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他达拉非每日一次给药与按需服用对2型糖尿病勃起功能障碍患者疗效及安全性的比较。

Comparison of the efficacy and safety of once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction.

作者信息

Park Soon Hyun, Park Sung Woo, Cha Bong Yun, Park Ie Byung, Min Kyung Wan, Sung Yeon Ah, Kim Tae Hwa, Lee Jae Min, Park Kang Seo

机构信息

Department of Internal Medicine, Eulji University, School of Medicine, Daejeon 302 799, South Korea.

出版信息

Asian J Androl. 2015 Jan-Feb;17(1):143-8. doi: 10.4103/1008-682X.135983.

Abstract

We compared the efficacy and safety between once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction (ED). A multi-center, randomized, open-label, parallel-group, 12-week study was conducted. 161 patients who improved with on-demand 200 mg of udenafil according to Sexual Encounter Profile (SEP) diary Question 2 and 3 (Q2 and Q3) were randomized into 200 mg on-demand (n = 80) or 50 mg once-daily (n = 81) dosing groups for 8 weeks. The dosing period was followed by a 4-week treatment-free period. The primary efficacy endpoint was the change of the International Index of Erectile Function (IIEF) erectile function domain (EFD) score. The secondary efficacy endpoints included changes to the SEP diary Q2, Q3, IIEF Q3, Q4, other domains of IIEF, Global Assessment Question, and shift to the normal rate (EFD ≥ 26). Vascular endothelial markers were also assessed. The IIEF-EFD score of both groups improved after 8 weeks of treatment (P < 0.0001). There was no statistically significant difference between two groups. Improvement was not maintained after the treatment-free follow-up period. Similar results were observed in the secondary efficacy endpoints. There was also no significant difference in vascular endothelial markers. Daily udenafil was well-tolerated, and there was no significant difference in the adverse drug reactions and adverse events between the two groups. Flushing and headache were the most frequent adverse events. Both regimens improved ED in diabetic patients and were well-tolerated. Further studies are needed to assess the effect of daily udenafil treatment in diabetic patients.

摘要

我们比较了他达拉非每日一次给药与按需使用对2型糖尿病勃起功能障碍(ED)患者的疗效和安全性。进行了一项多中心、随机、开放标签、平行组、为期12周的研究。161例根据性接触概况(SEP)日记问题2和3(Q2和Q3)按需服用200mg他达拉非后病情改善的患者被随机分为按需服用200mg组(n = 80)或每日一次服用50mg组(n = 81),为期8周。给药期后为4周的无治疗期。主要疗效终点是国际勃起功能指数(IIEF)勃起功能领域(EFD)评分的变化。次要疗效终点包括SEP日记Q2、Q3、IIEF Q3、Q4、IIEF其他领域、总体评估问题的变化以及转变为正常率(EFD≥26)。还评估了血管内皮标志物。两组的IIEF-EFD评分在治疗8周后均有所改善(P < 0.0001)。两组之间无统计学显著差异。在无治疗随访期后改善未得到维持。在次要疗效终点观察到类似结果。血管内皮标志物也无显著差异。每日服用他达拉非耐受性良好,两组之间的药物不良反应和不良事件无显著差异。潮红和头痛是最常见的不良事件。两种治疗方案均改善了糖尿病患者的ED且耐受性良好。需要进一步研究来评估每日服用他达拉非治疗糖尿病患者的效果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a71a/4291858/4e12cf95fd0e/AJA-17-143-g001.jpg

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