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글로벌 의료기기산업의 시장동향 및 주요 수출국의 의료기기 관련 규제에 관한 연구
이우천(Wo Chun LEE),박세훈(Se Hun PARK) 한국무역상무학회 2017 貿易商務硏究 Vol.75 No.-
In this paper, we examined trends and regulations of the global medical equipment industry through literature search. The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.
만성 심방세동에 대한 전기적 심율동전환 전 경식도 심초음파검사의 유용성
강천수(Chun Soo Kang),심원보(Won Bo Shim),임장근(Jang Gun Im),장용우(Young Wo Jang),양주동(Ju Dong Yang),김태균(Tae Gyun Kim),심지향(Ji Hyang Shim),이성주(Sung Ju Lee) 대한내과학회 1995 대한내과학회지 Vol.48 No.1
Objectives: Cardioversion is performed in patients with atrial fibrillation to improve cardiac function, relieve symptoms, and decrease the risk of thrombus formation. Because atrial thrombi are poorly detected by conventional noninvasive techniques, such as transthoracic echocardiography and successful cardioversion is associated with 5 to 7% incidence of embolism in case of no anticoagulant therapy, several weeks of anticoagulation before cardioversion is required. But anticoagulation carries its own risks and the patient must be rehospitalized for cardioversion after several weeks. We evaluated the efficacy of transesophageal echocardiography, a accurate method of detecting atrial thrombi, to exclude the presence of atrial thrombi in patients with chronic atrial fibrillation, thereby allowing early safe cardioversion. Methods: A total 154 consecutive patients after being excluded the cases of paroxysmal atrial fibrillation, sick sinus syndrome, digitalis toxicity, heart failure or angina class 4, myocardial infarction within 6 months, unstable angina, hyperthyroidism, severe systemic disease, long-term anticoagulation, or contraindication of TEE, underwent transthoracic and transesophageal echocardiography followed by cardioversion in 44 patients who agreed cardioversion among patients without thrombi. Before cardioversion, left atrial (LA) dimensions, LA area, left ventricular ejection fraction (LVEF) were measured. Short-term anticoagulation with heparin was used in 44 patients before cardioversion, and then heparin was continued for 24 hours after cardioversion success according to α-PTT. Oral anticoagulation with warfarin was used in selected cases of the failed cardioversion according to PT. Results: LA thrombi were identified in 32 patients (21%) on TEE, and LA thrombi of 25 patients were visualized only on TEE. Cardioversion was deferred with warfarin in these patients. 34 patients (77%) of the 44 patients without thrombi underwent successful cardioversion to sinus rhythm. Clinical and echocardiographic data showed the significant differences between cardioversion-success group and cardioversion-failure group in the duration of atrial fibrillation, LA area, and LVEF (all, p<0.01). None of these patients of both groups had an embolic event, but there're mild precordial hotnesses subsided spontaneously in 10 patients. Conclusion: In patients with chronic atrial fibrillation who are not receiving long-term anticoagulation, atrial thrombi are detected by TEE in a some portion (21%). Although large-scale trials are required to determine whether early cardioversion guided by TEE is safter than conventional therapy, our study suggest that early cardioversion can be performed safely without the prolonged oral anticoagulation before the procedure if TEE excludes the presence of thrombi.
(Hoon Jai Chun),(Dong Kyu Park),(Chul Hee Park),(Jae Hong Park),(Yoon Tae Jeen),(Soon Ho Um),(Sang Wo Lee),(Jai Hyun Choi),(Chang Duck Kim),(Ho Sang Ryu),(Jin Hai Hyun),(Yang Seok Chae),(Chang Sub Uhm 대한내과학회 2002 The Korean Journal of Internal Medicine Vol.17 No.1
N/A Background : The adhesion of H. pylori to the gastric epithelial cells may be an essential step for the pathophysiology of various H. pylori-induced gastrointestinal diseases. The purpose of this study was to investigate the ultrastructural relation of H. pylori and gastric epithelial cells in their adhesion. Methods : Endoscopic biopsy of gastric antrum and body was performed from 15 patients (9 men, 6 women) with chronic gastritis and H. pylori infection. The specimens were processed for electron microscopy and observed with a transmission electron microscope (Hitachi H-600). Results : On the basis of morphological appearances, the adhesions of H. pylori to the gastric epithelial cells were categorized into three types, filamentous connection, adhesion pedestals and membrane fusion. Coccoid and undetermined forms adhered mainly by the filamentous connection, whereas the bacillary forms adhered primarily by the adhesion pedestals and membrane fusion. Conclusion : Various types of adhesion were associated with H. pylori and gastric epithelium. Further studies are needed to evaluate the influence of different types of adhesion to the pathophysiology of H. pylori.
Yoon, Sun Ok,Lee, Tae Sup,Kim, Sang Jick,Jang, Myung Hee,Kang, Young Jun,Park, Jae Hyun,Kim, Keun-Soo,Lee, Hyun Sil,Ryu, Chun Jeih,Gonzales, Noreen R.,Kashmiri, Syed V. S.,Lim, Sang Moo,Choi, Chang Wo American Society for Biochemistry and Molecular Bi 2006 The Journal of biological chemistry Vol.281 No.11
결장 및 직장암 환자에서 혈청과 면역조직화학 염색에서 CA19-9의 의의
김민수(Min Soo Kim),주호민(Ho Min Joo),홍성우(Seong Wo Hong),강윤경(Yun Kyung Kang),천정우(Jung Woo Chun),장여구(Yeo Goo Chang),백인욱(In Wook Paik),이혁상(Hyucksang Lee) 대한외과학회 2008 Annals of Surgical Treatment and Research Vol.75 No.5
Purpose: There has been much debate about the significance of the CA19-9 level for predicting the prognosis of colorectal cancer patients. This study aimed to evaluate the prognostic value of the preoperative serum CA19-9 level and the CA19-9 expression in the tumor tissues of colorectal cancer patients Methods: One hundred patients with colorectal cancer and who had been treated by resection were studied. We assessed the correlations of the preoperative serum CA19-9 level and the status of the CA19-9 immunohistochemical staining with the clinicopathologic features, including the prognosis of the patients. Results: The preoperative serum CA19-9 level had significant correlation with the status of CA19-9 immunohistochemical staining. The presence of distant metastasis was significantly correlated with an elevated level of serum CA19-9. The depth of tumor, the presence of lymph node metastasis, the TNM stage and tumor cell differentiation were significantly correlated with the status of the CA19-9 immunohistochemical staining. In addition, the gross morphology, depth of tumor, the presence of lymph node metastasis, the TNM stage, the status of the CA19-9 immunohistochemical staining and the serum CEA level were correlated with survival on univariate analysis. However, multivariate analysis did not validate the status of CA19-9 immunohistochemical staining as a significantly independent predictor of the prognosis. Conclusion: The CA19-9 expression was frequently observed in advanced stage tumor tissue, yet its expression in tumor tissue or the preoperative CA19-9 serum level did not show independent prognostic value for colorectal cancer patients.