CAJ | 학술논문

中医药临床研究报告中,干预措施必须清晰报告,以使读者全面了解研究中所采用的干预措施的质量及其质量控制方法.按照中国国家药品与食品监督管理局有关中药新药的分类方法,结合中药质量的控制要求,可以按照复方中药类及中药有效成分类进行干预措施的报告.对于单味中药/中药复方/中药有效成分提取物类中药,具体报告的方法应包括:①名称、剂型和注册资料;②药物组成及其质量控制;③制剂程序及其质量控制;④终产品的稳定性和质量控制;⑤药效和安全性的描述;⑥疗程和剂量;⑦对照组.对于中药活性成分类中药,具体报告的方法应包括:①活性成分名称;②活性成分的中药来源;③提取活性成分的方法;④活性成分在药品中的分量比例;⑤药品中的附加物料及其质量控制.此外,干预措施的详细报告,可以考虑在网络版以附件形式发表.
중의약림상연구보고중,간예조시필수청석보고,이사독자전면료해연구중소채용적간예조시적질량급기질량공제방법.안조중국국가약품여식품감독관리국유관중약신약적분류방법,결합중약질량적공제요구,가이안조복방중약류급중약유효성분류진행간예조시적보고.대우단미중약/중약복방/중약유효성분제취물류중약,구체보고적방법응포괄:①명칭、제형화주책자료;②약물조성급기질량공제;③제제정서급기질량공제;④종산품적은정성화질량공제;⑤약효화안전성적묘술;⑥료정화제량;⑦대조조.대우중약활성성분류중약,구체보고적방법응포괄:①활성성분명칭;②활성성분적중약래원;③제취활성성분적방법;④활성성분재약품중적분량비례;⑤약품중적부가물료급기질량공제.차외,간예조시적상세보고,가이고필재망락판이부건형식발표.
Traditional Chinese medicine (TCM) intervention should be concisely and precisely reported in randomized controlled trials (RCTs). Based on State Food and Drug Administration's categories, we recommend reporting the interventions as follows: (1) Single Chinese herbal medicinebased/formula-based/extraction-based intervention includes 1)Name, dosage format and registration; 2)The composition and quality of intervention; 3) Pharmaceutical processing and quality control; 4) Stability of final product and quality control; 5) Function and safety description; 6) Dosage and treatment course; 7) Control group. (2) Active compound-based TCM drug intervention includes 1) Name of active compound(s); 2) Original source of active compound(s) ; 3) The brief process obtaining active compound(s) ; 4) Percentage of active compound(s) in final product; 5) Added materials and its quality and quantity control. Besides, the detailed information of intervention can be published as an online supplement in web site.