目的 分析國內(nèi)兒童非處方藥（OTC）–中成藥說明書范本存在的問題，提出對策與建議。方法 采用調(diào)研法對國內(nèi)OTC–中成藥說明書中具有兒童用法用量的品種進行梳理，并納入兒童OTC–中成藥目錄。對目錄中藥品的功效及屬性進行分類、歸納含毒性成分的藥品，并對說明書范本標(biāo)注情況進行匯總分析。結(jié)果 OTC–中成藥的藥品說明書中具體兒童用法用量的品種數(shù)共186種，被納入兒童OTC–中成藥藥品目錄，其中以消導(dǎo)劑（51種，27.42%）、扶正劑（44種，23.66%）、清熱劑（25種，13.44%）居多；甲類藥品（183種，98.39%）的品種數(shù)及占比明顯高于乙類藥品（3種，1.61%）；“雙跨藥品”共46種（24.73%）；兒童專用藥共175種（94.09%）；醫(yī)保藥物共45種（24.19%）。目錄中無含有“大毒”成分的藥品，4種藥品（2.15%）含有“有毒”成分，30種藥品（16.13%）含有“小毒”成分。說明書范本中除兒童用藥注意事項（100.00%）、藥物相互作用（99.46%）標(biāo)注率較高外，兒童用藥最大劑量（0.00%）、兒童用藥療程（9.68%）、兒童用藥不良反應(yīng)（12.37%）、兒童用藥禁忌（32.80%）的標(biāo)注率均較低。結(jié)論 說明書范本主要存在兒童用藥最大劑量、兒童用藥療程、兒童用藥不良反應(yīng)、兒童用藥禁忌等項目標(biāo)注率較低，研究性內(nèi)容較為匱乏，安全及提示性標(biāo)注更新滯后，缺乏有效的監(jiān)管機制等問題。建議從用法用量、服藥時間、不良反應(yīng)、禁忌證、藥物相互作用、專業(yè)術(shù)語的說明指導(dǎo)、相關(guān)部門加強監(jiān)管等方面進行改進，以促進OTC說明書從源頭更具規(guī)范性、嚴(yán)謹(jǐn)性、指導(dǎo)性，從而進一步保障兒童用藥的安全有效。

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