APT198K治疗婴儿腹绞痛的疗效与安全性：一项初步研究。
Efficacy and safety of APT198K for the treatment of infantile colic: a pilot study.
作者信息
Vandenplas Yvan, Bacarea Anca, Marusteri Marius, Bacarea Vlad, Constantin Mariana, Manolache Mihai
机构信息
Department of Pediatrics, UZ Brussel, Vrije Universiteit Brussel, Brussels, Belgium.
University of Medicine & Pharmacy Târgu Mureş City, Romania.
出版信息
J Comp Eff Res. 2017 Mar;6(2):137-144. doi: 10.2217/cer-2016-0059. Epub 2017 Jan 24.
AIM
Comparing efficacy and safety of APT198K (xyloglucan plus heat-killed Lactobacillus reuteri SGL01 and Bifidobacterium brevis SGB01) versus a lactase dietary supplement as first-line treatment of infantile colic.
METHODS
Randomized, multicenter, open-label, parallel group, active-controlled study, in 46 infants aged 3-16 weeks with infantile colic, receiving APT198K or a lactase dietary supplement for 10 days.
RESULTS
Number and duration of crying episodes decreased significantly versus baseline in both groups. On day 8, the mean duration of crying per episode was significantly shorter in the APT198K group compared with the lactase group (9.14 ± 5.34 vs 13.22 ± 5.29 min; p = 0.014) and remained so up to day 11.
CONCLUSION
APT198K decreased the mean duration per crying episode significantly more than a lactase dietary supplement in infants with colic. Further evaluation in larger studies is warranted. Clinical trial registry: EudraCT number 2014-002860-334; https://eudract.ema.europa.eu .
目的
比较APT198K（木葡聚糖加热灭活的罗伊氏乳杆菌SGL01和短双歧杆菌SGB01）与乳糖酶膳食补充剂作为婴儿腹绞痛一线治疗方法的疗效和安全性。
方法
一项随机、多中心、开放标签、平行组、活性对照研究，纳入46例3至16周龄患有婴儿腹绞痛的婴儿，给予APT198K或乳糖酶膳食补充剂，为期10天。
结果
两组哭闹发作的次数和持续时间均较基线显著减少。在第8天，APT198K组每次哭闹发作的平均持续时间显著短于乳糖酶组（9.14±5.34对13.22±5.29分钟；p=0.014），直至第11天均保持如此。
结论
在患有腹绞痛的婴儿中，APT198K比乳糖酶膳食补充剂更显著地缩短了每次哭闹发作的平均持续时间。有必要在更大规模的研究中进行进一步评估。临床试验注册编号：EudraCT编号2014-002860-334；https://eudract.ema.europa.eu 。
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