Lamm D L, Thor D E, Harris S C, Reyna J A, Stogdill V D, Radwin H M
J Urol. 1980 Jul;124(1):38-40. doi: 10.1016/s0022-5347(17)55282-9.
Thirty-seven patients were enrolled in a randomized prospective study to compare standard surgical therapy for superficial bladder cancer to standard therapy plus bacillus Calmette-Guerin (BCG). Side effects of BCG have been tolerated well and include dysuria in 95 per cent of the patients, urinary frequency in 83 per cent, hematuria in 39 per cent, fever in 22 per cent and nausea in 22 per cent. Of 19 control patients 8 (42 per cent) had recurrent tumors in the followup period, compared to 3 of 18 patients (17 per cent) treated with BCG. One patient treated wih BCG had 2 recurrences, yielding a recurrence rate of 22 per cent in the group receiving BCG compared to 42 per cent in controls. When the incidence of recurrent tumors in matched intervals before and after entry into the protocol is compared, no change in the rate of tumor recurrence (p equals 0.726 chi-square) occurred in controls, whereas tumor recurrences were reduced significantly in the group treated with BCG (p equals 0.010 chi-square). The reduction in tumor recurrence in patients treated with BCG compared to controls is statistically significant (p equals 0.029 chi-square). Of 4 patients who presented with new bladder tumors remain free of tumor after BCG therapy, while 2 of 5 comparable control patients developed recurrent tumors. Intravesical and percutaneous BCG immunotherapy appears to decrease the rate of tumor recurrence in patients followed for 1 year.
37名患者参与了一项随机前瞻性研究，以比较浅表性膀胱癌的标准手术治疗与标准治疗加卡介苗（BCG）的疗效。卡介苗的副作用耐受性良好，95%的患者出现排尿困难，83%出现尿频，39%出现血尿，22%出现发热，22%出现恶心。在19名对照患者中，8名（42%）在随访期间出现肿瘤复发，而接受卡介苗治疗的18名患者中有3名（17%）复发。一名接受卡介苗治疗的患者复发2次，接受卡介苗治疗组的复发率为22%，而对照组为42%。比较进入研究方案前后相同时间段内肿瘤复发的发生率，对照组肿瘤复发率无变化（卡方检验p = 0.726），而接受卡介苗治疗的组肿瘤复发显著减少（卡方检验p = 0.010）。与对照组相比，接受卡介苗治疗的患者肿瘤复发减少具有统计学意义（卡方检验p = 0.029）。4名出现新膀胱肿瘤的患者在卡介苗治疗后未再出现肿瘤，而5名可比的对照患者中有2名出现肿瘤复发。膀胱内和经皮卡介苗免疫疗法似乎可降低随访1年患者的肿瘤复发率。
