Remane Yvonne, Stolz Maria Astrid, Heinitz Katrin, Hoffmeister Albrecht, Mehdorn Matthias, Niebisch Stefan, Lincke Kirsten, Huke Annett, Seehofer Daniel, Bertsche Thilo
Pharmacy, Leipzig University Medical Center and Medical Faculty, Leipzig, Germany.
Drug Safety Center, Leipzig University and Leipzig University Medical Center, Bruederstraße 32, 04103, Leipzig, Germany.
Int J Colorectal Dis. 2025 May 10;40(1):113. doi: 10.1007/s00384-025-04907-9.
The pharmacokinetic properties of peroral drugs, e.g. considering dissolution, release and absorption, can be influenced by a shortened transit time after ostomy placement. Its aim was to find unexpected undissolved drugs in stoma bags and establish a correlation with formulations using patient interviews and chart review analysis.
(i) A patient chart review was performed to assess prescribed drugs on the basis of their formulation and potential influence on pharmacokinetics. (ii) Subsequent to the chart review, the patient was interviewed to ascertain (ii.a) the appearance of indigested drugs in the stoma bag, (ii.b) observed changes in drug efficacy and therapy, and (ii.c) information status regarding indigestible and undissolved formulations.
(i) 22.4% (134/598) of the prescribed formulations were assessed as critical concerning their pharmacokinetic release characteristics. (ii.a) A total of 22.0% (11/50) of the interviewed patients indicated that they had experienced this at least once. (ii.b) Of the patients, 14.0% (7/50) observed changes in drug efficacy, and 12% (6/50) experienced changes in their therapy regimens. (ii.c) More than 60% of the patients lacked information that indigestible and undissolved formulations could be found in their stoma bag.
A considerable proportion of formulations investigated caused problems for patients with ostomy. Additional patient education and resources are needed to support ostomy patients by managing drug release-related problems.
口服药物的药代动力学特性,例如考虑溶解、释放和吸收情况,可能会受到造口术后转运时间缩短的影响。其目的是在造口袋中发现意外未溶解的药物,并通过患者访谈和病历回顾分析建立与制剂的相关性。
(i)进行患者病历回顾,根据药物制剂及其对药代动力学的潜在影响来评估所开药物。(ii)在病历回顾之后,对患者进行访谈,以确定(ii.a)造口袋中未消化药物的外观,(ii.b)观察到的药物疗效和治疗变化,以及(ii.c)关于难消化和未溶解制剂的信息状况。
(i)在所开制剂中,22.4%(134/598)因其药代动力学释放特性被评估为关键制剂。(ii.a)总共22.0%(11/50)的受访患者表示他们至少经历过一次这种情况。(ii.b)在患者中,14.0%(7/50)观察到药物疗效变化,12%(6/50)经历了治疗方案的变化。(ii.c)超过60%的患者缺乏关于在其造口袋中可能发现难消化和未溶解制剂的信息。
相当一部分所研究的制剂给造口患者带来了问题。需要额外的患者教育和资源,通过管理与药物释放相关的问题来支持造口患者。