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外用盐酸维拉帕米、外用三氟拉嗪和外用硫酸镁治疗佩罗尼氏病——一项安慰剂对照的初步研究。

Topical verapamil HCl, topical trifluoperazine, and topical magnesium sulfate for the treatment of Peyronie's disease--a placebo-controlled pilot study.

作者信息

Fitch William P, Easterling W Jerry, Talbert Robert L, Bordovsky Michael J, Mosier Michael

机构信息

Urology Consultants, P.A., San Antonio, TX, USA.

出版信息

J Sex Med. 2007 Mar;4(2):477-84. doi: 10.1111/j.1743-6109.2006.00417.x.

DOI:10.1111/j.1743-6109.2006.00417.x
PMID:17367443
Abstract

INTRODUCTION

Transdermal and intralesional verapamil has been reported to be useful in the treatment of Peyronie's Disease. This study evaluates a topically applied calcium channel blocker (verapamil hydrochloride 15% gel), a topically applied calmodulin blocker (trifluoperazine), and a topically applied weak calcium channel blocker (magnesium sulfate), each incorporated in a transdermal vehicle.

AIM

This pilot study was conducted to assess the efficacy of a 15% verapamil gel applied topically to the penile shaft twice daily for the treatment of Peyronie's Disease.

MAIN OUTCOME MEASURE

To assess improvement in curvature, plaque size, resolution of painful erections, and improvement in erection quality.

METHODS

Two simultaneous, three armed, double blinded, placebo-controlled studies were conducted. After randomization into one of four groups, patients were treated for 3 months. At the end of 3 months' treatment using blinded drug, each patient was treated with open label topical verapamil for 6 months. The studies were completed after each patient had been treated and evaluated for 9 months after randomization.

RESULTS

Fifty-seven patients were randomized. In total, 94.4% of patients treated for 9 months with topical verapamil experienced improvement in curvature with an average percent curvature change of 61.1% compared with 43.6% curvature improvement at 3 months. At 9 months the average percent plaque change was 84.7% compared with 55% at 3 months. Pain resolution at 9 months was 100% compared with 87.5% at 3 months. Patient perception of erection quality also increased at 9 months to 81.8% compared with 72.7% at 3 months.

CONCLUSIONS

Topical verapamil gel proved effective in eliminating pain on erection, decreasing the size of plaque, decreasing curvature, and improving erection quality in patients with Peyronie's Disease. Treatment results improved significantly after 9 months' treatment as compared with 3 months' treatment.

摘要

引言

据报道,经皮和病灶内注射维拉帕米对佩罗尼氏病的治疗有效。本研究评估了一种局部应用的钙通道阻滞剂(15%盐酸维拉帕米凝胶)、一种局部应用的钙调蛋白阻滞剂(三氟拉嗪)和一种局部应用的弱钙通道阻滞剂(硫酸镁),每种药物都加入了透皮载体中。

目的

本初步研究旨在评估每天两次局部应用于阴茎干的15%维拉帕米凝胶治疗佩罗尼氏病的疗效。

主要观察指标

评估弯曲度改善情况、斑块大小、疼痛性勃起的缓解情况以及勃起质量的改善情况。

方法

进行了两项同步的、三臂、双盲、安慰剂对照研究。随机分为四组之一后,患者接受3个月的治疗。在使用盲法药物治疗3个月结束时,每位患者接受开放标签的局部维拉帕米治疗6个月。在每位患者随机分组后接受9个月的治疗和评估后,研究完成。

结果

57名患者被随机分组。总体而言,局部应用维拉帕米治疗9个月的患者中有94.4%的弯曲度得到改善,平均弯曲度变化百分比为61.1%,而3个月时弯曲度改善率为43.6%。9个月时斑块平均变化百分比为84.7%,而3个月时为55%。9个月时疼痛缓解率为100%,而3个月时为87.5%。患者对勃起质量的感知在9个月时也提高到了81.8%,而3个月时为72.7%。

结论

局部应用维拉帕米凝胶被证明对佩罗尼氏病患者消除勃起疼痛、减小斑块大小、降低弯曲度和改善勃起质量有效。与3个月的治疗相比,9个月的治疗后治疗效果有显著改善。

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