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首页> 外文期刊>Urology >Results at 43 months' follow-up of a double-blind, randomized, prospective clinical trial using intravesical interferon alpha-2b in the prophylaxis of stage pT1 transitional cell carcinoma of the bladder.
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Results at 43 months' follow-up of a double-blind, randomized, prospective clinical trial using intravesical interferon alpha-2b in the prophylaxis of stage pT1 transitional cell carcinoma of the bladder.

机译：使用膀胱内干扰素α-2b预防膀胱pT1期移行细胞癌的双盲，随机，前瞻性临床试验的43个月随访结果。

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OBJECTIVES: To assess the intravesical efficacy of 60 million units of interferon (IFN) alpha-2b in preventing recurrences of Stage pT1 transitional cell carcinoma of the bladder, as well as to assess its local and systemic toxicity. METHODS: A total of 90 patients were included in a double-blind, randomized, prospective clinical trial and divided into two groups of 45 patients. After complete transurethral resection, 60 million units IFN alpha-2b was instilled in one group; in the other, double-distilled water was used. The therapeutic regimen consisted of weekly instillation for 12 weeks, followed by once-monthly instillation until patients had completed 1 year of treatment. RESULTS: Only 78 patients were evaluable. After 12 months of follow-up, the relapse rate was 28.2% (11 of 39) for the IFN group and 35.8% (14 of 39) for the control group (P = NS). After 43 months (range 9 to 67), relapse rates were 53.8% (21 of 39) and 51.2% (20 of 39), respectively (P = NS). Progression, mortality, and local orsystemic toxicity were similar in both groups. Flu-like syndrome was not reported. CONCLUSIONS: At the dose used in this study, IFN alpha-2b proved ineffective in the prophylaxis of Stage pT1 transitional cell carcinoma of the bladder compared with a control group. Toxicity was virtually absent.
机译：目的：评估6000万单位干扰素（IFN）α-2b在预防膀胱pT1期转移性膀胱癌复发中的膀胱内功效，以及评估其局部和全身毒性。方法：将90例患者纳入一项双盲，随机，前瞻性临床试验，分为两组，每组45例。完全经尿道切除后，将6000万单位的IFNα-2b注入一组。另外，使用双蒸馏水。治疗方案包括每周滴注12周，然后每月滴注一次，直至患者完成1年的治疗。结果：只有78例患者是可评估的。随访12个月后，IFN组的复发率为28.2％（39个中的11个），对照组为35.8％（39个中的14个）（P = NS）。在43个月后（范围从9到67），复发率分别为53.8％（39中的21）和51.2％（39中的20）（P = NS）。两组的进展，死亡率和局部全身毒性相似。没有流感样综合征的报道。结论：在本研究中使用的剂量，与对照组相比，IFNα-2b被证明在预防pT1期膀胱移行细胞癌中无效。几乎没有毒性。

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