Rehme C, Niedworok C, Rübben H, Vom Dorp F
Urologische Universitätsklinik Essen, Hufelandstraße 55, 45122, Essen, Deutschland,
Urologe A. 2015 Feb;54(2):235-8. doi: 10.1007/s00120-014-3649-3.
The immediate instillation of mitomycin after transurethral resection of bladder tumor (TURBT) is widely used and recommended in the guidelines. Recently it was shown that pre-TURBT intravesical electromotive drug administration (EMDA) of mitomycin reduces the recurrence rate of non-muscle invasive bladder cancer. Our aim was to describe the pharmacokinetics and patient safety after post-TURBT EMDA.
We performed a single centre study with 25 patients diagnosed with non-muscle invasive bladder cancer. All patients underwent complete resection of all visible tumors and post-TURBT intravesical electromotive drug administration (EMDA) of mitomycin (40 mg) for 30 min. Blood samples were taken before starting the electrical current and 15, 30, 60, and 120 min after starting the procedure for quantification of mitomycin serum levels.
In 24 patients, the measured serum level of mitomycin was below the detection threshold of 50 ng/ml. In one patient serum level was elevated 15 min (155 ng/ml) and 30 min (65 ng/ml) after intravesical instillation. Nine patients reported a slight tingling sensation in the bladder during mitomycin administration. Discreet pressure in the suprapubic area was reported by one patient. One patient had a first degree skin burn at the site of one skin electrode.
Postoperative EMDA with mitomycin is a safe procedure. The measured mitomycin serum levels were below toxic concentrations. These findings encourage the initiation of large randomized controlled trials with postoperative EMDA-assisted instillation of mitomycin to test its influence on the recurrence rate of non-muscle invasive bladder cancer.
膀胱肿瘤经尿道切除术后（TURBT）立即灌注丝裂霉素在指南中被广泛应用并推荐。最近有研究表明，TURBT术前膀胱内丝裂霉素电动药物给药（EMDA）可降低非肌层浸润性膀胱癌的复发率。我们的目的是描述TURBT术后EMDA的药代动力学和患者安全性。
我们进行了一项单中心研究，纳入25例诊断为非肌层浸润性膀胱癌的患者。所有患者均对所有可见肿瘤进行了完整切除，并在TURBT术后进行膀胱内丝裂霉素电动药物给药（EMDA）（40mg），持续30分钟。在开始通电前以及开始操作后15、30、60和120分钟采集血样，用于定量丝裂霉素血清水平。
24例患者的丝裂霉素血清测量水平低于50ng/ml的检测阈值。1例患者在膀胱内灌注后15分钟（155ng/ml）和30分钟（65ng/ml）时血清水平升高。9例患者在丝裂霉素给药期间报告膀胱有轻微刺痛感。1例患者报告耻骨上区有轻微压痛。1例患者在一个皮肤电极部位出现一度皮肤烧伤。
术后丝裂霉素EMDA是一种安全的操作。测量的丝裂霉素血清水平低于中毒浓度。这些发现促使开展大型随机对照试验，采用术后EMDA辅助丝裂霉素灌注，以测试其对非肌层浸润性膀胱癌复发率的影响。
