他达拉非每日服用与按需服用治疗勃起功能障碍男性的长期疗效和耐受性的荟萃分析

Meta-Analysis of the Long-Term Efficacy and Tolerance of Tadalafil Daily Compared With Tadalafil On-Demand in Treating Men With Erectile Dysfunction.

作者信息

Zhou Zhongbao, Chen Hongyan, Wu Jitao, Wang Jipeng, Zhang Xuebao, Ma Jiajia, Cui Yuanshan

机构信息

Binzhou Medical University, Yantai, Shandong, China; Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.

Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Yantai, Shandong, China.

出版信息

Sex Med. 2019 Sep;7(3):282-291. doi: 10.1016/j.esxm.2019.06.006. Epub 2019 Jul 12.

DOI:10.1016/j.esxm.2019.06.006

PMID:31307951

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6728809/

Abstract

BACKGROUND

Erectile dysfunction (ED) is highly prevalent in aging men. Tadalafil daily and on-demand are widely used for the treatment of ED.

AIM

We performed a meta-analysis to evaluate the efficacy and safety of tadalafil daily compared with tadalafil on-demand in treating men with ED after at least 24 weeks of long-term treatment.

METHODS

Randomized controlled trials of tadalafil daily vs on-demand in treating men with ED were searched using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses. The data was calculated by RevMan version 5.3.0. The references of related articles were also searched.

OUTCOMES

International Index of Erectile Function-Erectile Function domain, sexual encounter profile question 2 (SEP2), SEP question 3 (SEP3), any treatment-emergent adverse event (AE), discontinuation due to AEs, myalgia, back pain, headache, dyspepsia, and nasopharyngitis.

RESULTS

4 articles, including 1,035 participants were studied. The analysis found that tadalafil daily had a greater improvement than tadalafil on-demand in terms of International Index of Erectile Function-Erectile Function (mean difference (MD) 1.24; 95% CI 0.03-2.44; P = .04), SEP2 (MD 10.08; 95% CI 9.15-11.01; P < .00001) and SEP3 (MD 8.19; 95% CI 2.09-14.29; P = .009) in treating ED after at least 24 weeks treatment cycle. For safety, tadalafil on-demand had a higher incidence of any treatment-emergent AE (odds ratio 0.73; 95% CI 0.56-0.96; P = .02) compared with tadalafil daily, but for other aspects, including discontinuation due to AEs, myalgia, back pain, headache, dyspepsia, and nasopharyngitis, there were no significant difference between the 2 treatments.

CLINICAL IMPLICATIONS

Tadalafil daily may offer a better effect for ED than on-demand for long-term treatment.

STRENGTHS AND LIMITATIONS

From the perspective of evidence-based medicine, we evaluated the efficacy and safety of tadalafil daily compared with tadalafil on-demand in treating men with ED after a long-term treatment. The quality of these studies included is flawed, primarily in difference in tadalafil doses and severity of the ED.

CONCLUSION

Tadalafil daily provides a preferable therapeutic effect for ED with a lower incidence of treatment-emergent side effects relative to tadalafil on-demand after at least 24 weeks of long-term treatment. Zhou Z, Chen H, Wu J, et al. Meta-Analysis of the Long-Term Efficacy and Tolerance of Tadalafil Daily Compared With Tadalafil On-Demand in Treating Men With Erectile Dysfunction. J Sex Med 2019;7:282-291.

摘要

背景

勃起功能障碍（ED）在老年男性中非常普遍。他达拉非每日服用和按需服用被广泛用于治疗ED。

目的

我们进行了一项荟萃分析，以评估长期治疗至少24周后，每日服用他达拉非与按需服用他达拉非治疗ED男性的疗效和安全性。

方法

使用MEDLINE、EMBASE和Cochrane对照试验注册库检索每日服用他达拉非与按需服用他达拉非治疗ED男性的随机对照试验。使用系统评价和荟萃分析的首选报告项目进行系统评价。数据由RevMan 5.3.0版计算。还检索了相关文章的参考文献。

结果指标

国际勃起功能指数-勃起功能领域、性经历概况问题2（SEP2）、SEP问题3（SEP3）、任何治疗中出现的不良事件（AE）、因AE停药、肌痛、背痛、头痛、消化不良和鼻咽炎。

结果

共研究了4篇文章，包括1035名参与者。分析发现，在至少24周的治疗周期后，每日服用他达拉非在国际勃起功能指数-勃起功能（平均差（MD）1.24；95%可信区间0.03-2.44；P = 0.04）、SEP2（MD 10.08；95%可信区间9.15-11.01；P < 0.00001）和SEP3（MD 8.19；95%可信区间2.09-14.29；P = 0.009）方面比按需服用他达拉非有更大改善。在安全性方面，与每日服用他达拉非相比，按需服用他达拉非出现任何治疗中出现的AE的发生率更高（优势比0.73；95%可信区间0.56-至0.96；P = 0.02），但在其他方面，包括因AE停药、肌痛、背痛、头痛、消化不良和鼻咽炎，两种治疗之间没有显著差异。