Pérez-Gaxiola Giordano, Cuello-García Carlos A, Florez Ivan D, Pérez-Pico Víctor M
Evidence-Based Medicine Department, Hospital Pediátrico de Sinaloa, Blvd. Constitución s/n, Col. Almada. 80200, Culiacán, Sinaloa, Mexico, 80200.
Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011526. doi: 10.1002/14651858.CD011526.pub2.
As mortality secondary to acute infectious diarrhoea has decreased worldwide, the focus shifts to adjuvant therapies to lessen the burden of disease. Smectite, a medicinal clay, could offer a complementary intervention to reduce the duration of diarrhoea.
To assess the effects of smectite for treating acute infectious diarrhoea in children.
We searched the Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (Pubmed), Embase (Ovid), LILACS, reference lists from studies and previous reviews, and conference abstracts, up to 27 June 2017.
Randomized and quasi-randomized trials comparing smectite to a control group in children aged one month to 18 years old with acute infectious diarrhoea.
Two review authors independently screened abstracts and the full texts for inclusion, extracted data, and assessed risk of bias. Our primary outcomes were duration of diarrhoea and clinical resolution at day 3. We summarized continuous outcomes using mean differences (MD) and dichotomous outcomes using risk ratios (RR), with 95% confidence intervals (CI). Where appropriate, we pooled data in meta-analyses and assessed heterogeneity. We explored publication bias using a funnel plot.
Eighteen trials with 2616 children met our inclusion criteria. Studies were conducted in both ambulatory and in-hospital settings, and in both high-income and low- or middle-income countries. Most studies included children with rotavirus infections, and half included breastfed children.Smectite may reduce the duration of diarrhoea by approximately a day (MD -24.38 hours, 95% CI -30.91 to -17.85; 14 studies; 2209 children; low-certainty evidence); may increase clinical resolution at day 3 (risk ratio (RR) 2.10, 95% CI 1.30 to 3.39; 5 trials; 312 children; low-certainty evidence); and may reduce stool output (MD -11.37, 95% CI -21.94 to -0.79; 3 studies; 634 children; low-certainty evidence).We are uncertain whether smectite reduces stool frequency, measured as depositions per day (MD -1.33, 95% CI -2.28 to -0.38; 3 studies; 954 children; very low-certainty evidence). There was no evidence of an effect on need for hospitalization (RR 0.93, 95% CI 0.75 to 1.15; 2 studies; 885 children; low-certainty evidence) and need for intravenous rehydration (RR 0.77, 95% CI 0.54 to 1.11; 1 study; 81 children; moderate-certainty evidence). The most frequently reported side effect was constipation, which did not differ between groups (RR 4.71, 95% CI 0.56 to 39.19; 2 studies; 128 children; low-certainty evidence). No deaths or serious adverse effects were reported.
AUTHORS' CONCLUSIONS: Based on low-certainty evidence, smectite used as an adjuvant to rehydration therapy may reduce the duration of diarrhoea in children with acute infectious diarrhoea by a day; may increase cure rate by day 3; and may reduce stool output, but has no effect on hospitalization rates or need for intravenous therapy.
随着全球范围内急性感染性腹泻导致的死亡率下降,重点转向辅助治疗以减轻疾病负担。蒙脱石,一种药用黏土,可能提供一种补充干预措施以缩短腹泻持续时间。
评估蒙脱石治疗儿童急性感染性腹泻的效果。
我们检索了Cochrane传染病组专业注册库、Cochrane对照试验中央注册库(CENTRAL)、MEDLINE(PubMed)、Embase(Ovid)、拉丁美洲及加勒比卫生科学数据库(LILACS)、研究和以往综述的参考文献列表以及会议摘要,检索截至2017年6月27日。
比较蒙脱石与对照组治疗1个月至18岁急性感染性腹泻儿童的随机和半随机试验。
两位综述作者独立筛选摘要和全文以确定纳入研究,提取数据,并评估偏倚风险。我们的主要结局是腹泻持续时间和第3天的临床缓解情况。我们使用平均差(MD)汇总连续型结局,使用风险比(RR)汇总二分法结局,并给出95%置信区间(CI)。在适当情况下,我们在Meta分析中合并数据并评估异质性。我们使用漏斗图探索发表偏倚。
18项试验共2616名儿童符合我们的纳入标准。研究在门诊和住院环境中均有开展,涉及高收入国家以及低收入或中等收入国家。大多数研究纳入了轮状病毒感染的儿童,半数研究纳入了母乳喂养儿童。蒙脱石可能使腹泻持续时间缩短约一天(MD -24.38小时,95%CI -30.91至-17.85;14项研究;2209名儿童;低质量证据);可能增加第3天的临床缓解率(风险比(RR)2.10,95%CI 1.30至3.39;5项试验;312名儿童;低质量证据);并且可能减少粪便排出量(MD -11.37,95%CI -21.94至-0.79;3项研究;634名儿童;低质量证据)。我们不确定蒙脱石是否能降低以每日排便次数衡量的排便频率(MD -1.33,95%CI -2.28至-0.38;3项研究;954名儿童;极低质量证据)。没有证据表明其对住院需求(RR 0.93,95%CI 0.75至1.15;2项研究;885名儿童;低质量证据)和静脉补液需求(RR 0.77,95%CI 0.54至1.11;1项研究;81名儿童;中等质量证据)有影响。最常报告的副作用是便秘,两组之间无差异(RR 4.71,95%CI 0.56至39.19;2项研究;128名儿童;低质量证据)。未报告死亡或严重不良反应。
基于低质量证据,蒙脱石作为补液疗法的辅助用药可能使急性感染性腹泻儿童的腹泻持续时间缩短一天;可能提高第3天的治愈率;并且可能减少粪便排出量,但对住院率或静脉治疗需求没有影响。