Academic Journal
Patients with Refractory Ascites Treated with alfapump® System have Better Health-related Quality of Life as Compared to those Treated with Large Volume Paracentesis: The Results of a Multicenter Randomized Controlled Study
| العنوان: | Patients with Refractory Ascites Treated with alfapump® System have Better Health-related Quality of Life as Compared to those Treated with Large Volume Paracentesis: The Results of a Multicenter Randomized Controlled Study |
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| المؤلفون: | Stepanova, M, Nader, F, Bureau, C, Adebayo, D, Elkrief, L, Valla, D, Peck-Radosavljevic, M, McCune, A, Vargas, V, Simon-Talero, M, Cordoba, J, Angeli, P, Rossi, S, Macdonald, S, Capel, J, Jalan, R, Younossi, ZM |
| المصدر: | Quality of Life Research , 27 (6) , Article 1573-2649. (2018) |
| سنة النشر: | 2018 |
| المجموعة: | University College London: UCL Discovery |
| مصطلحات موضوعية: | Cirrhosis, decompensation, MELD, alcoholic liver disease |
| الوصف: | Background Refractory ascites (RA) is a complication of cirrhosis which is treated with large volume paracentesis (LVP) as the standard of care. Alfapump® system is a fully implantable pump system which reduces the need for LVP. The aim was to assess health-related quality of life (HRQL) in patients treated with alfapump® versus LVP. Methods The data were collected in a multicenter open-label randomized controlled trial (clinicaltrials.gov #NCT01528410). Subjects with cirrhosis Child–Pugh class B or C accompanied by RA were randomized to receive alfapump® or LVP. The SF-36v2 and CLDQ scores were compared between the two treatment arms at screening and monthly during treatment. Results Of 60 subjects randomized, HRQL data were available for 58 (N = 27 received alfapump® and N = 31 received LVP only). At baseline, no differences were seen between the treatment arms (all p > 0.05): age 61.9 ± 8.4, 79.3% male, MELD scores 11.7 ± 3.3, 85.2% Child–Pugh class B, 70.7% had alcoholic cirrhosis. The mean number of LVP events/subject was lower in alfapump® than LVP (1.1 vs. 8.6, p < 0.001). The HRQL scores showed a moderate improvement from the baseline levels in subjects treated with alfapump® (p < 0.05 for abdominal and activity scores of CLDQ) but not with LVP (all one-sided p > 0.05) in the first 3 months. Multivariate analysis showed that treatment with alfapump® was independently associated with better HRQL at 3 months (total CLDQ score: beta = 0.67 ± 0.33, p = 0.05). Conclusion As compared to LVP, the use of alfapump® system is associated with both a reduction in the number of LVP events and improvement of health-related quality of life. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | text |
| اللغة: | English |
| Relation: | https://discovery.ucl.ac.uk/id/eprint/10043616/1/Jalan_manuscript_RAandHRQL_revisedfull.pdf; https://discovery.ucl.ac.uk/id/eprint/10043616/ |
| الاتاحة: | https://discovery.ucl.ac.uk/id/eprint/10043616/1/Jalan_manuscript_RAandHRQL_revisedfull.pdf https://discovery.ucl.ac.uk/id/eprint/10043616/ |
| Rights: | open |
| رقم الانضمام: | edsbas.4D1D5643 |
| قاعدة البيانات: | BASE |
| الوصف غير متاح. |