Hellstrom Wayne J G, Kendirci Muammer, Matern Richard, Cockerham Yolanda, Myers Leann, Sikka Suresh C, Venable Dennis, Honig Stanton, McCullough Andrew, Hakim Lawrence S, Nehra Ajay, Templeton Lance E, Pryor Jon L
Department of Urology, Tulane University School of Medicine, 1430 Tulane Avenue, New Orleans, LA 70112, USA.
J Urol. 2006 Jul;176(1):394-8. doi: 10.1016/S0022-5347(06)00517-9.
We investigated the efficacy and safety of intralesional interferon alpha-2b for the treatment of Peyronie's disease.
A total of 117 consecutive patients with a mean age of 55.1 years who had Peyronie's disease were enrolled in a single-blind, multicenter, placebo controlled, parallel study to determine the efficacy and safety of intralesional interferon alpha-2b therapy (Schering, Kenilworth, New Jersey), including 62 who received placebo and 55 who received interferon alpha-2b. Saline (10 ml) in controls and interferon alpha-2b (5 x 10(6) U) were administered biweekly for 12 weeks. Each patient was evaluated for penile curvature, plaque size and density, penile pain, erectile function and penile hemodynamics before and after study completion. Improvement in these parameters was statistically compared between the groups.
A total of 53 patients in the control arm and 50 in the interferon alpha-2b arm completed the study. Improvement in penile curvature, plaque size and density, and pain resolution was significantly greater in patients treated with interferon alpha-2b vs placebo. The increase in mean International Index of Erectile Function scores was not significantly different between the groups. Penile blood flow improvement was observed in interferon alpha-2b treated patients but not in those who received placebo. The decrease in the number of penile vascular pathologies was significantly higher in interferon alpha-2b cases. Side effects, mostly flu-like symptoms, which were frequently noted in patients on interferon alpha-2b, were mild to moderate in degree and of short duration.
This single-blind, multicenter, placebo controlled, parallel study demonstrates that intralesional interferon alpha-2b at a dose of 5 x 10(6) units biweekly for 12 weeks is effective and safe as minimally invasive therapy for Peyronie's disease.
我们研究了病灶内注射干扰素α-2b治疗佩罗尼氏病的疗效和安全性。
117例平均年龄55.1岁的佩罗尼氏病患者连续纳入一项单盲、多中心、安慰剂对照、平行研究，以确定病灶内注射干扰素α-2b疗法（先灵葆雅公司，新泽西州肯尼沃思）的疗效和安全性，其中62例接受安慰剂，55例接受干扰素α-2b。对照组注射生理盐水（10毫升），干扰素α-2b组注射（5×10⁶单位），每两周注射一次，共12周。在研究结束前后，对每位患者的阴茎弯曲度、斑块大小和密度、阴茎疼痛、勃起功能及阴茎血流动力学进行评估。对两组间这些参数的改善情况进行统计学比较。
对照组53例患者和干扰素α-2b组50例患者完成了研究。与安慰剂组相比，接受干扰素α-2b治疗的患者在阴茎弯曲度、斑块大小和密度改善以及疼痛缓解方面更为显著。两组间平均国际勃起功能指数评分的增加无显著差异。干扰素α-2b治疗的患者阴茎血流有所改善，而接受安慰剂治疗的患者则未出现此情况。干扰素α-2b组阴茎血管病变数量的减少更为显著。副作用主要为流感样症状，在干扰素α-2b治疗的患者中较为常见，程度为轻至中度，持续时间较短。
这项单盲、多中心、安慰剂对照、平行研究表明，每两周一次病灶内注射5×10⁶单位干扰素α-2b，持续12周，作为佩罗尼氏病的微创治疗方法是有效且安全的。
