碳酸钙口服混悬液治疗儿童消化不良临床分析

目的评价碳酸钙口服混悬液治疗儿童胃酸过多所致消化不良的效果和临床应用安全性。方法采用多中心、随机、对照方法,使用碳酸钙口服混悬液或硫糖铝混悬液治疗2～14周岁患有胃酸过多性消化不良症状的患儿各100例。所有参加临床验证的单位均严格按照入选标准、排除标准选择病例,试验方法和给药方法完全统一。观察口服药后的起效时间及第7、10天的症状缓解率。结果服药后上腹痛、嗳酸及上腹不适、烧心感症状的半小时缓解率,碳酸钙口服混悬液组优于硫糖铝混悬液组,分别为38.71%和10.87%、56.34%和20.27%、40.48%和11.76%(P均<0.01)。碳酸钙口服混悬液治疗后的第7天与第10天,临床症状总积分较治疗前显著下降(P<0.01),有效率分别为74%和96%,均高于硫糖铝混悬液组(51%、78%,P均<0.01),其中上腹痛、上腹不适与烧心感症状的改善更为明显。整个疗程中,碳酸钙口服混悬液组未发现不良反应。结论碳酸钙口服混悬液对小儿胃酸过多引起的消化不良症状具有显著的疗效,本试验期间未观察到任何毒副作用,口味香甜,受到患儿欢迎。

Effect of oral calcium carbonate suspension on the treatment of children with indigestion

Objectives To evaluate the efficacy and safety of oral calcium carbonate suspension on the treatment of childhood indigestion caused by hyperacidity. Methods A multi-center,randomized and controlled trial was designated for 200 patients aged from two to fourteen years. They were divided into two groups;each group included 100 children treated with oral calcium carbonate suspension or Ulcerlmin respectively. All the participating units strictly selected the cases in accordance with the criteria of selection and exclusion,the testing methods and instruction discussed before were completely standardized. The time of the efficiency appeared after therapy,the ease rate of abdominal pain,reflux and abdominal dis-comfort,heart burning on the seventh day and tenth day was recorded. Results The improvement of clinical symptoms (such as abdominal pain,abdominal discomfort,heart burning) was more significant in calcium carbonate group. The ease rate of abdominal pain,reflux and abdominal discomfort,heart burning within half an hour was higher in calcium carbonate group (38.71 % versus 10.87 %,56.34 % versus 20.27 %,40.48 % versus 11.76 %) (P < 0.01). The total scoring of clinical symptoms in calcium carbonate group was significantly decreased after 7 days and 10 days treatment (P < 0.01). The response rate on 7th day and 10th day was 74 % and 96 % respectively,higher than Ulcerlmin group (51 %, 78 %)(P < 0.01). And the improvement of the abdominal pain,abdominal discomfort with heart burning and reflux symptoms were more obvious. No adverse reactions could be found in calcium carbonate group. Conclusions Calcium carbonate suspension could be used to treat the dyspepsia symptoms caused by hyperacidity effectively with no any side effects. As the syrup tastes good,it was widely accepted by the sick children.