藥品臨床綜合評(píng)價(jià)是應(yīng)用多種評(píng)價(jià)方法和工具，從多個(gè)維度對(duì)藥物在臨床應(yīng)用中的安全性、有效性、經(jīng)濟(jì)性、創(chuàng)新性、適宜性和可及性進(jìn)行的綜合評(píng)價(jià)。中成藥作為評(píng)價(jià)對(duì)象之一，其評(píng)價(jià)體系在政策和技術(shù)推動(dòng)下逐步規(guī)范化，但仍面臨諸多挑戰(zhàn)。目前中成藥臨床綜合評(píng)價(jià)方法分為快速評(píng)價(jià)和完整評(píng)價(jià)，適用于不同場(chǎng)景；評(píng)價(jià)過程包括證據(jù)收集和決策2個(gè)階段，涉及文獻(xiàn)分析、真實(shí)世界數(shù)據(jù)、專家咨詢等多種方法。然而，其不足主要體現(xiàn)在數(shù)據(jù)碎片化、方法同質(zhì)化、中醫(yī)理論體現(xiàn)不足以及國(guó)際兼容性有限。針對(duì)這些問題，建議借鑒其他學(xué)科方法推動(dòng)方法學(xué)創(chuàng)新，構(gòu)建中醫(yī)特色評(píng)價(jià)維度，融合區(qū)塊鏈與人工智能（AI）技術(shù)優(yōu)化數(shù)據(jù)分析，以及推進(jìn)標(biāo)準(zhǔn)化與國(guó)際化雙軌發(fā)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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