Abstract
Using the double-blind method, we evaluated the efficacy, safety and usefulness of cefotiam hexetil (CTM-HE) for the treatment of chronic respiratory tract infections using cefaclor (CCL) as control drug. The results obtained were as follows: Patients were given orally, in 3 divided doses, CTM-HE in a daily dose of 1200mg (as cefotiam) or CCL in a daily dose of 1500 mg for 14 consecutive days as a rule. 1) Clinical response was judged by the committee as good and excellent in 67. 3%(76/113) of thepatients on CTM-HE treatment and 65.2%(73/112) of those on CCL treatment, and by the attending physicians in 67.0%(75/112) of those on CTM-HE and 59. 8%(67/112) of those on CCL. 2) Bacteriological response by causative organisms was judged as eradicated in 64.0%(48/75) in the CTM-HE treatment group and 55.8%(43/77) in the CCL treatment group. 3) As for the safety evaluation, adverse reactions were reported in 7.6%(9/119) of the patients on CTM-HE and 8.8%(11/125) of those on CCL. Abnormal alterations of laboratory findings occured in 21.4%(24/112) of the patients on CTM-HE and 13.3%(15/113) of those on CCL. Major adverse reactions to both treatments included gastrointestinal disorders such as diarrhea. Most of the abnormal laboratory findings were increase in eosinophils and in serum transaminases, which did not particularly differ from those observed with conventionally available cephem antibiotics. 4) As to utility, the drug was judged as fairly useful and better by the committee in 66.4%(75/113) of the patients on CTM-HE and 62.6%(72/115) of those on CCL, and by the attending physicians in 65.2%(73/112) of those on CTM-HE and 59.1%(68/115) of those on CCL. The above results indicate that the daily dose of 1200 mg of CTM-HE is comparable to 1500 mg of CCL in efficacy and safety, and we conclude that CTM-HE is useful for the treatment of chronic respiratory tract infections.
Original language | English |
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Pages (from-to) | 455-481 |
Number of pages | 27 |
Journal | Chemotherapy |
Volume | 37 |
Issue number | 4 |
DOIs | |
Publication status | Published - 1989 |
ASJC Scopus subject areas
- Pharmacology (medical)
- Infectious Diseases
- Pharmacology
- Drug Discovery
- Oncology