A double-blind, randomized, crossover study of the local tolerability of erythropoietin alfa formulations in dialysis patients
Bibliographic record
Abstract
Abstract Objectives: A double-blind, randomized, crossover study was conducted to compare the local tolerability of subcutaneous injections of epoetin alfa formulated with a citrate buffer (epoetin alfa-C) versus epoetin alfa formulated with a sodium phosphate buffer (epoetin alfa-P). Methods: The study utilized a 2-periocl, 2-treatment crossover design, with no washout period. Forty-eight dialysis patients were randomly assigned to receive 6 consecutive subcutaneous injections of epoetin alfa-C or epoetin alfa-P. After completing their first treatment period, patients were switched to the alternate therapy. The primary efficacy outcome was patient-evaluated pain assessed after each injection using a verbal descriptor scale (VDS) and a visual analog scale (VAS). The duration of injection-site discomfort and the degree of redness/and itching were also assessed. Results: At all evaluation time points, subjects rated pain consistently and significantly lower (e.g. VDS day 6, p=0.034; VAS day 6; p=0.023), and the duration of pain significantly shorter with epoetin alfa-P compared to epoetin alfa-C. However, further analysis detected a significant (p≤0.10) carryover effect in several time point comparisons, suggesting that these results be interpreted in light of possible carryover effects. Conclusions: The results of this study indicate that epoetin alfa-P is associated with less, and shorter, injection-site discomfort than epoetin alfa-C. RESUME Objectifs : Etude randomisee, a double insu avec permutation visant a comparer la tolerance locale des injections sous-cutanees d'epoetine alfa preparee avec un tampon de citrate (epoetine alfa-C) a celle de l'epoetine alfa preparee avec un tampon de phosphate de sodium (epoetine alfa-P). Methodes : L'etude a ete menee selon un modele a deux temps, deux traitements avec permutation, sans periode d'epuration therapeutique. Au total de 48 patients ont ete repartis au hasard pour recevoir six injections consecutives soit d'epoetine alfa-C, soit d'epoetine alfa-P. Apres avoir complete leur premiere periode de traitement, les patients ont simplement ete permutes pour recevoir l'autre traitement. Le premier parametre d'efficacite evalue a ete la douleur telle que decrite par le patient apres chaque injection, a l'aide de l'echelle de description verbale (VDS) et de l'echelle analogique visuelle (VAS). La duree de l'inconfort au point d'injection et le degre de la rougeur/des demangeaisons ont aussi ete evalues. Resultats : Pour tous les points clans le temps qui ont ete evaluees, les patients ont cote l'intensite de leurs douleurs (p. ex., VDS au jour 6 : p = 0,034; VAS au jour 6 : p = 0,023) la duree de leurs douleurs comme etant significativement et constamment moindre avec l'epoetine alfa-P qu'avec l'epoetine alfa-C. Cependant, des analyses plus poussees ont decele un effet differe significatif (p ≤ 0,10) pour de nombreux points clans le temps qui ont ete compares, ce qui porte a croire que ces resultats doivent etre interpretes a la lumiere d'un probable effet differe. Conclusions : Les resultats de cette etude incliquent que l’epoetine alfa-P est associee a un inconfort au point d'injection, d'intensite et de duree moindres qu'avec l'epoetine alfa-C.
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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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".