Bibliographic record
Abstract
Introduction: Currently available pharmacological interventions for calcium oxalate (CaOx) stone prevention produce mixed results.Well-tolerated and more effective agents with anti-lithogenic potential would have significant impact on patient quality of life.Arbutin (4-hydroxyphenyl-β-D-glucopyranoside), a glycosylated phenol, has previously been shown to inhibit CaOx nephrolithiasis in in vitro models.In this study, the safety and efficacy of arbutin in a rat model of CaOx kidney stone disease, as well its safety in a phase I human study, were tested.Methods: Kidney stones were induced in Wistar rats by the addition of hydroxy-L-proline (HLP; 5% [wt/wt]) to rat diets, which resulted in quantifiable CaOx stones after two weeks of feeding.A treatment group (arbutin given six weeks after HLP exposure, n=16), a prevention group (arbutin given concurrent to HLP diet exposure, n=16), and a positive control group (no arbutin given while on HLP diet) were compared to a control group (n=16, rats not given arbutin and maintained on a normal diet).In all models, experiments were terminated at 14 weeks.A phase I, randomized, double-blind, placebo-controlled human clinical trial was then conducted comparing arbutin to placebo in 39 healthy patients over a four-week interval.Patient questionnaires to document adverse effects and serum biochemistry were performed throughout the trial period.Results: Oral supplementation of arbutin at doses up to 125 mg/kg body weight three times per week did not change gross morphological (body, kidney, or liver weights) or serological markers of safety and was well-tolerated in rats.In both treatment and prevention group rats, arbutin decreased both the size and overall volume of stones (as quantified via micro-CT scans of kidneys collected at endpoint), and reduced renal tissue damage (as measured by microscopy, immunohistochemistry, and urine markers) at endpoint (stone volume arbutin vs. positive control: treatment model: male rats, p<0.0001, female rats, p<0.05; prevention: male rats, p<0.0001, female rats, p<0.001).In the human clinical trial, there were no significant differences in adverse events or serum biochemistry results between placebo or arbutin groups.Conclusions: Arbutin demonstrates CaOx crystal inhibition in vitro and is safe in humans.Further human efficacy trials are planned.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.383 | 0.186 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".