[논문]성조숙증 소아 대상 중재 임상시험의 등록 현황 보고 -Clinicaltrial.gov, WHO ICTPR, CRIS를 중심으로-

심수보; 서현식; 이현희; 이혜림

doi:10.7778/jpkm.2022.36.3.1

성조숙증 소아 대상 중재 임상시험의 등록 현황 보고 -Clinicaltrial.gov, WHO ICTPR, CRIS를 중심으로-
The Current State of Registration of Interventional Clinical Trials for Children and Adolescents with Precocious Puberty 원문보기

大韓韓方小兒科學會誌 = The journal of pediatrics of Korean medicine, v.36 no.3, 2022년, pp.1 - 18

심수보 (완도군 보건의료원 군외보건지소) , 서현식 (대전대학교 부속 대전한방병원 내과) , 이현희 (대전대학교 한의과대학 소아과학교실) , 이혜림 (대전대학교 한의과대학 소아과학교실)

Abstract ▼ AI-Helper

Objectives The purpose of this study was to investigate the current status of interventional clinical trial registration for children with precocious puberty and to secure basic data for the design of clinical trials for traditional Korean medicine treatment of precocious puberty. Methods The following resources were used to search for data: Clinicaltrial.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and Clinical Research Information Service (CRIS), using the search terms, 'Precocious puberty', 'child'. All clinical trials which were registered as of June 2022 were used. Results For the intervention and clinical trial design, gonadotropin releasing hormone (GnRH) analog was reported in 41.7% of trials, and single group assignment was performed in 66.7% of the studies. Prior consent had not been reported in 50% of the studies. Tanner stage and GnRH stimulation tests were reported by multiple trials as inclusion criteria, and prior treatment experiences for trial drugs were reported as exclusion criteria. The peak serum concentration of luteinizing hormone following GnRH stimulation test was used as a primary outcome in 45.8% of clinical trials, and other growth-related indicators such as growth rate, height, and predicted adult height were also reported. Conclusions In consideration of the design, eligibility criteria, and outcome measurement of the existing clinical trials identified in this study, it should be referred to in the design of clinical trials for traditional Korean medicine treatment of precocious puberty.

주제어

표/그림 (7)

그림 Figure 1. Flow diagram showing the results of the clinical trial search CRIS: Clinical research information service, ICTRP: International Clinical Trial Registry Platform, WHO: World health organization
표 Table 1. Characteristics of the Included Interventional Clinical Trials
표 Table 2. Composition of Herbal Medicine Prescription used in Included Clinical Trials
표 Table 3. Design and Methods of Included Clinical Trials
표 Table 4. Inclusion Criteria of Included Clinical Trials
표 Table 5. Exclusion Criteria of Included Clinical Trials
표 Table 6. Outcome Measurements of the Included Clinical Trials

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표제어: PCR

동의어: Packet Collision Rate

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용어 설명: PCR은 세균 특이성이 있는 primer를 이용하여 적은 수의 세균이 있을지라도 쉽게 검출할 수 있는 유용한 방법이며, 이를 이용하여 구강 내 치면세균막이나 타액에서 직접 세균을 검출할 수 있게 되었다[8].

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