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儿童药品临床综合评价方法研究——以儿童抗过敏药物为例
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| 篇名： | 儿童药品临床综合评价方法研究——以儿童抗过敏药物为例 |
| TITLE： | Research about clinical comprehensive evaluation methods of pediatric drugs ：taking pediatric anti-allergic drugs as an example |
| 摘要： | 目的 为我国儿童药品临床综合评价工作的全面开展提供借鉴。方法以儿童抗过敏药物为例，从主题遴选、评价内容与维度、评价指标、评价方法及评价结果报告等环节探索医疗机构开展儿童药品临床综合评价的方法。结果与结论在开展儿童药品临床综合评价时，可在国家临床综合评价相关指南指导下，按照重要性、相关性以及可评估性三大原则遴选评价主题，然后围绕安全性、有效性、经济性、适宜性、可及性、创新性6个维度，开发建立适宜的评价指标体系，对待评药品进行定性及定量数据整合分析。在评价中，应围绕儿童临床基本用药实践及决策需求，规范、科学、合理地定义不同维度证据所需的核心指标集和标准数据集，规范收集和使用真实世界数据，并结合其他类别证据，真正发挥其在我国儿童药品临床综合评价中的优势作用。 |
| ABSTRACT： | OBJEC TIVE To provide reference for clinical comprehensive evaluation of pediatric drugs in China. METHODS Taking pediatric anti-allergic drugs as an example ，the clinical comprehensive evaluation methods of pediatric drugs in medical institutions were explored from the aspects of theme selection ，evaluation content and dimension ，evaluation index ，evaluation method and evaluation result report. RESULTS & CONCLUSIONS During the clinical comprehensive evaluation of pediatric drugs，under the guidance of relevant national guidelines for clinical comprehensive evaluation ，the evaluation topics could be selected according to the three principles of importance ，relevance and evaluability ，and then an appropriate evaluation index system could be developed around the six dimensions of safety ， effectiveness， economy， suitability，accessibility and innovativeness；qualitative and quantitative data integration analysis of the drugs to be evaluated were performed. In the evaluation ， it is necessary to focus on children ’s clinical basic drug use practice and decision-making needs ，normatively，scientifically and reasonably define the core index set and standard data set required by different dimensions of evidence ，standardize the collection and use of real-world data ，and effectively combine other types of evidence to truly play its advantageous role in the clinical comprehensive evaluation of pediatric drugs in China. |
| 期刊： | 2022年第33卷第02期 |
| 作者： | 刘璐，肖月，刘畅，曲素欣，李蓉，于宝东，莫晓媚，刘克军，闫美兴 |
| AUTHORS： | LIU Lu，XIAO Yue，LIU Chang ，QU Suxin，LI Rong，YU Baodong ，MO Xiaomei ，LIU Kejun，YAN Meixing |
| 关键字： | 儿童药品；抗过敏药物；临床综合评价 |
| KEYWORDS： | pediatric drug ；anti-allergic drug ；clinical comprehensive evaluation |
| 阅读数： | 304 次 |
| 本月下载数： | 23 次 |
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