de Castro Jo-Anne A, Guno Mary Jean Villa-Real, Perez Marcos O
Department of Pediatrics, De La Salle Health Sciences Institute (DLSHSI) College of Medicine, Cavite, Philippines.
2Department of Microbiology and Parasitology, Pamantasang Lungsod ng Maynila College of Medicine (PLM-CM), Manila, Philippines.
Trop Dis Travel Med Vaccines. 2019 Jul 23;5:14. doi: 10.1186/s40794-019-0089-5. eCollection 2019.
Diarrhea is among the main causes of pediatric mortality in the Philippines. Probiotics have been shown to be beneficial in the management of acute diarrhea. Accordingly, the aim of this population-based study was to assess the safety and effectiveness of as an adjunct to standard therapy in Filipino children with acute community-acquired diarrhea of viral origin or associated with antibiotic administration.
A total of 3178 patients (median age of 2 years) were enrolled in this open-label, multicenter, observational study, and were treated with one to two vials of in the following bacterial stains: O/C, SIN, N/R, and T (oral suspension of 2 billion spores per 5-mL vial) for 5 to 7 days. Diarrhea duration, number of stools per day, improvement in gastrointestinal symptoms, children's overall acceptability of therapy, and safety and tolerability were assessed. Concomitant treatment with oral rehydration solutions (26.6%), zinc (23.9%), and antibiotics prescribed for conditions other than diarrhea (13.6%) was recorded during the study. All other probiotics and antidiarrheals were prohibited.
Therapy with was well-tolerated, and the adverse event rate was very low (0.09%). All reported adverse events, which included vomiting, erythematous rashes and stool color change, were mild to moderate. In more than half of the per-protocol population (1535/2916; 52.6%), diarrhea was resolved within the first 3 days of treatment with . There was no significant difference ( = 0.297) in mean diarrhea duration between patients with either antibiotic-associated (3.3 ± 1.3 days) or viral diarrhea (3.4 ± 1.3 days). However, children who only received supplementation without zinc had a significantly shorter diarrhea duration (3.3 ± 1.3 days) compared to zinc-treated children (3.6 ± 1.6 days; < 0.001). significantly reduced the mean number of stools per day, from 5.2 ± 2.0 stools at baseline to 1.2 ± 0.6 stools at study end ( < 0.001). Similarly, the proportion of patients with loose stools decreased from 81.6% at baseline to 9.2% at end of treatment period. Acceptability of therapy was high.
This study adds knowledge on the good safety profile and on the effectiveness of as an adjunct treatment for acute childhood diarrhea.
腹泻是菲律宾儿童死亡的主要原因之一。益生菌已被证明在急性腹泻的治疗中有益。因此，这项基于人群的研究旨在评估[具体益生菌名称]作为标准疗法辅助手段，用于菲律宾患有病毒源性急性社区获得性腹泻或与抗生素使用相关的儿童的安全性和有效性。
总共3178名患者（中位年龄2岁）参与了这项开放标签、多中心、观察性研究，并接受了1至2瓶以下细菌菌株的[具体益生菌名称]治疗：O/C、SIN、N/R和T（每5毫升小瓶含20亿孢子的口服混悬液），持续5至7天。评估腹泻持续时间、每日排便次数、胃肠道症状改善情况、儿童对[具体益生菌名称]治疗的总体可接受性以及安全性和耐受性。研究期间记录了同时使用口服补液溶液（26.6%）、锌（23.9%）以及因腹泻以外病症开具的抗生素（13.6%）的情况。禁止使用所有其他益生菌和止泻药。
[具体益生菌名称]治疗耐受性良好，不良事件发生率非常低（0.09%）。所有报告的不良事件，包括呕吐、红斑皮疹和大便颜色改变，均为轻度至中度。在超过一半的符合方案人群（1535/2916；52.6%）中，腹泻在使用[具体益生菌名称]治疗的前3天内得到缓解。抗生素相关性腹泻患者（3.3±1.3天）和病毒性腹泻患者（3.4±1.3天）的平均腹泻持续时间无显著差异（P = 0.297）。然而，仅接受[具体益生菌名称]补充而未补充锌的儿童腹泻持续时间明显短于补充锌的儿童（3.6±1.6天；P < 0.001），为3.3±1.3天。[具体益生菌名称]显著降低了每日平均排便次数，从基线时的5.2±2.0次降至研究结束时的1.2±0.6次（P < 0.001）。同样，稀便患者的比例从基线时的81.6%降至治疗期末的9.2%。[具体益生菌名称]治疗的可接受性很高。
本研究增加了关于[具体益生菌名称]良好安全性概况以及作为儿童急性腹泻辅助治疗有效性的知识。
