Naito Seiji, Koga Hirofumi, Yamaguchi Akito, Fujimoto Naohiro, Hasui Yoshihiro, Kuramoto Hiroshi, Iguchi Atsushi, Kinukawa Naoko
Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
J Urol. 2008 Feb;179(2):485-90. doi: 10.1016/j.juro.2007.09.031.
A prospective, randomized, controlled trial was done to evaluate whether oral administration of a preparation of the probiotic agent Lactobacillus casei (Yakult Honsha, Tokyo, Japan) could enhance the prevention of recurrence by intravesical instillation of epirubicin after transurethral resection for superficial bladder cancer.
Between August 1999 and December 2002, 207 patients clinically diagnosed with superficial bladder cancer were included as study candidates and underwent transurethral resection, followed by intravesical instillation of 30 mg epirubicin/30 ml saline twice during 1 week. After histological confirmation of superficial bladder cancer they were again included as study participants with 102 randomized to receive treatment with 6 additional intravesical instillations of epirubicin during the 3-month period after transurethral resection (epirubicin group) and 100 randomized to intravesical chemotherapy on the same schedule as the epirubicin group plus oral administration of 3 gm Lactobacillus casei preparation per day for 1 year (epirubicin plus Lactobacillus casei group). Patients were evaluated for intravesical recurrence, disease progression, prognosis and adverse drug reactions.
The 3-year recurrence-free survival rate was significantly higher in the epirubicin plus Lactobacillus casei group than in the epirubicin group (74.6% vs 59.9%, p = 0.0234), although neither progression-free nor overall survival differed between the groups. The incidence of adverse drug reactions did not significantly differ between the groups and there were no serious adverse drug reactions.
Intravesical instillation of epirubicin plus oral administration of Lactobacillus casei preparation is a novel, promising treatment for preventing recurrence after transurethral resection for superficial bladder cancer.
开展一项前瞻性、随机、对照试验，以评估口服益生菌干酪乳杆菌制剂（养乐多本社，东京，日本）能否增强经尿道浅表性膀胱癌切除术后膀胱内灌注表柔比星预防复发的效果。
1999年8月至2002年12月期间，207例临床诊断为浅表性膀胱癌的患者被纳入研究候选对象，接受经尿道切除术，随后在1周内分两次膀胱内灌注30mg表柔比星/30ml生理盐水。经组织学确诊为浅表性膀胱癌后，他们再次被纳入研究参与者，其中102例随机分配在经尿道切除术后的3个月内额外接受6次膀胱内表柔比星灌注治疗（表柔比星组），100例随机分配按照与表柔比星组相同的方案进行膀胱内化疗，并每日口服3g干酪乳杆菌制剂，持续1年（表柔比星加干酪乳杆菌组）。对患者进行膀胱内复发、疾病进展、预后及药物不良反应评估。
表柔比星加干酪乳杆菌组的3年无复发生存率显著高于表柔比星组（74.6%对59.9%，p = 0.0234），尽管两组的无进展生存率和总生存率无差异。两组间药物不良反应发生率无显著差异，且无严重药物不良反应。
膀胱内灌注表柔比星加口服干酪乳杆菌制剂是经尿道浅表性膀胱癌切除术后预防复发的一种新的、有前景的治疗方法。
