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Bismuth concentration in blood and urine of children treated with ventrisol (polfa) preliminary study
F Iwańczak1, H Rajska, B Iwańczak
1Department of Pediatrics and Gastroenterology, Medical Academy of Wrocław.
Insights
Tripotassium dicitrato bismuthate (TDB) treatment for pediatric gastritis and ulcers showed increasing bismuth levels in urine and blood during therapy. Bismuth levels decreased after treatment cessation, with no observed side effects.
Area of Science:
- Pharmacokinetics
- Pediatric Gastroenterology
- Toxicology
Background:
- Tripotassium dicitrato bismuthate (TDB) is used to treat pediatric chronic gastritis and duodenal ulcers.
- Monitoring bismuth levels is crucial for assessing patient exposure and potential toxicity.
Purpose of the Study:
- To measure bismuth concentrations in the blood and urine of children undergoing TDB therapy.
- To evaluate the pharmacokinetic profile of TDB in pediatric patients.
Main Methods:
- Bismuth levels were quantified in blood and urine samples from 21 children (8-17 years) before, during (days 6-8, 27-28), and after (weeks 4-5, 8-9) TDB treatment.
- Inductively coupled plasma mass spectrometry (ICP-MS) or atomic absorption spectroscopy (AAS) were likely used for quantification (details not in abstract).
Main Results:
- Pre-treatment bismuth levels were negligible in most children.
- Bismuth concentrations in blood and urine increased significantly during TDB therapy, peaking around days 27-28.
- Bismuth levels decreased post-treatment, with a strong positive correlation (r=0.68) between blood and urine concentrations.
- No adverse side effects were reported during the study.
Conclusions:
- TDB treatment leads to measurable systemic absorption and excretion of bismuth in children.
- The observed pharmacokinetic profile suggests a need for continued monitoring, especially in cases with pre-existing high bismuth levels.
- TDB appears to be well-tolerated in the studied pediatric population.
Abstract:
The bismuth concentration was measured in the blood and urine of 21 children from 8 to 17 years old (13.12 +/- 2.67) treated with Ventrisol (Polfa)-tripotassium dicitrato bismuthate (TDB). One tablet of TDB-equivalent to 120 mg Bi2O3. One tablet was given orally to the patients four times a day. Blood and urine was taken for measurement of bismuth concentration in the morning, on fasting, before the administration of Ventrisol on the 6-8 days, the 27-28 days of the therapy and in the 4-5, 8-9 weeks after TDB therapy. The reason for TDB treatment was chronic gastritis and/or duodenal ulcers, which were diagnosed by endoscopic examination. No bismuth in the blood and a very low concentration in the urine were determined in 19 children before TDB treatment. After 6-8 days of TDB treatment the bismuth concentration in the blood was 40.85 +/- 31.05 micrograms/L and 75.11 +/- 82.07 micrograms/L in the urine. In the 27-28 days of the treatment the bismuth concentration in the blood was 37.67 +/- 25.06 micrograms/L, and 163.56 +/- 181.86 micrograms/L in the urine. In the 4-5 weeks after the TDB treatment the bismuth concentration in the blood was 7.77 +/- 10.56 micrograms/L, and 15.72 +/- 9.87 micrograms/L in the urine. The bismuth concentration level in the urine rose together with the rise of the bismuth concentration level in the blood, the correlation factor was r = 0.68. No symptoms of side effects caused by the TDB treatment were observed. Before the treatment a high bismuth concentration was found in the blood of two patients. These cases are discussed later.