二重盲検法によるTSAA-291の前立腺肥大症に対する臨床効果の検討

Abstract

In order to evaluate the clinical effects of TSAA-291 in patients diagnosed as benign prostatic hyperplasia, a double blind controlled study was carried out incorporating the departments of urology at 53 hospitals. Four hundred mg (H: high dose group) or 40 mg (L: low dose group, control) of TSAA-291 was injected intramuscularly once a week for 12 weeks to 312 patients in addition to daily dose of 6 capsules of Paraprost. For the last 4 weeks, between 12th and 16th week, Paraprost only was administered. 1) The therapeutic effects were investigated in 236 patients (H: 123, L: 113), 76 being deleted for various reasons. There was no bias in the background features of the two groups. 2) Global improvement rates, evaluated by scoring dysuria, sensation of urinary retention, nycturia, residual urine volume, palpation and urethrocystogram, demonstrated that H was significantly superior to L (p<0.05-0.01). 3) General improvement rates evaluated by the attended doctors, demonstrated H to be superior to L (rank sum test, p<0.10), with marked improvement in 12 patients (11.4%) ofH but none in L. 4) Concerning dysuria, H was superior to L, especially, the difference between the two groups in "protracted urination" and that in "force of urinary stream" were pronounced (p<0.05, p<0.01). 5) The rate of patients whose residual urine volume decreased remarkably was significantly higher in H than in Lfrom4th to 16th week (p<0.05). On palpation predominance of H gradually became clear but the difference between the two groups was not significant. 6) Improvement on urethrocystograms were evaluated by 4 judges. H was generally superior to L (rank sum test, p<0.10) and the rate of improvement of H (36.0%) was higher than that of L (21.8%). 7) Analysis by stratification (age, duration of illness, severity at initiation of medication) revealed no particular trend in global evaluations. 8) Side effects were found in 17 patients of H (11.3%) and 7 patients of L(4.6%) and the frequency was higher in H (p<0.10), but they were mostly related to the symptoms at the injection site, such as pain. These symptoms disappeared during medication or within a week after the final administration. None of severe side effects were found. 9) Red blood cells, hemoglobin and hematocrit decreased slightly but these changes were judged reversible since they returned to the previous levels 5 weeks after the final administrations. 10) Blood pressure in 124 patients, ECG in 50 patients and hormones in blood, LH, FSH, cortisol and testosterone in 26 patients, were analyzed. No significant changes were observed and there were no differences between the two groups. 11) On the basis of these results, it is advocated that TSAA-291 could be a useful tool in nonsurgical treatment of benign prostatic hyperplasia.