Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhea: a randomized, double-blind, placebo controlled clinical trial [ISRCTN67363048].
Lactobacillus casei strain GG in the treatment of infants with acute watery diarrhea: a randomized, double-blind, placebo controlled clinical trial [ISRCTN67363048].
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DOI：
10.1186/1471-2431-4-18
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发表时间：
2004-09-02
期刊：
影响因子：
2.4
通讯作者：
Sack RB
中科院分区：
文献类型：
--
作者：
Salazar-Lindo E;Miranda-Langschwager P;Campos-Sanchez M;Chea-Woo E;Sack RB
益生菌对婴幼儿急性水样腹泻的ORT辅助治疗一直在积极研究中。大多数研究都是在发达国家进行的，显示只对病毒性轻度胃肠炎有好处。我们评估了一种含有10亿(109)cfu/ml干酪乳杆菌菌株GG(LGG)的配方奶粉对婴儿腹泻持续时间和严重程度的影响，环境中有更严重的急性腹泻，涉及轮状病毒以外的病原体更频繁，混合感染更普遍。3-36个月大的男性婴儿因治疗48小时内的急性水样腹泻而被带去治疗，符合条件。在用世界卫生组织的口服补液液完成补液后，患者被随机分配接受含有或不含LGG的配方奶粉。使用适合收集与尿液分离的粪便的装置定期测量大便容量。腹泻的持续时间是根据大便的物理特征来估计的。89名患者接受了安慰剂配方奶粉，90名患者接受了含有LGG的配方奶粉。两组患者的基线特征具有可比性。LGG组的大便总量(247.8毫升/千克)显著高于安慰剂组(195.0毫升/千克)(p=0.047)。在腹泻持续时间(服用LGG组为58.5小时，服用安慰剂组为50.4小时)、治疗失败率(服用LGG组为21.1%，服用安慰剂组为18.0%)以及120小时后腹泻未缓解的患者比例(服用LGG组为12.2%，服用安慰剂组为12.5%)方面没有显著差异。两组治疗24小时后大便中含有还原物质的比例均显著增加(从41.4%增加到72.2%，从45.9%增加到68.0%)。本研究未发现LGG对急性水样腹泻的临床病程有积极作用。正如其他地方报道的那样，在我们的研究中，由于短暂性乳糖吸收不良导致的腹泻恶化，LGG的积极益处可能被掩盖了。进一步研究低乳糖或非乳糖的LGG输送机是可取的。
Adjuvant therapy to ORT with probiotic bacteria for infants with acute watery diarrhea has been under active investigation. Most studies have been done in the developed world showing benefit only for viral mild gastroenteritis. We evaluated the effect of a milk formula containing one billion (109) cfu/ml of Lactobacillus casei strain GG (LGG) upon duration and severity of diarrhea in infants in an environment with more severe acute diarrhea, where etiologic agents other than rotavirus are involved more frequently, and where mixed infections are more prevalent. Male infants aged 3–36 months brought for treatment of acute watery diarrhea of less than 48 hours were eligible. After rehydration was completed with the WHO's oral rehydration solution, patients were randomly assigned to receive a milk formula either containing LGG or not. Stool volume was periodically measured using a devise suited to collect stools separate from urine. Duration of diarrhea was estimated based on stools physical characteristics. Eighty nine patients received the placebo milk formula and ninety received the LGG containing formula. Both groups were comparable in their baseline characteristics. Total stool output was significantly larger (p = 0.047) in the LGG group (247.8 ml/kg) than in the placebo group (195.0 ml/kg). No significant differences were found in duration of diarrhea (58.5 hours with LGG vs. 50.4 hours with placebo), rate of treatment failure (21.1% with LGG vs. 18.0% with placebo), and proportion of patients with unresolved diarrhea after 120 hours (12.2% with LGG vs. 12.5% with placebo). The rate of stools with reducing substances after 24 hours of treatment increased significantly in both groups (from 41.4% to 72.2% with LGG and from 45.9% to 68.0% with placebo). This study did not show a positive effect of LGG on the clinical course of acute watery diarrhea. Positive beneficial effects of LGG, as had been reported elsewhere, could have been masked in our study by worsening diarrhea due to transient lactose malabsorption. Further studies with low-lactose or non-lactose conveyors of LGG are desirable.