Comparative double-blind trial of KN-7 tablet and Robaveron injection in the treatment of neurogenic bladder

37施設で, 神経因性膀胱233例を対象に, ロバベロン注射剤を標準薬とし, KN-7錠剤の経口投与による排尿障害に対する有用性を, 二重盲検群間比較試験で比較検討した.解析対象例はKN-7群108例, ロバベロン群107例である.KN-7群は1日6錠投与した.改善度の効果判定では改善以上K群40.7%, R群38.7%, やゝ改善以上それぞれ76.9%, 72.6%と有意差はなかった.臨床所見中改善の良かった項目は, 尿意, 残尿感, 尿失禁, 排尿までの時間, 排尿時間, 尿勢-排尿力と尿線中断の改善などで, これらの改善以上はK群35.8%, R群30.8%で, 有意差はなかった.副作用はK群0.9%, R群6.8%, K群が有意に少なかった.両剤とも主として下痢で, R群ではその他頭痛, 頻脈, 肝機能障害, 発熱感などを少数例認めた.臨床検査値ではGOT, GPTの上昇が2例あった.有用度有用以上はK群46.3%, R群45.8%で有意差はなかった.疾患別では, 末梢神経疾患, 膀胱の性状では弛緩性, 時期では12ヵ月以内の例で特に改善率が高かった.以上から, KN-7錠剤は, ロバベロン注射剤に比べ, 同等の効果が期待でき, 安全性も高く, 長期投与あるいは外来患者の治療にも適するThe clinical effectiveness, safety and usefulness of KN-7 tablet as a new oral application of the prostatic extract, on urinary dysfunction of neurogenic bladder were compared with those of Robaveron injection by the double-blind test method. In the study, 2 tablets t.i.d. and a shot of intramuscular injection 1 ml a day were given successively for 3 weeks. A total of 233 cases were reported from 37 facilities belonging to the KN-7 Clinical Research Group. Some of them were excluded or dropped out. The number of cases used for analysing the effectiveness, safety and usefulness were 214, 232 and 215, respectively. There was no bias between the two groups with a significant homogeneity in the background. In the overall clinical effectiveness, the effective rate including excellent, moderate and slightly effective was 76.9% with KN-7 and 77.4% with Robaveron. In the clinical usefulness, the rate of usefulness of slightly useful or above was 75.0% with KN-7 and 75.7% with Robaveron. There was no significant difference between the two groups in the clinical effective and useful rates at a significant level of 5%. Side effects were observed in 1 of the 114 (0.9%) patients given KN-7 and 8 of the 118 (6.8%) patients given Robaveron. The incidence of adverse reactions with KN-7 was significantly lower than that with Robaveron. Based on the results, it was concluded that KN-7 tablets, 2 tablets t.i.d., would be as effective and useful as a Robaveron injection 1 ml daily and safer than the latter in the treatment of neurogenic bladder

Storage of sea urchin gonad in oxygenated sea water

Changes in the contents of ATP related compounds in the gonad of sea urchin Strongylocentrotus nudus stored in artificial seawater were investigated. A gradual decrease of ATP content was followed by an accumulation of HxR and Hx during storage, while total nucleotide content decreased from 2.6 to 1.2 mu mol/g in 8 days indicating a leaking of the compounds from the gonad. The ATP content relative to the sum of ATP related compounds was used to show the ATP content of the gonad. Turbidity of seawater used for storage, a commercial sensory freshness index of gonad of sea urchin, also increased during storage. The increase in turbidity seemed to correspond to the decrease in relative ATP content. The effect of oxygen volume filled in the storage bag on the change in the relative ATP content of gonad and on the turbidity increase of seawater was studied. Decrease in the relative ATP content and turbidity development were both suppressed by an increase in filled oxygen volume. Almost no increase in the marine bacteria population was observed during the storage under any conditions. It was concluded that storage of sea urchin gonad in oxygenated sea water was an effective method for main taining freshness

Endocrine therapy for prostatic carcinoma--the clinical trial to compare the efficacy of LH-RH analogue, ICI 118630 (Zoladex) with castration or estrogen

前立腺癌患者82例に対し, 「Zoladex療法」あるいはその対照として去勢術またはエストロゲン療法」を施行し, 臨床効果, 内分泌効果, 安全性および有用度について比較検討した.臨床効果は, 対象病巣改善度でZoladex群33例中21例に, 対照群33例中22例にPR以上の改善が, 自覚症状総合改善度ではZoladex群24例中21例, 対照群30例中24例が改善した.いずれも両群間に有意差はなかった.内分泌効果では両群とも全例に去勢効果が得られた.副作用はZoladex群39例中14例, 対照群34例中19例にみられたが, 発現率では両群に差はない.有用度については, やや有用以上でみると, Zoladex群, 対照群ともに33例中29例, 87.9%に有用と判定されているA multicenter randomized clinical trial was carried out between May, 1986 and May, 1987 involving 82 patients with stage B-D prostatic carcinoma from 29 centers. The clinical efficacy, endocrine effect, safety and usefulness of the luteinizing hormone-releasing hormone (LH-RH) analogue and other endocrine manipulations in the treatment of prostatic carcinoma. Zoladex depot containing 3.6 mg of ICI 118, 630, an LH-RH analogue, was administered every four weeks 3 times in total. Patients in the control group received either 300 mg of diethylstilbestrol diphosphate orally daily for 12 weeks or orchidectomy. An antitumor effect (CR + PR) was observed in 21 of the 33 patients (63.6%) in the Zoladex group and in 22 of the 33 (66.7%) in the control group, showing no significant difference between the two groups. There was no significant difference in overall subjective response either; 21 of the 24 (87.5%) in the Zoladex group and 24 of the 30 (80.0%) in the control group. In both groups, 100% endocrine effect was obtained as shown by achievement of castration in all patients. Adverse reactions were observed in 14 of the 39 (35.9%) patients treated with Zoladex as compared with 19 of the 34 (55.9%) control patients, resulting in no significant difference in the incidence between the two groups. These adverse reactions were not so severe as to require withdrawal from the study. In both groups, the treatment was assessed as slightly or more useful in 29 of the 33 (87.9%) patients. From these results, it is concluded that Zoladex, 3.6 mg depot, is a useful drug for treatment of prostatic cancer, having clinical efficacy and endocrine effects comparable to those of the conventional endocrine manipulations, being safe, and causing less physiological and psychological pain

Clinical evaluation on ofloxacin administered once daily in the treatment of acute uncomplicated cystitis

女子急性単純性膀胱炎の126例に対し, OFLX 300mg 1日1回3日間投与と, 同薬100mg 1日3回3日間投与の比較検討をした。UTI薬効評価可能のそれぞれ, 42例と43例とでは, ともに総合臨床効果の98%を呈するなど, 自覚症状・膿尿・細菌尿に対する効果も主治医による効果判定にも, あるいは第7病日における再発検討にても, ほとんど両群に差をみとめなかった。自覚的副作用は両群あわせてもわずかに1.2%であり, 全例に臨検値を検討しなかったため, 概括安全度に対する検討は不十分であったA comparative study of ofloxacin (OFLX), a new oral quinolone, was carried out at the Department of Urology, Osaka University Hospital and its eighteen affiliated hospitals to evaluate the clinical efficacy and safety of daily dose of 300 mg, given either once daily dose (SID group), or in three divided doses (TID group), in the treatment of acute uncomplicated cystitis in women. Clinical efficacy was evaluated in 42 cases from the SID group, and 43 cases from TID group, respectively, according to the criteria by the Japanese UTI Committee. In the SID group, the clinical efficacy was evaluated as excellent in 29 cases, moderate in 12 and poor in 1, with an overall clinical effectiveness rate of 98%. In the TID group, it was evaluated as excellent in 25 cases, moderate in 17 and poor in 1, with an overall clinical effectiveness rate of 98%. Safety was monitored only by subjective complaints. In the SID group, no subjective side effects appeared (0%). In the TID group, one of the 43 women (2.3%) complained of borborygmus. These findings suggest that there was no significant difference between the two groups in the safety and efficacy of ofloxacin