Departments of Radiation Oncology and Urology, Memorial Sloan Kettering Cancer Center, New York, New York.
Department of Radiation Oncology, Continuum Cancer Center of New York, New York, New York.
J Urol. 2014 Sep;192(3):868-74. doi: 10.1016/j.juro.2014.02.097. Epub 2014 Mar 3.
We studied adjuvant daily sildenafil citrate during and after radiotherapy for prostate cancer for erectile function preservation.
We performed a randomized, prospective trial of 279 patients with localized prostate cancer treated with radiotherapy who received sildenafil citrate (50 mg daily) or placebo (2:1 randomization). Medication/placebo was initiated 3 days before treatment and continued daily for 6 months. Before therapy and 3, 6, 9, 12, 18 and 24 months after radiotherapy patients completed the IIEF questionnaire, including the erectile function domain, the I-PSS questionnaire and the RAND SF-36®. All IIEF domains were scored.
At 12 months erectile function scores were better for sildenafil citrate than placebo (p = 0.018), 73% of patients on sildenafil citrate vs 50% on placebo had mild/no erectile dysfunction (p = 0.024) and the sildenafil citrate arm had superior overall satisfaction (p = 0.027) and IIEF total scores (p = 0.043). At 24 months erectile function and IIEF scores were no longer significantly better for sildenafil citrate (p = 0.172 and 0.09, respectively) and yet overall satisfaction scores were higher (p = 0.033). Sexual desire scores in patients who received sildenafil citrate were higher at 24 months although they had completed drug therapy 18 months previously (p = 0.049). At 24 months 81.6% of patients on sildenafil citrate and 56.0% of those on placebo achieved functional erection with or without erectile dysfunction medication (p = 0.045).
Daily sildenafil citrate during and after radiotherapy for prostate cancer was associated with improved overall sexual function compared with placebo for various sexual function domains. To our knowledge this is the largest randomized, prospective, controlled trial to show the usefulness of a phosphodiesterase-5 inhibitor as a rehabilitation strategy in patients with prostate cancer who received radiation therapy.
我们研究了在前列腺癌放疗期间和放疗后使用辅助性每日西地那非枸橼酸盐治疗以保存勃起功能。
我们对 279 例接受放疗的局限性前列腺癌患者进行了一项随机、前瞻性试验,这些患者接受了西地那非枸橼酸盐(每日 50mg)或安慰剂(2:1 随机化)治疗。药物/安慰剂在治疗前 3 天开始服用,并在 6 个月内每日服用。在治疗前和放疗后 3、6、9、12、18 和 24 个月,患者完成了 IIEF 问卷,包括勃起功能域、I-PSS 问卷和 RAND SF-36®。所有 IIEF 域都进行了评分。
在 12 个月时,西地那非枸橼酸盐组的勃起功能评分优于安慰剂组(p = 0.018),73%的西地那非枸橼酸盐组患者有轻度/无勃起功能障碍,而安慰剂组为 50%(p = 0.024),西地那非枸橼酸盐组的总体满意度(p = 0.027)和 IIEF 总分(p = 0.043)均较高。在 24 个月时,西地那非枸橼酸盐组的勃起功能和 IIEF 评分不再显著优于安慰剂组(p = 0.172 和 0.09),但总体满意度评分更高(p = 0.033)。尽管接受西地那非枸橼酸盐治疗的患者在 18 个月前已完成药物治疗,但在 24 个月时,他们的性欲评分仍较高(p = 0.049)。在 24 个月时,西地那非枸橼酸盐组 81.6%的患者和安慰剂组 56.0%的患者在有或没有勃起功能障碍药物的情况下实现了功能性勃起(p = 0.045)。
与安慰剂相比,前列腺癌放疗期间和放疗后每日使用西地那非枸橼酸盐可改善整体性功能,在多个性功能域中均如此。据我们所知,这是最大的一项随机、前瞻性、对照试验,表明 PDE5 抑制剂作为接受放疗的前列腺癌患者的康复策略具有实用性。