急性化膿性中耳炎および慢性化膿性中耳炎急性増悪症に対するAM-715の薬効評価--ABPCとの二重盲検比較試験

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In order to evaluate the clinical efficacy and safety of AM-715 on acute suppurative otitis media (ASOM) and acute exacerbation of chronic otitis media (AECSOM), a double blind trial was carried out comparing with ABPC as the control drug.800mg/day of AM-715 and 2, 000mg/day of ABPC were administered four times a day.Results obtained were as follows:1. Clinical effectiveness(1) The effectiveness rates for the patients with ASOM evaluated by the attending physicians and the evaluation committee were 76.9% and 65.4% in the AM-715 group and 76.7% and 73.3% in the ABPC group.(2) The effectiveness rate for the patients with AECSOM evaluated by the attending physicians and the evaluation committee were 55.2% and 42.9% in the AM-715 group and 41.5% and 34.1% in the ABPC group.(3) In the cases of AECSOM, the AM-715 group was significantly superior to the ABPC group in the single infections and in improvement of swelling of the tympanic cavity mucous membrane.2. Bacteriological effect(1) The bacteriological effect of the AM-715 group was significantly superior to the ABPC group.(2) In the rate of eradication of S. aureus in single and mixed infections, the AM-715 group was significantly superior to the ABPC group.3. Adverse reactionsAdverse reactions were observed in 8 of the 147 cases (5.45%) of the AM-715 group and in 17 of the 151 cases (11.3%) of the ABPC group. The incidenec of adverse reactions for the AM-715 group was less than that for the ABPC group (P<0.10).No abnormal laboratory findings were observed in either of the groups.

急性化膿性中耳炎および慢性化膿性中耳炎急性増悪症に対するAM-715の薬効評価--ABPCとの二重盲検比較試験

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