神経因性膀胱に対するKN-7錠の臨床評価 --ロバベロン注射剤を対照とした二重盲検比較試験--

Abstract

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.