双歧杆菌BB-12治疗婴幼儿腹泻临床疗效对照研究

A study on the efficacy of bifidobacterium BB-12 in treatment of children with acute diarrhea

目的评估双歧杆菌BB-12对婴幼儿腹泻治疗的有效性和安全性。方法对2015年12月至2016年8月吉林大学白求恩第一医院小儿消化内科诊治的120例腹泻患儿,采用随机、单盲方法,分为双歧杆菌BB-12治疗组、枯草杆菌二联活菌阳性对照组、未添加益生菌的安慰剂组,各40例。均配合蒙脱石散及补液等对症治疗,比较各组病例临床资料并进行分析。结果治疗组的显效率及有效率分别为37.50%、52.50%,阳性对照组为42.50%、42.50%,安慰剂组为17.50%、52.50%,差异有统计学意义(P<0.05),治疗组与阳性对照组相比,差异无统计学意义(P>0.05)。3组大便次数:第4天治疗组(3.10±1.41)次/d、阳性对照组(3.05±1.63)次/d、安慰剂组(3.93±1.91)次/d;第7天治疗组(1.45±0.64)次/d、阳性对照组(1.43±0.90)次/d、安慰剂组(1.95±1.30)次/d,3组较治疗前均明显减少,差异有统计学意义(P<0.05)。但治疗组与阳性对照组相比,差异无统计学意义(P>0.05),与安慰剂组比较差异有统计学意义(P<0.05)。3组患儿治疗后腹泻好转所需天数方面,治疗组、阳性对照组及安慰剂组分别为(4.20±1.32)d、(4.40±1.37)d、(5.18±1.57)d,3组差异有统计学意义(P<0.05),但治疗组与阳性对照组相比,差异无统计学意义(P>0.05)。结论双歧杆菌BB-12治疗婴幼儿腹泻安全有效。

Objective To evaluate the efficacy and safety of bifidobacterium BB- 12 in treatment of children with acute diarrhea. Methods In this single-blind study, 120 infant patients with diarrhea treated in the First Hospital of Jilin University from Dee 2015 to Aug 2016 were randomized into three groups： （1）treatment group：treated with Bifidobacterium BB-12; （2）positive control group：treated with live combined Bacillus subtilis and Enteroeoecus faeeium ; （3）placebo group ： treated with maltodextrin. There were 40 patients in each group, and all received montmorillonite and fluid re- placement. Clinical data of each group were analyzed and compared. Results The significant efficiency and efficiency of the treatment group was 37.50% and 52.50%, the positive control group was 42.50% and 42.50%, the placebo group was 17.50% and 52.50%. The treatment group had no significant difference with the positive control group, but significantly higher than that of the placebo group ; At the 4th day, the frequency of patients＇ defecation of the treatment group was （3.10 ± 1.41 ）/d, the positive control group was （3.05±1.63 ）/d, the placebo group was （3.93 ±1.91 ）/d, at the 7th day, the frequency of patients＇ defecation of the treatment group was （1.45 ±0.64）/d, the positive control group was （1.43±0.90）/d, the placebo group was （1.95±1.30）/d, the treatment group was similar to the positive control group, and was significantly less than the placebo group. The average duration of diarrhea of each group was （4.20±1.32） d, （4.40±1.37） d, （5.18± 1.57） d. Conclusion Bifidobacterium BB- 12 is safe and effective in the treatment of infantile diarrhea.