[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].
OBJECTIVE
To assess the efficacy and safety of reduced osmolarity 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(-), HCO(3)(-) 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 case in trial group had mild abdominal distention and recovered spontaneously.


CONCLUSIONS
ROORS was shown to be effective and safe in the treatment of mild and moderate dehydration induced by acute diarrhea. Compared to ORS II, ROORS could decrease the intravenous supplement of fluid and lower the risk of hypernatremia.
Yang
Dao-Feng
DF
Department of Infectious Diseases, Tongji Hospital, Huazhong University of Science and Technology, Wuhan 430030, China.
Guo
Wei
W
Tian
De-Ying
DY
Luo
Xiao-Ping
XP
He
Yong-Wen
YW
Dai
Yong-An
YA
Xu
Hua-Lin
HL
D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D002712:Chlorides / Q000097:blood; D003681:Dehydration / Q000209:etiology / Q000628:therapy*; D003967:Diarrhea / Q000150:complications / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D005440:Fluid Therapy / Q000379:methods*; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D009994:Osmolar Concentration; D011188:Potassium / Q000097:blood; D015532:Rehydration Solutions / Q000008:administration & dosage*; D012964:Sodium / Q000097:blood; D016896:Treatment Outcome; D014882:Water-Electrolyte Balance
D002712:Chlorides; D015532:Rehydration Solutions; D012964:Sodium; D011188:Potassium