Double-blind comparative clinical study of cefpiramide (SM-1652) and cefsulodin on complicated urinary tract infections due to P. aeruginosa

P. aeruginosaによる複雑性尿路感染症に対するCPMの治療効果と副作用を評価する目的で, CPM 2g/日とCFS 2g/日の二重盲検法による比較試験をおこなった.総投与例数は274例で, うち効果を判定し得たのはCPM群136例, CFS群118例であった.1) P. aeruginosaを含む感染症では, CPMあるいはCFSを1日2g, 5日間投与時の効果では, 前者の有効率が有意に高かった.2) P. aeruginosaのみを対象にした場合も同様であった.3) P. aeruginosaを含む感染で細菌尿の陰性化率はCPM群はCFS群より有意に高かった.4)交代菌の出現は, CFS群でS. faecalisの出現率が有意に高く, 全体的にもCFS群の投与後の細菌出現率が有意に高かった, 5)薬剤投与開始前の分離菌のMICでは, CPM群の方がCFS群よりもMICの低いものが多かった.6)副作用発現率, 臨床検査値の異常化は両群間に差はなかったThe therapeutic efficacy and safety of Cefpiramide (CPM, SM-1652) at a 2 g/day dose were objectively compared with those of Cefsulodin (CFS) at a 2 g/day dose in patients with chronic complicated urinary tract infections (UTI) by P. aeruginosa in a double-blind study at 46 institutions in Japan. The results are as follows: The therapeutic efficacy was analyzed in 254 patients (136 cases administered CPM and 118 cases administered CFS) after excluding 20 cases as drop-out. Among 254 cases, the number of patients with infection of P. aeruginosa was 190 cases (100 cases administered CPM and 90 cases administered CFS), while that with infection of organisms other than P. aeruginosa was 64 cases (36 cases administered CPM and 28 cases administered CFS). By the administration of a 2 g/day dose for 5 days, the overall clinical effective rate of CPM was significantly higher than that of CFS in total patients. When the patients were classified into 2 groups with respect to causative organisms (P. aeruginosa and others), the clinical effective rate of CPM in patients with infections of P. aeruginosa was significantly higher than that of CFS, while the clinical effective rate of CPM in patients with infection of other organisms than P. aeruginosa was the same as that of CFS. As to the bacteriological effect on bacteriuria, the eradication rate of CPM was significantly higher than that of CFS not only against all causative organisms but also against P. aeruginosa. The rate of replacement by S. faecalis was significantly higher in the CFS-treated group than in the CPM-treated group. The same result was obtained on the rate of replacement by other organisms. The MIC values of CPM for isolated organisms before drug administration were lower than those of CFS. The incidence rates of side effects and the abnormal findings of clinical laboratory tests were the same for the CPM- and CFS-treated groups. From the results, it was concluded that CPM is a useful drug for the treatment of patients with chronic complicated urinary tract infections caused by P. aeruginosa