探讨基于核心指标集构建中医特色的射血分数保留心力衰竭1+N模式疗效评价体系

Exploring efficacy evaluation system construction of a traditional Chinese medicine characteristic 1+N model for heart failure with preserved ejection fraction based on core outcome sets

核心指标集是就某一特定研究领域达成的所有临床研究都应该测量和报告的最少的临床结局,核心指标集可以提高临床疗效评价的规范性和可比性,是循证医学发展的必然、是中医药临床疗效评价的重要抓手、是推动中医药疗效评价与国际接轨的关键。如何运用核心指标集实现临床疗效国际化、标准化的同时,又能遵循中医诊疗特点体现自身优势是中医临床疗效评价的难点。针对这一难点,项目组创新性地提出了1+N模式的射血分数保留心衰(heart failure with preserved ejection fraction, HFpEF)疗效评价体系,即通用的核心指标集“1”+个性化指标集“N”,以满足循证医学和中医学疗效评价的双重需求。本文初探HFpEF疗效评价构建模式,主张在规范化基础上体现多样化和个性化的研究目的需求。结合HFpEF临床疗效评价的现状,综合业内专家意见,探讨了HFpEF 1+N模式疗效评价构建中核心指标集“1”的取舍以及“N”体系的构建思路,以期最大程度的形成符合中医药特色的临床评价体系新范式,推动中医药国际化进程。

The core outcome sets(COS)is the minimum clinical outcome that all clinical studies in a specific research field should be measured and reported,which could improve the standardization and comparability of clinical efficacy evaluation and is an inevitable trend in the development of evidence-based medicine(EBM).COS is an important lever and a key factor in promoting the integration of traditional Chinese medicine(TCM)efficacy evaluation with international standards.It is the difficult point to use COS to achieve internationalization and standardization of clinical efficacy,meanwhile reflect advantages of TCM.Focusing on the difficulty,we innovatively proposed a 1+N model for evaluating the efficacy of heart failure with preserved ejection fraction(HFpEF),which includes COS as"1"and diverse sets of"N",to meet the dual needs of EBM and TCM efficacy evaluation.This article reviewed the construction model of HFpEF efficacy evaluation,advocating for reflecting diversified and personalized research objectives on the basis of standardization.Based on the current situation of clinical efficacy evaluation of HFpEF and the opinions of industry experts.The selection of COS"1"and diverse"N"systems in the construction of HFpEF efficacy evaluation with 1+N mode was explored in order to form a new paradigm of clinical evaluation system that conforms to the characteristics of TCM and promote the internationalization process of TCM.