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接受临床试验的胃肠炎患儿短期使用益生菌的依从性预测因素。

Predictors of Adherence to Short-Course Probiotics Among Children with Gastroenteritis who are Enrolled in a Clinical Trial.

机构信息

Division of Pediatric Emergency Medicine, IWK Health, Halifax, NS, Canada.

Department of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.

出版信息

Clin Invest Med. 2023 Mar 26;46(1):E15-23. doi: 10.25011/cim.v46i1.39560.

DOI:10.25011/cim.v46i1.39560
PMID:36966390
Abstract

BACKGROUND

To improve our understanding of adherence to discharge medications in the ED and within research trials, we sought to quantify medication adherence and identify predictors thereof in children with acute gastroenteritis (AGE).

METHODS

We conducted a secondary analysis of a randomized trial of twice daily probiotic for 5 days. The population included previously healthy children aged 3-47 months with AGE. The primary outcome was patient-reported adherence to the treatment regimen, defined a priori as having received >70% of the prescribed doses. Secondary outcomes included predictors of treatment adherence and concordance between patient-reported adherence and the returned medication sachet counts.

RESULTS

After excluding participants with missing data on adherence, 760 participants were included in this analysis: 383 in the probiotic arm (50.4%); and 377 in the placebo arm (49.6%). Self-reported adherence was similar in both groups (77.0% in probiotic versus 80.3% in placebo). There was good agreement between self-reported adherence and sachet counts (87% within limits of agreement (-2.9 to 3.5 sachets) on the Bland-Altman plots). In the multivariable regression model, covariates associated with adherence were greater number of days of diarrhea post-emergency department visit, and the study site; covariates negatively associated with adherence were age 12-23 months, severe dehydration and greater total number of vomiting and diarrhea episodes after enrolment.

CONCLUSIONS

Longer duration of diarrhea and study site were associated with higher probiotic adherence. Age 12-23 months, severe dehydration and greater number of vomiting and diarrhea episodes post enrolment negatively predicted treatment adherence.

摘要

背景

为了提高我们对 ED 和研究试验中出院药物依从性的理解,我们试图量化儿童急性肠胃炎(AGE)患者的药物依从性,并确定其预测因素。

方法

我们对一项为期 5 天的每日两次益生菌随机试验进行了二次分析。研究人群包括此前健康的 3-47 月龄 AGE 儿童。主要结局是患者报告的治疗方案依从性,预先定义为接受了>70%规定剂量的药物。次要结局包括治疗依从性的预测因素以及患者报告的依从性与退回的药物袋计数之间的一致性。

结果

在排除了依从性数据缺失的参与者后,760 名参与者纳入本分析:益生菌组 383 名(50.4%);安慰剂组 377 名(49.6%)。两组的自我报告依从性相似(益生菌组为 77.0%,安慰剂组为 80.3%)。在 Bland-Altman 图中,自我报告的依从性与药袋计数之间有很好的一致性(87%在一致性界限内(-2.9 至 3.5 个药袋))。在多变量回归模型中,与依从性相关的协变量是急诊科就诊后腹泻的天数,以及研究地点;与依从性呈负相关的协变量是 12-23 月龄、严重脱水以及入组后呕吐和腹泻次数较多。

结论

腹泻持续时间较长和研究地点与较高的益生菌依从性相关。12-23 月龄、严重脱水以及入组后呕吐和腹泻次数较多与治疗依从性呈负相关。

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