布拉氏酵母菌治疗小儿急性腹泻病的临床研究

Saccharomyces Boulardii in Treatment of Acute Children Diarrhea:a Randomized Placebo-controlled Trial

目的：评估布拉氏酵母菌散剂治疗小儿急性腹泻病的临床疗效。方法：以我院2008年3月-6月收治的92例小儿急性腹泻病患儿为研究对象，随机分成两组各46例。两组均予补液、蒙脱石散剂口服、抗生素治疗，治疗组加服布拉氏酵母菌散剂连续治疗至出院，对92例患儿资料进行数据分析。结果：两组总有效率比较差异有统计学意义（z^2=4．84，P〈0．05）。腹泻平均持续时间对照组为（6．54±1．74）d，治疗组为（5．72±1．67）d（t=2．30，P〈0．05），两组比较差异有统计学意义；服药第4d治疗组日平均大便次数（3．13±0．95）次，对照组（3．74±0．91）次（t=3．14，P〈0．01），服药第7d治疗组日平均大便次数（1．74±0．93）次，对照组（2．24±0．95）次（t=2．55，P〈0．05），两组比较差异均有统计学意义；治疗组按给药治疗时机进行分层分析，比较第4d和第7d大便次数（t分别为3．90、3．71，P均〈0．01），差异有统计学意义。结论：布拉氏酵母菌可缩短小儿急性腹泻的持续时间，促进患儿恢复，患儿在腹泻发生48h内早期给予布拉氏酵母菌治疗效果更佳。

Objective：To evaluate the efficacy of the probiotie yeast Saccharomyces boulardii （S. boulardii） in treatment of children with acute diarrhea. Methods： In a period of three months （from March 2008 to June 2008 ） , 92 hospitalized children suffering from acute diarrhea, aged from 2 months to 7 years, were included in a randomized placebo-controlled trial evaluating the efficacy of S. boulardii administered full period in hospital, with 46 children in the controlled group receiving conventional treatment （ ORS, oral montmorillonite, antibiotics if necessary）, other 46 children in the S. boulardii group receiving S. boulardii plus conventional therapies. Results： The efficacy in the S. boulardii group was statistically significantly higher than controlled group （x^2 = 4.84, P 〈 0.05 ） , the mean diarrhea duration was 6.54± 1.74 days in the controlled group and 5.72 ± 1.67 days in the S. boulardii group （t = 2.30, P 〈 0.05 ）. On the 4th day, the patients in the S. boulardii group passed 3.13±0.95 stools/day versus 3.74 ±0.91 stools/day in the controlled group （ t = 3.14, P 〈0.01 ）. On the 7th day, the patients in the S. boulardii group passed 1.74 ± 0.93 stools/day versus 2.24 ± 0.95 stools/day in controlled group （ t = 2.55, P 〈 0.05 ）. A statistically significant difference was observed in the number of stools on the 4th and 7th day favouring the subgroup that received early treatment （within the first 48 h of the onset of diarrhea） （t = 3.90, 3.71, P 〈 0.01 ）. Conclusions： S. boulardii as an adjuvant to ORS in hospitals in children with mild or moderate acute diarrhea is effective in treatment of acute diarrhea, and it decreased the duration of diarrhea, accelerated recovery and reduced the risk of prolonged diarrhea. The data also indicated increased efficacy if S. boulardii is administered within the first 48 h of the onset of diarrhea.