Jagdish Rakesh Kumar, Kamaal Ahmed, Shasthry Saggere Muralikrishna, Benjamin Jaya, Maiwall Rakhi, Jindal Ankur, Choudhary Ashok, Rajan Vijayaraghavan, Arora Vinod, Bhardwaj Ankit, Kumar Guresh, Kumar Manoj, Sarin Shiv K
Department of Hepatology and Liver Transplantation, Institute of Liver and Biliary Sciences, D1 Vasant Kunj, New Delhi, 110070, India.
Department of Urology, Institute of Liver and Biliary Sciences, New Delhi, India.
Hepatol Int. 2023 Apr;17(2):434-451. doi: 10.1007/s12072-021-10264-w. Epub 2021 Nov 14.
Patients with cirrhosis have high prevalence of erectile dysfunction (ED). The aim of this study was to study the efficacy and safety of tadalafil for ED in patients with cirrhosis.
140 cirrhotic males with ED were randomized into tadalafil 10 mg daily (n = 70) or placebo (n = 70) for 12 weeks. ED was diagnosed if erectile function (EF) domain score was < 25 in International Index of Erectile Function (IIEF) questionnaire. The erectile function domain consists of six questions concerning erection frequency, erection firmness, frequency of partner penetration, frequency of maintaining erection after penetration, ability to maintain erection to completion of intercourse and confidence in achieving and maintaining erection. Primary outcome was proportion of patients having an increase in > 5 points in EF domain of the IIEF. Generalized Anxiety Disorder 7 (GAD-7) questionnaire was used for screening and severity measuring of GAD. The presence of depression was screened using the Patient Health Questionnaire (PHQ-9) and the assessment of health related quality of life was done using the Short Form (36) Health Survey.
At the end of 12 weeks, more patients in tadalafil group achieved > 5 points increase in the EF domain of the IIEF when compared with the placebo group [44(62.9%) vs. 21(30%), p < 0.001]. At the end of 12 weeks, patients receiving tadalafil had significantly more change in scores on the erectile function domain, orgasmic function domain, intercourse satisfaction domain, overall satisfaction domain, erection vaginal penetration rates and successful intercourse; significantly more decline in the GAD-7 and PHQ-9 scores; significantly more improvement in scores of five of the eight domains of SF-36 (general health perception, vitality score, social functioning, role emotional and mental health) and the mental component summary rates when compared with placebo. The development of side effects and the changes in HVPG were not significantly different between the two groups.
Tadalafil therapy may enhance erectile function, improve anxiety, depression and quality of life; and is well tolerated by men with cirrhosis (CTP score < 10) and ED. However, further larger and long-term studies are needed to confirm these results and look for rarer side effects of using tadalafil in patients with cirrhosis.
ClinicalTrials.gov identifier number NCT03566914; first posted date: June 25, 2018.
肝硬化患者勃起功能障碍（ED）的患病率较高。本研究旨在探讨他达拉非治疗肝硬化患者ED的疗效和安全性。
140例患有ED的肝硬化男性患者被随机分为两组，一组每日服用10mg他达拉非（n = 70），另一组服用安慰剂（n = 70），为期12周。如果国际勃起功能指数（IIEF）问卷中的勃起功能（EF）领域得分<25，则诊断为ED。勃起功能领域由六个问题组成，涉及勃起频率、勃起硬度、伴侣插入频率、插入后维持勃起的频率、维持勃起至性交完成的能力以及实现和维持勃起的信心。主要结局是IIEF的EF领域得分增加>5分的患者比例。使用广泛性焦虑障碍7（GAD-7）问卷进行广泛性焦虑症的筛查和严重程度测量。使用患者健康问卷（PHQ-9）筛查抑郁症的存在，并使用简短形式（36）健康调查进行健康相关生活质量的评估。
12周结束时，与安慰剂组相比，他达拉非组有更多患者的IIEF的EF领域得分增加>5分[44（62.9%）对21（30%），p<0.001]。12周结束时，接受他达拉非治疗的患者在勃起功能领域、性高潮功能领域、性交满意度领域、总体满意度领域、勃起阴道插入率和成功性交方面的得分变化显著更大；GAD-7和PHQ-9得分显著下降更多；与安慰剂相比，SF-36的八个领域中的五个领域（一般健康感知、活力得分、社会功能、角色情感和心理健康）的得分以及心理成分汇总率显著改善更多。两组之间副作用的发生情况和肝静脉压力梯度（HVPG）的变化没有显著差异。
他达拉非治疗可能增强勃起功能，改善焦虑、抑郁和生活质量；并且肝硬化（CTP评分<10）合并ED的男性对其耐受性良好。然而，需要进一步更大规模和长期的研究来证实这些结果，并寻找他达拉非在肝硬化患者中使用的罕见副作用。
ClinicalTrials.gov标识符编号NCT03566914；首次发布日期：2018年6月25日。
