• Title/Summary/Keyword: 임상적 성과지표

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Efficacy and Safety of a Biodegradable Hyaluronic Acid Microneedle Patch for Dry Skin in Atopic Dermatitis : A Single-blinded, Split-body, Randomized Controlled Trial (아토피피부염 피부건조 증상 개선에 대한 용해성 마이크로니들 패치의 유효성 및 안전성 평가 임상연구)

  • Ji-Hoon Song;Gi-Hyun Lee;Min-Yeong Jung;Jung-Hwa Choi;Soo-Yeon Park
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.1
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    • pp.78-95
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    • 2023
  • 목적 : 마이크로니들 패치는 피부장벽의 주요 구성성분인 각질층을 관통할 수 있어 일반적인 경피를 통한 약물 전달 수단보다 더 효율적으로 약물을 전달할 수 있다는 장점이 있어 다양한 분야에서 응용되고 있다. 본 임상연구는 아토피피부염 환자의 피부 건조 증상에 대하여 용해성 히알루론산 마이크로니들 패치와 외용제를 병행하여 용해성 마이크로니들 패치의 유효성과 안전성을 평가하였다. 방법 : 본 연구는 단일 기관, 연구자 주도, 평가자 눈가림, 인체 분할 연구로 설계된 무작위 배정 임상시험으로, 피부건조 증상이 있는 아토피피부염 환자 20명을 대상으로 임상연구를 수행하였다. 한 명의 피험자에서 2곳의 시험 병변을 선택한 후, 무작위 배정으로 각각 시험 병변과 대조 병변을 결정하여 2주 동안 매일 양측 병변에 모두 아로마 크림을 도포한 다음, 시험 병변에만 용해성 히알루론산 마이크로니들 패치를 추가로 부착하였다. 결과 : 1차 유효성 평가지표인 local scoring atopic dermatitis(L-SCORAD) index는 치료 후에 시험 병변이 대조 병변보다 유의성 있게 호전되었다. 2차 유효성 평가지표 중 피부 건조감 VAS와 피부 수분 함유량도 시험 병변이 대조 병변보다 유의성 있는 개선을 보였다. Investigator's Global Assessment scale, 소양감 VAS, 경피수분손실량에 있어서는 시험 병변과 대조 병변 모두 치료 후에 유의성 있게 호전되었으나, 두 병변 간의 차이에는 유의성이 없었다. 이상 반응은 나타나지 않았으므로 안전성도 확인되었다. 결론 : 용해성 히알루론산 마이크로니들 패치와 외용제 병행치료는 외용제만 사용하였을 때보다 L-SCORAD index 및 피부 건조감 VAS, 피부 수분 함유량에 있어서 아토피피부염의 증상을 유의성 있게 개선시켰다.

Influence of Ligament Deficits and Isthmic Defects on Instability in Lumbar Spine (인대 결손과 협부 결손이 요추 불안정성에 미치는 영향)

  • Choi, Dae-Kyung;Kim, Yoon-Hyuk;Kim, Kyung-Soo
    • Transactions of the Korean Society of Mechanical Engineers A
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    • v.35 no.10
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    • pp.1205-1210
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    • 2011
  • Spinal instability known to be related to low back pain. However, the quantitative definition of spinal instability has not been established because there is a lack of consensus regarding clinical and radiological studies. In addition, the major factors affecting such instability have not been elucidated, although disc degeneration, disc injury, ligament injury, and isthmic defects are considered to result in such problems. In this study, individual and combined influences on spinal instability with a three-dimensional finite element model of a one-level lumbar spinal motion segment were investigated, under the assumption that the rotation and translation in the sagittal plane under flexion and extension represented the instability indices. The results could be helpful in understanding the causes and mechanisms of spinal instability in the lumbar spine.

Echocardiographic Diagnosis of Pulmonary Arterial Hypertension in Chronic Lung Disease with Hypoxemia (만성 저산소성 폐질환의 폐동맥 고혈압에 대한 심초음파 검사)

  • Chang, Jung-Hyun
    • Tuberculosis and Respiratory Diseases
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    • v.46 no.6
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    • pp.846-855
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    • 1999
  • Background : Secondary pulmonary hypertension is an important final endpoint in patients with chronic hypoxic lung disease, accompanied by deterioration of pulmonary hemodynamics. The clinical diagnosis of pulmonary hypertension and/or cor pulmonale could be difficult, and simple noninvasive evaluation of pulmonary artery pressures has been an relevant clinical challenge for many years. Doppler echocardiography might to be a more reliable method for evaluating pulmonary hemodynamics in such patients in terms of the accuracy, reproducibility and easiness for obtaining an appropriate echocardiographic window than M-mode echocardiography. The aim of this study was to assess echocardiographic parameters associated with pulmonary arterial hypertension, defined by increasing right ventricular systolic pressure(RVSP), calculated from trans-tricuspid gradient in patients with chronic hypoxic lungs. Method : We examined 19 patients with chronic hypoxic lung disease, suspected pulmonary hypertension under the clinical guidelines by two dimensional echocardiography via the left parasternal and subcostal approach in a supine position. Doppler echocardiography measured RVSP from tricuspid regurgitant velocity in continuous wave with 2.5MHz transducer and acceleration time(AT) on right ventricular outflow tract in pulsed wave for the estimation of pulmonary arterial pressure. Results : On echocardiography, moderate to severe degree of pulmonary arterial hypertension was defined as RVSP more than 40mmHg, presenting tricuspid regurgitation. Increased right ventricular endsystolic diameter and shortened AT were noted in the increased RVSP group. Increased RVSP was correlated negatively with the shortening of AT. Other clinical data, including pulmonary functional parameters, arterial blood gas analysis and M mode echocardiographic parameters were not changed significantly with the increased RVSP. Conclusion : These findings suggest that shortened AT on pulsed doppler can be useful when quantifying pulmonary arterial pressure with increased RVSP in patients with chronic lung disease with hypoxemia. Doppler echocardiography in pulmonary hypertension of chronic hypoxic lungs is an useful option, based on noninvasiveness under routine clinical practice.

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The Guideline for Colorectal Cancer Screening (대장암 선별검사 권고안)

  • Dong Il Park
    • Journal of Digestive Cancer Research
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    • v.4 no.1
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    • pp.17-20
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    • 2016
  • Colorectal cancer is the 2nd most common cancer in men, and the 3rd most common cancer in women in Korea. This incidence has been increasing steadily since the data analysis began in 1999. Guidelines from many countries including Korea recommend annual or biennial fecal occult blood test as a national colorectal cancer screening program, however, colonoscopy, stool DNA test, double contrast barium enema, and sigmoidoscopy are recommended in some countries. I will summarize the Korean National Screening Guideline for colorectal cancer revised by multi-society expert committee in Korea last year. They recommend annual or biennial fecal immunochemical test between 45 and 80 year-old asymptomatic average risk people. Selective use of colonoscopy is recommended, taking into consideration of individual preference and the risk of colorectal cancer. There is no evidence for the risks or benefits of double contrast barium enema or computed tomographic colonography for colorectal cancer screening.

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Clinical Features of Kawasaki Disease with Pyuria (농뇨 동반 가와사키병의 임상적 특징)

  • Kim, Hyo-Jin;Lee, Joo-Young;Choi, Ui-Yoon;Lee, Soo-Young
    • Pediatric Infection and Vaccine
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    • v.24 no.3
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    • pp.141-145
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    • 2017
  • Purpose: Clinical and laboratory features of two Kawasaki disease (KD) groups were evaluated; the patient with pyuria and those without pyuria. Methods: From January 2015 to December 2016, the medical records of 140 (86 males and 54 females) inpatients with KD were retro-spectively analyzed. Results: Forty-eight KD patients (34.3%) presented with pyuria. KD patients with pyuria showed a higher level of C-reactive protein (CRP) and a higher proportion of elevated liver enzymes than those without pyuria. There were no differences in the proportions of unresponsiveness to intravenous immunoglobulin and coronary artery lesions between the two groups. Six KD patients (12.5%) with pyuria underwent a renal imaging study to rule out the possibility of a urinary tract infections. Thirty-two KD patients (66.7%) with pyuria received treatment with antibiotics in addition to the standard treatment for KD. Conclusions: KD patients with pyuria showed a higher level of CRP and elevated levels of liver enzymes than those without pyuria. These findings suggest that KD patients with pyuria have more severe systemic inflammation than those without pyuria.

Relationship between the Lipid Accumulation Product Index and Alanine Aminotransferase in Korean Adult Men (한국 성인남성에서 Lipid Accumulation Product 지수와 Alanine Aminotransferase와의 관련성)

  • Shin, Kyung-A
    • Korean Journal of Clinical Laboratory Science
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    • v.49 no.4
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    • pp.374-381
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    • 2017
  • The LAP (lipid accumulation product) index is an indicator of excessive fat accumulation in combination with the fasting triglyceride concentration and waist circumference. This study examined the relationship between the LAP index and ALT (alanine aminotransferase) level and the effect of the LAP index on the ALT level. Cross-sectional studies were conducted on healthy adult males without a history of liver disease. From January 2015 to June 2017, 13,854 adults between 20 and 70 years of age, who underwent health screening at a general hospital in Gyeonggi-do, were enrolled in this study. The LAP index was calculated as [waist circumference (cm)-65]${\times}$[triglyceride (mmol/L)] for males. Serum ALT abnormalities were set at 40 IU/L or more in males. All subjects underwent measurements of the anthropometric indicators and physiological examinations. A significant increase in ALT with increasing LAP quintiles was observed (p<0.001). The LAP index correlated with ALT (r=0.238, p<0.001). Insulin (r=0.449, p<0.001) and HDL-cholesterol (r=-0.369, p<0.001) were strongly correlated with LAP. In addition, the LAP index is a factor affecting the ALT level (p<0.001). As the LAP index increased, the risk of an elevated ALT was higher (p<0.001). In conclusion, the LAP index was a predictor of an ALT elevation in Korean men.

Clinical Trials and Accuracy of Diagnostic Tests (진단법의 임상시험연구와 진단정확도)

  • Lee, You-Kyoung;Lee, Sang-Moo
    • Journal of Genetic Medicine
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    • v.8 no.1
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    • pp.28-34
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    • 2011
  • Most clinicians understand clinical trials as the evaluation process for new medicine before their use. However, clinical trials can also be applied to laboratory diagnostic tests (LDTs) to verify diagnostic accuracy and efficacy before their clinical laboratory implementation for patients. The clinical trial of LDT has two distinctive characteristics that are different from the case of pharmaceuticals and thus worth special consideration. One of them is the level of evidence. The well-designed randomized controlled trials (RCTs) are known to provide the best evidence to prove the clinical efficacy of any pharmaceutical products. However, RCTs lose practicality when applied to LDTs due to various issues including ethical complications. For this reason, comparative study format is considered more feasible approach for LDTs. In addition pharmaceuticals and LDTs are different in that the user's intervention is not required for the former but critical to the latter. Moreover, in the case of pharmaceuticals, end-products are produced by manufacturers before being used by clinicians. However, in LDTs, once reagents and instruments are provided by manufacturers, they are first utilized by clinical laboratories to produce test results in order for clinicians to use them later. In other words, when it comes to LDTs, clinical laboratories play the role of manufacturers, providing reliable test results with improved quality assurance. Considering the distinctive characteristics of LDTs, we would like to offer detailed suggestions to successfully perform clinical trials in LDTs, which include analytical performance measures, clinical test performance measures, diagnostic test accuracy measures, clinical effectiveness measures, and post-implementation surveillance.

Relationship between Calcium/Inorganic Phosphorus and Parathyroid Hormone Concentrations in Dogs with Renal Failure (신부전증의 개에서 혈중 칼슘/무기인과 부갑상샘 호르몬의 관계)

  • Kang, Dong-Joon;Lee, Soo-Han;Park, Hee-Myung;Chung, Byung-Hyun
    • Journal of Veterinary Clinics
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    • v.25 no.4
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    • pp.236-240
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    • 2008
  • Parathyroid hormone (PTH) regulates calcium (Ca) and phosphate transport. Secondary hyperparathyroidism usually occur in chronic renal failure (CRF), and it is a common complication of CRF in dogs and cats. Twenty one dogs with renal failure were enrolled in this study. Plasma Ca, inorganic phosphorus (iP) and PTH concentrations were measured. Dogs were divided into two groups by the ratio of Ca to iP (Ca/iP$\leq$1; Group I, Ca/iP$\leq$1.5; Group II). The PTH level between sexes ages were not significantly different. The PTH level and Ca/iP between two groups were significantly different (p < 0.0001). In conclusion, The ratio of Ca to iP may be considered as useful surrogator to predict PTH level of dogs with renal failure.

Validity of Arch Relationship Measurements in Digital Dental Models (디지털 치열 모형에서 악궁 관계 지표 측정의 타당성)

  • Ryu, Jiin;Yang, ByoungEun;Lee, Hyelim
    • Journal of the korean academy of Pediatric Dentistry
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    • v.49 no.1
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    • pp.14-24
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    • 2022
  • The aim of the present study is to evaluate the validity of orthodontic measurements including tooth width, Bolton ratio, overjet and overbite on the digital dental models. Dental models of the subjects aged 12 to 18 were obtained in 3 different forms, which were conventional stone model, digital model created with Freedom HD model scanner, and digital model produced with CS3600 intraoral scanner. After measurements were made on the models, reliability and reproducibility of the measurements were evaluated by using intraclass correlation coefficient, while validity was assessed with paired t-test. As a result, significant reliability and reproducibility were verified, with intraclass correlation coefficient exceeding 0.750 in all groups. Measurements of the model scanned group showed an adequate validity in overall and anterior Bolton ratio, overjet, and overbite. Intraoral scanned models showed an adequate validity in anterior Bolton ratio, and overjet. Measurement on intraoral scanned digital models can be considered as an alternative for young children who have difficulty in taking impression. Furthermore, careful considerations on measurement error should be made in clinical situations.

A Study on the Effects of the R&D Activities and Patent on the Corporate Performance of Medical Device Firms in Korea (국내 의료기기 제조기업의 연구개발활동과 특허가 기업 경영성과에 미치는 영향에 관한 연구)

  • Kim, Dosung;Lee, Jungsoo;Cho, Sung Han;Kim, Min Seok;Kim, Nam-Hyun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.11
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    • pp.157-165
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    • 2018
  • Companies conduct R&D for continuous development and enhancement of corporate value, and obtain patents as an intangible asset resulting from this process. This study screened 103 medical device firms whose R&D information, patent information, and management performance information were all published to determine how R&D activities and patents affect corporate operational performance. The number of patents, R&D costs, company type and Inno-Biz of the company were set as independent variables, and the companies' sales, intangible assets, operating profit ratios, net profit margins, corporate ratings and profit-related financial ratios were used as dependent variables. The results confirmed that R&D expenditure had negative (-) effects on most indicators, including sales volume, operating profit ratio, and net profit ratio, while it had positive (+) [ED highlight - these are unnecessary if negative and positive are also written out.] effects only on intangible assets. Additionally, domestic patents were found to have negative (-) effects on sales, cash flow ratings, and dropped capital return, and positive (+) effects on net profit growth. Moreover, the business performance variables affected by the company characteristics were sales volume and cash flow ratings. The medical device industry is dominated by small and medium-sized businesses Although research and development activities and patents have been shown to have a negative impact on corporate management in the short term, they are expected to have a positive long-term impact when reflecting the characteristics of the medical device industry that must undergo clinical trials and authorization procedures after R&D.