低渗口服补液盐治疗儿童急性腹泻轻中度脱水的疗效和安全性评价

Efficacy and safety of reduced osmolarity oral rehydration salts in treatment of dehydration in children with acute diarrhea——A multicenter,randomized,double blind clinical trial

目的评价国产低渗口服补液盐(ROORS)治疗脱水患者的临床疗效和安全性。方法采用多中心、随机双盲、阳性药物(口服补液盐Ⅱ)平行对照试验,共治疗17岁及以下急性腹泻脱水患儿125例,其中试验组62例,使用 ROORS;对照组63例,使用口服补液盐Ⅱ(ORSⅡ)。结果试验组和对照组的总有效率分别为96.8%和96.8%;试验组全身症状、脱水症状及腹泻症状的改善率分别为96%、97%和78%,对照组分别为96%、98%和85%。两组上述指标的差异及需静脉补液人数差异均无统计学意义(P>0.05),但试验组静脉补液量较对照组少。试验组治疗前后血清 Na^+浓度差异无统计学意义,但对照组治疗后血清 Na^+均值高于治疗前。两组患儿经治疗后,总体病情严重程度均改善明显,但两组间比较,差异无统计学意义(P>0.05)。试验组1例受试者出现轻度腹胀,未停药自行消失。未发生其他不良事件。结论 ROORS 在治疗急性腹泻病导致的轻、中度脱水的疗效和安全性方面与 ORSⅡ相似,且能减少静脉补液量,降低发生高钠血症的风险。

Objective To assess the efficacy and safety of reduced esmolarity oral rehydration salts （ROORS） in treatment of mild to moderate dehydration caused by acute diarrhea in children. Methods A multicenter, randomized, double-blind, positive drug controlled clinical trial was conducted in 125 cases aged 1 to 17 years. These children with acute diarrhea and signs of dehydration were randomly assigned to receive either ROORS （trial group, n =62） or oral rehydration salts Ⅱ （ORS Ⅱ） （control group, n =63）. The volume of intravenous infusion were recorded. The improvements of systemic symtoms and signs, diarrhea, dehydration and total scores were compared between the two groups. The adverse events and changes of electrolyte and other laboratory tests during treatment were also observed and analyzed. Results The overall effective rates in trial group and control group were 96. 8% and 96. 8%, respectively. The recovery of systemic symptoms, dehydration signs and diarrhea occurred in 96%, 97% and 78% patients in trial groups, and 96%, 98% and 85% patients in control group. The scores of symptoms and signs in both groups decreased significantly after treatment. All the above parameters and the number of cases who needed intravenous infusion （41 vs. 39） were not statistically different between two groups. However, the average volume of intravenously infused fluids in trial group was （450. 98 ± 183.07 ） ml, 24. 5% less than that in the control group （597. 30± 343. 37 ） ml （ P 〈 0. 05 ）. The mean serum Na^＋ concentration elevated from （137.48 ±4.55） mmol/L to （139.52 ±3.25） mmol/L （P〈0.01） in control group after treatment, but the change was not statistically significant in trail group. Serum K ^＋ , Cl^-, HCO3^- and other laboratory result did not change significantly after treatment. The total scores in both groups decreased obviously after treatment, but no significant difference was demonstrated between two groups （ P 〉 0. 05 ）. A ease in trial group had mild abdominal distention and recovered spontaneously. Conclusion ROORS was shown to be effective and safe in the treatment of mild and moderate dehydration induced by acute diarrhea. Compared to ORS H, ROORS could decrease the intravenous supplement of fluid and lower the risk of hypernatremia.