• Asian Spine Journal
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• 제12권6호
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• pp.1010-1016
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• 2018

Study Design: Retrospective cohort study. Purpose: To report on spinal fusion assessment using computed tomography (CT) after adult spinal deformity (ASD) surgery using ultra-low dose recombinant human bone morphogenetic protein 2 (RhBMP-2). Overview of Literature: The reported dose of RhBMP-2 needed for successful spinal posterolateral fusion in ASD ranges from 10 to 20 mg per spinal level. This study reports the use of ultra-low dose of RhBMP-2 (0.07 mg per facet) to achieve spinal fusion in multilevel ASD surgery. Methods: Consecutive patients who underwent ASD surgery using ultra-low dose RhBMP-2 were recruited. Routine postoperative CT analysis for spinal fusion was performed by two spine surgeons. Inter-observer agreement was calculated for facet fusion (FF) and interbody fusion (IBF) at 6 and 12 months after the procedure. Results: Six consecutive ASD patients with a mean age of 62 years (28-72 years) were examined. Each patient received a total dose of 12 mg with an average dose of $0.69{\pm}0.2mg$ (0.42-1 mg) per single FF and $1.38{\pm}0.44mg$ (0.85-2 mg) for IBF. Total 131 FF and 15 IBF were examined in the study, with 88 FFs and nine IBFs being analyzed specifically at 6 months after the surgery. FF and IBF reported by surgeons A and B at 6 months were 97.7% vs. 91.9% FF, respectively (${\kappa}=0.95$) and 100% vs. 100% IBF, respectively (${\kappa}=1$). Two patients underwent longitudinal follow-up CT at 12 months, and the FF rates reported by surgeons A and B were 100% vs. 95.8%, respectively (${\kappa}=0.96$). Five out of nine facet (56%) non-unions were identified at the cross-links. The remaining four facet pseudarthrosis were noted at 1-2 spinal levels caudal to the cross-links. At the final clinical follow-up, there was no rod breakage, deformity progression, neurological deficit, or symptom recurrence. The Oswestry Disability Index improved by an average of $32.8{\pm}6.3$, while the mental component summary of the 36-item Short-Form Health Survey improved by an average of $4.7{\pm}2.1$, and physical component summary improved by an average of $10.5{\pm}2.1$. Conclusions: To our knowledge, this is the first study to report a CT that defined 92%-98% FF and 100% IBF using the lowest reported dose of RhBMP-2 in multilevel ASD surgery. The use of ultra-low dose RhBMP-2 reduces the RhBMP-2 related complications and healthcare costs.

• Nuclear Medicine and Molecular Imaging
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• 제41권4호
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• pp.309-316
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• 2007

감시 림프절 생검은 유방암 수술에서 림프절 전이 상태를 알기 위한 표준 시술이다. 환자는 방사성 콜로이드를 주사 받은 후 수술을 받게 된다. 이 과정에서 검사를 하는 핵의학과, 수술장, 유방암 검체를 다루는 병리과의 관계자는 미량이나마 환자와 검체에 의해서 방사선 피폭을 받을 수 있다. 이 연구의 목적은 감시 림프절 생검 과정, 특히 병리처리 과정에서 받는 방사선피폭을 정량하여 그 안전성을 확인하고 병리 시설과 폐기물에 대해서도 방사선 관련 안전성을 확인하는 것이다. 대상 및 방법 : 감시림프절 생검은 방사성 콜로이드를 이용하여 일반적인 임상적 방법으로 시행되었다. 병리기사, 핵의학 기사 및 핵의학 의사의 피폭량을 열형광선량계를 이용하여 1달간 측정하였다. 또한 작업과정중의 잔존 방사능량, 흡수선량, 작업시간, 작업거리, 조직폐기물 및 병리검사실의 공간선량을 측정하였다. 결과 전신 및 손의 피폭량은 병리기사에서 각각 0.21 및 0.85 uSv/study이었고 핵의학과 의사 및 핵의학과 기사의 전신피폭량은 각각 0.2 및 2.3 uSv/study 이었다. 일반인 기준(1000 uSv/year)으로 병리기사는 년간 약 1100건 감시림프절 관련 검체 처리를 할 수 있었다. 각 과정의 잔존방사성 및 피폭거리, 시간으로 측정한 피폭량은 수술의사는 전신/손의 피폭량이 건당 2.47/22.4 uSv 이었고 수술장간호사는 건당 0.22/0 uSv 이었다. 병리실의 공간선량률은 0.02-0.03 mR/hr로 방사성 관리구역의 설정 기준에 도달하지 않았다. 폐기되는 검체 조직의 방사능은 거의 측정되지 않아 100 Bq/g에 훨씬 미치지 않았다. 결론: 방사성동위원소를 이용한 감시림프절 검사에 관계된 병리처리과정은 방사선안전측면에서 일반적으로 안전하며 별도의 안전관리나 시설 없이 이루어 질 수 있다.

• Journal of Dental Anesthesia and Pain Medicine
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• 제18권5호
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• pp.295-300
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• 2018

Background: Removal of the plate following Le Fort I osteotomy and BSSO (bilateral sagittal split osteotomy) is a common procedure. However, patients who undergo plate removal experience intense pain and discomfort. This study investigated the half-maximal effective concentration ($Ce_{50}$) of remifentanil in the prevention of plate removal pain under sedation using dexmedetomidine. Methods: The study evaluated 18 patients, between 18 and 35 years of age, scheduled for elective surgery. Remifentanil infusion was initiated after sedation using dexmedetomidine, and started at a dose of 1.5 ng/mL on the first patient via target-controlled infusion (TCI). Patients received a loading dose of $1.0{\mu}g/kg$ dexmedetomidine over 10 min, followed by a maintenance dose of $0.7{\mu}g/kg/h$. When the surgeon removed the plate, the patient Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score was observed. Results: The Ce of remifentanil ranged from 0.9 to 2.1 ng/mL for the patients evaluated. The estimated effect-site concentrations of remifentanil associated with a 50% and 95% probability of reaching MOAA/S score of 3 were 1.28 and 2.51 ng/mL, respectively. Conclusion: Plate removal of maxilla can be successfully performed without any pain or adverse effects by using the optimal remifentanil effect-site concentration ($Ce_{50}$, 1.28 ng/mL; $Ce_{95}$, 2.51 ng/mL) combined with sedation using dexmedetomidine.

• 한국조경학회지
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• 제18권2호
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• pp.1-13
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• 1990

In recent years, the construction of golf course has been increasing very rapidIy and serious concern is paid to its environmental consequences both in Korea and in Japan. EIA systems as a major requirements for golf course developments emerged to reduce the adverse impact of their developments in Korea as well as in Japan. This study aims to compare EIA systems, procedures and methodologies employed between Korea and Japan in order to demonstrate the success and failure of EIAs in each country. The results of this study can be summarized as follows : 1) EIAs are systematically undertaken based upon law in Korea but on regulation in Japan. 2) Public participation Isn't encouraged in the Korean EIA procedure while the Japan EIA system involves public participation. 3) Korean EISs shall be prepared after the proposed projects are approved according to the related laws and be followed by the necessary procedures, but in the carte of Japan, EISs be prepared prior to their approval . 4) ELSs shall be prepared by agencies with special expertise with respect to 7he environmental impacts (appointed by government) or the sponsoring agencies themselves in Korea whereas they be prepared by agencies proposing the projects in japan. 5) EISs both in Korea and in Japan are characterized by cliches which may be unfamiliar to reviews and the public. 6) EIAs describe the existing presence and predict and evaluate that a development work influences the present conditions. Here Japan EIA treats mainly natural - and life environment, whereas Korean EIA dose social - and economic environment. And hence in the case of Japan is undertaken more quantitative and scientific analysis, whereas in the case of Korea is less. It is suggested that the key point to impact analysis is to use the correct concepts, fomulate the comparative studies of methodologies and find the methods that suit the decision as well as which country's own circumstances.

• 한국환경과학회지
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• 제25권4호
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• pp.505-516
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• 2016

With the development of nanotechnology, nanomaterials are used in various fields. Therefore, the interest regarding the safety of nanomaterial use is increasing and much effort is diverted toward establishment of exposure assessment and management methods. Occupational exposure limits (OELs) are effectively used to protect the health of workers in various industrial workplaces. This study aimed to propose an OEL for domestic multi-walled carbon nanotubes (MWCNTs) based on animal inhalation toxicity test. Basic procedure for development of OELs was examined. For OEL estimation, epidemiological study and quantitative risk assessment are generally performed based on toxicity data. In addition, inhalation toxicity data-based no observed adverse effect level (NOAEL) and benchmark dose (BMD) are estimated to obtain the OEL. Three different estimation processes (NEDO in Japan, NIOSH in USA, and Baytubes in Germany) of OELs for carbon nanotubes (CNTs) were intensively reviewed. From the rat inhalation toxicity test for MWCNTs manufactured in Korea, a NOAEL of $0.98mg/m^3$ was derived. Using the simple equation for estimation of OEL suggested by NEDO, the OEL of $142{\mu}g/m^3$ was estimated for the MWCNT manufacturing workplace. Here, we used test rat and Korean human data and adopted 36 as an uncertainty factor. The OEL for MWCNT estimated in this work is higher than those ($2-80{\mu}g/m^3$) suggested by previous investigators. It may be greatly caused by different physicochemical properties of MWCNT and their dispersion method and test rat data. For setting of regulatory OELs in CNT workplaces, further epidemiological studies in addition to animal studies are needed. More advanced technical methods such as CNT dispersion in air and liquid should be also developed.

• 대한방사선치료학회지
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• 제11권1호
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• pp.53-59
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• 1999

The aim of this study is to improve the accuracy of field placement and junction between adjacent fields and block shielding through the use of a computed tomography(CT) simulator and virtual simulation. The information was acquired by assessment of Alderson Rando phantom image using CT simulator (I.Q. Xtra - Picker), determination of each field by virtual fluoroscopy of voxel IQ workstation AcQsim and colored critical structures that were obtained by contouring in virtual simulation. And also using a coronal, sagittal and axial view can determine the field and adjacent field gap correctly without calculation during the procedure. With the treatment planning by using the Helax TMS 4.0, the dose in the junction among the adjacent fields and the spinal cord and cribriform plate of the critical structure was evaluated by the dose volume histogram. The pilot image of coronal and sagittal view took about 2minutes and 26minutes to get 100 images. Image translation to the virtual simulation workstation took about 6minutes. Contouring a critical structure such as cribriform plate, spinal cord using a virtual fluoroscopy were eligible to determine a correct field and shielding. The process took about 20 minutes. As the result of the Helax planning, the dose distribution in adjacent field junction was ideal, and the dose level shows almost 100 percentage in the dose volume histogram of the spinal cord and cribriform plate CT simulation can get a correct therapy area due to enhancement of critical structures such as spinal cord and cribriform plate. In addition, using a Spiral CT scanner can be saved a lot of time to plan a simulation therefore this function can reduce difficulties to keep the patient position without any movements to the patient, physician and radiotherapy technician.

• 한방재활의학과학회지
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• 제25권3호
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• pp.1-9
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• 2015

Objectives To evaluate Shinbaro Pharmacopuncture safety through analysis of potential single-dose intramuscular toxicity of Sinbaro Pharmacopucture in SD rats and Beagle dogs. Methods Single-dose intramuscular toxicity of Shinbaro Pharmacopuncture was assessed in accordance with Korea Food and Drug Administration Guidelines for toxicity testing of Medicinal Products. The SD rats were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 0, 4.6, 9.2, and 18.5 mg/kg, respectively. The Beagle dogs were treated intramuscularly with Shinbaro Pharmacopuncture at doses of 2.3, and 4.6 mg/kg, respectively, and after 3 days, the procedure was repeated a second time at doses of 0.6, and 1.2 mg/kg, respectively, for toxicity testing. Mortality, change in body weight, and necropsy findings were examined for the study period. Results There were no mortalities, general symptoms, or body weight changes in the SD rats. While pyelectasis of the left kidney was observed in a male rat in the 4.6 mg/kg administration group, natural occurrence is common, and does not appear to be related with the test substance. No mortalities were observed in the Beagle dogs. In assessment of general symptoms, a female dog in the 9.2 mg/kg group displayed body weight decrease due to leftover food, but the change in body weight was within the normal range seen at 6~7 months, and the necropsy findings were not significant. The toxicity of the test substance appears to be minimal. Conclusions The results suggest that the lethal dose 50 ($LD_{50}$) and approximate lethaldose (ALD) value in single intramuscular administration of Shinbaro Pharmacopuncture in SD rats and Beagle dogs are higher than 18.5 mg/kg.

• Journal of Pharmaceutical Investigation
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• 제28권1호
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• pp.35-42
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• 1998

A $3{\times}3$ Latin square crossover study for the bioequivalence of three ondansetron formulations was conducted. Test products were $Vominon^{\circledR}$ 8 mg and $Vominon^{\circledR}$ 4 mg tablets and reference product was $Zofran^{\circledR}$ tablet. Twenty one healthy Korean male subjects received each formulation at the ondansetron dose of 8 mg and plasma concentrations of ondansetron were monitored by HPLC for over a period of 12 hr after the oral administration. Statistical procedure for bioequivalence evaluation of AUC {e.g., analysis of variance (ANOVA), multiple comparison and confidence intervals} was carried out. There were no significant differences in AUC among the formulations. The confidence intervals for the AUC of $Vominon^{\circledR}$ 8 mg and $Vominon^{\circledR}$ 4 mg were between -0.24 and 15.54% and between -2.41 and 13.36% respectively, within a range that proposed by the Korea Food and Drug Administration Guidelines for Bioequivalence. These statistical procedure could be standardized and generally applicable for the assessment of bioequivalence for multiple (more than two) formulations.

• 약학회지
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• 제42권1호
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• pp.101-107
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• 1998

The antiparkinsonian agent l-deprenyl, a selective monoamine oxidase (MAO)-B inhibitor, is metabolized in part to l-methamphetamine and l-amphetamine. l< /I>-Deprenyl was evaluated for amphetamine and methamphetamine-like discriminative stimulus effects in rats and its mechanism of action was investigated. Rats were trained under a 5-response, fixed ratio schedule of stimulus-shock termination or a 10-response. Fixed-ratio schedule of food-presentation which discriminate between d-amphetamine (1mg/kg, i.p.) and saline or d-methamphetamine (1mg/kg, i.p.) and saline in a two-lever, operant conditioning procedure. Full generalization was obtained to d-amphetamine (1~3mg/kg). d-methamphetamine (1~3mg/kg) and l-deprenyl (17~30mg/kg) under both the food presentation and stimulus shock termination schedule. l-Deprenyl has dose-dependent amphetamine-and methamphetamine-like discriminative stimulus properties in rats only at doses of 17 and 30mg/kg. Reversible MAO-B inhibitor, RO 16-6491 didn`t show any amphetamine-like discriminative properties. Aromatic amino acid decarboxylase inhibitor, NSD 1015 decreased % responding of l-deprenyl in the methamphetamine-trained rats under the stimulus-shock termination schedule. SKF-525A produced partial inhibition of methamphetamine-like discriminative effects of l-deprenyl under the food presentation schedule. These results suggest that l-deprenyl has no abuse liability at the therapeutic range but there needs some caution at high doses and furthermore, drug discrimination studies under the food presentation and shock termination schedule are useful for the assessment of abuse liability of psychostimulants.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제43권4호
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• pp.229-238
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• 2017

Objectives: The primary purpose of this study was to investigate the factors related with additional administration of sedative agent during intravenous conscious sedation (IVS) using midazolam (MDZ). The secondary purpose was to analyze the factors affecting patient satisfaction. Materials and Methods: Clinical data for 124 patients who had undergone surgical extraction of mandibular third molar under IVS using MDZ were retrospectively investigated in this case-control study. The initial dose of MDZ was determined by body mass index (BMI) and weight. In the case of insufficient sedation at the beginning of surgery, additional doses were injected. During surgery, peripheral oxygen saturation, bispectral index score (BIS), heart rate, and blood pressure were monitored and recorded. The predictor variables were sex, age, BMI, sleeping time ratio, dental anxiety, Pederson scale, and initial dose of MDZ. The outcome variables were additional administration of MDZ, observer's assessment of alertness/sedation, intraoperative amnesia, and patient satisfaction. Descriptive statistics were computed, and the P-value was set at 0.05. Results: Most patients had an adequate level of sedation with only the initial dose of MDZ and were satisfied with the treatment under sedation; however, 19 patients needed additional administration, and 13 patients were unsatisfied. In multivariable logistic analysis, lower age (odds ratio [OR], 0.825; P=0.005) and higher dental anxiety (OR, 5.744; P=0.003) were related to additional administration; lower intraoperative amnesia (OR, 0.228; P=0.002) and higher BIS right before MDZ administration (OR, 1.379; P=0.029) had relevance to patient dissatisfaction. Conclusion: The preoperative consideration of age and dental anxiety is necessary for appropriate dose determination of MDZ in the minor oral surgery under IVS. The amnesia about the procedure affects patient satisfaction positively.