The clinical efficacy, safety and usefulness of
DL-8280 for the treatment of complicated
urinary tract infections were compared with those of
pipemidic acid (PPA) by a double-blind method.
DL-8280 and PPA were orally administered at a daily dose of 600 mg (t.i.d.) and 2.0 g (q.i.d.) for 5 days, respectively. Of the 311 patients who received
DL-8280 or PPA, clinical efficacy, safety and usefulness were evaluated in 228 patients (
DL-8280, 115; PPA, 113), 306 patients (
DL-8280, 153; PPA, 153) and 250 patients (
DL-8280, 124; PPA, 126), respectively. There was no significant difference in the background characteristics between the two groups. In the
DL-8280 group the overall clinical efficacy was excellent in 39.1% and moderate in 41.7%, the effectiveness rate being 80.9%, whereas in the PPA group it was excellent in 23.9% and moderate in 33.6%, the effectiveness rate being 57.5%. The efficacy in the
DL-8280 group was significantly higher than that in the PPA group (P less than 0.001). According to classification by the type of
infection, the overall clinical efficacy of
DL-8280 in groups except group 2 (monomicrobial
infection, post
prostatectomy) and group 3 (monomicrobial
infection, upper
urinary tract infection) was superior to that of PPA, the difference being significant.
Pyuria was cleared or improved in 59.1% of the patients treated with
DL-8280 and in 46.0% of the patients with PPA. The difference was not significant.
Bacteriuria was eliminated in 76.5% in the
DL-8280 group and in 50.4% in the PPA group.
DL-8280 demonstrated a significantly higher response than PPA (P less than 0.001). Of the bacteria isolated from the
DL-8280 group and PPA group 89.0% and 72.1%, respectively, were eradicated after the treatment, a significant difference being observed between the two groups (P less than 0.001). The clinical efficacy evaluated by the doctor in charge was excellent in 46.1% and good in 37.4% of the patients treated with
DL-8280 and excellent in 26.5% and good in 34.5% of the patients treated with PPA, the intergroup difference in the efficacy being significant (P less than 0.001). The evaluation of usefulness of
DL-8280 and PPA was "satisfactory" for 71.8% and 47.6%, respectively, the difference being significant (P less than 0.001). Side effects were observed in 11 patients (7.2%) in the
DL-8280 group and in 12 patients (7.8%) in the PPA group, but none were serious.(ABSTRACT TRUNCATED AT 400 WORDS)