探讨布拉酵母菌散联合蒙脱石散治疗轮状病毒性肠炎(RVE)患儿的临床疗效，以及对患儿免疫功能与肠道微生态影响。

选择2018年5月至2020年5月，于海南省妇女儿童医学中心就诊的126例RVE患儿为研究对象。采用随机数字表法，将其随机分为研究组(n＝63，采取布拉酵母菌散+蒙脱石散治疗)与对照组(n＝63，采取双歧杆菌+蒙脱石散治疗)。采用χ²检验，进行2组患儿临床疗效及不良反应率比较。采用成组t检验与配对t检验，对2组患儿临床症状持续时间、住院时间，治疗前、后血清肿瘤坏死因子(TNF)-α、白细胞介素(IL)-8，免疫功能指标CD4⁺、CD8⁺、CD4⁺/CD8⁺水平，以及肠道菌群数量等进行比较。2组患儿性别构成比、年龄、体重、轻与中度脱水发生率等临床资料，治疗前2组患儿血清TNF-α、IL-8及CD4⁺、CD8⁺、CD4⁺/CD8⁺水平，以及拟杆菌、大肠埃希菌、肠球菌、乳酸杆菌与双歧杆菌数量比较，差异均无统计学意义(P>0.05)。本研究经过海南省妇女儿童医学中心伦理委员会批准(审批文号：Z20180111)，与患儿监护人均签署临床研究知情同意书。

①研究组患儿的治疗总有效率为96.8%(61/63)，显著高于对照组的87.3%(55/63)，并且差异有统计学意义(χ²＝3.910、P＝0.048)。②研究组患儿腹泻、呕吐、腹痛持续时间及住院时间分别为(32.4±5.5) h、(23.4±4.4) h、(25.6±3.9) h、(46.3±6.7) h，均显著短于对照组的(54.4±7.3) h、(46.8±6.6) h、(49.9±5.9) h、(66.3±7.5) h，并且差异均有统计学意义(t＝7.498、16.427、11.944、8.420, P<0.001)。③治疗后，2组患儿血清TNF-α、IL-8水平组内比较，均较治疗前显著降低；研究组亦均较对照组显著降低，并且差异均有统计学意义(P<0.001)。④治疗后，2组患儿CD4⁺、CD4⁺/CD8⁺水平组内比较均显著增高，而CD8⁺水平组内比较，则显著降低；治疗后，研究组CD4⁺、CD4⁺/CD8⁺水平，亦较对照组显著增高，而CD8⁺水平则较对照组显著降低，并且差异均有统计学意义(P<0.05)。⑤治疗后，2组患儿拟杆菌、乳酸杆菌及双歧杆菌数量组内比较，均较治疗前显著增高；研究组亦均较对照组显著增高；2组患儿肠球菌、大肠埃希菌数量，均较治疗前显著下降，研究组亦均较对照组显著下降，并且上述差异均有统计学意义(P<0.05)。⑥治疗中，2组患儿治疗相关不良反应率比较，差异无统计学意义(P>0.05)。

布拉酵母菌散联合蒙脱石散治疗RVE患儿的临床疗效良好，可降低患儿炎症反应、改善机体免疫功能、调节肠道菌群，并且安全性较高。

To explore clinical effect of Saccharomyces boulardii sachets combined with montmorillonite powder in treatment of children with rotavirus enteritis (RVE) and its influence on immune function and intestinal microecology.

From May 2018 to May 2020, a total of 126 cases of RVE children were selected as research subjects. They were randomly divided into study group (n=63) and control group (n=63) according to random digital table method. Children in study group were treated with Saccharomyces boulardii sachets and montmorillonite powder, and children in control group were treated with Bifidobacterium and montmorillonite powder. The clinical effect and incidence of adverse reactions between two groups were compared by chi-square test. Duration of clinical symptoms, length of hospital stay, and levels of inflammatory factors [tumor necrosis factor (TNF)-α, interleukin (IL)-8], immune function indexes (CD4⁺ , CD8⁺ and CD4⁺ /CD8⁺ ), and amount of intestinal flora before and after treatment were compared between two groups by independent-samples t test and paired-samples t test. There were no statistically significant differences between two groups of children in clinical data, such as gender composition, age, weight, and incidence of mild and moderate dehydration, and serum levels of TNF-α and IL-8, levels of CD4⁺ , CD8⁺ , CD4⁺ /CD8⁺ , and amount of Bacteroides, Escherichia coli, Enterococcus, Lactobacillus and Bifidobacterium between two groups before treatment (P>0.05). This study was approved by the Ethics Committee of Hainan Women and Children Medical Center (approval No. Z20180111), and informed consent was signed with the guardians of children.

①Total effective rate of study group was 96.8% (61/63), which was statistically higher than 87.3% (55/63) of control group, and the difference was statistically significant (χ²=3.910, P=0.048). ②Duration of diarrhea, vomiting, abdominal pain and length of hospital stay in study group were (32.4±5.5) h, (23.4±4.4) h, (25.6±3.9) h, and (46.3±6.7) h, respectively, which all were shorter than those in control group (54.4±7.3) h, (46.8±6.6) h, (49.9±5.9) h, (66.3±7.5) h, and all differences were statistically significant (t=7.498, 16.427, 11.944, all P<0.001). ③After treatment, serum TNF-α and IL-8 levels of two groups were significantly lower than those within each group before treatment, serum TNF-α and IL-8 levels in study group after treatment were significantly lower than those of control group after treatment, and all differences were statistically significant (P<0.001). ④After treatment, levels of CD4⁺ and CD4⁺ /CD8⁺ of two groups were significantly higher than those within each group before treatment, while levels of CD8⁺ were significantly lower than those within each group before treatment, and levels of CD4⁺ and CD4⁺ /CD8⁺ in study group after treatment were significantly higher than those of control group after treatment, while levels of CD8⁺ were significantly lower than those of control group after treatment, and all differences were statistically significant (P<0.05). ⑤After treatment, amount of Bacteroides, Lactobacillus and Bifidobacterium of two groups were significantly higher than those within each group before treatment, and amount of the above flora in study group after treatment were significantly higher than those of control group after treatment, while amount of Enterococcus and Escherichia coli of two groups were significantly lower than those within each group before treatment, and amount of Enterococcus and Escherichia coli in study group after treatment were significantly lower than those of control goup after treatment and all differences were statistically significant (P<0.05). ⑥Incidence of adverse reactions during treatment in study group was 4.8% (3/63), and the control group was 6.3% (4/63), there was no statistically significant difference between two groups (P>0.05).

Saccharomyces boulardii sachets combined with montmorillonite powder has a good clinical effect in treatment of children with RVE, which can improve the inflammatory reaction and immune function, regulate intestinal flora of children, and has high safety.