Esteban Carretero J, Durbán Reguera F, López-Argüeta Alvarez S, López Montes J
Department of Gastroenterology, Hospital Torrecárdenas, Almería, Spain.
Rev Esp Enferm Dig. 2009 Jan;101(1):41-8. doi: 10.4321/s1130-01082009000100005.
The study aims to observe the response to treatment with ORS only or ORS + gelatin tannate in two cohorts of pediatric patients with acute diarrhea, with the primary efficacy endpoint being the number of stools at 12 hours from baseline.
Children aged 3 months to 12 years were included in the study. Only children with acute diarrhea, more than 3 liquid stools, and duration inferior to 72 h were included. Number of stools was recorded as absolute number, categorized as <or= 3 and >or= 4 stools over 12 hours, and as a stool decrease index (SDI). Other clinical variables were recorded, including weight, fever, vomiting, stool characteristics, and signs of peritonitis/sepsis.
Baseline characteristics for the two populations included a mean age of 2.3 years in the ORS group and 2.6 years in the ORS + gelatin tannate group. Children younger than 2 years represented 59.8 and 54.3% in the ORS and ORS + gelatin tannate groups, respectively. Clinical variables such as vomiting, dehydration, weight, and stool decrease index were used to compare the two groups. We found a statistical significant difference between the two groups (p < 0.0001) -- SDI for the ORS group was -0.1894; for the ORS + gelatin tannate group was -0.6023.
We observed a significant decrease in the number of stools and an improvement in the consistency of stools in the ORS + gelatin tannate group. Other clinical variables such as vomiting, dehydration, weight, bloody stools, and peritonitis/sepsis signs showed no statistical differences between the two groups, but did show a general trend toward improvement. The Stool Decrease Index (SDI) showed a 18% decrease in the number of stools for the ORS group and 60% for the ORS + gelatin tannate group. The use of ORS + gelatin tannate was associated with a greater decrease in SDI. Gelatin tannate decreased the number of stools at twelve hours in children.
本研究旨在观察两组急性腹泻儿科患者单独使用口服补液盐（ORS）或ORS加鞣酸明胶治疗的反应，主要疗效终点为自基线起12小时时的排便次数。
年龄在3个月至12岁的儿童纳入本研究。仅纳入患有急性腹泻、排便超过3次且病程短于72小时的儿童。排便次数记录为绝对次数，分类为12小时内≤3次和≥4次排便，并计算为粪便减少指数（SDI）。记录其他临床变量，包括体重、发热、呕吐、粪便特征以及腹膜炎/脓毒症体征。
两组的基线特征包括，ORS组的平均年龄为2.3岁，ORS加鞣酸明胶组为2.6岁。2岁以下儿童在ORS组和ORS加鞣酸明胶组中分别占59.8%和54.3%。使用呕吐、脱水、体重和粪便减少指数等临床变量对两组进行比较。我们发现两组之间存在统计学显著差异（p<0.0001）——ORS组的SDI为-0.1894；ORS加鞣酸明胶组为-0.6023。
我们观察到ORS加鞣酸明胶组的排便次数显著减少，粪便稠度有所改善。呕吐、脱水、体重、血便和腹膜炎/脓毒症体征等其他临床变量在两组之间无统计学差异，但总体上呈现改善趋势。粪便减少指数（SDI）显示，ORS组的排便次数减少了18%，ORS加鞣酸明胶组减少了60%。使用ORS加鞣酸明胶与SDI的更大降低相关。鞣酸明胶可减少儿童12小时时的排便次数。
