Comparative Clinical Study of DL-8280 and Cefaclor for Suppurative Skin and Soft Tissue Infections by a Double-Blind Method

The effectiveness, safety and utility of DL-8280, a pyridonecarboxylic acid derivative, in the field ofsuppurative skin and soft tissue infections were compared with those of Cefaclor (CCL) by a double-blindmethod. DL-8280 was orally administered in daily dose of 600 mg and CCL was orally administered in dailydose of 750 mg. Each group was treated for 14 days. The results were as follows: 1) Final global improvement rate of DL-8280 was evaluated in 121 patients and out of them “Cured” was marked in 67, “Remarkably improved” in 28, “Moderately improved” in 12, “Slightlyimproved” in 8, “Unchanged” in 2 and “Aggravated” in 4. The percentage of “Cured” and “Remarkably improved” was 78.5%, and increased to 88.4% when “Moderately improved” was included. “Aggravated” and “Remarkably aggravated” shared 3.3%. For the global improvement rate of CCL, “Cured” was noted in 56, “Remarkably improved” in 27, “Moderately improved” in 23, “Slightly improved” in 5, “Unchanged” in 7, “Aggravated” in 1 and “Remarkably aggravated” in 1 out of 120 patients. The percentage of “Cured” and “Remarkably improved”was 69.2%, increased to 88.3% by addition of “Moderately improved”, whereas “Aggravated”and “Remarkably aggravated” rated 1.7%. No significant difference was shown between two drug groups. 2) Side effect was noted in 2.3% of 129 patients treated with DL-8280 and 5.4% of 130 patientstreated with CCL, showing no statistically significant difference between two drug groups. 3) In regard to global utility rate of DL-8280, “Remarkably useful” was noted in 65 cases, “Useful” in 39, “Slightly useful” in 11, “Not useful” in 6 out of 121 patients. “Remarkably useful”shared 53.7% and the total of “Remarkably useful” and “Useful” shared 86.0%.In the CCL group, “Remarkably useful” was noted in 55, “Useful” in 41, “Slightly useful” in 14, “Not useful” in 11, “Harmful” in 1 out of 122 patients. “Remarkably useful” shared 45.1%, and thetotal of “Remarkably useful” and “Useful” shared 78.7%. No significant difference was shown between two drug groups. 4) In regard to global improvement rate by evaluation day, DL-8280 group was significantlysuperior to CCL group on days 3, 10 and 14. Especially in the group 1, DL-8280 group was significantly superior to CCL group throughout thestudy period. Taking together, DL-8280 has tendency to superior to CCL in treatment of suppurative skin and softtissue infections. Because of the result obtained and that no resistant bacteria was observed so far, DL-82