We compared the efficacy and safety of cefdinir (CFDN), a new oral cephem, in bacterial pneumonia at two doses by the double- blind comparative method to determine the optimal dosage for respiratory ...tract infections. Patients with mild or moderate bacterial pneumonia were aged 15 to 70 years, of both sexes, and patients with either pulmonary tuberculosis or chronic airway infection were excluded. Patients given test drug in doses of 100 mg t.i.d.(L-group) or 200 mg t.i.d.(H-group) for 14 days as a rule were evaluated for clinical and bacteriological effects, safety and usefulness. Out of the 87 patients (42 at 100 mg t. i. d., 45 at 200 mg t. i. d.), 69 were evaluated for clinical efficacy and usefulness, 81 for safety and 75 for laboratory evaluation. A comparative evaluation of clinical efficacy and usefulness was performed mainly by the committee in patients with bacterial pneumonia and in all patients, including those with mycoplasmal pneumonia, primary atypical pneumonia, and psittacosis. The results were as follows. 1. There was no significant difference between the two groups in characteristics except the distribution of ESR values, which was higher in the H- group in the bacterial pneumonia group. 2. The overall clinical efficacy rate assessed by the committee in patients with bacterial pneumonia was 93.1%(27/29) in the L-group and 82.4%(28/34) in the H-group. There was no significant difference between the two groups. The clinical efficacy rate in all patients was 93.8%(30/32) in the L-group and 78.4%(29/37) in the H- group. There was a significant difference between the two groups. 3. The bacteriological eradication rate was 71.4%(5/7) in the L-group and 78.6%(11/14) in the H- group. There was no significant difference between the two groups. 4. The incidence of side effects was 2.6%(1/39) in the L-group and 4.8%(2/42) in the H-group. The incidence of abnormal laboratory findings was 22.9%(8/35) in the L-group and 22.5%(9/40) in the H-group. There was no significant difference between the two groups. Considering side effects and laboratory findings, the safety rate was 76.9% in the L- group and 76.2% in the H- group. There was no significant difference between the two groups. 5. In usefulness evaluation under consideration of clinical efficacy combined with safety evaluation, there was no significant difference between the two groups. As described above, there was no difference in safety evaluation between the two groups, and efficacy rate was high even in the L-group. From these results, it is concluded that CFDN 100 mg t. i. d. is very useful in the treatment of bacterial pneumonia.
Using a double-blind controlled trial, we compared the clinical efficacy, safety and usefulness of cefotiam hexetil (CTM-HE) with those of cefaclor (CCL) in patients with bacterial pneumonia. ...Patients with obvious clinical signs and symptoms were given orally CTM-HE (at a daily dose of 600 mg) or CCL (at a daily dose of 1, 500 mg) for 14 days as a rule.We then assessed clinical and bacteriological efficacy, improvement in signs and symptoms, side effects, changes in laboratory findings and clinical usefulness.The results were as follows: 1) The clinical efficacy rate (excellent and good) was: in the committee's evaluation, 79.0%(64/81) for CTM-HE versus 83.3%(65/78) for CCL, and in the attending physician's evaluation, 77.0%(77/100) for CTM-HE versus 78.9%(75/95) for CCL.Thus, both evaluations generated similar results. 2) As to bacteriological effect, the eradication rate was 76.5%(26/34) for CTM-HE versus 83.9%(26/31) for CCL. 3) The safety evaluation showed that the two drugs were almost equivalent with regard to the incidence of side effects: 2.0%(2/102) for CTM-HE versus 3.0%(3/99) for CCL, and abnormal laboratory findings: 24.2%(23/95) for CTM-HE versus 18.7%(17/91) for CCL. With both drugs, gastrointestinal disorders and fever were found as accompanying symptoms, and most of the abnormal laboratory findings were eosinophilia and changes in liver function.No side effects were found particularly different from those reported with cephems.
A multi-center double-blind three-group comparison study of sulbactam·ampicillin (SBT·ABPC) vs. ampicillin (ABPC) was performed to evaluate their efficacy, safety and usefulness in the treament of ...patients with respiratory tract infections. The clinical efficacy rated by Investigators' Judgment Committee was compared among three dosage groups of 3 g SBT·ABPC, 6g SBT·ABPC and 4g ABPC. In the patients with pulmonary parenchymal infections, the efficacy rate was 82.5%, 92.1% and 94.6%, respectively. In chronic respiratory tract infections, that rate was 86.7%, 81.6% and 82.1%, respectively. All of these three groups showed excellent efficacy rates, and there were no significant differences among them. The bacterial eradication rate was 93.2%, 83.7%and85.4%, respectively, suggesting that there were no significant differences in the bacteriological efficacy among the three dosage groups. The MICs, determined at a central laboratory, indicated that almost all the strains were sensitive to SBT·ABPC and many to ABPC alone. The MICs of ABPC were 25 μg/ml and above against 13 strains, whereas those of SBT·ABPC were 2-to 5-fold lower. All dosagegroups exhibitedhigh usefulness rates with a low incidence of side effects and parameter abnormalities in laboratory tests, suggesting no significant differences in safety and usefulness. The results obtained in this study indicate that SBT· ABPC is useful in the treatment of patients with respiratory tract infections.
