1. The therapeutic efficacies of sulfamethoxazole (SMX) -trimethoprim (TMP) combination product and SMX alone were compared in acute uncomplicated cystitis by a double-blind technic.
2. The clinical material of this study consisted of a total of 257 patients, of which 215 patients were evaluated (97 patients for SMX-TMP combination product and 118 patients for SMX alone).
3. No significant difference was found between the clinical backgrounds of 2 treatment groups before the commencement of drug therapy.
4. The most frequently isolated bacterial strain was
E. coli. The MIC distribution of the 87 strains of E. coli isolated from the urine cultures found its peak at O. 19 mcg/ml of TMP, whereas the majority of isolates had MICs of SMX greater than 100 mcg/ml. The potentiation of antimicrobial activities by combination of 2 drugs as assessed by the checkerboard method was demonstrated in 76 of 87 strains tested (87%).
5. The improvement of subjective symptoms assessed on the 4 th day of treatment indicated an improvement rate of 90.4% for SMX-TMP combination product and 78. 6 % for SMX alone (p<0. 05).
6. The changes of urinary findings in patients treated with SMX-TMP combination preparation as examined on the 4 th day of treatment gave improvement of pyuria in 87%, that of bacteriuria in 88. 2%, The normalization of pyuria was recorded in 69. 4% and that of bacteriuria in 80%, respectively. In contrast, the results of SMX therapy in 105 patients gave improvement of pyuria in 82% and that of bacteriuria in 76%. The normalization of pyuria was recorded in 66% and that of bacteriuria in 65%, respectively. There was a statistically significant difference between SMX-TMP combination product and SMX alone in normalizing bacteriuria (p<0. 05).
7. The evaluation of the clinical efficacy of drug therapy in acute uncomplicated cystitis was based on changes of the urinalysis findings. The SMX-TMP therapy gave an effective rate of 77%, whereas SMX-treated group gave an effective rate of 69%.
8. Subjective symptoms and urinalysis findings were re-assessed on the 8 th, that is, 4 days after the cessation of the drug therapy. The therapy of SMX-TMP combination product gave more favorable results than that of SMX alone with regard to subjective symptoms and the rate of aggravation by objective criteria.
9. The clinical results of patients treated by SMX alone were correlated with MISs of SMX of the urinary isolates.
10. Of 209 patients subjected to the analysis, there were 5 cases of untoward reactions, all belonging to the SMX-treated group. The major complaints were gastrointestinal troubles which were generally slight without necessitating withdrawal of the drug.
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