基于非线性模糊综合评价模型心血管中成药临床优势评价方法

To orientate a patent drug in question to a specific clinical use that gives full play to its unique overall effects is key to successful secondary development of famous and excellent Chinese patent medicine. Basing on previous studies, we introduced the concept of IPD (Individual Patient Data) from Evidence-based Medicine and tried to manage source data from past clinical studies of Compound Danshen Dripping Pills using a new evaluation tool. This new method involves a Fuzzy Comprehensive Assessment Model that can both reflect the influence of a certain outcome measure and is compatible with the Linear Weight Average Model. .Firstly, data regarding primary outcome measures was mined, classified and graded, and the coefficient of notable effects for different outcomes was determined. Then results of the new analysis were compared with the old using the mean of maximum method, another integral part of the new evaluation tool. Finally we applied and validated this method using statistics from clinical trials in which cardiac syndrome X was the target disease and Tongxinluo Capsules the designated therapy. With the help of this method, the quality of clinical evidence can be improved and the probability of repeated investment decreased. Therefore, we recommend the use of this newly established evaluation tool for the scientific assessment and selection of Chinese patent drugs for inclusion into the National List of Essential Medicine.

如何在明确中药临床定位的基础上，突出其整体效应，彰显优势，是名优中成药二次开发的关键。本项目在前期研究工作基础上，精选治疗冠心病具有代表性的中成药复方丹参滴丸，借鉴循证医学中单个病例数据（individual patient data, IPD）的理念，重新对其既往规范的临床研究原始数据进行整理，建立非线性模糊综合评价模型，特点是既能够反映某种指标的突出影响，又能把线性加权平均模型看作它的特例，对临床研究中反映中成药的主要疗效指标数据进行深度挖掘、分类分级、确定不同指标的突出影响程度系数，采用最大隶属度法综合评价，并与原评价结果进行比对分析，建立名优中成药临床优势疗效的评价方法；继而以中医药优势病种心脏X综合征为目标疾病，通心络胶囊作为目标药物，应用、验证、完善此方法。建立的方法可推广应用到《国家基本药物目录》中成药的科学评价和筛选，减少重复投入，促进中药临床证据质量的快速提升。

项目组借鉴循证医学中对单个病例数据二次研究的理念，收集整理以复方丹参滴丸为代表的心血管中成药既往相对规范的临床研究病例原始数据，提出了针对患者个体进行整体评价的创新思路，建立了模糊综合评价数学模型，特点是既能够反映某种指标的突出影响，又能把线性加权平均模型看作它的特例，对临床研究中反映中成药的核心指标数据集进行深度挖掘、分类分级、确定不同指标的突出影响程度系数，采用最大隶属度法综合评价，并与原评价结果进行比对分析，建立了中成药临床优势疗效的整体综合评价方法和程序，并在若干中成药的临床优势整体综合评价中得到应用。该方法的建立和其中蕴含的核心指标集构建新理念将有助于减少低水平的设计和重复投入，明确中成药的临床定位，凸显整体效应、综合优势，强力促进中成药临床研究水平和证据质量的整体提升。