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5型磷酸二酯酶抑制剂短期和长期、规律和按需治疗方案在保留神经的根治性前列腺切除术后勃起功能障碍治疗中的疗效和安全性:一项系统评价和荟萃分析

Efficacy and safety of short- and long-term, regular and on-demand regimens of phosphodiesterase type 5 inhibitors in treating erectile dysfunction after nerve-sparing radical prostatectomy: a systematic review and meta-analysis.

作者信息

Tian Daxue, Wang Xiao-Yan, Zong Huan-Tao, Zhang Yong

机构信息

Beijing Tian Tan Hospital, Capital Medical University, Beijing, People's Republic of China.

出版信息

Clin Interv Aging. 2017 Feb 20;12:405-412. doi: 10.2147/CIA.S122273. eCollection 2017.

DOI:10.2147/CIA.S122273
PMID:28260869
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5325109/
Abstract

BACKGROUND

We performed a meta-analysis to evaluate the efficacy and safety of short-term (≤6 months) and long-term (>6 months), regular (OaD) and on-demand (PRN) regimens of phosphodiesterase type 5 inhibitors (PDE5-Is) in treating erectile dysfunction (ED) after nerve-sparing radical prostatectomy (NSRP).

METHODS

We conducted a literature search in August 2016. Sources included PubMed, EMBASE, and MEDLINE databases. The main outcome was International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, and the secondary outcome was treatment-emergent adverse events (TEAEs).

RESULTS

Eight articles involving 13 randomized controlled trials (RCTs) were used in this analysis: they suggested that PDE5-Is can improve the IIEF-EF distinctly in comparison with placebo in short and long term (mean difference [MD]: 2.26, 95% confidence interval [CI]: 1.45-3.08, <0.00001, and MD: 4.5, 95% CI: 3.6-5.4, <0.00001), and long-term use of PDE5-Is (>6 months) can improve the IIEF-EF distinctly in comparison with short-term use of PDE5-Is (≤6 months) (MD: 3.9, 95% CI: 3.01-4.8, <0.00001). OaD of PDE5-Is significantly improved the IIEF-EF compared to placebo in short and long term (MD: 4.08, 95% CI: 3.2-4.97, <0.00001, and MD: 4.74, 95% CI: 3.79-5.69, <0.00001). No significant differences were found in IIEF-EF changes between PRN and placebo (≤6 months) (MD: 2.64, 95% CI: -0.87 to 6.14, =0.14), and between PRN and OaD group (>6 months) (MD: -0.58, 95% CI: -9.86 to 8.74, =0.91). There were more TEAEs in PDE5-Is group in comparison with placebo (odds ratio [OR]: 1.55, 95% CI: 1.26-1.91, <0.0001), and TEAEs in OaD group were not significantly different from those seen in PRN group (OR: 1.05, 95% CI: 0.78-1.4, =0.77).

CONCLUSION

Our meta-analysis suggests that PDE5-Is are efficient and safe for treatment of ED after NSRP, and we should choose the regular regimen for short term and regular or on-demand regimen for long term. Further high-quality RCTs are needed to validate this result.

摘要

背景

我们进行了一项荟萃分析,以评估5型磷酸二酯酶抑制剂(PDE5-Is)短期(≤6个月)和长期(>6个月)、规律(每日一次)和按需(必要时)给药方案治疗保留神经的根治性前列腺切除术(NSRP)后勃起功能障碍(ED)的疗效和安全性。

方法

我们于2016年8月进行了文献检索。来源包括PubMed、EMBASE和MEDLINE数据库。主要结局是国际勃起功能指数-勃起功能(IIEF-EF)领域评分,次要结局是治疗中出现的不良事件(TEAEs)。

结果

本分析纳入了8篇文章,涉及13项随机对照试验(RCTs):结果表明,与安慰剂相比,PDE5-Is在短期和长期均能显著改善IIEF-EF(平均差值[MD]:2.26,95%置信区间[CI]:1.45-3.08,<0.00001;MD:4.5,95%CI:3.6-5.4,<0.00001),且与短期使用PDE5-Is(≤6个月)相比,长期使用PDE5-Is(>6个月)能显著改善IIEF-EF(MD:3.9,95%CI:3.01-4.8,<0.00001)。与安慰剂相比,PDE5-Is的规律给药在短期和长期均能显著改善IIEF-EF(MD:4.08,95%CI:3.2-4.97,<0.00001;MD:4.74,95%CI:3.79-5.69,<0.00001)。在按需给药与安慰剂(≤6个月)之间(MD:2.64,95%CI:-0.87至6.14,P=0.14)以及按需给药与规律给药组(>6个月)之间(MD:-0.58,95%CI:-9.86至8.74,P=0.91),IIEF-EF变化无显著差异。与安慰剂相比,PDE5-Is组的TEAEs更多(比值比[OR]:1.55,95%CI:1.26-1.91,<0.0001),且规律给药组的TEAEs与按需给药组无显著差异(OR:1.05,95%CI:0.78-1.4,P=0.77)。

结论

我们的荟萃分析表明,PDE5-Is治疗NSRP术后ED有效且安全,短期应选择规律给药方案,长期应选择规律或按需给药方案。需要进一步的高质量RCT来验证这一结果。

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