Bellemare Steven, Hartling Lisa, Wiebe Natasha, Russell Kelly, Craig William R, McConnell Don, Klassen Terry P
Alberta Research Centre for Child Health Evidence, Department of Pediatrics, University of Alberta, 2C3,00 WMC, Edmonton, Alberta, Canada, T6G 2R7.
BMC Med. 2004 Apr 15;2:11. doi: 10.1186/1741-7015-2-11.
Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children.
RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques.
The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to children with persistent vomiting.
There were no clinically important differences between ORT and IVT in terms of efficacy and safety. For every 25 children (95% CI: 20, 50) treated with ORT, one would fail and require IVT. The results support existing practice guidelines recommending ORT as the first course of treatment in appropriate children with dehydration secondary to gastroenteritis.
尽管各组织都给出了治疗建议,但口服补液疗法(ORT)的使用仍未得到充分利用,尤其是在高收入国家的医生中。我们对随机对照试验(RCT)进行了系统评价,以比较ORT和静脉输液疗法(IVT)治疗儿童急性胃肠炎继发脱水的效果。
通过MEDLINE、EMBASE、CENTRAL、纳入试验的作者和参考文献、制药公司及相关组织来识别RCT。由两名审阅者独立进行筛选和纳入,以确定比较ORT和IVT治疗急性腹泻和脱水儿童的随机或半随机对照试验。两名审阅者使用Jadad量表和分配隐藏独立评估研究质量。数据由一名审阅者提取并由另一名审阅者检查。主要结局指标为补液失败。我们使用标准的荟萃分析技术分析数据。
纳入的14项试验质量在0至3分(Jadad评分)之间;除一项研究外,所有研究的分配隐藏情况均不明确。使用随机效应模型,治疗失败率无显著差异(风险差[RD]3%;95%置信区间[CI]:0,6)。Mantel-Haenzsel固定效应模型显示治疗组之间存在显著差异(RD 4%;95%CI:2,5),支持IVT。根据四项报告死亡情况的研究,IVT组有6例死亡,ORT组有2例死亡。在6小时和24小时的总液体摄入量、体重增加、腹泻持续时间或低钠血症/高钠血症方面无显著差异。ORT组的住院时间显著缩短(加权平均差[WMD]-1.2天;95%CI:-2.4,-0.02)。IVT导致静脉炎的发生率显著更高(需治疗人数[NNT]33;95%CI:25,100);ORT导致麻痹性肠梗阻的发生率更高(NNT 33;95%CI:20,100)。这些结果可能不适用于持续性呕吐的儿童。
ORT和IVT在疗效和安全性方面没有临床重要差异。每25名接受ORT治疗的儿童(95%CI:20,50)中,就有1名会治疗失败而需要IVT。这些结果支持现有实践指南,推荐ORT作为治疗胃肠炎继发脱水的合适儿童的首选治疗方法。