评估牛奶相关症状评分（CoMiSS）作为牛奶蛋白过敏的诊断工具：中国的一项前瞻性、多中心研究（MOSAIC 研究）。
Assessment of the Cow's Milk-related Symptom Score (CoMiSS) as a diagnostic tool for cow's milk protein allergy: a prospective, multicentre study in China (MOSAIC study).
机构信息
Vrije Universiteit Brussel, UZ Brussel, KidZ Health Castle, Brussels, Belgium.
Children's Hospital Zhejiang, University School of Medicine, Zhejiang University, Hangzhou, China
出版信息
BMJ Open. 2022 Feb 17;12(2):e056641. doi: 10.1136/bmjopen-2021-056641.
OBJECTIVES
The MOSAIC study aimed to evaluate if the Cow's Milk-related Symptom Score (CoMiSS) can be used as a stand-alone diagnostic tool for cow's milk protein allergy (CMPA).
DESIGN
Single-blinded, prospective, multicentre diagnostic accuracy study.
SETTING
10 paediatric centres in China.
PARTICIPANTS
300 non-breastfed infants (median age 16.1 weeks) with suspected CMPA.
INTERVENTIONS
After performing the baseline CoMiSS, infants commenced a cow's milk protein elimination diet with amino acid-based formula for 14 days. CoMiSS was repeated at the end of the elimination trial. Infants then underwent an open oral food challenge (OFC) with cow's milk-based formula (CMF) in hospital. Infants who did not react during the OFC also completed a 14-day home challenge with CMF. A diagnosis of CMPA was made if acute or delayed reactions were reported.
PRIMARY OUTCOME MEASURES
A logistic regression model for CoMiSS to predict CMPA was fitted and a receiver-operator characteristic (ROC) curve generated. An area under the curve (AUC) of ≥0.75 was deemed adequate to validate CoMiSS as a diagnostic tool (target sensitivity 80%-90% and specificity 60%-70%).
RESULTS
Of 254 infants who commenced the OFC, 250 completed both challenges, and a diagnosis of CMPA made in 217 (85.4%). The median baseline CoMiSS in this group fell from 8 (IQR 5-10) to 5 (IQR 3-7) at visit 2 (p<0.000000001), with a median change of -3 (IQR -6 to -1). A baseline CoMiSS of ≥12 had a low sensitivity (20.3%), but high specificity (87.9%) and high positive predictive value (91.7%) for CMPA. The ROC analysis with an AUC of 0.67 fell short of the predefined primary endpoint.
CONCLUSIONS
The present study did not support the use of CoMiSS as a stand-alone diagnostic tool for CMPA. Nevertheless, CoMiSS remains a clinically useful awareness tool to help identify infants with cow's milk-related symptoms.
TRIAL REGISTRATION NUMBER
NCT03004729; Pre-results.
目的
MOSAIC 研究旨在评估牛奶相关症状评分（CoMiSS）是否可作为牛奶蛋白过敏（CMPA）的独立诊断工具。
设计
单盲、前瞻性、多中心诊断准确性研究。
地点
中国 10 个儿科中心。
参与者
300 名非母乳喂养的疑似 CMPA 婴儿（中位年龄 16.1 周）。
干预措施
在进行基线 CoMiSS 后，婴儿开始接受 14 天的牛奶蛋白消除饮食，采用基于氨基酸的配方。在消除试验结束时重复进行 CoMiSS。然后，婴儿在医院接受含有牛奶配方的口服食物挑战（OFC）。在 OFC 期间没有反应的婴儿也完成了 14 天的 CMF 家庭挑战。如果报告有急性或延迟反应，则诊断为 CMPA。
主要结局测量
拟合 CoMiSS 的逻辑回归模型以预测 CMPA，并生成接收者操作特征（ROC）曲线。曲线下面积（AUC）≥0.75 被认为足以验证 CoMiSS 作为诊断工具的有效性（目标灵敏度 80%-90%，特异性 60%-70%）。
结果
在 254 名开始进行 OFC 的婴儿中，有 250 名完成了两次挑战，并在 217 名（85.4%）婴儿中做出了 CMPA 诊断。在该组中，基线 CoMiSS 中位数从 8（IQR 5-10）降至 2 访次时的 5（IQR 3-7）（p<0.000000001），中位数变化为-3（IQR -6 至 -1）。基线 CoMiSS≥12 时，对 CMPA 的敏感性较低（20.3%），但特异性（87.9%）和阳性预测值（91.7%）较高。ROC 分析的 AUC 为 0.67，未达到预设的主要终点。
结论
本研究不支持 CoMiSS 作为 CMPA 的独立诊断工具。然而，CoMiSS 仍然是一种有用的临床意识工具，可帮助识别与牛奶相关的症状的婴儿。
试验注册号
NCT03004729；预结果。
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