We carried out a double-blind comparative study on cefetamet pivoxil (CEMT-PI) to evaluate its clinical efficacy and safety in the treatment of bacterial pneumonia, using cefixime (CFIX) as the ...active reference drug. Either CEMT-PI at the dose of 1, 000 mg/day or CFIX at the dose of 400 mg/day was given orally in two divided doses for 14 days in principle. The results obtained were as follows. (1) The efficacy rates were 88.9 %(56/63) in the CEMT-PI group and 91.5 %(54/59) in the CFIX group as judged by the committee, and 88.9 %(56/63) in the CEMT-PI group, 84.7 %(50/59) in the CFIX group as judged by the doctor in charge. No significant differences were observed in efficacy rates between the two treatment groups. (2) The rates of eradication of the causative organisms were 86.4%(19/22) in the CEMT-PI group and 91.7 %(22/24) in the CFIX group as judged by the committee, with no significant difference between the two treatment groups. (3) The incidence of side effects was 2.5%(2/79) in the CEMT-PI group and 5.3 (4/76) in the CFIX group and that of abnormal laboratory findings was 25.0 %(19/76) in the CEMT-PI group and 15.3%(11/72) in the CFIX group as judged by the committee. No significant differences were observed in the incidences of side effects and of abnormal laboratory findings. From the results we conclude that CEMT-PI is highly effective and useful in the treatment of bacterial pneumonia and is equivalent to CFIX.
The efficacy, safety, and usefulness of Cefuzonam (CZON) was objectively evaluated as a treatment of suppurative otitis media (acute infections and acute exacerbation of chronic infections), using ...Cefotiam (CTM) as a comparison drug. The dosages used were 1g, IV, bid for 7 days, as a rule. Results were: 1. A clinical efficacy rate was 68.7% (68/99) for CZON and 62.4% (58/93) for CTM as judged by the physicians in charge. The rate was 66.7% (66/99) for CZON and 63.4% (59/93) for CTM when assessed by committee. Neither of these reflects a significant difference between the two groups. When assessed by disease type, the efficacy rate for the CTM group was higher in acute otitis media and that for the CZON group was higher in chronic otitis media, but there was no significant difference. 2. No significant difference in subjective and objective findings was observed on days 3 or 7.3. Bacteriological effect was not significantly different. In total cases, bacterial eradication (excluding bacterial replacement) was noted in 64.0% (55/86) of the CZON group and 58.8% (47/80) of the CTM group. CZON was noted to be significantly superior to CTM in the MIC against S. aureus and all strains isolated prior to drug administration. 4. There was nosignificant difference between the groups in overall safety. Side effects were noted in one patient from each group. Abnormal laboratory values were noted in 4 cases (6.2%) of the CZON group and 2 cases (3.6%) of the CTM group. The difference is not significant. 5. The rate of usefulness was 65.7% (65/99) for the CZON group and 64.5% (60/93) for the CTM group, with no significant difference between the groups. From these results, we conclude that CZON is highly useful for the treatment of suppurative otitis media.
Cefotiam hexetil (CTM-HE) was evaluated for its efficacy, safety and usefulness in acute tonsillitis, in a double blind manner using cefaclor (CCL) as a control drug. The drug was orally administered ...after each meal, as a rule, for consecutive 7 days (CTM-HE: 200mg×3/day, CCL: 250mg×3/day). Out of the 231 patients recruited in this trial, 192 (99 on CTM-HE and 93 on CCL) were adopted by the committee for the evaluation of therapeutic efficacy. 1. The clinical responses judged by the attending physicians were positive in 91.9% of the patients on CTM-HE and 88.2% of the patients on CCL (commitee's judgement: 88.9% on CTM-HE, 86.0% on CCL). 2. The bacteriological responses were assessed as “eradicated” in 95.7% of the patients on CTM-HE and 97.6% of the patients on CCL. 3. Adverse events, mainly mild or moderate gastrointestinal tract symptoms, were observed in 7.5% (8/107) of the patients on CTM-HE, and in 4.0% (4/100) of the patients on CCL. No abnormal alterations of laboratory findings were noted in any groups. 4. The usefulness was rated as “very useful” and “fairly useful” in 91.0% of the patients on CTM-HE and 91.4% of the patients on CCL. 5. There was no statistically significant difference between the two treatment groups in any evaluation described above. The above results suggest that CTM-HE is a useful drug for the treatment of acute tonsillitis at the daily dosage of 600mg (t. i. d.).
Cefotiam hexetil (CTM-HE) was evaluated for its efficacy, safety and usefulness in suppurative otitis media, in a double blind manner using cefaclor (CCL) as a control drug. The drug was orally ...administered after each meal, as a rule, for 7 consecutive days (CTM-HE: 200mg×3/day, CCL: 250mg×3/day). Of the 240 patients recruited in this trial, 224 (111 on CTM-HE and 113 on CCL) were adopted by the committee for the evaluation of therapeutic efficacy. 1. The clinical responses were positive in 61.3% of all patients with suppurative otitis media on CTM-HE treatment and 60.2% of those on CCL as judged by the attending physicians (committee's judgement: 55.9% on CTM-HE, 63.7% on CCL). 2. The bacteriological responses in all patients with suppurative otitis media were judged as “eradicated” and “replaced” in 64.4% on CTM-HE and 69.7% on CCL. 3. The adverse reactions reported were mainly mild gastrointestinal symptoms and occurred in 5.1% of patients (6/117) on CTM-HE treatment and in 1.8% (2/114) on CCL treatment. Abnormal alterations of laboratory findings were not recognized in any treatment groups. 4. Usefulness evaluation showed that the drug was “very useful” or “fairly useful” in 60.7% of all patients with suppurative otitis media on CTM-HE and 63.7% of those on CCL. 5. There was no statistically significant difference between the two treatment groups in any evaluation described above. The above results indicate that the daily dosage of 600mg of CTM-HE has a usefulness comparable to the daily dosage of 750mg of CCL for the treatment of suppurative otitis media.
In order to compare the clinical efficacy, safety and utility of T-2588 with Cefaclor (CCL) in acute lacunar tonsillitis, a double blind trial was carried out with a daily dosage of 100mg×3 of T-2588 ...or 250mg×3 of CCL. The number of cases evaluated for clinical efficacy were 169 (80 treated with T-2588 and 89 treated with CCL). The effectiveness rating of T-2588 and CCL were 93.8% and 87.6% respectively, as judged by a committee; and 91.3% and 91.0% as judged by the attending physician. Bacteriological effects were satisfactory, yielding eradication rates of 97.0% with T-2588 and 97.4% with CCL. The number of cases evaluated for safety were 181 (88 treated with T-2588 and 93 treated with CCL). The incidence of side effect was 5.7% (5/88) with T-2588 and 1.1% (1/93) with CCL. The most common side effect was mild gastro-intestinal disorders. The number of cases evaluated for utility were 169 (80 treated with T-2588 and 89 treated with CCL). The usefulness rates were 93.7% with T-2588 and 92.1% with CCL. There was no significant difference between T-2588 and CCL in clinical effect, bacteriological effect, safety and utility. From these results, a daily 300mg dosage of T-2588 was as useful as a daily 750mg dosage of CCL in the treatment of acute lacunar tonsillitis.
