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布拉氏酵母菌散剂治疗儿童急性腹泻病的疗效和安全性:一项双盲随机对照临床试验。

Efficacy and safety of Saccharomyces boulardii in acute childhood diarrhea: a double blind randomised controlled trial.

机构信息

Department of Pediatrics, Jawaharlal Nehru Medical College, AMU, Aligarh, UP, India.

出版信息

Indian J Pediatr. 2012 Apr;79(4):478-82. doi: 10.1007/s12098-011-0573-z. Epub 2011 Oct 14.

Abstract

OBJECTIVE

To see the efficacy and safety of 250 mg of Saccharomyces boulardii twice daily for 5 d in acute childhood diarrhea.

METHODS

Children aged between 3 mo and 59 mo with acute onset diarrhea (of less than 48 h) admitted in DTTU (diarrhea treatment and training unit) were included and those with clinical evidence of severe malnutrition, systemic infection, encephalopathy and/or convulsion, electrolyte imbalance, invasive diarrhea or previous use of any probiotics were excluded from the study. Those included randomly were given either a placebo or Saccharomyces boullardi (SB) in identical packets mixed with puffed rice powder.

RESULTS

Mean post intervention duration of diarrhea was significantly (95% CI = -28.13 to -5.43) shorter in SB group (52.08 ± 24.57 h) as compared to placebo group (64.04 ± 30.43 h). The time of appearance of first semi formed stool in SB group (39.48 ± 23.09 h) was significantly (95% CI -25.4 to -3.87) shorter than the placebo group (54.13 ± 28.21 h). No statistically significant difference was found in rest of the parameters.

CONCLUSIONS

There is initial evidence available that SB may have a therapeutic role in the management of acute childhood diarrhea.

摘要

目的

观察每日两次、每次 250mg 布拉氏酵母菌连用 5d 治疗儿童急性腹泻的疗效和安全性。

方法

纳入年龄在 3 个月至 59 个月、急性起病(<48h)腹泻且无严重营养不良、全身感染、脑病和/或抽搐、电解质紊乱、侵袭性腹泻或既往使用过任何益生菌临床证据的患儿,并排除符合条件的患儿。入组患儿随机分为安慰剂组和 SB 组,SB 组给予 SB(与膨化米粉混合),安慰剂组给予安慰剂,剂量和包装均相同。

结果

SB 组患儿腹泻干预后平均持续时间[(95%CI:-28.13 至-5.43)]明显短于安慰剂组[(64.04±30.43)h]。SB 组患儿首次排半成形便的时间[(39.48±23.09)h]明显短于安慰剂组[(54.13±28.21)h](95%CI:-25.4 至-3.87)。其余参数两组间无统计学差异。

结论

目前初步证据表明 SB 可能对儿童急性腹泻的治疗有一定作用。

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