表在性膀胱腫瘍に対するEtretinateの再発防止効果 - 封筒法による比較試験 -

Abstract

174例の表在性膀胱性腫瘍について, ビタミンAのβイオノン環をベンゼン環に, 側鎖末端をカルボン酸エステルとしたretinoidの一種であるEtretinateを投与して, 再発防止効果を検討した.その結果Etretinate 10 mg/day経口投与を2年以上持続した場合, 2年目以後の再発が抑制されることが示唆された.対象は表在性膀胱腫瘍患者で, TUC/TURによりtumor freeとなηた患者である.方法は封筒法による比較試験で, 対象を2群に分け, 1群は1日1回Etretinate 10 mg 1カプセルを投与し, もう1群は薬物投与を行なわず対照とした.3ヵ月毎に再発をチェックし, Etretinate投与群で9例(9.6%), 対照群で8例(10%)の脱落が生じた.結局第1群85例, 第2群(対照群)72例について統計的な解析を行なηた.2年以上の観察を行なηた例のうち, 第1群で18%, 第2群38%の再発率が見られ, 第1群では明らかな再発の低下が見られた(p<0.1).1年以上観察した例の累積再発抑制率は, Kaplan Meier法によれば対照群と比べEtretinate群で高い傾向が認められた(p<0.1).Etretinateは再発生, 多発, 1 cm以下の腫瘍において高い再発抑制効果(p<0.05)を有することが示された.本剤による副作用は21例(22.3%)に見られ, 主なものは口唇乾燥, 口内炎, 皮膚落屑等であり, 7例(7.4%)に投与を中断した.中断後にこれらの症状はすべて消失した

The recurrence preventing effect of Etretinate on 174 superficial bladder tumors was examined by a randomized study using the envelope method. After transurethral resection of the bladder tumor, the tumor-free patients were divided into two groups, one administered one 10 mg capsule of Etretinate once a day, and the other group untreated (control group). As a rule, the patients were examined for recurrence every 3 months. There were 9 drop outs (9.6%) in the Etretinate group, and 8 (10%) in the control group. Therefore, 85 subjects in the Etretinate group and 72 patients in the control group were analyzed for statistics. The recurrence rate during the observation period of over 2 years was 38% in the control group and 18% in the Etretinate group, the number of relapsing cases in the latter group tending to be decreased (P less than 0.1). The cumulative recurrence inhibition rate for cases observed over one year tested by the Kaplan Meier method tended to be higher in the Etretinate group compared to the control group (P less than 0.1). Etretinate administration had a high recurrence inhibitory effect (P less than 0.05) in the cases of relapse, multiple tumors, and tumors less than 1 cm. Side effects of Etretinate administration were seen in 21 cases (22.3%). The major symptoms were dry lips, cheilitis, stomatitis, dermal desquamation, etc., and drug use was discontinued in 7 cases (7.4%). The symptoms all disappeared after drug administration was discontinued.