一项双盲临床试验，比较世界卫生组织口服补液盐与含有等量钠和葡萄糖的低渗溶液。

A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose.

作者信息

Santosham M, Fayad I, Abu Zikri M, Hussein A, Amponsah A, Duggan C, Hashem M, el Sady N, Abu Zikri M, Fontaine O

机构信息

Department of International Health, Center for American Indian and Alaskan Native Health, Johns Hopkins University School of Hygiene and Public Health, Baltimore, Maryland, USA.

出版信息

J Pediatr. 1996 Jan;128(1):45-51. doi: 10.1016/s0022-3476(96)70426-2.

DOI:10.1016/s0022-3476(96)70426-2

PMID:8551420

Abstract

OBJECTIVE

To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea.

METHODS

One hundred ninety boys, aged 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours.

RESULTS

In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 +/- 6 mEq/L) than in children receiving the standard WHO ORS (138 +/- 7 mEq/L) (p < 0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups.

CONCLUSION

The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea.

摘要

目的

比较含钠和葡萄糖均为75 mmol/L的口服补液盐（ORS）与世界卫生组织（WHO）标准ORS对埃及急性腹泻儿童的安全性和有效性。

方法

190名年龄在1至24个月、因急性腹泻和脱水迹象入院的男童被随机分配接受标准ORS（311 mmol/L）或低渗ORS（245 mmol/L）。每3小时测量摄入量和排出量。

结果

在接受低渗ORS治疗的组中，补液阶段的平均粪便排出量比接受WHO标准ORS治疗的组低36%（95%置信区间，1%，100%）。接受低渗ORS治疗的儿童在补液阶段呕吐的相对风险显著更低（相对风险，2.4；95%置信区间，1.2，4.8）。在维持阶段，治疗组的粪便排出量、食物和ORS的平均摄入量、腹泻持续时间以及体重增加情况相似。接受WHO标准ORS的儿童治疗失败（需要非计划内静脉补液）的相对风险显著增加（相对风险，7.9；95%置信区间，1.1，60.9）。接受低渗ORS溶液的儿童在24小时时的平均血清钠浓度（134±6 mEq/L）显著低于接受WHO标准ORS的儿童（138±7 mEq/L）（p<0.001）。给予低渗ORS的儿童发生或加重低钠血症的相对风险未增加，且治疗组的尿量相似。