西地那非规律服用治疗勃起功能障碍疗效及安全性评估
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摘要
目的:探讨西地那非规律服用治疗阴茎勃起功能障碍(ED)的疗效及安全性。方法:334例ED患者随机分为3组,分别给予西地那非50 mg每日1次口服(西地那非规律治疗组,n=111)、西地那非100 mg性生活前30 min口服(西地那非按需治疗组,n=102)、他达拉非10 mg每日1次口服(他达拉非规律治疗组,n=121)。3个月后评估国际勃起功能指数(IIEF-5)评分、阴茎勃起硬度评分(EHS)以及不良反应等。结果:334例ED患者中316例获得随访,3组患者年龄、BMI、受教育情况、病程、失访率、基线IIEF-5评分及EHS评分无统计学差异(P>0.05)。3组患者治疗后IIEF-5评分及EHS评分均较治疗前明显改善,差异有统计学意义(P<0.05)。治疗后西地那非规律治疗组、西地那非按需治疗组及他达拉非规律治疗组IIEF-5评分[(15.15±2.05)分vs(15.55±2.36)分vs(15.54±2.27)分]无统计学差异(P>0.05),但西地那非规律治疗组EHS评分[(3.12±1.52)分]低于西地那非按需治疗组[(3.48±1.80)分](P<0.05)。西地那非规律治疗组、西地那非按需治疗组及他达拉非规律治疗组治疗有效率分别为76.2%、62.4%和80.8%,西地那非按需治疗组明显低于其他两组(P<0.05)。3组不良反应均较轻微,且3组之间不良反应发生率无明显统计学差异(P>0.05)。结论:西地那非规律治疗与他达拉非规律治疗疗效相当,优于西地那非按需治疗,且不良反应无明显增加,是一种值得推荐的ED治疗方法。
Objective: To investigate the efficacy and safety of regular oral use of sildenafil in the treatment of ED. Methods: We randomly divided 334 ED patients into three groups to be treated orally with sildenafil tablets at 50 mg qd(sildenafil regular), sildenafil tablets at 100 mg 30 minutes before intercourse(sildenafil on-demand), and tadalafil tablets at 10 mg qd(tadalafil regular), all for 3 months. Then we recorded the IIEF-5 score and penile erection hardness score(EHS) and adverse reactions and compared them among the three groups of patients. Results: There were no statistically significant differences among the three groups of patients in age, body mass index, education, ED duration, or baseline IIEF-5 and EHS(P > 0.05). After 3-month medication, both IIEF-5 score and EHS were significantly improved in the three groups of patients as compared with the baseline(P < 0.05), with no statistically significant difference in the IIEF-5 score among the sildenafil regular, sildenafil on-demand and tadalafil regular groups(15.15 ± 2.05 vs 15.55 ± 2.36 vs 15.54 ± 2.27, P > 0.05), but the EHS markedly higher in the sildenafil on-demand than in the sildenafil regular group(3.48 ± 1.80 vs 3.12 ± 1.52, P < 0.05). The effectiveness rates in the sildenafil regular, sildenafil on-demand and tadalafil regular groups were 76.2%, 62.4% and 80.8%, respectively, significantly lower in the sildenafil on-demand than in the other two groups(P < 0.05). Adverse reactions were mild and showed no statistically significant difference in the incidence rate among the three groups(P > 0.05). Conclusion: Regular use of sildenafil has a therapeutic effect similar to that of tadalafil but better than that of sildenafil on-demand, without more adverse effects.
Objective: To investigate the efficacy and safety of regular oral use of sildenafil in the treatment of ED. Methods: We randomly divided 334 ED patients into three groups to be treated orally with sildenafil tablets at 50 mg qd(sildenafil regular), sildenafil tablets at 100 mg 30 minutes before intercourse(sildenafil on-demand), and tadalafil tablets at 10 mg qd(tadalafil regular), all for 3 months. Then we recorded the IIEF-5 score and penile erection hardness score(EHS) and adverse reactions and compared them among the three groups of patients. Results: There were no statistically significant differences among the three groups of patients in age, body mass index, education, ED duration, or baseline IIEF-5 and EHS(P > 0.05). After 3-month medication, both IIEF-5 score and EHS were significantly improved in the three groups of patients as compared with the baseline(P < 0.05), with no statistically significant difference in the IIEF-5 score among the sildenafil regular, sildenafil on-demand and tadalafil regular groups(15.15 ± 2.05 vs 15.55 ± 2.36 vs 15.54 ± 2.27, P > 0.05), but the EHS markedly higher in the sildenafil on-demand than in the sildenafil regular group(3.48 ± 1.80 vs 3.12 ± 1.52, P < 0.05). The effectiveness rates in the sildenafil regular, sildenafil on-demand and tadalafil regular groups were 76.2%, 62.4% and 80.8%, respectively, significantly lower in the sildenafil on-demand than in the other two groups(P < 0.05). Adverse reactions were mild and showed no statistically significant difference in the incidence rate among the three groups(P > 0.05). Conclusion: Regular use of sildenafil has a therapeutic effect similar to that of tadalafil but better than that of sildenafil on-demand, without more adverse effects.
引文
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[2] 龚知城,钟义洋,赵善超.勃起功能障碍药物治疗的研究现状.分子影像学杂志,2018,41 (2):201-206.
[3] Vardi Y,Appel B,Ofer Y,et al.Effect of chronic sildenafil treatment on penile endothelial function:A randomized,double-blind,placebo controlled study.J Urol,2009,182(6):2850-2855.
[4] Qiu S,Tang Z,Deng L,et al.Comparisons of regular and on-demand regimen of PED5-Is in the treatment of ED after nerve-sparing radical prostatectomy for Prostate Cancer.Sci Rep,2016,6:32853.
[5] 蔡阳,王涛,刘继红.男性性功能障碍相关问卷的应用进展.中华男科学杂志,2014,20(9):840-845.
[6] Peng Z,Yang L,Dong Q,et al.Efficacy and safety of Tadalafil once-a-day versus Tadalafil on-demand in patients with erectile dysfunction:A systematic review and meta-analyses.Urol Int,2017,99(3):343-352.
[7] 姜睿.长期低剂量PDE5抑制剂治疗勃起功能障碍的新进展.中华男科学杂志,2013,19(3):195-198.
[8] Gong B,Ma M,Xie W,et al.Direct comparison of tadalafil with sildenafil for the treatment of erectile dysfunction:A systematic review and meta-analysis.Int Urol Nephrol,2017,49(10):1731-1740.
[9] 饶可,杜广辉,杨为民.夜间阴茎勃起监测在勃起功能障碍诊治中的进展.中华男科学,2004,10(2):142-146.
[10] 郭军,王瑞.男性性功能障碍诊断与治疗.第3版.北京:人民军医出版社,2012.58
[11] 陆笑非.血管性阴茎勃起功能障碍血流动力学检查运用及研究进展.医学影像学杂志,2014,24(10):1842-1844.
[12] 中华医学会男科学分会.中国男科疾病诊断治疗指南与专家共识(2016版).北京:人民卫生出版社,2017.9
[13] Olsson AM,Speakman MJ,Dinsmore WW,et al.Sildenafil citrate (Viagra) is effective and well tolerated for treating erectile dysfunction of psychogenic or mixed aetiology.Int J Clin Pract,2000,54(9):561-566.
[14] Konstantinopoulos A,Giannitsas K,Athanasopoulos A,et al.The impact of daily sildenafil on levels of soluble molecular markers of endothelial function in plasma in patients with erectile dysfunction.Expert Opin Pharmacother,2009,10(2):155-160.
[15] Ferrini MG,Kovanecz I,Sanchez S,et al.Long-term continuous treatment with sildenafil ameliorates aging-related erectile dysfunction and the underlying corporal fibrosis in the rat.Biol Reprod,2007,76(5):915-923.
[2] 龚知城,钟义洋,赵善超.勃起功能障碍药物治疗的研究现状.分子影像学杂志,2018,41 (2):201-206.
[3] Vardi Y,Appel B,Ofer Y,et al.Effect of chronic sildenafil treatment on penile endothelial function:A randomized,double-blind,placebo controlled study.J Urol,2009,182(6):2850-2855.
[4] Qiu S,Tang Z,Deng L,et al.Comparisons of regular and on-demand regimen of PED5-Is in the treatment of ED after nerve-sparing radical prostatectomy for Prostate Cancer.Sci Rep,2016,6:32853.
[5] 蔡阳,王涛,刘继红.男性性功能障碍相关问卷的应用进展.中华男科学杂志,2014,20(9):840-845.
[6] Peng Z,Yang L,Dong Q,et al.Efficacy and safety of Tadalafil once-a-day versus Tadalafil on-demand in patients with erectile dysfunction:A systematic review and meta-analyses.Urol Int,2017,99(3):343-352.
[7] 姜睿.长期低剂量PDE5抑制剂治疗勃起功能障碍的新进展.中华男科学杂志,2013,19(3):195-198.
[8] Gong B,Ma M,Xie W,et al.Direct comparison of tadalafil with sildenafil for the treatment of erectile dysfunction:A systematic review and meta-analysis.Int Urol Nephrol,2017,49(10):1731-1740.
[9] 饶可,杜广辉,杨为民.夜间阴茎勃起监测在勃起功能障碍诊治中的进展.中华男科学,2004,10(2):142-146.
[10] 郭军,王瑞.男性性功能障碍诊断与治疗.第3版.北京:人民军医出版社,2012.58
[11] 陆笑非.血管性阴茎勃起功能障碍血流动力学检查运用及研究进展.医学影像学杂志,2014,24(10):1842-1844.
[12] 中华医学会男科学分会.中国男科疾病诊断治疗指南与专家共识(2016版).北京:人民卫生出版社,2017.9
[13] Olsson AM,Speakman MJ,Dinsmore WW,et al.Sildenafil citrate (Viagra) is effective and well tolerated for treating erectile dysfunction of psychogenic or mixed aetiology.Int J Clin Pract,2000,54(9):561-566.
[14] Konstantinopoulos A,Giannitsas K,Athanasopoulos A,et al.The impact of daily sildenafil on levels of soluble molecular markers of endothelial function in plasma in patients with erectile dysfunction.Expert Opin Pharmacother,2009,10(2):155-160.
[15] Ferrini MG,Kovanecz I,Sanchez S,et al.Long-term continuous treatment with sildenafil ameliorates aging-related erectile dysfunction and the underlying corporal fibrosis in the rat.Biol Reprod,2007,76(5):915-923.