目的 基于辨证角度对治疗心律失常的中成药进行综合评价，旨在为集采决策、临床遴选及合理用药提供证据支持。方法 基于《医疗机构中成药遴选专家共识2022》建立“6+1”维度的评价框架，采用定性定量方法对药品进行综合评价。同时在有效性评价部分创新嵌套肖小河团队的“整合证据链法”，将传统证据与新型评价体系进行优化对比。结果 共纳入16种治疗心律失常的中成药，70%达到临床推荐阈值（＞60分），气滞血瘀型产品数量最多（10/16）。证型得分梯度为气阴两虚型＞痰热扰心型≈心肾阳虚型＞气滞血瘀型。采用新“整合证据链法”后，药品整体的综合评分较原评分体系提高，与整合临床经验和实验研究相关。最终气阴两虚型推荐参松养心胶囊、稳心颗粒及通脉养心丸（强推荐）；痰热扰心型推荐心速宁胶囊（弱推荐）；气滞（虚）血瘀型推荐振源胶囊（强推荐）、养心定悸胶囊、心可舒制剂、养心达瓦依米西克蜜膏、黄杨宁片、灵宝护心丹（弱推荐）；心肾阳虚型推荐参仙升脉口服液、心宝丸（弱推荐）。结论 结合“整合证据链法”的评价体系能更全面地反映药物特点，同时揭示抗心律失常中成药存在气阴两虚型循证强、痰热型选择单一、气滞血瘀型品种繁杂且质量参差不齐的临床格局，并提出整体需增加有效性、安全性的循证支持，为优化临床决策提供科学依据。

Objective To conduct comprehensive evaluation of Chinese Patent Medicines forarrhythmia treatment from the perspective of syndromic differentiation, aiming to provide evidence support for centralized procurement decisions, clinical drug selection, and rational drug use. Methods An evaluation framework with “6+1” dimensions was established based on the Expert Consensus on the Selection of Chinese Patent Medicines in Medical Institutions (2022), qualitative and quantitative methods were adopted for the comprehensive evaluation of drugs. Meanwhile, the “Integrated Evidence Chain Method” proposed by Xiao Xiaohe’s team was innovatively embedded in the efficacy evaluation section, and an optimized comparison was conducted between traditional evidence and the new evaluation system. Results A total of 16 kinds of antiarrhythmic Chinese patent medicines were included, 70% met the clinical recommendation threshold (> 60 points). The number of products for the “qi stagnation and blood stasis type” was the largest (10/16). The score gradient of syndromic types was as follows: Qi and yin deficiency type > phlegm-heat disturbing the heart type ≈ heart and kidney yang deficiency type > qi stagnation (deficiency) and blood stasis type. After applying the new “Integrated Evidence Chain Method”, the overall comprehensive scores of the drugs were higher than those under the original evaluation system, which was associated with the integration of clinical experience and experimental research. Finally, the recommended drugs for each syndromic type were determined: For qi and yin deficiency type: Shensong Yangxin Capsules, Wenxin Granules, and Tongmai Yangxin Pills (strong recommendation); For phlegm-heat disturbing the heart type: Xinsuning Capsules (weak recommendation); For qi stagnation (deficiency) and blood stasis type: Zhenyuan Capsules (strong recommendation), Yangxin Dingji Capsules, Xinkeshu Preparations, Yangxin Dawayi Mixike Honey Ointment, Huangyangning Tablets, and Lingbao Huxin Dan (weak recommendation); For heart and kidney yang deficiency type: Shenxian Shengmai Oral Liquid and Xinbao Pills (weak recommendation). Conclusion The evaluation system combined with the “Integrated Evidence Chain Method” can more comprehensively reflect the characteristics of drugs. It also reveals the clinical pattern of antiarrhythmic Chinese Patent Medicines: Strong evidence-based support for the qi and yin deficiency type, limited options for the phlegm-heat type, and a wide variety of products with uneven quality for the qi stagnationand blood stasis type. Additionally, it is proposed that the overall evidence-based support for efficacy and safety should be strengthened, which provides a scientific basis for optimizing clinical decisions.

R965

民族药重点品种全产业链培育与技术攻关——新疆民族药临床应用研究与评价（2023LQ01002-05）