[Clinical efficacy and reduction effect on prostatic volume of chlormadinone acetate combined with tamsulosin hydrochloride in benign prostatic hyperplasia patients insufficiently treated with tamsulosin hydrochloride only].

Alpha adrenergic blocker has become the first choice in the medical treatment of benign prostatic hyperplasia (BPH). The efficacy of alpha adrenergic blocker has been suggested to be related to the prostatic tissue components, and to be ineffective in treating the clinical symptoms caused by BPH in some cases. The efficacy and prostate reduction of an anti-androgenic agent, chlormadinone acetate, combined with alpha adrenergic blocker, tamsulosin hydrochloride, were evaluated using 40-BPH patients insufficiently treated with tamsulosin hydrochloride alone. Fifty mg of chlormadinone acetate and 0.2 mg of tamsulosin hydrochloride were administered orally once a day for 16 weeks to patients with a prostate subjective symptoms score, I-PSS, of greater than 13 or a peak flow rate of less than 12 ml/s, even after the treatment with 0.2 mg of tamsulosin hydrochloride alone for more than four weeks. Total I-PSS decreased significantly after four weeks. The total irritative symptom score did not change for 16 weeks, but the total obstructive symptom score decreased significantly, as did the total I-PSS. In objective data, the estimated volume of both total prostate and the transition zone on transrectal ultrasonogram decreased significantly at the end of the treatment, and the peak flow rate decreased significantly after 12 weeks. These findings suggest that the addition of chlormadinone acetate may be a reasonable alternative in the treatment of BPH patients responding insufficiently to tamsulosin hydrochloride alone, and that combination therapy using chlormadinone acetate and tamsulosin hydrochloride may be useful for BPH patients with serious obstructive symptoms.

[A double blind clinical trial of the alpha-adrenergic blocker, Ea-0643 tablet, in the treatment of neurogenic bladder].

The clinical effectiveness, safety and usefullness of the alpha-adrenergic blocker, Ea-0643 tablet, for the treatment of the neurogenic bladder were evaluated by the double blind test method. A total of 61 patients was treated. Five of them were excluded or dropped out. Eighteen patients (group-A) received a 1.0 mg tablet of Ea-0643, 20 patients (group-B) received a 0.5 mg tablet of Ea-0643 and 17 patients (group-C) received a placebo tablet. Each tablet was administered orally three times a day for two weeks. There was no significant difference in the background factors between the three groups. The rate of effectiveness for subjective symptoms was 22.2% in group-A, 30.0% in group-B and 35.3% in group-C. There was no significant difference between the three groups. The rate of effectiveness for residual urine, judged by decrease in value of residual urine rate after treatment of less than 25%, was 55.6% in group-A, 35.0% in group-B and 17.6% in group-C. The rate of effectiveness in group-A was significantly higher than that in group-C. The mean value of net decreased residual urine rate after treatment in group-A was significantly higher than that in group-C. Decrease of maximal urethral pressure by more than 5 cm H2O was seen in 44.4% of group-A, 35.0% of group-B and 41.2% of group-C. There was no significant difference between the three groups. The rate of improvement for flow rate was 66.7% in group-A, 46.2% in group-B and 36.4% in group-C.(ABSTRACT TRUNCATED AT 250 WORDS)

[A double blind clinical trial of cefamandole and cefmetazole in complicated urinary tract infections].

We conducted a randomized double blind comparison of cefamandole (CMD) and cefmetazole (CMZ) in the treatment of 193 patients with complicated urinary tract infections. The patients received 1 gram of CMD or CMZ twice a day intravenously by drip infusion over 1 hour for 5 days. Pretreatment urinary leukocyte counts and urinary bacterial counts were at least 5 cells/hpf and 10(4) bacteria/ml, respectively. Each patient was randomly allocated either to CMD or CMZ group. There were 93 patients in CMD group and 100 patients in CMZ group. Clinical efficacy was evaluated based on the effect of treatment on bacteriuria and pyuria according to the criteria set by the UTI Committee, Japan. The response to CMD treatment was excellent in 18 cases (19.4%), moderate in 38 cases (40.9%) and poor in 37 cases (39.8%) with an overall effectiveness of 60.2%, whereas the response to CMZ was excellent in 19 cases (19.0%), moderate in 40 cases (40.0%) and poor in 41 cases (41.0%) with an overall effectiveness of 59.0%. No statistical significant difference was found between 2 treatment groups. Comparison of the bacteriological response between 2 groups showed that the eradication rate for strains of Gram-positive cocci were significantly higher in those patients treated with CMD. Gram-negative rods were eradicated from 68.4% of cases treated with CMD, and 78.0% of those with CMZ, but the difference was not significant. Adverse reactions were observed in 3 patients receiving CMD 1 case each of diarrhea, eruption and epigastric pain. Abnormality in laboratory tests was found in 6 patients in each treatment group. The results indicate that CMD is effective, safe and useful in the treatment of patients with complicated urinary tract infections, and its efficacy, safety and usefulness are comparable with those of CMZ.