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比较 30mg 和 40mg 丝裂霉素 C 膀胱内灌注治疗韩国表浅性膀胱癌患者的效果:前瞻性、随机研究。

Comparison of 30 mg and 40 mg of mitomycin C intravesical instillation in Korean superficial bladder cancer patients: prospective, randomized study.

机构信息

Department of Urology, Seoul National University College of Medicine, Seoul, Korea.

出版信息

Cancer Res Treat. 2005 Feb;37(1):44-7. doi: 10.4143/crt.2005.37.1.44. Epub 2005 Feb 28.

Abstract

PURPOSE

A prospective study was performed to compare the efficacy and safety of intravesical mitomycin C (MMC) instillation for the prophylaxis of bladder cancer at different concentrations (30 mg or 40 mg).

MATERIALS AND METHODS

Ninety-seven patients that received complete transurethral resection for superficial bladder cancer were divided into two-randomized groups. One group (n=53) received 30 mg and the other group (n=44) received 40 mg dose of MMC weekly for 8 weeks, which was followed monthly for 10 months as maintenance therapy. The recurrence rates and side effects in both groups were recorded. The mean follow-up period was 32.4 months in the 30 mg group, and 32.0 months in the 40 mg group.

RESULTS

The overall one and two year recurrence rates were 19% and 24% in the 30 mg group, and 12% and 22% in the 40 mg group, which was not significantly different (p>0.05). Most of the side effects were mild and transient. Moreover, the rates of the individual side effects were not statistically different in the two groups.

CONCLUSION

Our comparison of 30 mg and 40 mg intravesical MMC instillation showed no difference in either response or side effects. Thus, we tentatively conclude that we can use 30 mg instead of 40 mg as an intravesical MMC instillation dose.

摘要

目的

前瞻性研究比较了不同浓度(30mg 或 40mg)膀胱内丝裂霉素 C(MMC)灌注预防膀胱癌的疗效和安全性。

材料和方法

97 例接受完全经尿道膀胱肿瘤切除术的浅表膀胱癌患者分为两组。一组(n=53)接受 30mg 剂量,另一组(n=44)接受 40mg 剂量 MMC,每周 1 次,共 8 周,随后每月 1 次作为维持治疗,共 10 个月。记录两组的复发率和不良反应。30mg 组平均随访 32.4 个月,40mg 组平均随访 32.0 个月。

结果

30mg 组的总体 1 年和 2 年复发率分别为 19%和 24%,40mg 组分别为 12%和 22%,差异无统计学意义(p>0.05)。大多数不良反应为轻度和短暂的。此外,两组间个别不良反应的发生率无统计学差异。

结论

我们比较了 30mg 和 40mg 膀胱内 MMC 灌注,无论是反应还是不良反应均无差异。因此,我们推测可以用 30mg 代替 40mg 作为膀胱内 MMC 灌注剂量。

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