薬理と治療

Abstract

Objective　AQUASOLITA® Jelly(AQSJ)is a jelly–like liquid derived from AQUASOLITA® solution(AQS), formulated to aid in water and electrolyte replenishment during dehydration. Both AQSJ and AQS have identical concentrations of key ingredients such as Na, K, Cl, and glucose. This study evaluated the clinical equivalence of AQSJ and AQS for water and electrolyte replenishment in healthy adult men with sauna–induced dehydration. Method　A randomized, crossover comparison study was conducted with 30 healthy men. Participants stayed in a dry sauna for 10–minute periods. After three sauna sessions and a 30–minute rest, they ingested an amount of AQSJ or AQS equivalent to their weight loss due to dehydration. Measurements of fractional excretion of Na(FENa), body weight, serum and urinary electrolyte concentrations, hematological parameters, and blood chemistry values were taken before sauna bathing and up to 240 minutes after consuming AQSJ or AQS. Equivalence was determined if the 90% confidence interval(CI)for the estimated mean value ratio of the two groups was within 80% to 125%. Result　Participants showed mild dehydration after sauna bathing. The peak value of FENa, serum electrolyte concentrations, hematological parameters, and blood chemistry values were considered equivalent for the two groups, although FENa and urinary electrolyte concentrations at each timepoint were not considered equivalent due to different water absorption rates by the different forms. Conclusion　Although the water absorption of AQSJ was slightly slower than that of AQS, the effectiveness of water and electrolyte replenishment by AQSJ and AQS was clinically equivalent in healthy adults with sauna–induced dehydration. (UMIN ID: UMIN000054163)(Jpn Pharmacol Ther 2024;52:1337‒53)