特发性肺纤维化在病证结合模式指导下的疗效评价体系框架

特发性肺纤维化（IPF）为一种慢性、进展性、纤维化型间质性肺炎的特殊类型，目前尚缺乏有效、安全的治疗手段。近年来，中医药手段治疗IPF的临床试验开展较多，但评价标准、指标的选取却各有不同，缺乏统一的、规范的认识。本文从病证结合诊疗模式的角度，概括和整理目前广泛应用的评价手段，结合最新诊疗规范的要求，提出了该病的疗效评价体系框架，并对框架内重要指标、方法进行阐述。以期由此完善临床试验设计，为今后的循证医学研究提供高质量的“证据链”。

Establishment on Evaluation System of Clinical Effects on Idiopathic Pulmonary Fibrosis Under Guidance of Combination of Disease and Syndrome Model

Idiopathic pulmonary fibrosis (IPF) is defined as a specific form of chronic and progressive fibrosing interstitial pneumonia. Till now, it is lack of effective and safe treatment. In recent years, more and more clinical trials of traditional Chinese medicine (TCM) have been conducted with different evaluation criteria and indexes. The knowledge is disunity and unsystematic. From the perspective of combination of disease and TCM syndrome model, this article summarized and organized the current data and medical standards, and then come up with the new evaluation system of clinical effect and describe important indexes and methods. This article was aimed to improve the clinical trial design and provide high quality evidences for evidence-based medicine.