Primerjava računalniških programov za terapevtsko spremljanje plazemskih koncentracij zdravilnih učinkovin

Marko, Andreja (author), Kerec - Kos, Mojca (mentor), Drofenik, Polonca (comentor)

Terapevtsko spremljanje koncentracij (TDM) omogoča optimizacijo individualnega odmerjanja zdravilnih učinkovin (ZU) z ozkim terapevtskim oknom in z veliko inter- ter intraindividualno variabilnostjo farmakokinetičnih parametrov. Pomembno je, da obstaja dobra povezava med koncentracijo ZU v krvi in njenim farmakološkim učinkom. Pri vzdrževanju terapevtskih koncentracij ZU so lahko v veliko pomoč farmakokinetični programi, ki zdravstvenemu osebju pomagajo določiti optimalen režim odmerjanje ZU. Z retrospektivno raziskavo smo v Centralni lekarni Univerzitetnega kliničnega centra Maribor ovrednotili klinično uporabnost sedmih farmakokinetičnih računalniških programov (Kinetidex®, DoseMe®, ClinCalc.com Vancomycin Calculator®, GlobalRPh®, PrecisePK®, MwPharm++® in JPKD®), namenjenih TDM. Primerjali smo splošne karakteristike programov ter vrednotili napovedane nadaljnje dnevne odmerke in serumsko koncentracijo ZU v času naslednje meritve s pomočjo anonimiziranih podatkov 50 bolnikov različnih starostnih skupin (nedonošenčki, otroci, mlajši odrasli in starejši odrasli), ki so že zaključili zdravljenje z gentamicinom ali vankomicinom in jim je bil v času zdravljenja izveden TDM. Primerjava lastnosti programov je pokazala, da so zahtevnejši programi boljši, saj jih lahko uporablja sočasno več uporabnikov, omogočajo shranjevanje podatkov o bolnikih in zgodovini zdravljenja, vključujejo modele za več ZU in za različne populacije bolnikov, omogočajo grafične prikaze in izpise poročil, vendar so ti programi dražji. Največ možnosti za nastavitve, vstavljanje podatkov in primerjanje rezultatov ima MwPharm++®, vendar je delo z njim zelo zapleteno. Za rutinsko delo sta se najbolje izkazala programa DoseMe® in Kinetidex®, ki po naši oceni ustvarita tudi najboljše poročilo. S primerjavo napovedi dnevnih odmerkov smo ugotovili, da sta PrecisePK® in JPKD® v povprečju najbolj odstopala od ostalih programov, ki so napovedovali v približno podobnem razponu odstopanj. Generalno najuspešnejši v ujemanju napovedi koncentracij z izmerjenimi serumskimi koncentracijami ZU je bil DoseMe®. Programi so v povprečju najboljše napovedi serumskih koncentracij prikazali na populaciji mlajših odraslih bolnikov, najslabše pa na populaciji otrok. Primerjava lastnosti in preverjanja točnosti napovedovanja uporabljenih farmakokinetičnih programov je pokazala, da nobeden od njih ne izpolnjuje vseh zahtev za idealno orodje. Vendar lahko zaključimo, da se je v skoraj vseh kategorijah vrednotenja, najbolje izkazal najnovejši od uporabljenih programov – DoseMe®.

• Language: Slovenian
• Keywords: terapevtsko spremljanje koncentracij, farmakokinetični programi, vrednotenje lastnosti programov, vrednotenje napovedi programov, gentamicin, vankomicin
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2019
• PID: 20.500.12556/RUL-108319
• Publication date in RUL: 28.06.2019

Secondary language

• Language: English
• Title: Comparison of software used for therapeutic drug monitoring

Abstract

Therapeutic drug monitoring (TDM) enables the optimization of individual dosing of drugs with a narrow therapeutic window and with a high inter- and intraindividual variability of pharmacokinetic parameters. The existence of a good connection between the concentration of the drug in the blood and its pharmacological effect is essential. In maintaining the therapeutic concentrations of drugs, pharmacokinetic software can be highly useful, helping the healthcare personnel to determine the optimum regimen for the dosing of drugs. In the Central Pharmacy of the University Medical Centre Maribor, by means of a retrospective research, we evaluated the clinical applicability of seven pharmacokinetic software (Kinetidex®, DoseMe®, ClinCalc.com Vancomycin Calculator®, GlobalRPh®, PrecisePK®, MwPharm++® in JPKD®) intended for TDM. We compared the general properties of the software and evaluated the predicted maintenance daily doses and the serum concentration of the drugs at the time of the next measurement, using anonymised data of 50 patients from different age groups (premature infants, children, younger adults, older adults) who had already completed the treatment with gentamicin or vancomycin and had undergone TDM during their treatment. The comparison of the properties of the pharmacokinetic software has shown that more demanding software are better, since they can be used simultaneously by several users, they include models for multiple drugs and for different patient populations, enable graphical displays and printouts of the reports, but are more expensive. MwPharm++® has the most options for settings, entering the data and comparing the results, but working with it its highly complex. DoseMe® and Kinetidex® have proved to be the best for routine work, which, according to our assessment, also create the best reports. By comparing the daily dose predictions, we determined that PrecisePK® and JPKD® on average deviated the most from the other software, which predicted in a similar range of deviations. Overall, the most successful in matching the predictions of the concentrations with the measured serum concentrations of the drugs was DoseMe®. On average, the software showed the best predictions of serum concentrations in the population of young adult patients and the worst in the population of children. A comparison of the features and verification of the accuracy of the predictions made by the seven selected pharmacokinetic software has shown that none of them meets all the requirements for an ideal tool. However, we can conclude that, in almost all the categories of evaluation, the newest of the software used – DoseMe® has proven to be the best.

• Keywords: therapeutic drug monitoring, pharmacokinetic software, evaluating the properties of the software, evaluating the predictions made by the software, gentamicin, vancomycin