• Title/Summary/Keyword: Risk Treatment Method

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Analysis of Repeated Measured VAS in a Clinical Trial for Evaluating a New NSAID with GEE Method (퇴행성 관절염 환자를 대상으로 새로운 진통제 평가를 위한 임상시험자료의 GEE 분석)

  • Lim, Hoi-Jeong;Kim, Yoon-I;Jung, Young-Bok;Seong, Sang-Cheol;Ahn, Jin-Hwan;Roh, Kwon-Jae;Kim, Jung-Man;Park, Byung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.37 no.4
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    • pp.381-389
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    • 2004
  • Objective : To compare the efficacy between SKI306X and Diclofenac by using generalized estimating equations (GEE) methodology in the analysis of correlated bivariate binary outcome data in Osteoarthritis (OA) diseases. Methods : A randomized, double-blind, active comparator-controlled, non-inferiority clinical trial was conducted at 5 institutions in Korea with the random assignment of 248 patients aged 35 to 75 years old with OA of the knee and clinical evidence of OA. Patients were enrolled in this study if they had at least moderate pain in the affected knee joint and a score larger than 35mm as assessed by VAS (Visual Analog Scale). The main exposure variable was treatment (SKI 306X vs. Diclofenac) and other covariates were age, sex, BMI, baseline VAS, center, operation history (Yes/No), NSAIDS (Y/N), acupuncture (Y/N), herbal medicine (Y/N), past history of musculoskeletal disease (Y/N), and previous therapy related with OA (Y/N). The main study outcome was the change of VAS pain scores from baseline to the 2nd and 4th weeks after treatment. Pain scores were obtained as baseline, 2nd and 4th weeks after treatment. We applied GEE approach with empirical covariance matrix and independent(or exchangeable) working correlation matrix to evaluate the relation of several risk factors to the change of VAS pain scores with correlated binary bivariate outcomes. Results : While baseline VAS, age, and acupuncture variables had protective effects for reducing the OA pain, its treatment (Joins/Diclofenac) was not statistically significant through GEE methodology (ITT:aOR=1.37, 95% CI=(0.8200, 2.26), PP:aOR=1.47, 95% CI=(0.73, 2.95)). The goodness-of-fit statistic for GEE (6.55, p=0.68) was computed to assess the adequacy of the fitted final model. Conclusions : Both ANCOVA and GEE methods yielded non statistical significance in the evaluation of non-inferiority of the efficacy between SKI306X and Diclofenac. While VAS outcome for each visit was applied in GEE, only VAS outcome for the fourth visit was applied in ANCOVA. So the GEE methodology is more accurate for the analysis of correlated outcomes.

A Comparison of the Independent Verification Methods for the Results of Leksell GammaPlan for Gamma Knife Predecessor with the Hemispherical Collimators (반구형 시준기를 가진 감마나이프에 대한 렉셀감마플랜 결과물의 독립적인 검증방법들의 비교)

  • Hur, Beong Ik
    • Journal of the Korean Society of Radiology
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    • v.10 no.7
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    • pp.521-529
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    • 2016
  • Since Gamma Knife(R) radiosurgery(GKRS) is based on a single-fraction high dose treatment strategy, independent verification for the results of Leksell GammaPlan(R) (LGP) is an important procedure in assuring patient safety and minimizing the risk of treatment errors. Several verification methods have been developed and reported previously. Thus these methods were tested statistically and tried on Leksell Gamma Knife(LGK) target treatments through the embodiment of the previously proposed algorithms(PPA). The purpose of this study was to apply and evaluate the accuracy of verification methods for LGK target treatments using PPA. In the study 10 patients with intracranial lesion treated by GKRS were included. We compared the data from PPA and LGP in terms of maximum dose, arbitrary point dose, and treatment time at the isocenter locations. All data were analyzed by Paired t-test, which is statistical method used to compare two different measurement techniques. No statistical significance in maximal dose at 10 cases was observed between PPA and LGP. Differences in average maximal dose ranged from -0.53 Gy to 3.71 Gy. The arbitrary point dose calculated by PPA and LGP was not statistically significant too. But we found out the statistical difference with p=0.021 between TMR and LGP for treatment time at the isocenter locations. PPA can be incorporated as part of a routine quality assurance(QA) procedure to minimize the chance of a wrong overdose. Statistical analyses demonstrated that PPA was in excellent agreement with LGP when considering the maximal dose and the arbitrary point dose for the best plan of GKRS. Due to the easy applicability we hope PPA can be widely used.

The efficacy of continuous positive airway pressure (CPAP) for patient with left breast cancer (좌측 유방암 방사선치료에서 CPAP(Continuous Positive Airway Pressure)의 유용성 평가)

  • Jung, Il Hun;Ha, Jin Sook;Chang, Won Suk;Jeon, Mi Jin;Kim, Sei Joon;Jung, Jin Wook;Park, Byul Nim;Shin, Dong Bong;Lee, Ik Jae
    • The Journal of Korean Society for Radiation Therapy
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    • v.31 no.2
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    • pp.43-49
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    • 2019
  • Purpose: This study examined changes in the position of the heat and lungs depending on the patient's breathing method during left breast cancer radiotherapy and used treatment plans to compare the resulting radiation dose. Materials and methods: The participants consisted of 10 patients with left breast cancer. A CT simulator(SIMENS SOMATOM AS, Germany) was used to obtain images when using three different breathing methods: free breathing(FB), deep inspiration breath hold(DIBH with Abches, DIBH), inspiration breath hold(IBH with CPAP, CPAP). A Ray Station(5.0.2.35, Sweden) was used for treatment planning, the treatment method was volumetric modulated arc therapy (VMAT) with one partial arc of the same angle, and the prescribed dose to the planning target volume (PTV) was a total dose of 50Gy(2Gy/day). In treatment plan analysis, the 95% dose (D95) to the PTV, the conformity index(CI), and the homogeneity index (HI) were compared. The lungs, heart, and left anterior descending artery (LAD) were selected as the organs at risk(OARs). Results: The mean volume of the ipsilateral lung for FB, DIBH, and CPAP was 1245.58±301.31㎤, 1790.09±362.43 ㎤, 1775.44±476.71 ㎤. The mean D95 for the PTV was 46.67±1.89Gy, 46.85±1.72Gy, 46.97±23.4Gy, and the mean CI and HI were 0.95±0.02, 0.96±0.02, 0.95±0.02 and 0.91±0.01, 0.90±0.01, 0.92±0.02. The V20 of Whole Lung was 10.74±4.50%, 8.29±3.14%, 9.12±3.29% and The V20 of the ipsilateral lung was 20.45±8.65%, 17.18±7.04%, 18.85±7.85%, the Dmean of the heart was 7.82±1.27Gy, 6.10±1.27Gy, 5.67±1.56Gy, and the Dmax of the LAD was 20.41±7.56Gy, 14.88±3.57Gy, 14.96±2.81Gy. The distance from the thoracic wall to the LAD was measured to be 11.33±4.70mm, 22.40±6.01mm, 20.14±6.23mm. Conclusion: During left breast cancer radiotherapy, the lung volume was 46.24% larger for DIBH than for FB, and 43.11% larger for CPAP than FB. The larger lung volume increases the distance between the thoracic wall and the heart. In this way, the LAD, which is one of the nearby OARs, can be more effectively protected while still satisfying the treatment plan. The lung volume was largest for DIBH, and the distance between the LAD and thoracic wall was also the greatest. However, when performing treatment with DIBH, the intra-fraction error cannot be ignored. Moreover, communication between the patient and the radiotherapist is also an important factor in DIBH treatment. When communication is problematic, or if the patient has difficulty holding their breath, we believe that CPAP could be used as an alternative to DIBH. In order to verify the clinical efficacy of CPAP, it will be necessary to perform long-term follow-up of a greater number of patients.

Ecological Risk Assessment of Pharmaceuticals in the Surface Water Near a Pharmaceutical Manufacturing Complex in Korea (제약단지 인접 지역 지표수의 잔류 의약물질 생태위해성평가)

  • Park, Suhyun;Kang, Habyeong;Shin, Hyesoo;Ryoo, Ilhan;Choi, Kyungho;Kho, Younglim;Park, Kyunghwa;Kim, Kyungtae;Ji, Kyunghee
    • Journal of Environmental Health Sciences
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    • v.46 no.1
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    • pp.45-64
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    • 2020
  • Objectives: Limited information is available on the presence and associated ecological risks of pharmaceutical residues in aquatic environments near pharmaceutical manufacturing areas in Korea. In this study, we investigated the current state of pharmaceutical contamination and its associated ecological risks in streams near a pharmaceutical manufacturing complex. Methods: Seven pharmaceuticals (acetaminophen, clarithromycin, diclofenac, diphenhydramine, ibuprofen, mefenamic acid and roxithromycin) were measured in water samples collected from the streams near a pharmaceutical manufacturing complex. A predicted no-effect concentration (PNEC) was derived using either the assessment factor method or species sensitivity distribution method. In addition, a hazard quotient for each pharmaceutical was calculated by dividing its measured environmental concentration by its PNEC. Results: Samples collected downstream from the wastewater treatment plant (WWTP) had higher concentrations of pharmaceuticals than those collected from the reference site (upstream). Moreover, pharmaceutical concentrations were greater in ambient water than in the final effluent from the WWTP, which suggested that non-point sources were contributing to the contamination of the ambient water environment. Some of the target pharmaceuticals exhibited a hazard quotient >1, indicating that their potential ecological effects on the aquatic environment near the pharmaceutical industrial area should not be ignored. Conclusion: This study demonstrated that the pharmaceutical manufacturing area was contaminated with residual drugs, and that there was a possible non-point source near the WWTP effluent discharge area. The results of this study will aid in the development of management plans for pharmaceuticals, particularly in hotspots such as pharmaceutical industrial sites and their vicinities.

Closed Manual Reduction of Mandibular Condylar Fracture Assisted by C-arm Fluoroscopy (C-arm 형광투시를 이용한 하악관절돌기골절의 비관혈적 도수정복)

  • Choi, Eui Chul;Kang, Sang Gue;Jung, Sung Gyun
    • Archives of Craniofacial Surgery
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    • v.10 no.2
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    • pp.131-134
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    • 2009
  • Purpose: Mandible fractures are common in maxillofacial trauma and the incidence of condylar fracture is high. The management of mandibular condylar fracture continues to be controversial. Conservative treatment of it may lead to complications such as asymmetry, malocclusion, temporomandibular joint dysfunction. Moreover, open reduction can cause facial nerve injury, parotid gland injury, scarring and hematoma formation. We present a case of mandibular condylar fracture that was treated by manual reduction without incision under C-arm fluoroscopy. Methods: A 76-year-old female was admitted due to left side mandibular condylar fracture that required surgical intervention. Because of her age, history of diabetes mellitus, hypertension, she underwent closed manual reduction under general anesthesia. We adopted C-arm fluoroscopy as a method of identifying the fracture site and a evaluation of reduction state. C-arm fluoroscopy was set up like modified Towne's view. Results: The reduction was successful and didn't result in any complications that could occur in open reduction-facial nerve injury, infection, parotid gland injury, hematoma, avascular necrosis. The mandibular-maxillary fixations were removed after 4 weeks and patients were could open 3.5 cm after 6 weeks with physical therapy. Conclusion: We tried closed manual reduction of mandibular condylar fracture due to high risk of complication using C-arm fluoroscopy and did achieve anatomic reduction with avoiding open incision. This is simple, effective, reversible, time saving and fairly attemptable method in condylar fracture cases before open reduction.

Effect of Encapsulating Nitrate in Sesame Gum on In vitro Rumen Fermentation Parameters

  • Mamvura, Chiedza Isabel;Cho, Sangbuem;Mbiriri, David Tinotenda;Lee, Hong-Gu;Choi, Nag-Jin
    • Asian-Australasian Journal of Animal Sciences
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    • v.27 no.11
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    • pp.1577-1583
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    • 2014
  • Encapsulation is a method used to protect material from certain undesirable environments, for controlled release at a more favorable time and place. Animal productivity would be enhanced if feed additives are delivered to be utilized at their site of action, bypassing the rumen where they are likely to be degraded by microbial action. A novel method of encapsulation with sesame gum was used to coat nitrate, a known enteric methane mitigating agent, and tested for the effect on methane reduction and other in vitro fermentation parameters using rumen fluid from cannulated Hanwoo steers. Orchard grass was used as basal diet for fermentation. The treatments were matrix (1.1 g sesame gum+0.4 g sesame oil cake) only, encapsulated nitrate (matrix+nitrate [21 mM]), free nitrate (21 mM), and a control that contained no additive. Analyses of fermentation parameters were done at 0, 3, 6, 9, 12, 24, and 48 h time periods. In comparison to control, both free and encapsulated nitrate produced significantly reduced (p<0.01) methane (76% less) and also the total volatile fatty acids were reduced. A significantly higher (p<0.01) concentration of ammonia nitrogen was obtained with the encapsulated nitrate treatment (44%) compared to the free form (28%) and matrix only (20%) (p = 0.014). This might suggest slow release of encapsulated nitrate so that it is fully reduced to ammonia. Thus, this pioneering study found a significant reduction in methane production following the use of sesame gum encapsulated nitrate that shows the potential of a controlled release system in enhancing sustainability of ruminant production while reducing/eliminating the risk of nitrite toxicity.

Prevalence of Abnormal Papanicolaou Test Results and Related Factors among Women Living in Zanjan, Iran

  • Maleki, Azam;Ahmadnia, Elahe;Avazeh, Azar;Mazloomzadeh, Saeideh;Molaei, Behnaz;Jalilvand, Ahmad
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.16
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    • pp.6935-6939
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    • 2015
  • Background: Currently, a comprehensive program for screening and early detection of cervical cancer does not exist in Iran. This study aimed to determine the prevalence of abnormal Papanicolaou (Pap) smears and some related factors among women living in Zanjan, Iran. Materials and Methods: This cross-sectional study was conducted in 2012 in Zanjan on 4274 married women aged 20-65 years. The study participants were selected through two-stage cluster sampling. After obtaining written consent, demographic and fertility questionnaires were completed. Samples from cervix were obtained through a standard method using the Rover Cervex- Brush. Evaluation and interpretation of the samples were reported using the Bethesda 2001 method. Data were statistically analyzed using chi-square and logistic regression models. Results: Most inflammatory changes in the samples were mild (37.4%). Abnormal atypical changes in the epithelial cells were found in 4.04%. The highest percentage of abnormal changes in the epithelial cells was atypical squamous cells of undetermined significance (ASCUS) (1.9%). Abnormal results of Pap smear was significantly and independently associated with age, papillomavirus infection, and lack of awareness about Pap smear tests. Conclusions: Given the high prevalence of inflammatory and precancerous changes in this study, compared to other studies in Iran and other Muslim countries, and the effect of demographic variables and individual factors on abnormal results, increasing the awareness of women and their families regarding the risk factors for cervical cancer, preventive measures such as screening, and timely treatment seem necessary.

Incidence and Survival Rates among Pediatric Osteogenic Sarcoma Cases in Khon Kaen, Thailand, 1985-2010

  • Wiromrat, Pattara;Jetsrisuparb, Arunee;Komvilaisak, Patcharee;Sirichativapee, Winai;Kamsa-Ard, Supot;Wiangnon, Surapon
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4281-4284
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    • 2012
  • Background: Osteosarcoma is the most common bone cancer in children, responsible for a high rate of amputation and death. This is the first long-term, population-based, epidemiologic and survival study in Thailand. Objective: To study the incidence and survival rates of pediatric osteosarcoma in Khon Kaen. Method: Childhood osteosarcoma cases (0-19 years) diagnosed between 1985-2010 were reviewed. The data were retrieved from the population-based data set of the Khon Kaen Cancer Registry and medical records from Srinagarind Hospital, Faculty of Medicine, Khon Kaen University. All cases were censored until the end of April 2012. The age-standardized incidence rate (ASR) was calculated using the standard method. Survival experience was analyzed using the standard survival function (STATA 9.0) and presented with a Kaplan-Meier curve. Results: 58 cases were enrolled. The overall ASR was 14.1 per million. Males and females were equally affected. The peak incidence was for 15-19 year-olds in both sexes (ASR=10.4 per million in males and 8.5 in females). The 5-year overall survival rate was 27.6% (95% CI: 15.8-40.8%). The median survival time was 1.6 years (95% CI: 1.2-2.1). In a subgroup analysis, the patients who received only chemotherapy survived longer (5-year survival 45.7%, median survival time 4.1 years, p=0.12). Conclusion: The incidence rate for childhood osteosarcoma was slightly less than those reported for Western countries. The survival rate was also lower than reports from developed countries. Further evaluation of the treatment protocol and risk factor stratification is needed.

An alternative method to reduce anaphylaxis by moxibustion

  • Jeong, Hyun-Ja;Nam, Sun-Young;Lee, Byong-Joo;Kim, Min-Gi;Kim, Jeong-Hwa;Kim, Hyung-Min
    • CELLMED
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    • v.4 no.2
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    • pp.12.1-12.12
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    • 2014
  • Epinephrine is a critical drug for patients at risk for anaphylaxis. Here, we suggest moxibustion as an alternative method to reduce anaphylaxis. Moxibustion was applied to the Shimen (CV5) acupoint and found to attenuate compound 48/80-induced mortality. Capsazepine, a transient receptor potential vanilloid (TRPV) 1 antagonist, significantly improved overall survival rates compared to groups treated with moxibustion or 2-aminoethoxydiphenyl borate (an activator of TRPV1, 2, and 3). Probenecid (a TRPV2 agonist) also increased survival rate and reduced histamine levels. Survival rates increased by moxibustion and probenecid were completely inhibited by ruthenium red (a TRPV2 and 3 antagonist) and gadolinium chloride (general TRPV antagonist), respectively. Passive cutaneous anaphylaxis and ear swelling were significantly reduced by moxibustion and probenecid (p < 0.05). In cardiomyocytes, TRPV2 was over-expressed by compound 48/80 and histamine but this increased TRPV2 expression decreased to baseline with moxibustion and probenecid treatment. In addition, intracellular calcium levels increased by compound 48/80 were reduced by probenecid. Overall, these findings suggest that the reduction of anaphylaxis caused by moxibustion could represent a new mechanism of moxibustion related to the regulation of TRPV2 activation and promotion of epinephrine secretion.

INTRAORAL OPEN REDUCTION OF MANDIBULAR SUBCONDYLAR FRACTURES USING KIRSCHNER WIRE (Kirschner wire를 사용한 과두하 골절의 구강내 접근법)

  • Kim, Seong-Il;Kim, Seung-Ryong;Baik, Jin-Ah;Ko, Seung-O;Shin, Hyo-Keun
    • Maxillofacial Plastic and Reconstructive Surgery
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    • v.23 no.3
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    • pp.270-276
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    • 2001
  • The treatment of mandibular subcondylar fractures is a matter of controversy. The majority of mandibular subcondylar fracture are treated by closed reduction, but the displaced or dislocated mandibular subcondylar fractures may be treated by open reduction. The characteristics of open reduction are the anatomical reduction, the functional restoration, the rapid function, the maintenance of vertical ramus dimension, the better appearance and the less resultant TMJ problem etc. When an open reduction is considered, the wire, miniplate, lag screw and Kirschner wire are available with internal fixation. Of these, Kirschner wire is a simple method relatively and correct positioning of the wire achieves rigid fixation. But many open reduction methods for mandibular subcondylar fractures require extraoral approach. The extraoral approach has some problems, the facial scar and the risk of facial nerve injury. On the other hand, the intraoral approach eliminates the potency of the facial scar and the facial nerve injury, but is difficult to access the operation site. Since the intraoral approach was first described by Silverman (1925), the intraoral approach to the mandibular condyle has been developed with modifications. The purpose of this article is to describe the intraoral technique with the Kirschner wire on mandibular subcondylar fractures. Conclusion : The intraoral reduction with Kirschner wire on mandubular subcondylar fractures avoids the facial scar and facial nerve injury and is simple method to the extraoral approach. And it has minimal morbidity and better esthetics.

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