Yoshida O, Miyakawa M, Watanabe H, Mishina T, Okajima E, Hirao Y, Matushima M, Nihira H, Nakatsu H
Hinyokika Kiyo. 1986 Sep;32(9):1349-58.
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.
采用信封法随机研究，检测了依曲替酯对174例浅表性膀胱肿瘤的复发预防效果。膀胱肿瘤经尿道切除术后，无瘤患者被分为两组，一组每天服用一粒10毫克的依曲替酯胶囊，另一组不进行治疗（对照组）。通常情况下，每3个月对患者进行一次复发检查。依曲替酯组有9例退出（9.6%），对照组有8例（10%）。因此，对依曲替酯组的85名受试者和对照组的72名患者进行了统计学分析。在超过2年的观察期内，对照组的复发率为38%，依曲替酯组为18%，后一组的复发病例数有减少趋势（P小于0.1）。用Kaplan Meier法检测，依曲替酯组观察一年以上病例的累积复发抑制率与对照组相比有升高趋势（P小于0.1）。在复发、多发肿瘤和肿瘤小于1厘米的病例中，依曲替酯给药具有较高的复发抑制作用（P小于0.05）。依曲替酯给药出现副作用的有21例（22.3%）。主要症状为嘴唇干燥、唇炎、口腔炎、皮肤脱屑等，7例（7.4%）停药。停药后症状均消失。
