化膿性中耳炎 (急性および慢性の急性増悪症) に対するCefotiam hexetilの薬効評価

Cefaclorとの二重盲検比較試験

抄録

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.