中国临床药学杂志

目的 探讨布拉氏酵母菌联合消旋卡多曲颗粒治疗小儿轮状病毒肠炎（RVE）的临床疗效及对细胞因子水平的影响。方法 将180例RVE患儿随机分为观察组（n=90）与对照组（n=90）。在常规方法治疗基础上，对照组予消旋卡多曲颗粒1.5 mg·kg-1,po,tid；观察组予消旋卡多曲颗粒1.5 mg·kg-1,po,tid联合布拉氏酵母菌0.25 g,po,bid。疗程均为5 d。治疗期间，观察症状与体征的变化，记录不良反应发生情况。治疗后，检测粪轮状病毒抗原，评估临床疗效。治疗前后采集血清样本，测定细胞因子INF-γ、IL-8和TNF-α的水平，观察细胞因子水平的变化。结果 观察组总有效率显著高于对照组（98.89%vs 80.00%,P <0.01）。治疗5 d内观察组腹泻症状消失率和粪轮状病毒抗原转阴率均明显高于对照组（83.33%vs 53.33%,P <0.01;72.22%vs 42.22%,P <0.01）。治疗后，2组血清INF-γ均较治疗前升高，而TNF-α、IL-8较治疗前降低，且观察组变化幅度大于对照组，差异均具有统计学意义（P <0.01）。结论 布拉氏酵母菌联合消旋卡多曲治疗小儿RVE可使病程缩短，临床疗效提高；且通过调节血清细胞因子水平，从而改善RVE的临床症状。

AIM To investigate the clinical effect of Saccharomyces boulardii combined with racecadotril granules on infantile rotavirus enteritis(RVE) and its effect on cytokine levels. METHODS A total of 180 cases of children with RVE were randomly divided into observation group(n = 90) and the control group(n = 90). Two groups were treated with conventional method, the control group was given racecadotril granules(1.5 mg·kg-1, po, tid). The observation group was given racecadotrel granules(1.5 mg·kg-1, po, tid) combined with Saccharomyces boulardii(0.25 g, po, bid). The treatment course was 5 d. During the treatment, the changes of symptoms and signs were observed, and the occurrence of adverse drug reactions were record. After treatment, fecal rotavirus antigen was detected to evaluate the clinical efficacy. Serum samples were collected before and after treatment to determine the level of cytokine INF-γ, IL-8 and TNF-α. RESULTS The total effective rate of the observation group was significantly higher than that of the control group(98.89% vs 80.00%,P < 0.01). Within 5 d of treatment, the disappearance rate of diarrhea symptoms and negative rate of fecal rotavirus antigen in the observation group were significantly higher than those in the control group(83.33% vs 53.33%, P < 0.01; 72.22%vs 42.22%, P < 0.01). After treatment, serum INF-γ in both groups increased, while TNF-α and IL-8 decreased, and the range of change in the observation group was greater than that in the control group, and the differences were statistically significant(P < 0.01). CONCLUSION Saccharomyces boulardii combined with racecadotril granules in the treatment of pediatric RVE can shorten the course of disease and improve the clinical efficacy. The clinical symptoms of RVE can be improved by regulating serum cytokine levels.