目的:我们旨在评估益生菌和合生元治疗儿童功能性便秘的疗效和安全性。
方法:PubMed,Embase,科克伦图书馆,ClinicalTrials.gov,和国际临床试验注册平台(ICTRP)搜索截至2023年6月.纳入以罗马III/IV标准诊断为FC的儿童的随机对照试验。治疗成功,排便频率,大便稠度,痛苦的排便,大便失禁,不良事件作为结局进行评估.适当计算二分变量和连续变量的赔率比(OR)和标准平均差(SMD)以及95%置信区间(CI)。Cochrane偏差风险工具版本2评估了偏差风险。
结果:纳入了1504例患者的17个RCTs。与安慰剂相比,益生菌显着改善排便频率(SMD0.40,95%CI0.10至0.70,I2=0%)和大便失禁(OR0.53,95%CI0.29至0.96,I2=0%)。然而,它没有显著提高治疗成功率,痛苦的排便,和腹痛。益生菌,作为附加疗法,未能产生治疗成功率的显着差异(OR0.82,95%CI0.15至4.48,I2=52%),排便频率(SMD0.13,95%CI-0.13至0.39,I2=0%),排便一致性(SMD-0.01,95%CI-0.40至0.38,I2=1%),大便失禁(OR0.95,95%CI0.48至1.90,I2=0%),和腹痛(或,0.60,95%CI0.24至1.53,I2=0%)与泻药单药治疗相比。合生元加泻药对排便频率(SMD-0.57;95%CI-1.29至0.14,I2=74%)和排便疼痛(OR,3.39;95%CI0.74至15.55,I2=0%)与单用泻药相比。
结论:目前的证据并不提倡使用益生菌和合元治疗儿童功能性便秘。此时,菌株特异性益生菌的作用,益生菌混合物,益生菌和合生元的最佳剂量和治疗持续时间尚不清楚。需要更多严格的证据来评估和确定益生菌和合生元治疗儿童功能性便秘的有效性和安全性。
■CRD42020195869。
We aimed to evaluate the efficacy and safety of probiotics and synbiotics in childhood functional constipation.
PubMed, Embase, Cochrane Library, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP) were searched up to June 2023. Randomized controlled trials involving children diagnosed with FC with Rome III/IV criteria were included. Treatment success, defecation frequency, stool consistency, painful defecation, fecal incontinence, and adverse events were assessed as outcomes. Odds ratios (ORs) and standard mean difference (SMD) with 95% confidence intervals (CIs) were calculated for dichotomous and continuous variables as appropriate. Cochrane risk-of-bias tool version 2 assessed the risk of bias.
Seventeen RCTs with 1504 patients were included. Compared to placebo, probiotics significantly improved defecation frequency (SMD 0.40, 95% CI 0.10 to 0.70, I2 = 0%) and fecal incontinence (OR 0.53, 95% CI 0.29 to 0.96, I2 = 0%). However, it did not significantly improve treatment success, painful defecation, and abdominal pain. Probiotics, as add-on therapy, failed to yield a significant difference in treatment success (OR 0.82, 95% CI 0.15 to 4.48, I2 = 52%), defecation frequency (SMD 0.13, 95% CI -0.13 to 0.39, I2 = 0%), defecation consistency (SMD -0.01, 95% CI -0.40 to 0.38, I2 = 1%), fecal incontinence (OR 0.95, 95% CI 0.48 to 1.90, I2 = 0%), and abdominal pain (OR, 0.60, 95% CI 0.24 to 1.53, I2 = 0%) versus laxatives monotherapy. Synbiotics plus laxatives showed no significant effect on defecation frequency (SMD -0.57; 95% CI -1.29 to 0.14, I2 = 74%) and painful defecation (OR, 3.39; 95% CI 0.74 to 15.55, I2 = 0%) versus laxatives alone.
Current evidence did not advocate using probiotics and synbiotics in treating functional constipation in children. At this time, the effects of strain-specific probiotics, probiotics mixtures, and the optimal doses and treatment durations of the probiotics and synbiotics were unclear. Additional rigorous evidence is required to evaluate and establish the effectiveness and safety of probiotics and synbiotics for childhood functional constipation.
CRD42020195869.