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自制及复配包装谷物类口服补液盐溶液的安全性与有效性:一项随机临床试验

Safety and effectiveness of homemade and reconstituted packet cereal-based oral rehydration solutions: a randomized clinical trial.

作者信息

Meyers A, Sampson A, Saladino R, Dixit S, Adams W, Mondolfi A

机构信息

Division of General Pediatrics, Boston Medical Center, Boston University School of Medicine, Boston, MA 02118, USA.

出版信息

Pediatrics. 1997 Nov;100(5):E3. doi: 10.1542/peds.100.5.e3.

DOI:10.1542/peds.100.5.e3
PMID:9346997
Abstract

OBJECTIVES

Parents may be deterred from obtaining commercial oral rehydration solutions (ORS) for their young children with acute diarrheal disease because of its availability and/or cost, especially if they are poor. We conducted a randomized clinical trial to determine 1) whether low-income parents could safely mix and administer cereal-based ORS (CBORS) both from ingredients commonly found in the home and from a premixed packet; 2) whether these CBORS were as effective in maintaining hydration as commercial glucose-based ORS; and 3) whether CBORS were more effective in reducing severity and duration of illness.

METHODS

Children 4 to 36 months of age discharged from emergency departments and health centers with acute diarrheal disease were randomized to receive either homemade CBORS, reconstituted packet CBORS, or Pedialyte. A study nurse saw the child at home each day until the illness resolved, and obtained capillary blood for serum sodium at enrollment and at 24 to 48 hours; a sample of CBORS for sodium concentration; stool for pathogen analysis; and daily fluid intake, stool frequency, and weight.

RESULTS

A total of 232 children were enrolled, of whom 203 (88%) completed the study. Two parents (3%) in the homemade CBORS group and one parent (1%) in the packet CBORS group made mixing errors resulting in a high sodium concentration (>100 mEq/L); their children refused the solution and had normal serum sodium values. Mean CBORS sodium concentration for the remainder of the homemade CBORS group was 60 +/- 10 mEq/L, and for the packet CBORS group, 54 +/- 13. Eighteen children (11%) had abnormal serum sodium values at presentation, which returned to normal in all groups in most cases. Three children (4.5%) in the homemade CBORS group, 4 (6%) in the packet CBORS group, and 1 child (1.4%) in the Pedialyte group failed therapy. Children refused to take homemade CBORS and packet CBORS (43% and 32%, respectively) more often than Pedialyte (9%), and those in the CBORS groups tended to take less ORS and total fluids. There were no significant differences among the three groups in incidence of daily vomiting or stooling, duration of diarrhea, or weight gain.

CONCLUSIONS

CBORS do not offer a clinically significant advantage over glucose-based ORS. Homemade CBORS represent a treatment option in carefully selected cases, but it is not the safest alternative for regular clinical use.

摘要

目的

由于商业口服补液盐(ORS)的可获取性和/或成本问题,尤其是对于贫困家庭而言,家长可能不愿为患急性腹泻病的幼儿购买此类产品。我们开展了一项随机临床试验,以确定:1)低收入家长能否安全地用家中常见食材和预混包装调配并使用谷物基ORS(CBORS);2)这些CBORS在维持水合状态方面是否与市售葡萄糖基ORS同样有效;3)CBORS在减轻疾病严重程度和缩短病程方面是否更有效。

方法

从急诊科和健康中心出院的4至36个月大的急性腹泻病患儿被随机分组,分别接受自制CBORS、复配包装CBORS或口服补液盐(Pedialyte)。一名研究护士每天到患儿家中访视,直至疾病痊愈,并在入组时以及24至48小时采集毛细血管血检测血清钠;采集一份CBORS样本检测钠浓度;采集粪便进行病原体分析;记录每日液体摄入量、排便频率和体重。

结果

共纳入232名儿童,其中203名(88%)完成了研究。自制CBORS组有2名家长(3%)、复配包装CBORS组有1名家长(1%)调配错误,导致钠浓度过高(>100 mEq/L);他们的孩子拒绝服用该溶液,血清钠值正常。自制CBORS组其余儿童的CBORS平均钠浓度为60±10 mEq/L,复配包装CBORS组为54±13。18名儿童(11%)就诊时血清钠值异常,大多数情况下所有组的该指标均恢复正常。自制CBORS组有3名儿童(4.5%)、复配包装CBORS组有4名儿童(6%)、口服补液盐组有1名儿童(1.4%)治疗失败。儿童拒绝服用自制CBORS和复配包装CBORS的比例(分别为43%和32%)高于口服补液盐(9%),CBORS组儿童服用的ORS和总液体量往往较少。三组在每日呕吐或排便发生率、腹泻持续时间或体重增加方面无显著差异。

结论

CBORS与葡萄糖基ORS相比并无显著临床优势。自制CBORS在经过精心挑选的病例中可作为一种治疗选择,但并非常规临床使用的最安全替代品。

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