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附: 编写说明
本《指南》旨在建立我国中西医结合诊断与治疗肝纤维化疾病的临床共识,为从事肝脏疾病防治的中医、中西医结合临床医师提供指导性意见,而不是强制性标准。因此,临床医生在针对某一具体患者时,应充分了解本病的最佳临床证据和现有医疗资源,并在全面考虑患者的具体病情及其意愿的基础上,根据自己的知识和经验,制定合理的诊疗方案。本指南将根据研究进展和需要不断更新和完善。
本《指南》所推荐药物的证据质量要求:
新药:经国家药品监督管理局批准,有明确的肝纤维化适应证,并有公开发表的具有达到统计学要求的肝组织学评价的抗肝纤维化临床研究资料。
经典方药:指出自中医学四大经典著作的方剂,并且具有肝病应用的临床报道,有抗肝纤维化作用的实验研究发表资料。
经验方:发表的研究资料中有肝组织学药效评价,证据等级Ⅱ-1级以上。
药物名称与剂量:根据中华人民共和国药典2005年版,标注名称、剂量、应用范围,剂量单位为g。经典方根据原方剂量及古今度量衡折算法换算为g。
《指南》涉及的名词术语与药物,参考国家药品监督管理局安全监管司国家药品监督管理局药品评价中心编写的“国家基本药物-西药”(2002年第2版)、
“国家基本药物-中成药”(2002年第1版),以及“中医大辞典“(2005年第2版)和“中医药学名词审定委员会编写的“中医药学名词-2004”(2005年第1版)等资料。 |