Markovinović Leo, Knezović Ivica, Kniewald Tihana, Stemberger Marić Lorna, Trkulja Vladimir, Tešović Goran
University Hospital for Infectious Diseases "Dr. Fran Mihaljević", Zagreb, Croatia.
School of Dental Medicine, University of Zagreb, Zagreb, Croatia.
Front Pediatr. 2020 Dec 21;8:553960. doi: 10.3389/fped.2020.553960. eCollection 2020.
The aim of this study was to compare two adjunct therapies in the treatment of childhood rotavirus gastroenteritis (RVGE). We compared the recommended treatment, probiotic DSM 17938 (BioGaia®), vs. a novel treatment, enterosorbent polymethylsiloxane polyhydrate (Enterosgel®). This was an open-label, randomized, clinical controlled trial at the University Hospital for Infectious Diseases (UHID) in Zagreb, Croatia. A total of 149 children aged 6-36 months with acute rotaviral gastroenteritis over a period of <48 h, with no significant chronic comorbidity, were randomized to receive the standard therapy with DSM 17938 (hereafter ) or polymethylsiloxane polyhydrate (hereafter PMSPH) therapy, during 5 days. The primary end point was time to recovery in days in both groups. The recovery was defined as absence of fever and vomiting and either the first firm stool, absence of stool for more than 24 h, or return of usual bowel habit. A total of 75 children were randomized into the group and 74 were randomized into the PMSPH group; after excluding missing data, the data from 65 children in each group were analyzed. There was no significant difference in the treatment efficacy between the two regimens with an estimated median time of recovery of 6 days in both groups ( = 0.754). No significant side effects were observed in either group. Novel enterosorbent PMSPH had a similar efficacy to probiotic in the treatment of rotaviral gastroenteritis in preschool children. ClinicalTrials.gov Identifier: NCT04116307 [October 3, 2019] (retrospectively registered). https://clinicaltrials.gov/show/NCT04116307.
本研究的目的是比较两种辅助疗法在儿童轮状病毒胃肠炎（RVGE）治疗中的效果。我们比较了推荐治疗方法——益生菌DSM 17938（拜奥益畅®）与一种新型治疗方法——肠吸附剂聚甲基硅氧烷多水合物（依特安格®）。这是一项在克罗地亚萨格勒布传染病大学医院（UHID）进行的开放标签、随机、临床对照试验。共有149名年龄在6至36个月、急性轮状病毒胃肠炎病程小于48小时且无显著慢性合并症的儿童，被随机分为两组，在5天内分别接受DSM 17938标准疗法（以下简称 ）或聚甲基硅氧烷多水合物（以下简称PMSPH）疗法。主要终点是两组患儿恢复所需的天数。恢复定义为无发热和呕吐，且出现首次成形大便、无大便超过24小时或恢复正常排便习惯。共有75名儿童被随机分到 组，74名儿童被随机分到PMSPH组；在排除缺失数据后，对每组65名儿童的数据进行了分析。两种治疗方案的疗效无显著差异，两组的估计中位恢复时间均为6天（ = 0.754）。两组均未观察到显著的副作用。新型肠吸附剂PMSPH在学龄前儿童轮状病毒胃肠炎治疗中的疗效与益生菌相似。ClinicalTrials.gov标识符：NCT04116307 [2019年10月3日]（追溯注册）。https://clinicaltrials.gov/show/NCT04116307 。
