药品临床综合评价是应用多种评价方法和工具，从多个维度对药物在临床应用中的安全性、有效性、经济性、创新性、适宜性和可及性进行的综合评价。中成药作为评价对象之一，其评价体系在政策和技术推动下逐步规范化，但仍面临诸多挑战。目前中成药临床综合评价方法分为快速评价和完整评价，适用于不同场景；评价过程包括证据收集和决策2个阶段，涉及文献分析、真实世界数据、专家咨询等多种方法。然而，其不足主要体现在数据碎片化、方法同质化、中医理论体现不足以及国际兼容性有限。针对这些问题，建议借鉴其他学科方法推动方法学创新，构建中医特色评价维度，融合区块链与人工智能（AI）技术优化数据分析，以及推进标准化与国际化双轨发展。

Comprehensive clinical evaluation of drugs involves the application of multiple evaluation methods and tools to assess the safety, efficacy, economy, innovation, suitability and accessibility of drugs in clinical use from multiple dimensions. As one of the evaluation objects, the evaluation system of Chinese patent medicines has gradually become standardized under the impetus of policies and technologies, but still faces many challenges. Through literature analysis, this paper summarizes the characteristics of comprehensive clinical evaluation of Chinese patent medicines: First, the evaluation methods are divided into rapid evaluation and complete evaluation, which are suitable for different scenarios; Second, the evaluation process includes two stages of evidence collection and decision-making, involving various methods such as literature analysis, real-world data, and expert consultation. However, its shortcomings mainly lie in data fragmentation, method homogenization, insufficient reflection of traditional Chinese medicine theory, and limited international compatibility. In response to these problems, this paper proposes the following countermeasures: Drawing on methods from other disciplines to promote methodological innovation, constructing evaluation dimensions with Chinese medicine characteristics, integrating blockchain and AI technologies to optimize data analysis, and promoting dual-track development of standardization and internationalization.

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