Alam N H, Majumder R N, Fuchs G J
International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka.
Lancet. 1999 Jul 24;354(9175):296-9. doi: 10.1016/s0140-6736(98)09332-5.
The effects of oral rehydration solution (ORS) with reduced osmolarity on children with acute watery diarrhoea are known, but little is known about the effects of such ORS on adults with cholera. We aimed to compare the efficacy and safety of an ORS with reduced osmolarity with that of standard WHO ORS in adults with cholera.
We undertook a double-blind, controlled clinical trial in adults with severe cholera at the International Centre for Diarrhoeal Disease Research, Bangladesh. Our primary outcomes were mean stool output in the 24 h after randomisation, proportion of patients who needed unscheduled intravenous therapy, and proportion of patients with biochemical hyponatraemia 24 h after randomisation.
147 patients received ORS with reduced osmolarity and 153 received standard WHO ORS. There was no significant difference between the two groups in terms of main outcome variables: mean initial 24 h and total stool output (reduced osmolarity vs standard WHO ORS 212 [SE 8] vs 207 [8] and 284 [13] vs 273 [13] g/kg respectively), duration of diarrhoea (46 [1.5] vs 43 [1.5]). The proportion of patients vomiting during the first 24 h and the proportion who received unscheduled intravenous infusion during the first 24 h was similar between groups. More patients on reduced osmolarity ORS than on standard WHO ORS developed hyponatraemia during the first 24 h, defined as serum sodium concentration below 130 mmol/L (29 of 142 vs 16 of 150; odds ratio 2.1 [95% CI 1.1-4.1]). However, all hyponatraemic patients in both groups were symptom-free and the proportion of patients with serum sodium concentration below 125 mmol/L was similar between groups.
There was no difference in clinical outcome between cholera patients treated with reduced osmolarity ORS solution and those treated with standard WHO ORS. The risk of increased incidence of symptom-free hyponatraemia in patients with cholera treated with an ORS with reduced osmolarity should be further assessed by meta-analysis. The risk should be taken into account when choice of ORS is made in areas in which cholera is endemic.
低渗口服补液盐（ORS）对急性水样腹泻儿童的疗效已为人所知，但对于此类ORS对霍乱成人患者的影响知之甚少。我们旨在比较低渗ORS与世界卫生组织（WHO）标准ORS对霍乱成人患者的疗效和安全性。
我们在孟加拉国腹泻疾病国际研究中心对重症霍乱成人患者进行了一项双盲对照临床试验。我们的主要结局指标为随机分组后24小时内的平均粪便排出量、需要非计划静脉治疗的患者比例以及随机分组后24小时发生生化性低钠血症的患者比例。
147例患者接受了低渗ORS，153例患者接受了WHO标准ORS。两组在主要结局变量方面无显著差异：平均初始24小时及总粪便排出量（低渗组与WHO标准组分别为212[标准误8]对207[8]以及284[13]对273[13]g/kg）、腹泻持续时间（46[1.5]对43[1.5]）。两组在最初24小时内呕吐患者的比例以及接受非计划静脉输液患者的比例相似。在最初24小时内，接受低渗ORS的患者发生低钠血症（定义为血清钠浓度低于130 mmol/L）的人数多于接受WHO标准ORS的患者（142例中的29例对150例中的16例；比值比2.1[95%可信区间1.1 - 4.1]）。然而，两组所有低钠血症患者均无症状，且血清钠浓度低于125 mmol/L的患者比例在两组间相似。
低渗ORS溶液治疗的霍乱患者与WHO标准ORS治疗的霍乱患者在临床结局方面无差异。对于霍乱流行地区在选择ORS时，应通过荟萃分析进一步评估使用低渗ORS治疗的霍乱患者无症状性低钠血症发生率增加的风险。此风险应予以考虑。
