Çağan Eren, Ceylan Saime, Mengi Şenay, Çağan Havva Hasret
Training and Research Hospital, University of Medical Sciences Bursa Yüksek İhtisas, Yildirim/Bursa, Turkey.
Med Sci Monit. 2017 Apr 27;23:2029-2034. doi: 10.12659/msm.903158.
BACKGROUND Acute diarrhea is the second most common cause of morbidity and mortality worldwide, especially in children aged ≤3 years. Some drugs (e.g., the mucoprotector gelatin tannate) plus a reduced osmolality oral rehydration solution (ORS) may effectively reduce symptom duration and severity. The current trial was therefore designed to assess the efficacy and safety of gelatin tannate in pediatric patients with acute diarrhea. MATERIAL AND METHODS This was a randomized, controlled, double-blind, parallel-group, single-center study comparing gelatin tannate plus ORS (103 patients) with ORS plus placebo (100 patients) in children aged 3 months to 12 years with infectious or noninfectious acute diarrhea. Details about stool consistency and total time to resolution of diarrhea comprised the primary study endpoints. Secondary study endpoints included symptoms of diarrhea at 12, 24, 36, 48, and 72 hours after the first dose of study medication. RESULTS From 12 hours onwards, the incidence of watery stools was significantly lower in the gelatin tannate group than in the ORS group (at 12 hours: 59.2% vs. 77.0%; p=0.01). The same was true for stool frequency (at 12 hours: mean 2 vs. 3 stool productions in the previous 12 hours; p<0.01). At all timepoints during the study, the proportion of patients with Stool Decrease Index improvement was significantly greater (p<0.01) in the gelatin tannate group than in the placebo group (at 12 hours: 66.6% vs. 33.3%; p<0.01). CONCLUSIONS Gelatin tannate plus ORS is an effective and safe option for the treatment of acute diarrhea in children. Significant symptom relief is evident 12 hours after starting treatment.
背景 急性腹泻是全球发病率和死亡率的第二大常见原因，尤其是在3岁及以下儿童中。一些药物（如粘膜保护剂鞣酸蛋白）加低渗口服补液盐（ORS）可能有效缩短症状持续时间并减轻严重程度。因此，本试验旨在评估鞣酸蛋白对小儿急性腹泻患者的疗效和安全性。材料与方法 这是一项随机、对照、双盲、平行组、单中心研究，比较鞣酸蛋白加ORS（103例患者）与ORS加安慰剂（100例患者）在3个月至12岁患有感染性或非感染性急性腹泻的儿童中的疗效。粪便稠度细节和腹泻完全缓解的总时间构成主要研究终点。次要研究终点包括首次服用研究药物后12、24、36、48和72小时的腹泻症状。结果 从12小时起，鞣酸蛋白组水样便的发生率显著低于ORS组（12小时时：59.2%对77.0%；p=0.01）。粪便频率也是如此（12小时时：前12小时平均排便2次对3次；p<0.01）。在研究期间的所有时间点，鞣酸蛋白组粪便减少指数改善的患者比例显著高于安慰剂组（p<0.01）（12小时时：66.6%对33.3%；p<0.01）。结论 鞣酸蛋白加ORS是治疗儿童急性腹泻的有效且安全的选择。开始治疗12小时后症状明显缓解。
