Velásquez-Jones L, Becerra F C, Faure A, de León M, Moreno H, Maulén I, Abraham-Jalil A, Muraira A
Hospital Infantil de Mexico Federico Gomez, Mexico City.
Clin Ther. 1990;12 Suppl A:95-103.
A clinical trial was conducted to compare the safety and efficacy of a new oral rehydration solution (ORS) with that of the ORS recommended by the World Health Organization (WHO). One hundred thirty infants with dehydration due to acute diarrhea were randomized into two groups: 68 infants received the WHO ORS containing sodium and glucose in a concentration of 90 and 111 mmol/L, respectively, and an osmolality of 311 mosm/kg (ORS-90); 62 infants received an ORS containing sodium and glucose in a concentration of 60 and 90 mmol/L, respectively, with an osmolality of 240 mosm/kg (ORS-60). Treatment failure was noted in seven infants (10.3%) in the ORS-90 group; the causes of failure were high stool output (three cases), persistent vomiting (three cases), and ileus (one case). Only one patient in the ORS-60 group (1.6%) was considered a failure because of high stool output. No significant differences were noted in the serum sodium levels in either group of patients, both in relation to the natremia seen on admittance or that seen after rehydration. A trend was observed toward correction of hypernatremia or hyponatremia with both types of ORS. A similar situation was observed with respect to the variations seen in serum potassium levels. The results from this study suggest that there may be clinical advantages of using an ORS with concentrations of sodium and glucose and a total osmolality lower than that of ORS-90, because of the lower incidence of treatment failures.
开展了一项临床试验，比较一种新型口服补液盐（ORS）与世界卫生组织（WHO）推荐的ORS的安全性和有效性。130名因急性腹泻而脱水的婴儿被随机分为两组：68名婴儿接受WHO的ORS，其中钠和葡萄糖浓度分别为90 mmol/L和111 mmol/L，渗透压为311 mosm/kg（ORS-90）；62名婴儿接受一种ORS，其中钠和葡萄糖浓度分别为60 mmol/L和90 mmol/L，渗透压为240 mosm/kg（ORS-60）。ORS-90组有7名婴儿（10.3%）治疗失败；失败原因是大便排出量高（3例）、持续呕吐（3例）和肠梗阻（1例）。ORS-60组只有1名患者（1.6%）因大便排出量高被视为治疗失败。两组患者的血清钠水平，无论是入院时的血钠情况还是补液后的血钠情况，均未观察到显著差异。两种类型的ORS在纠正高钠血症或低钠血症方面均观察到一种趋势。血清钾水平的变化情况也类似。这项研究的结果表明，使用钠和葡萄糖浓度及总渗透压低于ORS-90的ORS可能具有临床优势，因为治疗失败的发生率较低。
