Hyperuricemia Clinical Trial
Official title:
A Randomized, Prospective, Controlled Study of the Efficacy and Safety of Uralyt-U Combined With Febuxostat in the Treatment of Hyperuricemia With Uric Acid Stones
The purpose of the study is to provide a more direct and objective basis for the widespread use of potassium sodium hydrogen citrate granules in the treatment of uric acid stones.
Hyperuricemia (HUA) is a common systemic metabolic disease. Its incidence is increasing year
by year and more young people suffer from hyperuricemia. HUA can not only cause the onset of
gouty arthritis, and then affect joint function, and even cause joint deformities. It can
also cause damage to multiple organs such as the heart, brain, and kidney through multiple
channels. Chronic kidney disease (CKD) refers to chronic kidney structural and dysfunction
caused by various reasons. HUA is an independent risk factor that accelerates the progress of
CKD. Studies have shown that lowering uric acid is another key treatment to delay the
progress of CKD. A large number of studies have shown that the formation of uric acid
crystals is the main mechanism of inducing renal injury.
In 2017, the "Multidisciplinary Expert Consensus for the Diagnosis and Treatment of
Hyperuricemia-Related Diseases in China" recommended that patients with hyperuricemia
receiving uric acid lowering drugs, especially those treated with uric acid excretion drugs
and patients with uric acid nephrolithiasis, recommended that the pH of urine be adjusted
during pH6.2 ~ 6.9 to increase the solubility of uric acid in urine. It is recommended to use
sodium bicarbonate or potassium sodium citrate drugs to alkalinize urine, but it is not clear
if there is any difference in the kinetic parameters of urine alkalinity, compliance rate of
alkalinized urine and safety between sodium bicarbonate and potassium sodium citrate. No
"head-to-head" clinical publications have been reported. This clinical trial was designed to
evaluate the rate of alkalinization of urine, the therapeutic effect of renal lithiasis and
adverse reactions between the sodium bicarbonate and potassium sodium hydrogen citrate
granules in healthy people and patients with hyperuricemia and renal calculi (uric acid).
This study provides a more direct and objective basis for the widespread use of potassium
sodium hydrogen citrate granules in the treatment of uric acid stones.
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