*Department of Pediatrics, Kaohsiung Veterans General Hospital, Kaohsiung †School of Medicine, National Yang-Ming University, Taipei ‡Department of Public Health, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
J Clin Gastroenterol. 2014 Jan;48(1):37-42. doi: 10.1097/MCG.0b013e31828f1c6e.
Quantitative Vesikari scales and qualitative severe diarrhea (Vesikari scale ≥11) assessments were used to grade the Salmonella-induced and rotavirus-induced gastroenteritis severity. A significant reduction in severe diarrhea (Vesikari score ≥11) was used to evaluate the efficacy of three-combination probiotics (BIO-THREE).
Several studies have shown that rotavirus and Salmonella infections are the leading causes of infectious gastroenteritis. Although probiotics have been effective in some studies, the use of 3-combination formulation probiotics is rare.
This single-center, open-label, randomized, controlled trial included 159 patients (age range, 3 mo to 14 y) hospitalized with infectious gastroenteritis between February 2009 and October 2010.
Patients were grouped according to the pathogen identified (48, Salmonella; 42, rotavirus; and 69, unknown origin). The total diarrhea duration was significantly shorter for children who received BIO-THREE (P<0.0001). After BIO-THREE administration, there were significantly less intervention group patients with severe diarrhea at intervention day 3. Vesikari scale or diarrhea frequency results did not reveal significant differences between groups (except for day 5 in patients with rotavirus), and there were no significant changes in other clinical parameters or the length of hospital stay.
Seven-day BIO-THREE administration demonstrated high efficacy and safety in infants and children with severe gastroenteritis. The incidence of severe gastroenteritis was significantly reduced in the rotavirus origin and BIO-THREE intervention groups.
采用定量 Vesikari 量表和定性严重腹泻(Vesikari 量表≥11)评估来分级沙门氏菌和轮状病毒引起的肠胃炎严重程度。采用严重腹泻(Vesikari 评分≥11)显著减少来评估三联益生菌(BIO-THREE)的疗效。
几项研究表明,轮状病毒和沙门氏菌感染是传染性肠胃炎的主要病因。虽然益生菌在一些研究中有效,但三联配方益生菌的使用很少见。
这是一项单中心、开放标签、随机、对照试验,纳入了 2009 年 2 月至 2010 年 10 月期间因传染性肠胃炎住院的 159 名(年龄 3 个月至 14 岁)患者。
根据病原体(48 例沙门氏菌、42 例轮状病毒和 69 例未知来源)将患者分组。接受 BIO-THREE 治疗的患者总腹泻持续时间明显更短(P<0.0001)。在 BIO-THREE 给药后,干预第 3 天干预组严重腹泻患者明显减少。Vesikari 量表或腹泻频率结果在组间没有显著差异(轮状病毒患者除外第 5 天),其他临床参数或住院时间没有显著变化。
7 天 BIO-THREE 给药在严重肠胃炎的婴儿和儿童中显示出高疗效和安全性。轮状病毒来源和 BIO-THREE 干预组严重肠胃炎的发生率显著降低。