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目的:梳理中成药说明书中有关女性患者用药信息的标注现状,针对其存在的问题,提出相关项目修订完善的思考与建议。方法:通过实地收集、文献检索等方式获取1 572个示例中成药品种的说明书实物,提取其中女性患者用药的各方面信息,对标注内容及分布情况进行频次统计和对比分析。结果:1 572份中成药说明书,其中64.6%提示了女性的用药信息,绝大多数为对孕期妇女的用药警戒。女性患者用药信息可见于说明书的警示语、[用法用量]、[不良反应]、[禁忌]、[注意事项]及[孕妇及哺乳期妇女用药]等6项,涉及内容丰富,包括特殊人群用药禁忌、饮食起居禁忌、给药时间、给药方式、疗程等,但仍存在警示语缺失、安全用药信息不全面、用药警戒对象局限、禁忌等级划分有待统一标准等问题。结论:中成药说明书对女性患者合理用药的关注度尚可,但警示内容仍不够全面,有待对说明书相关项目进行修订和完善,可按照扩大信息来源、明确转化路径和规范撰写模式等步骤实施。
OBJECTIVE: To sort out the current status of labeling of medication information for female patients in the manual of proprietary Chinese medicines, and to put forward some suggestions and suggestions on the revision and improvement of relevant items in light of the existing problems. Methods: The samples of 1 572 Chinese patent medicines were obtained through on-the-spot collection and literature search. The information of all aspects of female drug use was extracted and the frequency statistics and comparative analyzes were made on the content and distribution of the labeled drugs. Results: 1 572 instructions for proprietary Chinese medicines, of which 64.6% prompted the female medication information, the vast majority of pregnant women medication warning. Information on the medication for female patients can be found in six warning labels, [usage and dosage], [adverse reactions], [taboo], [precautions] and [pregnant women and lactating women], including rich content, including special population medication Taboo, taboo diet, time of administration, mode of administration, course of treatment, etc. However, there are still some problems such as lack of warning signs, incomplete safety medication information, limitation of medication caution objects and the unification of contraindications. Conclusion: The instructions of proprietary Chinese medicine (TCM) can still be used properly in female patients. However, the contents of the warnings are still not comprehensive enough. The related items in the manuals need to be revised and perfected. The steps can be taken to expand the sources of information, clarify the transformation path and regulate the writing mode.