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中成药临床综合评价类文献质量分析及建议
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| 篇名： | 中成药临床综合评价类文献质量分析及建议 |
| TITLE： | Quality analysis and suggestions on the literature on clinical comprehensive evaluation of Chinese patent medicines |
| 摘要： | 目的 分析中成药临床综合评价类文献的质量现状及存在的问题，为优化研究设计、提升报告质量提供参考。方法系统检索中国知网、万方数据、维普网和中华医学期刊全文数据库中2020年1月1日－2025年12月31日发表的中成药临床综合评价类文献。依据报告完整性、内容规范性和研究透明度构建评价框架，逐项提取文献基本特征及各评价条目的报告信息，进行描述性统计分析。结果共纳入文献107篇，涉及146种中成药，文献数量呈逐年上升趋势，研究领域以心脑血管系统疾病为主（33篇，30.8%）；评价对象为单一药品的有99篇，多药品横向比较的有8篇。纳入文献的摘要部分及安全性、有效性等核心评价结果条目报告较为充分，报告率多在98%以上，但指南推荐意见（59.8%）、中医药特色维度（64.5%）和利益冲突声明（39.3%）等条目的报告率相对偏低，证据收集过程、证据综合及质量控制等过程性条目的报告亦不充分（69.2%～76.6%）。结论现有中成药临床综合评价类文献已初步形成以“6+1”维度为核心的框架，核心评价内容的报告较为完整，但在指南证据呈现和利益冲突披露等方面仍显不足，中医药特色维度的结构化表达亦有待完善。后续应进一步强化报告透明度、方法可复核性并明确适用范围，以提升评价结果对临床和政策的决策参考价值。 |
| ABSTRACT： | OBJECTIVE To analyze the current quality status and existing problems of literature on clinical comprehensive evaluation studies of Chinese patent medicines （CPMs）， and to provide a reference for optimizing the research design and improving the reporting quality.METHODS Articles on clinical comprehensive evaluation of CPMs published from January 1， 2020 to December 31， 2025 were systematically searched in CNKI， Wanfang Data， VIP and Chinese Medical Journal Full-text Database. An evaluation framework was constructed based on reporting completeness， content standardization and research transparency. The basic characteristics of the literature and the reporting information of each evaluation item were extracted item by item， and descriptive statistical analysis was performed.RESULTS A total of 107 articles were included， involving 146 CPMs. The number of articles showed an increasing trend year by year， and the research field mainly focused on cardiovascular and cerebrovascular diseases （33 articles ， 30.8%）. There were 99 articles evaluating a single drug and 8 articles conducting horizontal comparison among multiple drugs. The reporting of abstract sections and evaluation result items such as safety and effectiveness were relatively sufficient， with reporting rates mostly above 98%. However， the reporting rates of items such as guideline recommendations （59.8%）， the dimension of traditional Chinese medicine characteristics （64.5%） and conflict of interest statements （39.3%） were relatively low， and the reporting of process items such as evidence collection， evidence synthesis and quality control was also insufficient （69.2%-76.6%）.CONCLUSIONS The existing literature on clinical comprehensive evaluation of CPMs have initially formed a framework centered on the “6+1” dimensions， and the reporting of core evaluation contents is relatively complete. However， deficiencies remain in the presentation of guideline evidence and the disclosure of conflicts of interest， and the structured expression of the traditional Chinese medicine characteristic dimension also needs to be improved. In the future， reporting transparency， methodological reproducibility should be further strengthened， and the scope of application should be clearly defined， so as to enhance the value of evaluation results in informing clinical and policy decision-making. |
| 期刊： | 2026年第37卷第18期 |
| 作者： | 李雪园；张千飞；何柏鹤；杨薇 |
| AUTHORS： | LI Xueyuan，ZHANG Qianfei，HE Baihe，YANG Wei |
| 关键字： | 中成药;临床综合评价;报告规范;质量控制;规范化报告 |
| KEYWORDS： | Chinese patent medicine;clinical comprehensive evaluation;reporting standards;Quality control;standardized reporting |
| 阅读数： | 1 次 |
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