PDF(Pubmed)
Abstract：
UNASSIGNED: Cow\'s milk protein allergy (CMPA) is the most frequent food allergy in early childhood. For those infants requiring breastmilk substitutes, formulas with extensively hydrolyzed proteins (EHF), should be the treatment of choice. As there are limited data showing the progression of initial symptoms in infants newly diagnosed with CMPA who are treated with EHF with added synbiotics, the main objective of this study was to evaluate the resolution of symptoms in said infants after 4 weeks of treatment. As a secondary objective this study aimed to assess the impact of the treatment on the family\'s quality of life.
UNASSIGNED: observational, longitudinal, prospective, and multicentric real-world evidence study. The intervention phase (EHF with synbiotics) lasted 28 days and was completed by 65 patients. Treating physicians registered child´s anthropometry, Infant Gastrointestinal Symptoms Questionnaire (IGSQ-13) and CoMiSS (Cow´s Milk Allergy Symptoms Score) both at baseline and after 28 days of treatment. During treatment, caregivers reported child´s regurgitation and stools, PO-SCORAD (Patient Oriented Scoring of Atopic Dermatitis) and FAQL-PB (Family Quality of Life-Parental Burden). Data were collected using Google Forms and analyzed through the STATA program.
UNASSIGNED: 95.4% of the patients showed an improvement or disappearance of the overall initial symptoms after 4 weeks of treatment. Gastrointestinal symptoms improved or disappeared in 92% of patients (p < 0.05) while dermatological symptoms improved or disappeared in 87.5% of patients (p < 0.05). The median CoMiSS at baseline was 9, with 21 patients exceeding the cut-off point of 12. After 4 weeks of treatment, the median dropped to 3, and no patient exceeded the 12-cut-off point (p = 0.000). At baseline, patients had a PO-SCORAD of 11.5 (interquartile range 1-23) that went to 1.0 (interquartile range 1-6) at day 28 (p = 0.000). The treatment diminished stool frequency (p < 0.05), improved stool consistency (p = 0.004) and decreased the frequency of regurgitation in infants with CMPA (p = 0.01). The percentage of patients who no longer had any episode of regurgitation increased from 11% to 31% on day 28 (p = 0.003). At baseline, 13% of patients cried more than 3 h per day, while at day 28 that percentage dropped to 3% (p = 0.03). An improvement in the infants\' sleep pattern was also appreciated with the treatment. At study onset, 56% of the families reported feeling very overwhelmed, a percentage that dropped to 17% after 28 days of treatment (p < 0.05). The small percentage of families who did not feel overwhelmed at study onset (17%), grew to 43% on day 28 (p < 0.05).
UNASSIGNED: The use of an EHF with synbiotics for the management of infants diagnosed with or suspected to have CMPA suggested a good safety profile, an adequate infant growth, and improvement of overall, gastrointestinal, and dermatological symptoms. It also suggested a lower daily frequency of regurgitations and stools, and an improvement in stool consistency, sleeping pattern, and quality of life of the infant and his family.
UNASSIGNED: observational, longitudinal, prospective, and multicentric real-world evidence study. The intervention phase (EHF with synbiotics) lasted 28 days and was completed by 65 patients. Treating physicians registered child´s anthropometry, Infant Gastrointestinal Symptoms Questionnaire (IGSQ-13) and CoMiSS (Cow´s Milk Allergy Symptoms Score) both at baseline and after 28 days of treatment. During treatment, caregivers reported child´s regurgitation and stools, PO-SCORAD (Patient Oriented Scoring of Atopic Dermatitis) and FAQL-PB (Family Quality of Life-Parental Burden). Data were collected using Google Forms and analyzed through the STATA program.
UNASSIGNED: 95.4% of the patients showed an improvement or disappearance of the overall initial symptoms after 4 weeks of treatment. Gastrointestinal symptoms improved or disappeared in 92% of patients (p < 0.05) while dermatological symptoms improved or disappeared in 87.5% of patients (p < 0.05). The median CoMiSS at baseline was 9, with 21 patients exceeding the cut-off point of 12. After 4 weeks of treatment, the median dropped to 3, and no patient exceeded the 12-cut-off point (p = 0.000). At baseline, patients had a PO-SCORAD of 11.5 (interquartile range 1-23) that went to 1.0 (interquartile range 1-6) at day 28 (p = 0.000). The treatment diminished stool frequency (p < 0.05), improved stool consistency (p = 0.004) and decreased the frequency of regurgitation in infants with CMPA (p = 0.01). The percentage of patients who no longer had any episode of regurgitation increased from 11% to 31% on day 28 (p = 0.003). At baseline, 13% of patients cried more than 3 h per day, while at day 28 that percentage dropped to 3% (p = 0.03). An improvement in the infants\' sleep pattern was also appreciated with the treatment. At study onset, 56% of the families reported feeling very overwhelmed, a percentage that dropped to 17% after 28 days of treatment (p < 0.05). The small percentage of families who did not feel overwhelmed at study onset (17%), grew to 43% on day 28 (p < 0.05).
UNASSIGNED: The use of an EHF with synbiotics for the management of infants diagnosed with or suspected to have CMPA suggested a good safety profile, an adequate infant growth, and improvement of overall, gastrointestinal, and dermatological symptoms. It also suggested a lower daily frequency of regurgitations and stools, and an improvement in stool consistency, sleeping pattern, and quality of life of the infant and his family.
摘要：
■牛乳蛋白过敏（CMPA）是儿童早期最常见的食物过敏。对于那些需要母乳替代品的婴儿，广泛水解蛋白（EHF）的配方，应该是治疗的选择。由于有限的数据显示新诊断为CMPA的婴儿的初始症状进展，这些婴儿接受EHF治疗并添加合生元，这项研究的主要目的是评估治疗4周后所述婴儿的症状缓解情况.作为次要目的，本研究旨在评估治疗对家庭生活质量的影响。
■观测，纵向,prospective,和多中心的真实世界证据研究。干预阶段（EHF与合生元）持续28天，由65名患者完成。治疗医生注册了孩子的人体测量学，在基线和治疗28天后的婴儿胃肠道症状问卷(IGSQ-13)和CoMiSS(牛乳过敏症状评分)。治疗期间,看护人报告了孩子的反流和大便，PO-SCORAD（以患者为导向的特应性皮炎评分）和FAQL-PB（家庭生活质量-父母负担）。使用GoogleForms收集数据，并通过STATA程序进行分析。
■95.4％的患者在治疗4周后表现出总体初始症状的改善或消失。92％的患者胃肠道症状改善或消失（p<0.05），而87.5％的患者皮肤症状改善或消失（p<0.05）。基线时的中位数CoMiSS为9，其中21名患者超过12的截止点。治疗4周后,中位数降至3,无患者超过12截止点(p=0.000).在基线,患者的PO-SCORAD为11.5(四分位距1-23),在第28天达到1.0(四分位距1-6)(p=0.000).治疗减少大便频率（p<0.05），改善CMPA婴儿的粪便稠度（p=0.004）并降低反流频率（p=0.01）。在第28天，不再有任何反流发作的患者百分比从11％增加到31％（p=0.003）。在基线,13%的患者每天哭3小时以上，而在第28天，这一百分比下降到3%(p=0.03)。婴儿睡眠模式的改善也受到了赞赏。在研究开始时，56%的家庭报告感到非常不知所措，治疗28天后下降到17%(p<0.05)。一小部分在研究开始时没有感到不知所措的家庭（17％），在第28天增长到43%(p<0.05)。
■将EHF与合生元一起用于诊断或怀疑患有CMPA的婴儿的管理，表明安全性良好，足够的婴儿成长，和整体的改进，胃肠,和皮肤病学症状。它还表明每天反流和大便的频率较低，以及粪便稠度的改善，睡眠模式，以及婴儿及其家人的生活质量。
■观测，纵向,prospective,和多中心的真实世界证据研究。干预阶段（EHF与合生元）持续28天，由65名患者完成。治疗医生注册了孩子的人体测量学，在基线和治疗28天后的婴儿胃肠道症状问卷(IGSQ-13)和CoMiSS(牛乳过敏症状评分)。治疗期间,看护人报告了孩子的反流和大便，PO-SCORAD（以患者为导向的特应性皮炎评分）和FAQL-PB（家庭生活质量-父母负担）。使用GoogleForms收集数据，并通过STATA程序进行分析。
■95.4％的患者在治疗4周后表现出总体初始症状的改善或消失。92％的患者胃肠道症状改善或消失（p<0.05），而87.5％的患者皮肤症状改善或消失（p<0.05）。基线时的中位数CoMiSS为9，其中21名患者超过12的截止点。治疗4周后,中位数降至3,无患者超过12截止点(p=0.000).在基线,患者的PO-SCORAD为11.5(四分位距1-23),在第28天达到1.0(四分位距1-6)(p=0.000).治疗减少大便频率（p<0.05），改善CMPA婴儿的粪便稠度（p=0.004）并降低反流频率（p=0.01）。在第28天，不再有任何反流发作的患者百分比从11％增加到31％（p=0.003）。在基线,13%的患者每天哭3小时以上，而在第28天，这一百分比下降到3%(p=0.03)。婴儿睡眠模式的改善也受到了赞赏。在研究开始时，56%的家庭报告感到非常不知所措，治疗28天后下降到17%(p<0.05)。一小部分在研究开始时没有感到不知所措的家庭（17％），在第28天增长到43%(p<0.05)。
■将EHF与合生元一起用于诊断或怀疑患有CMPA的婴儿的管理，表明安全性良好，足够的婴儿成长，和整体的改进，胃肠,和皮肤病学症状。它还表明每天反流和大便的频率较低，以及粪便稠度的改善，睡眠模式，以及婴儿及其家人的生活质量。
