Clinical studies on tosufloxacin (TFLX) in urology

横浜市立大学泌尿器科およびその関連施設を加えた13施設で, TFLXを使用して有効性と安全性について検討した.1)女子急性単純性膀胱炎164例の総合有効率は98.78%であった.2)男子急性単純性膀胱炎4例, 急性単純性腎盂腎炎3例, 非淋菌性尿道炎1例, 複雑性尿路感染症7例にも投与して100%の有効率がえられた.3)原因菌の中で, グラム陰性菌は100%の消失率で, グラム陽性菌は90.60%の消失率であった.4)副作用発現は5例にみられ, その発現率は2.42%であったWe clinically evaluated the usefulness of a new oral antimicrobial agent, TFLX, in the field of urology. The dose administered was 150 mg t.i.d and the duration of administration was 3 days. The clinical effect was evaluated according to the criteria of the Japanese UTI committee. The clinical response obtained on 164 female patients with acute simple cystitis was excellent in 118, moderate in 44 and poor in 2 patients. The efficacy rate was 98.78%. The clinical response obtained on 4 male patients with acute simple cystitis was excellent in 2 and moderate in 2 patients. The efficacy rate was 100%. The clinical response obtained on 3 female patients with simple pyelonephritis was excellent in 2 and moderate in 1 patient. The efficacy rate was 100%. The clinical response obtained on one patient with non-gonococcal urethritis was excellent by doctor's evaluation. The clinical response obtained on 7 patients with complicated UTI was excellent in 3 and moderate in 4 patients. The efficacy rate was 100%. Three patients complained of stomach distress or malaise and 2 patients developed rash. No abnormal laboratory data were observed. Thus, TFLX appears to be safe and suitable for use in the field of urology

Clinical early phase II study of bicalutamide (Casodex) in patients with prostatic cancer

ビカルタミド1日1回50mg群, 80mg及び100mgを12週間投与する3群比較の無作為化非盲検試験を実施した. 1)登録症例は124例で, 適格例は122例であった. 2)総合効果における奏効率は50mg群, 80mg群及び100mg群でそれぞれ50.5%, 61.0%及び53.7%であった. 3)PSAに対する奏効率は50mg群, 80mg群及び100mg群でそれぞれ84.2%, 92.7%及び97.6%であった. 4)副作用発現率は3群ほぼ6割で副作用による中止例は80mg群の1例のみで, 安全度において3群間に有意差はなかった.主な副作用は乳房腫脹, 乳房圧痛等であったTo investigate the efficacy and safety of bicalutamide (Casodex(R)) with its clinically recommended dose, the randomized early phase II study was performed in 124 patients with prostatic cancer (stage C, D). The patients were given 50, 80 or 100 mg of bicalutamide orally once a day in fixed doses for 12 weeks ; 122 patients were eligible for evaluation. The overall response rate was 50.0% (20/40); 61.0% (25/41) and 53.7% (22/41) in the 50 mg, 80 mg and 100 mg groups, respectively. The response rate in prostate lesion, bone and lymph node metastases was slightly higher in the 80 mg group than in the 50 mg and 100 mg groups. The proportion of patients showing a response with regard to serum PSA (CR and PR) was 84.2, 92.7 and 97.6% in the 50, 80 and 100 mg groups, respectively. The incidence of adverse reactions was 65.0, 61.0 and 61.0% in the 50, 80 and 100 mg groups, respectively, and there was no significant difference in overall safety rating in the three groups. Frequent adverse reactions were gynecomastia and breast pain. Only one patient in the 80 ing group was withdrawn due to shortness of breath. Serum concentrations of LH, testosterone and estradiol increased significantly after treatment. Bicalutamide was concluded to be effective and well tolerated in patients with prostatic cancer, and its recommended dose was 80 mg once daily

Characterization of apoptotic cells induced in vitro in Meckel\u27s chondrocytes by anticancer agents

抗癌剤のエトポシトとカンプトセシンによってメッケル軟骨に誘導される細脳死かアポトーシスによるものか否かを検索した。細脳死は胎生16日のマウスから分離した培養メッケル軟骨にエトポシト(200μg/ml)とカンプトセシン(50μg/ml)によって誘導した。これらの効果はTUNEL法と光顕およひ電顕に加え、免疫組織化学的に解析した。エトポント処理した培養細胞はアポトーシスの指標となる多くのTUNEL陽性細胞を示した。微細構造的にエトポシトてのアポトーシス様の細脳死は細脳性出芽、核クロマチンの濃縮、アポトーシス小体の形成によって引き続かれた。これに対し、カンプトセシンによる細脳死はエトポシトと同様にTUNEL陽性細胞の増加を示した。これらの抗癌剤処理後のアポトーシスは時間依存的に増加し、特に、12時間後から急速に増加した。P53の免疫染色では、この蛋白は正常な培養軟骨細胞では陰性であったか、エトポノトとカンプトセシン処理群では恒常的に促進された。一方、bcl-2の反応は培養初期の正常軟骨細胞に局在したが、抗癌剤処理群では認められなかった。本研究から、エトポシトとカンプトセシンによってメッケル軟骨に誘導された細脳死は典型的なアポトーシスによる細脳死で、これらの抗癌刻は腫瘍細胞のみならす、正常な軟骨細脳にもアポトーシスを誘導することか示唆された。Cell death induced in Meckel\u27s chondrocytes in vitro with the anticancer drugs, etoposide and camptothecin, was examined from the viewpoint of an apoptotic event. Cell death was induced in vitro in Meckel\u27s chondrocytes that were enzymatically isolated from 16-day gestation mouse embryos. The effects were assayed histologically and immunohistochemically by using the TUNEL procedure, and light and electron microscopy. Etoposide and camptothecin-treated cultures were followed by the strong appearance of TUNEL (TdT-mediated biotinylated dUTP nick end-labeling)-positive apoptotic cells; statistical analysis showed that these agents induced apoptosis significantly 12-24hrs after treatment. At an ultrastructural level, apoptotic cell death from etoposide was followed by the formation of cell blebs, chromatin condensation and the formation of apoptotic bodies. Immunostaining for p53 revealed that this protein was absent from intact chondrocytes but was continuously accelerated in the cells treated with etoposide and camptothecin. Bcl- 2 was immunolocalized in intact chondrocytes at an early stage of culture, but was not detected in anticancer-treated cells. In the present study, we confirmed that cell death in Meckel\u27s chondrocytes induced by etoposide and camptothecin is typical apoptotic cell death, and that these agents also induce apoptosis in intact chondrocytes

High Cycle Fatigue Performance of Buckling-Restrained Braces

プロジェク