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

Multi-center trial on the early effects of silodosin on lower urinary tract symptoms associated with benign prostatic hyperplasia

Silodosin (URIEF), a new so-called 3rd generation alpha-1 blocker, is widely expected to be effective and useful for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), due to its high specificity to alpha-1A receptor. We evaluated the efficacy of Silodosin, on 187 males 50 years old or over with the diagnosis of BPH. Silodosin significantly improved the International Prostate Symptom Score (IPSS) and quality of life (QOL) score from the day after administration was started. Among 166 patients whose data were available for the analysis of efficacy of Silodosin, 77.5% showed apparent subjective improvement. Eighty three patients, who had been taking another alpha-1 blocker but without satisfactory effects, showed almost the same improvements in IPSS and QOL score after switching to Silodosin as the remaining 83 patients who had no preceding treatment with an alpha-1 blocker. The improvements were not only in voiding symptoms but also in storage symptoms. The patients, who had serious storage symptoms, responded rather well to Silodosin and showed significant improvement. Taken together, Silodosin showed a quick effect for improving subjective symptoms and QOL, and was found to be useful for the management of LUTS with BPH.2006年11月～2007年10月の前立腺肥大症166例(年齢69.9±6.4歳)を対象にシロドシン服用後超早期での有効性を検討した。シロドシン8mg/日を2週間処方し、排尿症状日誌に国際前立腺症状スコア(IPSS)、QOLスコア、BPH impact indexを記入してもらい、効果判定を行った。その結果、IPSSは服用開始後1、2、3日目と低下し、いずれの観察日も開始時と有意差を認め、14日目は更に低下した。QOLスコアも同様に有意な低下を示し、IPSSとQOLスコアの相関関係を認めた。また、α1遮断薬から切り替えた患者とα1遮断薬を初めて服用した患者との比較では、両群とも服用後1日目からIPSSは有意に低下して14日目まで低下し続け、2群間に有意差は認めなかった。14日目の治療判定ではExcellent 25例、Well 99例、Poor 36例であり、Poor例はいずれの観察日もIPSSの低下を認めなかった。IPSSのサブスコアの排尿、蓄尿症状の変化量は服用後1日目より有意に改善し、蓄尿症状重症例においても同様に1日目より有意に改善効果を認めた。副作用は187例中23例(12.3%)に認め、下痢が11例5.9%と最も多く、重篤な副作用は認めず、高齢により高くなる傾向は認めなかった。以上よりシロドシンの早期からの効果が判明し、無効な症例では早い時点で適した薬剤・治療法の提供が可能になると考えた