17 research outputs found

    Clinical evaluation of cefixime (CFIX) in the treatment of urinary tract infection

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    1988年2月から同年7月の間に大阪大学泌尿器科ならびにその関連病院16施設において, 238例の尿路感染症に対してCFIXを投与し, その臨床効果と安全性について検討した.1)評価基準に基づいて効果の判定を行いえた症例は135例であり, そのうち女子急性単純性膀胱炎の92例では93%, 複雑性尿路感染症の42例では57%の総合有効率を得た.単純性腎盂腎炎の1例でも著効を示した.2)自覚的副作用は236例について検討され, 3例に軽い消化管症状と, 服薬を中止した全身掻痒感の1例, 合計4例に副作用を認めた.臨床検査値の異常変動は141例中6例に認め, 肝機能値の変動を主とした.総じて重篤な副作用は認めなかったCefixime (CFIX, Cefspan), a new oral cephem, was used in the treatment of urinary tract infections, and was evaluated for its therapeutic effectiveness and safety at the Department of Urology, Osaka University Hospital and 16 affiliated hospitals. A total of 238 patients were administered daily doses of 200 or 400 mg. Clinical efficacy was assessed on 92 female patients with acute uncomplicated cystitis and 42 patients with complicated UTI according to the Criteria for Clinical Evaluation of Antimicrobial Agents in UTI (3rd ed.) recommended by the Japan UTI Committee, to which we added our own minimum modification. Clinical efficacy was evaluated as excellent in 57 of the acute uncomplicated cystitis cases, moderate in 33 and poor in 2, with an overall clinical effectiveness rate of 98%. Clinical efficacy was evaluated as excellent in 12 of the complicated UTI cases moderate in 12 and poor in 18, with an overall clinical effectiveness rate of 57%. In one case of uncomplicated pyelonephritis, CFIX showed an excellent efficacy. Of the total of 102 bacterial strains isolated from uncomplicated UTIs, 95 (93%) were eradicated by CFIX, while 36 (72%) eradicated in 50 strains isolated from complicated UTIs. Subjective adverse reactions were seen in 4 cases (1.7%) of the 236 patients, as generalized pruritus and upper gastrointestinal discomforts. Abnormal laboratory findings were recorded in 6 out of 141 cases. They were increases in serum GPT, GOT, alkaline phosphatases, total bilirubin, as well as increases in peripheral leukocytes. These adverse symptoms and abnormal laboratory findings disappeared after the termination of CFIX administration. CFIX might therefore be considered as a clinically useful oral antibiotic in the treatment of UTI

    Prostatic tissue levels of ceftizoxime

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    1983年4月より1984年3月までの間に東北大学泌尿器科関連21施設において前立腺切除術を施行した前立腺肥大症患者130例を対象として, 術前CZX 2 gをone shot静注し, 前立腺組織内濃度および組織切除時の血中濃度を測定した.各組織に2倍量のM/15リン酸緩衝液(pH 7.0)を加え, ホモジネート後, 2300 G 10分間遠心してその上清の薬剤濃度を測定した.CZXの濃度測定は, B. subtilis ATCC 6633を検定菌とするdisk法で行なった.同時にTUR-P前後の尿所見及び尿中細菌の分離同定, MICの測定も行なった.尿中検出菌に対するCZXのMICの測定は, LMOX, CPZ, CMX, CTX, CEZ, CTMを対照薬剤とした.これら抗生物質の血清に対する前立腺組織内濃度の割合は, FOMが100%を超える以外は, ほぼ22~78%であった.また前立腺組織内濃度は, しだいに血清中濃度に近づく傾向にあった.CPZとCZXの血清中濃度と前立腺組織内濃度の比較においては, 血清中濃度ではCPZがCZXを上まわるが, 後者では逆にCZXがCPZを上まわり, CZXについて血清中からの優れた移行性が報告されている.CZX 2 g静注で, 血清より前立腺組織への移行率は30分で49.1%, 1時間で51.4%, 1.5時間で54.3%, 2時間で60.8%, 4時間で64.2%, 6時間38.2%, 8時間74.5%, 9時間で81.4%であり, 6時間値で下降を示したものの, 全体の傾向としては前立腺組織内CZXの濃度は血清濃度に近づいてゆくことがわかった.この成績から, 今回検査したE. coli, Klebsiella, P. vulgaris, P. mirabilisなどのグラム陰性桿菌群に対しCZXが長時間の前立腺組織内濃度の維持を示すことから, 前立腺手術後の感染症や感染防止に使用して十分な治療効果が期待できると考えられたThe concentration of Ceftizoxime (CZX) was determined in the prostatic tissue and serum of 130 patients with benign prostatic hypertrophy. Two grams of CZX was given by intravenous injection prior to TUR. The mean value of CZX levels in prostatic tissue and prostatic level/serum levels ratio (p/s ratio) after administration were 47.2 +/- 2.8 micrograms/g, 49.1% at 30 minutes, 33.3 +/- 2.2 micrograms/g, 51.4% at one hour, 22.2 +/- 2.7 micrograms/g, 60.8% at 2 hours, 13.6 +/- 3.9 micrograms/g, 64.2% at 4 hours, 3.04 +/- 0.54 micrograms/g, 74.5% at 8 hours, respectively. In conclusion, the concentration of CZX in the prostatic tissues attained the minimal inhibitory concentration of 80% for the gram-negative bacteria, the excluding P. aeruginosa. Thus clinical effectiveness of CZX could be expected on bacterial prostatitis and bacterial infection after prostatic operations

    Clinical evaluation of the combination of carumonam and cefotiam in the treatment of complicated urinary tract infection

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    18施設で, 109例の複雑性尿路感染症に対して, CRMNとCTMを, 1日量それぞれ2 gずつを分2混合投与し, 効果と安全性を検討した.効果判定基準に合致した65例では, 対膿尿改善率が54%, 菌消失率が83%, 総合有効率が72%の結果を得た.副作用の頻度は3件と低く, この2剤の併用投与は複雑性尿路感染症に対し, first choiceとして使用する場合, 十分に効果が期待でき, かつ安全な方法であるThe combination of carumonam (CRMN) and cefotiam (CTM), expected to have a broader spectrum of coverage in connection with urinary tract infections, was evaluated for its effectiveness and safety at the Department of Urology, Osaka University Hospital and 17 affiliated hospitals. CRMN and CTM were given together to 109 patients with complicated urinary tract infections (UTI), of whom 65 cases satisfied the "Criteria of UTI Committee for the Evaluation of Drug Efficacy in the UTI (3rd Ed.)", which was modified by adopting the midstream urine data for women. CRMN and CTM were administered by drip or one-shot infusion at a total daily dose of 4 g (equally mixed 1 g plus 1 g each, twice a day) for 5 consecutive days or longer. The overall clinical efficacy rate in the 65 cases of complicated UTI was 72%, estimated by the criteria cited above. The efficacy rate according to the infection type groupings was 72% for the 29 patients in the 1st group, 100% for the 1 patient in the 2nd group, 100% for the 7 patients in the 3rd group, 83% for the 6 patients in the 4th group, 50% for the 14 patients in the 5th group and 75% for the 8 patients in the 6th group. The disappearance rate of both urinary Gram positive cocci and Gram negative bacilli was 83.3%. Fifteen strains appeared after the treatment, only 4 of which were Gram positive cocci. Among the 109 patients treated with CRMN+CTM, no subjective side effects were recorded and the abnormalized laboratory findings observed were: eosinophilia in one patient, increases in both GPT and GOT in one patient, and lowered creatinine clearance in one patient. With a broader spectrum and safe regimen, the combination of CRMN/CTM is recommended as the first choice against complicated UTI

    Clinical study of RU 23908 (nilutamide) in prostatic cancer

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    前立腺癌に対するRU 23908の有効性および安全性を検討するため, stage C, Dの前立腺癌患者47例に1日1回150または300 mg経口投与による早期第2相臨床試験を行った.対象病巣に対する効果では, 総合効果判定は40例中CR+PRが34例, 部位別効果は原発巣では40例中CR+PRが35例, 骨転移では22例中10例, リンパ節転移では6例中5例, 肺転移は1例のみにみられCRであり, PAP判定では34例中CR+PRは33例であった.臨床症状に対する改善率は骨疼痛8/9例, 排尿障害25/30例, P.S. 15/33例であった.副作用は調査症例数47例中29例にみられ, 中止例は7例あった.特殊な副作用として間質性肺炎が試験期間の12週以後の継続投与期間も含めて6例に認められ, その他2例では出現の可能性が否定できないと判定されたTo investigate the efficacy and the safety of RU23908 for the treatment of prostatic cancer, an early phase 2 study with the oral administration of 150 or 300 mg daily was performed in 47 patients with stage C or D prostatic cancer at 15 institutions from April 1987 to June 1988. Forty patients were evaluable for efficacy. Concerning the effect on the object lesion, the results of the overall evaluation revealed that complete or partial response (CR + PR) was obtained in 34 of the 40 cases (85.0%). As to the effect classified by site, CR + PR were observed in 35 out of the 40 cases with primary lesion (87.5%), in 10 of the 22 cases with bone metastasis (45.5%), in 5 of the 6 cases with lymph node metastasis (83.3%) and CR was observed in one case with lung metastasis. In the PAP evaluation, 33 out of the 34 cases were judged to be CR + PR (97.1%). The improvement rate of clinical symptoms was 88.9% for bone pain, 83.3% for dysuria and 45.5% for performance status. Adverse reactions were observed in 29 of the 47 cases (61.7%) investigated and 7 cases (14.9%) were withdrawn. During the study period of 12 weeks and the subsequent period of continued administration, 6 cases (12.8%) and 2 possible cases of interstitial pneumonia were diagnosed. From the above results, the treatment of prostatic cancer with RU23908 150 mg/day or 300 mg/day in combination with surgical castration showed an excellent clinical effect compared to conventional endocrine therapy, but has a problem of safety. Therefore, this drug may be expected to be a highly useful therapeutic drug, if safely is improved in the future by reviewing the dose
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