[논문]간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰

한가진; 김동훈; 박은주; 성신; 김성수; 임정태

doi:10.22246/jikm.2019.40.1.89

간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰
Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer] 원문보기

대한한방내과학회지 = The journal of internal Korean medicine, v.40 no.1, 2019년, pp.89 - 116

한가진 (소람한방병원) , 김동훈 (소람한방병원) , 박은주 (소람한방병원) , 성신 (소람한방병원) , 김성수 (소람한방병원) , 임정태 (청연중앙연구소)

Abstract ▼ AI-Helper

Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

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질의응답

핵심어	질문	논문에서 추출한 답변
	원발성 간암이란 무엇인가?	원발성 간암은 병리학적으로 간세포암종 외에도 담관암, 혈관육종 및 간모세포암 등이 포함되지만, 흔히 간암이라 함은 성인의 원발성 간암의 85% 이상을 차지하는 간세포암종을 일컫는다1. 2018년 전 세계적으로 새롭게 발생한 간암환자는 약 84만 명으로, 폐, 유방, 결장직장, 전립선, 위암에 이어 6번째로 많이 발생하였으며, 간암으로 인한 사망자 수는 78만 여명으로 세 번째로 많았다.
	간암 발생에 큰 작용을 하는 원인은 무엇인가?	2018년 전 세계적으로 새롭게 발생한 간암환자는 약 84만 명으로, 폐, 유방, 결장직장, 전립선, 위암에 이어 6번째로 많이 발생하였으며, 간암으로 인한 사망자 수는 78만 여명으로 세 번째로 많았다. 간암은 전 세계 발생과 사망의 70% 이상이 아시아에서 일어났으며, 특히 우라나라가 속한 동아시아에서 50% 이상이 발생하였는데, 만성 B형 간염 바이러스(HBV)감염이 중요한 요인으로 작용하였다2,3. 우리나라 국가 암 정보센터 통계에 따르면 2016년 한 해 동안 간암의 발생은 갑상선암을 제외하고 남자에서 5위, 여자에서 6위로, 남녀를 합했을 때 5위였으며, 사망자 수는 폐암에 이어 두 번째로 많았다4.

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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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