目的 分析国内儿童非处方药（OTC）–中成药说明书范本存在的问题，提出对策与建议。方法 采用调研法对国内OTC–中成药说明书中具有儿童用法用量的品种进行梳理，并纳入儿童OTC–中成药目录。对目录中药品的功效及属性进行分类、归纳含毒性成分的药品，并对说明书范本标注情况进行汇总分析。结果 OTC–中成药的药品说明书中具体儿童用法用量的品种数共186种，被纳入儿童OTC–中成药药品目录，其中以消导剂（51种，27.42%）、扶正剂（44种，23.66%）、清热剂（25种，13.44%）居多；甲类药品（183种，98.39%）的品种数及占比明显高于乙类药品（3种，1.61%）；“双跨药品”共46种（24.73%）；儿童专用药共175种（94.09%）；医保药物共45种（24.19%）。目录中无含有“大毒”成分的药品，4种药品（2.15%）含有“有毒”成分，30种药品（16.13%）含有“小毒”成分。说明书范本中除儿童用药注意事项（100.00%）、药物相互作用（99.46%）标注率较高外，儿童用药最大剂量（0.00%）、儿童用药疗程（9.68%）、儿童用药不良反应（12.37%）、儿童用药禁忌（32.80%）的标注率均较低。结论 说明书范本主要存在儿童用药最大剂量、儿童用药疗程、儿童用药不良反应、儿童用药禁忌等项目标注率较低，研究性内容较为匮乏，安全及提示性标注更新滞后，缺乏有效的监管机制等问题。建议从用法用量、服药时间、不良反应、禁忌证、药物相互作用、专业术语的说明指导、相关部门加强监管等方面进行改进，以促进OTC说明书从源头更具规范性、严谨性、指导性，从而进一步保障儿童用药的安全有效。

Objective The problems of OTC Chinese patent medicine specification model were analyzed, and countermeasures and suggestions were put forward. Methods By using the research method of this paper, we sorted out the varieties with children's usage and dosage in the domestic OTC Chinese patent medicine manual, and included them in the children's OTC Chinese patent medicine catalog. This paper classifies the efficacy and attributes of drugs in the catalog, summarizes the drugs containing toxic ingredients, and summarizes and analyzes the labeling situation of the instructions. Results A total of 186 kinds of OTC Chinese patent medicines were included in the list of OTC Chinese patent medicines for children. Most of them were Xiaodao (51 kinds/27.42%), Fuzheng (44 kinds/23.66%) and Qingre (25 kinds/13.44%). The number and proportion of class A drugs (183 kinds/98.39%) were significantly higher than that of class B drugs (3 kinds/1.61%). There were 46 kinds of "double cross drugs" (24.73%), 175 kinds of special drugs for children (94.09%), and 45 kinds of medicare (24.19%). There were no "major toxic" drugs in the list, 4 (2.15%) drugs contained "toxic" components, and 30 (16.13%) drugs contained "minor toxic" components. In addition to the high labeling rate of precautions (100.00%) and drug interaction (99.46%), the labeling rates of maximum dose (0.00%), course of treatment (9.68%), adverse drug reactions (12.37%) and contraindications (32.80%) were low. Conclusion There are some problems in the instruction manual, such as the low labeling rate of the maximum dosage for children, the course of treatment for children, the adverse drug reactions for children, the drug contraindications for children, the lack of research content, lag of safety and prompt labeling, and the lack of effective supervision mechanism. It is suggested to improve the usage and dosage, medication time, adverse reactions, contraindications, drug interactions, the guidance of professional terms, and the strengthening of supervision by relevant departments, so as to promote the standardization, strictness, and guidance of OTC instructions from the source, so as to further ensure the safety and effectiveness of children's medication.

R288.1