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中医药在我国慢性乙型肝炎治疗中发挥着十分重要的作用,尤其在改善临床症状和中医证候、抗肝脏炎症(保肝、降酶、退黄)、抗肝纤维化及抗乙肝病毒、调控免疫等方面具有一定的优势。为更好地评价治疗慢性乙型肝炎的中药新药的疗效,作者结合慢性乙型肝炎的临床特点和临床需求,从受试者的合理选择、中医证候分类与评分、治疗方案及合并用药、对照药的选择、疗程及随访、评价指标等方面,对慢性乙型肝炎的中药新药临床试验设计中需要注意的技术问题进行了分析与探讨。
Chinese medicine plays a very important role in the treatment of chronic hepatitis B in our country, especially in improving clinical symptoms and TCM syndromes, anti-liver inflammation (protecting the liver, reducing enzyme, reversion), anti-liver fibrosis and anti-hepatitis B virus, Regulation of immunity and so has some advantages. In order to better evaluate the curative effect of traditional Chinese medicine for treating chronic hepatitis B, the author combined the clinical features and clinical needs of chronic hepatitis B, from the reasonable choice of subjects, classification and score of TCM syndromes, treatment plan and combination therapy, The selection, course of treatment and follow-up, evaluation index and other aspects of the control drug, technical problems that need attention in the clinical trial design of new drug of traditional Chinese medicine for chronic hepatitis B were analyzed and discussed.