[关键词]
[摘要]
目的 评价肠炎宁颗粒治疗小儿消化不良(脾胃湿热证)的有效性和安全性。方法 采用随机、双盲、阳性药对照、多中心的试验方法,选择480例消化不良患儿随机分为对照组和试验组,试验组给予肠炎宁颗粒口服治疗;对照组患儿给予小儿喜食片口服治疗。观察两组患儿临床症状改善情况、中医证候总积分疗效、中医症状各单项症状疗效。结果 中医证候疗效比较方面,1~3岁年龄组愈显率和总有效率两组比较无显著性差异(P> 0.05),4~5岁年龄组总有效率两组比较有显著性差异(P<0.05),6~14岁年龄组愈显率和总有效率两组比较均有显著性差异(P<0.05)。中医症状和体征总积分疗效比较方面,除4~5岁年龄组组外,其余各年龄组组间变化率比较和组内前后比较均有显著性差异(P<0.05)。中医症状和体征各单项症状疗效方面,各年龄组单项症状治疗前后比较均有显著性差异(P<0.001),且1~3岁年龄组的脘腹痞满症状改善、6~14岁年龄组的食少纳呆、身重困倦、小便短黄症状改善两组比较有显著性差异(P<0.05),试验组优于对照组。通过对安全指标及不良事件的分析,肠炎宁颗粒治疗小儿消化不良安全性好。结论 肠炎宁颗粒是一种适用于小儿消化不良脾胃湿热证的具有清热利湿、行气作用的中药颗粒,其疗效可靠,值得在儿科推广使用。
[Key word]
[Abstract]
Objective To evaluate the effects of Changyanning Granule for treating children with dyspepsia (damp heat syndrome of spleen and stomach). Methods A randomized double-blind positive-controlled multi-center trial was used. Four hundred and eighty cases of children with dyspesia were randomly divided into experimental group and control group. The children in experimental group were given Changyanning Granule, and those in the control group were treated by Xiaoer Xishi Pian, then to evaluate the children with the disease in these two groups in improvement of clinical symptoms, total score of TCM syndrome efficacy, score of TCM individual symptome efficacy. Results Two groups of 1—3 year old children in both the healing rate and significant efficiency and the total effective rate had no significant difference (P > 0.05). Two groups of 4—5 year old children in the healing rate and significant efficiency had no significant difference while the total effective rate was statistically significant (P < 0.05). Two groups of 4—5 year old children in both the healing rate and significant efficiency and the total effective rate were statistically significant (P < 0.05). Two groups of children in total score of TCM syndrome efficacy were statistically significant (P < 0.05). The same group of score for TCM individual symptome efficacy after treatment, the difference was statistically significant (P < 0.001), the improvement of abdominal fullness at the group of 1—3 year old, anorexia, body weight drowsiness, and short yellow urine symptoms at the group of 6—14 year old, meanwhile, were statistically significant (P < 0.05), and the improvement of the experimental group was better than that of the control group. It was confirmed that Changyanning Granule in the treatment of children with dyspepsia is good safety through the analysis of safety indicators and adverse events. Conclusion Changyanning Granule is a kind of Chinese medicine granule, which can be used for the treatment of children with dyspesia, spleen, and stomach damp heat syndrome by TCM syndrome differentiation. The therapeutic effect is reliable, and it is worth to be popularized in pediatrics.
[中图分类号]
[基金项目]