Comparative study on sultamicillin and bacampicillin in the treatment of respiratory tract infections]

The clinical effectiveness, safety and usefulness of sultamicillin tosilate (SBTPC) were compared with those of bacampicillin hydrochloride (BAPC) in patients with respiratory tract infections (RTI) by a double-blind study. RTI included in protocol were pneumonia, lung abscess and chronic RTI (chronic bronchitis, diffuse panbronchiolitis and other chronic RTI).SBTPC tablet (375 mg) or BAPC tablet (250 mg) was administered orally for 14 days at daily dose of 3 tablets, one tablet at a time, to assess clinical effectiveness, bacteriological response, side effects, laboratory findings and clinical usefulness.The following results were obtained:1) Number of patients: SBTPC and BAPC were administered to a total of 265 patients (134 on SBTPC and 131 on BAPC). Out of this, 33 patients were excluded or dropped out; clinical effectiveness was analyzed statistically in 232 patients (116 on SBTPC and 116 on BAPC). Side effects were evaluated in 256 patients (129 on SBTPC and 127 on BAPC).2) Clinical effectiveness: Clinical effectiveness rates by the committee judgement was 82.8%(96/116) for SBTPC and 69.8%(81/116) for BAPC, respectively; the statistical analysis revealed that SBTPC was significantly more effective than BAPC. Analysis based on the severity of infections showed that the clinical effectiveness of SBTPC (88.6%) in moderate infections was significantly superior to that of BAPC (65.5%). Furthermore analysis based on diseases showed that the clinical effectiveness of SBTPC (89.2%) in patients with chronic RTI was significantly superior to that of BAPC (63.2%).3) Bacteriological response: The bacteriological elimination rates of causative organisms was 75.4% for 70 strains treated with SBTPC and 65.2% for 72 strainstreated with BAPC, and the difference was not statistically significant.4) Time-course improvement of signs and symptoms and laboratory findings: On the 14th day or the final day of treatment, white blood cells count improved significantly more in the SBTPC group than in the BAPC group.Improvements of white blood cells count on the final day in the pneumonia group, of body temperature on the 14th day and on the final day, of sputum property in the 7th day and on the final day, and of white blood cells count on the final day of treatment in the chronic RTI group were superior in the SBTPC to the BAPC group.5) Side effect: Side effects were observed in 16.3% of 129 patients in the SBTPC group and in 6.3% of 127 patients in the BAPC group. SBTPC produced significantly more side effects than BAPC, but in most cases these side effects were mild and the severity of side effect was not significantly different between the both groups. Incidence of diarrhea observed in the SBTPC group was significantly more than that in the BAPC group, but no severe side effects affecting the prognosis were observed in the both groups. Abnormal laboratory findings, mainly transaminase elevations and eosinophil increase, were not significantly different between the two groups. The severity was mild in all cases except one in the BAPC group who showed a moderate degree of abnormal findings (elevations of GOT, GPT and Al-P).6) Usefulness: Usefulness rates judged by committee members for the SBTPC group and BAPC group were 77.1% and 66.9%, respectively, and these were not significantly different statistically.But rates of usefulness in the chronic RTI group was 83.6% for the SBTPC group and 61.0% for the BAPC group and the difference was significant. Also in the chronic RTI, usefulness rates judged by doctors in charge were 80.6% for the SBTPC group and 62.3% for the BAPC group, and this difference was statistically significant.From the above results it was concluded that usefulness of SBTPC was significantly superior to that of BAPC, being highly useful agent for the treatment of RTI, especially for chronic RTI.