一项以临床需求为导向的特定全营养配方食品分类优化的核心指标集研究

目的 确定对特定全营养配方食品（FSMP-S）具有高度临床需求的疾病/医学状态，为优化该类特医食品的注册和监管提供科学依据。方法 使用核心指标集构建方法，通过系统评价确定可由FSMP-S干预的疾病/医学状态清单，而后通过德尔菲和共识会议遴选FSMP-S高临床需求的疾病/医学状态清单，提出FSMP-S分类优化建议。结果 从5 984篇中英文献中纳入27项相关研究，获取共103种可由FSMP-S干预的疾病/医学状态；邀请147名三甲医院医师或临床营养师连续参与了2轮德尔菲调查，遴选出23种对FSMP-S临床需求较高的疾病/医学状态；通过多方共识会议确定11种具有高临床需求的疾病/医学状态，并提出在FSMP-S的分类维度中增加营养代谢特征的“1+1”优化策略（疾病/医学状态和营养素需求特征并用）。结论 共识所得“1+1”策略反映出了临床应用需求角度下的FSMP-S分类优化建议，可为决策参考，但仍需谨慎论证其可行性。

Optimizing the classification of specific whole-nutrient food for special medical purposes based on clinical needs: a core outcome set study

Objective To provide a scientific basis for optimizing the registration and regulation， disease/medical states with a high clinical need for specific whole-nutrient foods for special medical purposes （FSMP-S） were identified.Methods A core outcome set construction method was used in this study. A systematic review was conducted to determine the list of diseases/medical states that could be supported by FSMP-S. Then， a list of diseases/medical states with high clinical demand for FSMP-S was selected through the Delphi method and face-to-face consensus meetings， and optimization suggestions for classifying the FSMP-S were proposed.Results A total of 27 studies were identified， and 103 diseases/medical states with FSMP-S intervention were obtained from 5，984 papers in Chinese and English. Forty-seven physicians and dietitians from 3A hospitals participated in two rounds of Delphi surveys， after which 23 diseases/medical states were recognized as having high clinical demand for FSMP-S. The consensus meeting narrowed the scope of the FSMP-S to a high clinical need of 11 diseases/medical states. Finally， a “1+1” optimization strategy was proposed to add nutritional metabolic characteristics to the classification method for FSMP-S.Conclusion The “1+1” strategy could optimize the classification of FSMP-S from the perspective of clinical application requirements； however， its feasibility remains undemonstrated.