Romanian Society of Pharmaceutical Sciences
 

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THE ROLE OF α1-BLOCKERS IN THE MEDICAL EXPULSIVE THERAPY FOR URETERAL CALCULI – A PROSPECTIVE CONTROLLED RANDOMIZED STUDY COMPARING TAMSULOSIN AND SILODOSIN

DRAGOŞ GEORGESCU1, FLORENTINA IONIŢĂ-RADU2*, RĂZVAN MULŢESCU1, MIHAI DRAGUŢESCU1, BOGDAN GEAVLETE1, PETRIŞOR GEAVLETE1, CAROLINA NEGREI3, DAN MISCHIANU4, MARA GEORGESCU5, OCTAV GINGHINA6

1.”Sf. Ioan” Hospital, Department of Urology, “Carol Davila” University of Medicine and Pharmacy, Faculty of Medicine, 13, Vitan-Barzesti Street, 042122, Bucharest, Romania
2.Central Universitary Emergency Military Hospital, “Carol Davila’’- Department of Gastroenterology
3.Department of Toxicology, “Carol Davila” University of Medicine and Pharmacy, Faculty of Pharmacy, 6, Traian Vuia Street, 020956, Bucharest, Romania
4.Universitary Emergency Central Military Hospital Bucharest, Department of Urology, “Carol Davila” University of Medicine and Pharmacy, Faculty of Medicine, 134, Calea Plevnei Street, 010825, Bucharest, Romania
5.University of Agronomic Sciences and Veterinary Medicine of Bucharest, 59 Mărăşti Blvd, 011464, Veterinary Medicine Faculty of Bucharest, Bucharest, Romania
6.”Sf. Ioan” Hospital, Department of Oncological Surgery, “Carol Davila” University of Medicine and Pharmacy, Faculty of Dental Medicine, 13, Vitan-Barzesti Street, 042122, Bucharest, Romania

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In patients with newly diagnosed ureteral stones under 10 mm, observation is an optional initial treatment. The aim of this prospective trial was to evaluate the efficacy of tamsulosin and silodosin associated with anti-inflammatory drugs by comparison with anti-inflammatory therapy alone in the medical expulsive treatment of uncomplicated ureteral stones. A total of 150 patients over 18 years with unilateral, uncomplicated ureteral stones under 1cm were enrolled in a randomized prospective trial. Subjects in Group I were given tamsulosin 0.4 mg once daily and diclofenac sodium 50 mg/12 h, those in Group II were given silodosin 8 mg once daily and diclofenac sodium 50 mg/12 h and patients of third group of study only received the anti-inflammatory medication. In all three groups, drug administration was continued until the patients were rendered stone-free by intervention or spontaneous stone expulsion, or for a maximum of 4 weeks. Stone expulsion rate was 76% in Group I, in 82% in Group II and 54% in Group III. The statistical analysis demonstrates significant higher expulsion rate in both study groups by comparison to control group. The difference between the expulsion rates of cases from the tamsulosin and silodosin groups did not reach statistical significance. The use of tamsulosin and silodosin in medical expulsive treatment of ureteral stones proved to be safe and effective. The efficacy of both drugs seems to be similar.