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An Observational Multi-Center Study Protocol for Distribution of Pattern Identification and Clinical Index in Parkinson's Disease

파킨슨병 변증 유형 및 지표 분포에 대한 전향적 다기관 관찰연구 프로토콜

  • HuiYan Zhao (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Ojin Kwon (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Bok-Nam Seo (Clinical Research Coordinating Team, Korea Institute of Oriental Medicine) ;
  • Seong-Uk Park (Dept. of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University) ;
  • Horyong Yoo (Dept. of Internal Korean Medicine, College of Korean Medicine, Daejeon University) ;
  • Jung-Hee Jang (KM Science Research Division, Korea Institute of Oriental Medicine)
  • 조혜연 (한국한의학연구원 한의과학연구부) ;
  • 권오진 (한국한의학연구원 한의과학연구부) ;
  • 서복남 (한국한의학연구원 임상연구협력팀) ;
  • 박성욱 (경희대학교 한의과대학 순환⋅신경내과) ;
  • 유호룡 (대전대학교 한의과대학 심계내과학교실) ;
  • 장정희 (한국한의학연구원 한의과학연구부)
  • Received : 2024.02.20
  • Accepted : 2024.03.26
  • Published : 2024.03.30

Abstract

Objectives: This study investigated the pattern identification (PI) and clinical index of Parkinson's disease (PD) for personalized diagnosis and treatment. Methods: This prospective observational multi-center study recruited 100 patients diagnosed with PD from two Korean medicine hospitals. To cluster new subtypes of PD, items on a PI questionnaire (heat and cold, deficiency and excess, visceral PI) were evaluated along with pulse and tongue analysis. Gait analysis was performed and blood and feces molecular signature changes were assessed to explore biomarkers for new subtypes. In addition, unified PD rating scale II and III scores and the European quality of life 5-dimension questionnaire were assessed. Results: The clinical index obtained in this study analyzed the frequency statistics and hierarchical clustering analysis to classify new subtypes based on PI. Moreover, the biomarkers and current status of herbal medicine treatment were analyzed using the new subtypes. The results provide comprehensive data to investigate new subtypes and subtype-based biomarkers for the personalized diagnosis and treatment of PD patients. Ethical approval was obtained from the medical ethics committees of the two Korean medicine hospitals. All amendments to the research protocol were submitted and approved. Conclusions: An objective and standardized diagnostic tool is needed for the personalized treatment of PD by traditional Korean medicine. Therefore, we developed a clinical index as the basis for the PI clinical evaluation of PD. Trial Registration: This trial is registered with the Clinical Research Information Service (CRIS) (KCT0008677)

Keywords

Acknowledgement

본 연구는 한국연구재단의 연구비 지원을 받아 수행하였습니다(NRF-2021R1I1A2048890).

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