[Comparative studies of DL-8280 and pipemidic acid in complicated urinary tract infections by double-blind method].

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)

RCT Entities:   Population Interventions Outcomes