[Uroprotection with mesna in the chemotherapy of malignant tumors with oxazaphosphorines. Biometric evaluation of a sequential clinical study].
A multicentre, randomised, clinical study was performed by sequential analysis to quantify the uroprotective efficacy of sodium 2-mercaptoethane sulfonate (mesna, Asta D 7093, Uromitexan) during high-dosed chemotherapy with oxazaphosphorines. Patients were entered as matched pairs serially according to time of admission, trial centre, cytostatic therapy (cyclophosphamide, Endoxan; ifosfamide, Holoxan) and tumor diagnosis, and were given uroprotection at random either with mesna or standard prophylactic measures. The maximum number of erythrocytes in the urine (n/microliter) was chosen as effect variable in a qualitative manner: effective protection delta less than or equal to 15 erythrocytes/microliter urine ineffective protection delta greater than 15 erythrocytes/microliter urine. The scheme of sequential analysis was based on 1. a uroprotective efficacy of 70% of the standard prophylaxis, 2. an assumed efficacy of 95% of mesna treatment and 3. an alpha-error and beta-error of 0.05 and 0.10 respectively. The admission of the twentieth patient completed the eighth matched pair of patients. This pair proved to be the sixth discordant pair with regard to uroprotective efficacy. The significant uroprotective superiority (p less than 0.05) of mesna was proven in view of clear decisions in favour of the test compound.
D006417:Hematuria / Q000139:chemically induced / Q000517:prevention & control; D006801:Humans; D008623:Mercaptoethanol / Q000031:analogs & derivatives*; D015080:Mesna / Q000008:administration & dosage / Q000627:therapeutic use*; D010752:Phosphoramide Mustards / Q000009:adverse effects*; D014570:Urologic Diseases / Q000139:chemically induced / Q000517:prevention & control*
D010752:Phosphoramide Mustards; D008623:Mercaptoethanol; D015080:Mesna
Uroprotektion mit Mesna bei der Chemotherapie maligner Tumoren mit Oxazaphosphorinen. Biometrische Auswertung einer sequentiellen klinischen Prüfung.