目的 设计防喷溅婴幼儿肛门内粪便标本取样器并评价其应用效果。方法 该取样器采用医用级柔性塑料材质，集成储液球囊负压吸引、通气细管单向活瓣防喷溅及预润滑涂层结构，采用环氧乙烷灭菌独立纸塑包装。临床应用选取2025年3月—4月在杭州市某三级甲等医院门诊需粪便采样的婴幼儿400例，随机分为试验组（使用防喷溅婴幼儿肛门内粪便标本取样器，n=200）和对照组（使用传统肛拭子，n=200），对比两组样本采集成功率、肠道黏膜损伤率、粪便喷溅率、患儿舒适度及护士满意度。结果 试验组样本采集成功率为100%，显著高于对照组的93.0%（χ²=14.508，P<0.001）；试验组黏膜损伤率（0与3.0%，P=0.013）与粪便喷溅率（0与7.0%，P<0.001）显著低于对照组；患儿舒适度评分0分（无不适）占比试验组（23.0%）高于对照组（9%），护士满意度（98.0%）高于对照组（86.0%），差异均具有统计学意义（P<0.001）。结论 防喷溅婴幼儿肛门内粪便标本取样器可提升婴幼儿粪便采样的安全性与操作效率，实现零黏膜损伤与零喷溅污染，提高患儿的舒适度和护士的满意度。

Objective To design an anti-splashing anal fecal specimen sampler for infants and young children，and evaluate its application effectiveness. Methods The sampler was made of medical-grade flexible plastic material，integrating a liquid-storage balloon for suction under negative pressure，a one-way valve on a ventilation tube to prevent splashing，and a pre-lubricated coating structure. It was sterilized with ethylene oxide and packaged in independent paper-plastic packaging. For clinical application，400 infants requiring fecal sampling at a tertiary Grade A hospital in Hangzhou from March to April 2025 were selected and randomly divided into an experimental group （using the novel sampler，n=200） and a control group（using traditional anal swabs，n=200）. The success rate of sample collection，intestinal mucosal injury rate，fecal splashing rate，pediatric comfort level，and nurse satisfaction were compared between the two groups. Results The success rate of sample collection in the experimental group was 100.0%，significantly higher than that in the control group（93.0%）（χ²=14.508，P<0.001）. The mucosal injury rate（0 vs 3.0%，P=0.013） and fecal splashing rate（0 vs 7.0%，P<0.001） in the experimental group were significantly lower than those in the control group. The proportion of moderate to severe discomfort in the experimental group（23.0%） was lower than that in the control group（41.0%），and nurse satisfaction in the experimental group（98.0%） was higher than that in the control group（86.0%），with all differences being statistically significant（P<0.001）. Conclusion This design significantly enhances the safety and operational efficiency of fecal sampling in infants and young children，achieving zero mucosal damage and zero splash contamination，thereby increasing the comfort of pediatric patients and the satisfaction of nurses.