 mice as experimental hosts; the effects of immunosuppression were also observed. The metacercariae isolated from naturally infected oysters, 300 or 1,000 in number, were infected orally to each mouse, and the mice were killed at days 3-21 post-infection (PI). In immunocompetent (IC) mice, only a small number of flukes were found in the mucosa of the duodenum and jejunum during days 3-7 PI, with their large oral suckers pinching and sucking the root of villi. The intestinal mucosa showed mild villous atrophy crypt hyperplasia, and inflammations in the villous stroma and crypt, with remarkable goblet cell hyperplasia. These mucosal changes were almost restored after days 14-21 PI. In immunosuppressed (IS) mice. displacement as well as complete loss of villi adjacent to the flukes was frequently encountered, otherwise the histopathology was generally mild, with minimal goblet cell hyperplasia. In these mice, numerous flukes were found, and it seemed that they were actively moving and rotating in situ. Several flukes were found to have invaded into the submucosa, almost facing the serosa. These results indicate that in IC mice the intestinal histopathology caused by G. seoi is generally mild, and the flukes do not penetrate beyond the mucosa, however, in IS mice. the flukes can cause severe destruction of neighboring villi. and some of them invade into the submucosa.

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Smoking-Induced Dopamine Release Studied with $[^{11}C]Raclopride$ PET ($[^{11}C]Raclopride$ PET을 이용한 흡연에 의한 도파민 유리 영상 연구)

  • Kim, Yu-Kyeong;Cho, Sang-Soo;Lee, Do-Hoon;Ryu, Hye-Jung;Lee, Eun-Ju;Ryu, Chang-Hung;Jeong, In-Soon;Hong, Soo-Kyung;Lee, Jae-Sung;Seo, Hong-Gwan;Jeong, Jae-Min;Lee, Won-Woo;Kim, Sang-Eun
    • The Korean Journal of Nuclear Medicine
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    • v.39 no.6
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    • pp.421-429
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    • 2005
  • Purpose: It has been postulated that dopamine release in the striatum underlies the reinforcing properties of nicotine. Substantial evidence in the animal studies demonstrates that nicotine interacts with dopaminergic neuron and regulates the activation of the dopaminergic system. The aim of this study was to visualize the dopamine release by smoking in human brain using PET scan with $[^{11}C]raclopride$. Materials and Methods: Five male non-smokers or ex-smokers with an abstinence period longer than 1 year (mean age of $24.4{\pm}1.7$ years) were enrolled in this study $[^{11}C]raclopride$, a dopamine D2 receptor radioligand, was administrated with bolus-plus-constant infusion. Dynamic PET was performed during 120 minutes ($3{\times}20s,\;2{\times}60s,\;2{\times}120s,\;1{\times}180s\;and\;22{\times}300s$). following the 50 minute-scanning, subjects smoked a cigarette containing 1 mg of nicotine while in the scanner. Blood samples for the measurement of plasma nicotine level were collected at 0, 5, 10, 15, 20, 25, 30, 45, 60, and 90 minute after smoking. Regions for striatal structures were drawn on the coronal summed PET images guided with co-registered MRI. Binding potential, calculated as (striatal-cerebellar)/cerebellar activity, was measured under equilibrium condition at baseline and smoking session. Results: The mean decrease in binding potential of $[^{11}C]raclopride$ between the baseline and smoking in caudate head, anterior putamen and ventral striatum was 4.7%, 4.0% and 7.8%, respectively. This indicated the striatal dopamine release by smoking. Of these, the reduction in binding potential in the ventral striatum was significantly correlated with the cumulated plasma level of the nicotine (Spearman's rho=0.9, p=0.04). Conclusion: These data demonstrate that in vivo imaging with $[^{11}C]raclopride$ PET could measure nicotine-induced dopamine release in the human brain, which has a significant positive correlation with the amount or nicotine administered bt smoking.

Universal Design in Main Entrance Space of Underground Passage Shopping Center (지하도상가 주출입 공간의 유니버설 디자인 적용 현황에 관한 연구)

  • Lee, Hyo-Chang;Ha, Mi-Kyoung
    • Proceedings of the Korean Institute of Interior Design Conference
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    • 2007.11a
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    • pp.99-102
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    • 2007
  • Underground passage shopping center which is one of the underground space is a public facility. Therefore, underground passage shopping center needs physical environment that everyone (such as ordinary adults, seniors, disabled and ETC) could use it without any difficulties. The purpose of this research is to evaluate the application of universal design into main entrance space of underground passage shopping center. The scope of this research was adjusted as 8 underground passage shopping centers that are located in Seoul. Spacial scope of the research was set as public space such as main entrance space, slope way, stairway of underground passage shopping center and the content of scope of this research was the application of universal design. The conclusion of this research is as following. First, public space of underground passage shopping center needs physical environmental improvement for the convenient usage for seniors and disabled. Second, the application of universal design is needed for public space for shelter and rescue of underground passage shopping center. Third, Underground passage shopping center needs a plan to minimize the safety infringement of user by commercial activity of stores in it.

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Diagnostic Efficacy of FDG-PET in Solitary Pulmonary Nodule (고립성폐결절에서 FDG-PET의 진단적 유용성)

  • Kim, Woo-Jin;Yim, Jae-Joon;Yoo, Chul-Gyu;Kim, Young-Whan;Shim, Young-Soo;Han, Sung-Koo
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.6
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    • pp.1263-1270
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    • 1997
  • Background : Differentiation of malignity and benignity is crucial for management of solitary pulmonary nodule(SPN). Clinical parameters such as patient's age, nodule size, smoking history, doubling time, typical calcification in X-ray and CT findings have been reported as helpful in this purpose. However, in most cases, these parameters are not conclusive. Glucose metabolism is increased in cancer tissues including lung cancer tissues. After uptake of 2-[F-18]-fluoro-2-deoxy-D-glucose(FDG), the glucose analogue, by cancer cell, FDG is trapped in the cell without further metabolism after phosphorylation. Thus, hypermetabolic focus in FDG-positron emission tomography (PET) imaging suggest malignancy. We evaluated the diagnostic efficacy of FDG-PET imaging in distinguishing malignant and benign SPN. Methods : We evaluated 28 patients with SPN from Jan. 1995 to Jan. 1997. CT scan of chest and whole-body FDG-PET imaging were performed in all patients. Histologic diagnosis was confirmed by transthoracic fine needle aspiration and biopsy, bronchoscopic biopsy and open thoracotomy. Results : Of the 28 SPN's, 22 nodules were malignant and 6 nodules were benign. FDG-PET imaging diagnosed all malignant nodules correctly as positive, and diagnosed 4 of 6 benign nodules correctly as negative. One tuberculous granuloma and one aspergilloma showed hypennetabolic focus and were diagnosed falsely positve with FDG-PET imaging. In the diagnosis of SPN with FDG-PET, sensitivity and specificity were 100% and 66.7%, positive predictive value and negative predictive value were 92% and 100%. Conclusion : FDG-PET imaging is highly useful noninvasive diagnostic tool in distinguishing between malignant SPN and benign SPN.

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