治疗慢性胃炎中成药说明书的不良反应项与禁忌项的现状及相关问题探讨

Current Situation and Related Problems Discussion on Adverse Reactions and Contraindications in Instructions of Chinese Patent Medicines for Chronic Gastritis Treatment

摘要: 目的：分析治疗慢性胃炎中成药说明书中【不良反应】项与【禁忌】项的标注现状，探讨其存在的问题及对临床用药安全的影响。方法：基于药智网“中成药处方数据库”与“药品说明书数据库”，筛选297个符合条件的中成药产品，统计其说明书【不良反应】和【禁忌】项的标注情况，结合《上市中成药说明书安全信息项目修订技术规范》等标准进行问题分析。结果：71.04%的中成药说明书【不良反应】项标注为“尚不明确”，仅27.95%的中成药说明书进行了详细表述；【禁忌】项中42.76%标注为“尚不明确”，且证候禁忌(6.47%)与配伍禁忌(0%)缺失严重。结论：当前中成药说明书安全信息标注体系不完善，存在企业间透明度差异大、动态修订滞后等问题，导致用药风险被低估、误用可能性增加。建议强制规范不良反应与禁忌项内容，统一说明书模板，强化中医证候禁忌标注，并推动企业间信息互通，以提升用药安全性。

Abstract: Objective: To analyze the current labeling status of the “Adverse Reactions” and “Contraindications” sections in the package inserts of Chinese Patent Medicines (CPMs) for chronic gastritis, and to explore the existing problems and their impacts on the safety of clinical medication. Methods: Based on the “Chinese Patent Medicine Prescription Database” and “Drug Package Insert Database” of Yaozhiwang (a professional pharmaceutical information platform in China), 297 eligible CPM products were selected. The labeling status of the “Adverse Reactions” and “Contraindications” sections in their package inserts was statistically analyzed, and the problems were evaluated in combination with standards such as the Technical Specifications for the Revision of Safety Information Items in Package Inserts of Marketed Chinese Patent Medicines. Results: Among the CPM package inserts, 71.04% labeled the “Adverse Reactions” section as “Not yet clear”, while only 27.95% provided detailed descriptions. For the “Contraindications” section, 42.76% were labeled as “Not yet clear”, with a serious lack of syndrome contraindications (6.47%) and compatibility contraindications (0%). Conclusion: The current labeling system for safety information in CPM package inserts is incomplete, with problems such as significant transparency differences among enterprises and delayed dynamic revisions. These issues lead to underestimated medication risks and increased potential for misuse. It is recommended to compulsorily standardize the content of adverse reactions and contraindications, unify the package insert template, strengthen the labeling of TCM syndrome contraindications, and promote information sharing among enterprises to improve medication safety.