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권범선 대한의사협회 2019 대한의사협회지 Vol.62 No.9
This study aimed to describe adverse effects or reactions by medical devices. There may be unexpected effects caused by medical devices that can often be harmful to the patient. This is defined as a medical device adverse event or adverse effect (MDAE). We should prevent the recurrence of MDAEs by reporting them to regulatory authorities and device manufacturers. This reporting requires that manufacturers check the manufacturing process and update the medical device. However, it is difficult for both patients and medical persons to recognize and report MDAEs because adverse effects can be ambiguous to them in many cases. In addition, many medical persons lack an understanding of the role of this reporting. In Korea, the Ministry of Health and Welfare enacted laws and regulations for MDAE reporting in 2005. However, the number of MDAEs reported was still very small. The Ministry of Food and Drug Safety started the Medical Device Safety Monitoring Center project in 2011, with the purpose of promoting MDAE reporting. Since the Medical Device Safety Monitoring Center project began, the number of reported MDAEs rapidly increased from 137 in 2010 to 6,078 in 2017. Medical persons and device manufacturers should be encouraged to voluntarily report MDAEs and provide useful information. Korea is an important member of the International Medical Device Regulators Forum and leader of the Asia-Pacific Economic Cooperation Regulatory Committee. There should be medical device vigilance with global cooperation.
권범선,류기형,박진우,이호준 동국대학교 의학연구소 2009 東國醫學 Vol.15 No.2
신경발달치료(neurodevelopmental treatement, NDT)는 1940년대 초 보바스 부부가 개발하여 뇌성마비 치료에 처음 적용한 이후로 현재까지 유럽과 미국 등지 에서 널리 사용되고 있다. 신경 발달치료 개발 당시는 중추신경계 발달이론이 정립되지 않았고 근거 중심적 의학이 보편화 되지 못한 관계로 의사의 임상적 관찰이 매우 존중되었다. 따라서 신경발달치료는 일정한 치료법이 적용되기 힘들고, 치료 횟수나 강도 등을 정량화하기 어려운 약점이 있음에도 불구하고 현재 뇌성마비 치료의 근간을 이루고 있는 치료법이 되었다. 최근 뇌성마비 치료에 있어서 신경발달치료 효과를 객관적으로 입증하려는 시도가 있었으나 아직까지 이견이 있다. 이는 신경발달치료가 객관화하기 어려운 치료법인 이유도 있겠으나 뇌성마비도 유병률이 낮고 매우 다양한 양상을 보이므로 치료 효과를 판정하는 연구의 제한점이 되고 있다. 본 연구는 'cerebral palsy'와 'NDT'를 검색어로 전자논문을 검색하여 근거 중심적 연구 성적 수준이 높은 논문을 대상으로 신경발달치료의 효과를 운동발달, 정신발달 및 관절 구축과 변형으로 나누어 평가하였다. 연구결과 NDT치료군은 대조군에 비하여 세가지 영역 모두 유의한 수준의 우수한 결과를 보이지 않았다. 그러나 신경발달치료가 임상에서 이미 뇌성마비의 일차적인 치료법으로 확립되어 있으므로 현재 신경발달치료의 효과를 명확히 하고자 치료를 하지 않은 대조군을 통한 비교 연구는 더 이상 윤리적 일 수 없다. 따라서 뇌성마비 치료에 있어서 신경발달치료의 효과는 근거 중심적 접근보다는 최선의 근거를 찾아내서 치료에 적용하는 것이 필요하고, 신경발달치료를 대조군으로 하여 새로운 치료법을 개발하는 방향으로 이루어져야 할 것이다. As early as the 1940s, Berta and Karel Bobath began to develop an therapeutic approach, neurodevelopmental treatment (NDT), that grew out of clinical observation and was initially understood in the theory of neuroscience at that time. NDT spreads so widely and has heavily influenced physical, occupational and speech therapy for the management of cerebral palsy (CP) for half a century. However, the effects of NDT has not been established because it is not specific management delivered in a standardized manner and there is no discrete dosage administered under specific, invariable procedures in conditions that are held constant. Furthermore, CP has low incidence with highly heterogeneous conditions which could be complicated by ongoing changes due to growth and maturation. Thus articles investigating the effects of NDT showed controversial results and several reviews also reported the pros and cons. In this study, we searched the literature by 'cerebral palsy' and 'neurodevelopmental treatment' electronically and effects of NDT were analyzed by three sections; motor development, mental development, and contracture and deformity. The results did not confer any advantage to NDT over the alternatives. We have a little evidence-base of NDT for the management of CP, although NDT has already been established as a basic management tool. We suggested that best-evidence approach should be considered for the management of CP instead of evidence-base investigation of NDT. We could use NDT as a control management tool for CP when new treatment methods were developed.