Jurincic C D, Engelmann U, Gasch J, Klippel K F
Department of Urology, General Hospital Celle, Mainz, Federal Republic of Germany.
J Urol. 1988 Apr;139(4):723-6. doi: 10.1016/s0022-5347(17)42610-3.
A randomized, controlled study was begun in 1982 on the effect of keyhole-limpet hemocyanin and mitomycin C in the prevention of recurrent superficial bladder cancer (stages pTa to pT1, grades 0 to 3) in 44 patients. All tumors were resected and all patients were presumed to be free of tumor at initiation of the prophylactic instillations. Before the bladder instillation program was begun all patients in the keyhole-limpet hemocyanin group Ia were immunized with 1 mg. keyhole-limpet hemocyanin intracutaneously and then monthly bladder instillations of 10 mg. were given. The control group Ib received 20 mg. mitomycin C monthly. Of the 21 patients in the keyhole-limpet hemocyanin group Ia (mean followup 20.7 months) 3 (14.2 per cent) had recurrences, compared to 9 of 23 (39.1 per cent) in the mitomycin C group Ib (mean followup 18.3 months). The over-all preventive effect was significantly better (p less than 0.05, chi-square) in keyhole-limpet hemocyanin-treated patients than in those given mitomycin C. In 1984 a new single drug study (group II) was started with keyhole-limpet hemocyanin alone, administered as in group Ia. Of 81 patients in group II (nonrandomized, mean followup 22.8 months) 17 (20.9 per cent) had recurrences. Of the patients given keyhole-limpet hemocyanin 20 of 21 (95.2 per cent) in group Ia and 70 of 81 (86.4 per cent) in group II had complete and partial prevention (downgrading), compared to 16 of 23 (69.5 per cent) in group Ib. Our study was established to analyze the effect of a new method of immunotherapy; no adverse local or systemic side effects were noted.
1982年开展了一项随机对照研究，以探讨钥孔戚血蓝蛋白和丝裂霉素C对44例复发性浅表性膀胱癌（pTa至pT1期，0至3级）的预防效果。所有肿瘤均已切除，且假定所有患者在开始预防性灌注时均无肿瘤。在开始膀胱灌注方案之前，钥孔戚血蓝蛋白组Ia的所有患者均接受1毫克钥孔戚血蓝蛋白皮内免疫，然后每月进行10毫克的膀胱灌注。对照组Ib每月接受20毫克丝裂霉素C。钥孔戚血蓝蛋白组Ia的21例患者（平均随访20.7个月）中有3例（14.2%）复发，而丝裂霉素C组Ib的23例患者中有9例（39.1%）复发（平均随访18.3个月）。接受钥孔戚血蓝蛋白治疗的患者的总体预防效果明显优于接受丝裂霉素C治疗的患者（p<0.05，卡方检验）。1984年开始了一项新的单药研究（II组），仅使用钥孔戚血蓝蛋白，给药方式与I组相同。II组的81例患者（非随机，平均随访22.8个月）中有17例（20.9%）复发。接受钥孔戚血蓝蛋白治疗的患者中，I组的21例中有20例（95.2%）、II组的81例中有70例（86.4%）实现了完全或部分预防（病情降级），而Ib组的23例中有16例（69.5%）实现了这一效果。我们开展这项研究是为了分析一种新的免疫治疗方法的效果；未观察到不良的局部或全身副作用。
