Evaluation of the Clinical Efficacy of Prednisolone in the Treatment of Inflammatory Bowel Diseases with Different Dosage Methods

Aim: to investigate the clinical efficacy of two methods of oral dosing of prednisolone (in mg and mg/kg) for the induction of remission for patients with ulcerative colitis (UC) and Crohn's disease (CD) using the technology of constructing and evaluating the effectiveness function (dose-effect...

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Main Authors: O. P. Alekseeva, S. V. Krishtopenko, A. A. Alekseeva
Format: Article
Language:Russian
Published: Gastro LLC 2023-05-01
Series:Российский журнал гастроэнтерологии, гепатологии, колопроктологии
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Online Access:https://www.gastro-j.ru/jour/article/view/747
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author O. P. Alekseeva
S. V. Krishtopenko
A. A. Alekseeva
author_facet O. P. Alekseeva
S. V. Krishtopenko
A. A. Alekseeva
author_sort O. P. Alekseeva
collection DOAJ
description Aim: to investigate the clinical efficacy of two methods of oral dosing of prednisolone (in mg and mg/kg) for the induction of remission for patients with ulcerative colitis (UC) and Crohn's disease (CD) using the technology of constructing and evaluating the effectiveness function (dose-effect relationship).Material and methods. In this study were included 86 patients aged from 18 to 65 years with moderate or severe active inflammatory bowel disease (61 — UC, 25 — CD). All patients were treated with prednisolone at an initial daily dose from 30 to 60 mg with a subsequent tapering of dose. The clinical response to treatment was evaluated at the time of complete withdrawal of prednisolone using the generally accepted criteria. Two efficiency functions were constructed, compared and analyzed: the first — at the initial dosage of prednisolone in mg and the second calculating the dose in mg/kg of patient weight. The patients' body weight ranged from 41 to 98 kg. The “dose-effect” relationship for prednisolone was constructed with statistical transformation of the baseline clinical data and a quantitative expression of the actual doses and alternative responses into a graph of the effectiveness function. The mean value at each point was estimated based on the regression kernel scoring method.Results. Two graphs of the “dose-effect” of prednisolone in mg and mg/kg of patient weight were constructed. The optimal clinically effective dose (OCED) when calculated in mg/kg of weight was 0.70 ± 0.01 (0.68 + 0.72) mg/kg with the corresponding effect 79.25 ± 6.26 (66.62 91.88) %. When two graphs in mg and mg / kg of weight were superimposed, it is shown that when an initial dose of 40 mg is prescribed without taking into account the patient's weight, the effect of therapy will be 25 % lower. Prescribing a dose of 60 mg per day without weight will be optimal for patients with a body weight of 85-90 kg. With a lower body weight, the clinical effect will not decrease, but the likelihood of recognized side effects of prednisolone should be expected in proportion to the decrease in body weight.Conclusion. The clinical efficacy of two methods of prednisolone dosing (mg and mg/kg) for patients with IBD during the first induction course was compared.Using a new technology for constructing and evaluating the effectiveness function (dose-effect relationship) allowed us to prove a reliable relationship between the body weight of patients with the clinical effect of prednisolone in patients with UC and CD. Based on the analysis of the dose-effect relationship, the optimal clinically effective dose of prednisolone for patients with UC and CD during the first induction course was established, equal to 0.70 mg/kg, which can be recommended for use in clinical practice for calculating individual doses.
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spelling doaj-art-40b1ca1b1a134c979b7d1acb0e7d97eb2025-02-10T16:14:37ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732023-05-01326404610.22416/1382-4376-2022-32-6-40-46519Evaluation of the Clinical Efficacy of Prednisolone in the Treatment of Inflammatory Bowel Diseases with Different Dosage MethodsO. P. Alekseeva0S. V. Krishtopenko1A. A. Alekseeva2Nizhny Novgorod Regional Clinical Hospital named after N.A. SemashkoNizhny Novgorod Regional Clinical Hospital named after N.A. SemashkoPrivolzhsky Research Medical UniversityAim: to investigate the clinical efficacy of two methods of oral dosing of prednisolone (in mg and mg/kg) for the induction of remission for patients with ulcerative colitis (UC) and Crohn's disease (CD) using the technology of constructing and evaluating the effectiveness function (dose-effect relationship).Material and methods. In this study were included 86 patients aged from 18 to 65 years with moderate or severe active inflammatory bowel disease (61 — UC, 25 — CD). All patients were treated with prednisolone at an initial daily dose from 30 to 60 mg with a subsequent tapering of dose. The clinical response to treatment was evaluated at the time of complete withdrawal of prednisolone using the generally accepted criteria. Two efficiency functions were constructed, compared and analyzed: the first — at the initial dosage of prednisolone in mg and the second calculating the dose in mg/kg of patient weight. The patients' body weight ranged from 41 to 98 kg. The “dose-effect” relationship for prednisolone was constructed with statistical transformation of the baseline clinical data and a quantitative expression of the actual doses and alternative responses into a graph of the effectiveness function. The mean value at each point was estimated based on the regression kernel scoring method.Results. Two graphs of the “dose-effect” of prednisolone in mg and mg/kg of patient weight were constructed. The optimal clinically effective dose (OCED) when calculated in mg/kg of weight was 0.70 ± 0.01 (0.68 + 0.72) mg/kg with the corresponding effect 79.25 ± 6.26 (66.62 91.88) %. When two graphs in mg and mg / kg of weight were superimposed, it is shown that when an initial dose of 40 mg is prescribed without taking into account the patient's weight, the effect of therapy will be 25 % lower. Prescribing a dose of 60 mg per day without weight will be optimal for patients with a body weight of 85-90 kg. With a lower body weight, the clinical effect will not decrease, but the likelihood of recognized side effects of prednisolone should be expected in proportion to the decrease in body weight.Conclusion. The clinical efficacy of two methods of prednisolone dosing (mg and mg/kg) for patients with IBD during the first induction course was compared.Using a new technology for constructing and evaluating the effectiveness function (dose-effect relationship) allowed us to prove a reliable relationship between the body weight of patients with the clinical effect of prednisolone in patients with UC and CD. Based on the analysis of the dose-effect relationship, the optimal clinically effective dose of prednisolone for patients with UC and CD during the first induction course was established, equal to 0.70 mg/kg, which can be recommended for use in clinical practice for calculating individual doses.https://www.gastro-j.ru/jour/article/view/747ulcerative colitiscrohn's diseaseprednisoloneefficiency functiondose calculation
spellingShingle O. P. Alekseeva
S. V. Krishtopenko
A. A. Alekseeva
Evaluation of the Clinical Efficacy of Prednisolone in the Treatment of Inflammatory Bowel Diseases with Different Dosage Methods
Российский журнал гастроэнтерологии, гепатологии, колопроктологии
ulcerative colitis
crohn's disease
prednisolone
efficiency function
dose calculation
title Evaluation of the Clinical Efficacy of Prednisolone in the Treatment of Inflammatory Bowel Diseases with Different Dosage Methods
title_full Evaluation of the Clinical Efficacy of Prednisolone in the Treatment of Inflammatory Bowel Diseases with Different Dosage Methods
title_fullStr Evaluation of the Clinical Efficacy of Prednisolone in the Treatment of Inflammatory Bowel Diseases with Different Dosage Methods
title_full_unstemmed Evaluation of the Clinical Efficacy of Prednisolone in the Treatment of Inflammatory Bowel Diseases with Different Dosage Methods
title_short Evaluation of the Clinical Efficacy of Prednisolone in the Treatment of Inflammatory Bowel Diseases with Different Dosage Methods
title_sort evaluation of the clinical efficacy of prednisolone in the treatment of inflammatory bowel diseases with different dosage methods
topic ulcerative colitis
crohn's disease
prednisolone
efficiency function
dose calculation
url https://www.gastro-j.ru/jour/article/view/747
work_keys_str_mv AT opalekseeva evaluationoftheclinicalefficacyofprednisoloneinthetreatmentofinflammatoryboweldiseaseswithdifferentdosagemethods
AT svkrishtopenko evaluationoftheclinicalefficacyofprednisoloneinthetreatmentofinflammatoryboweldiseaseswithdifferentdosagemethods
AT aaalekseeva evaluationoftheclinicalefficacyofprednisoloneinthetreatmentofinflammatoryboweldiseaseswithdifferentdosagemethods