用于治疗良性前列腺增生的5α-还原酶抑制剂：一项系统评价和荟萃分析

5α-Reductase Inhibitors for Treatment of Benign Prostatic Hyperplasia: A Systematic Review and Meta-Analysis.

作者信息

Jun Jennifer E J, Kinkade Angus, Tung Anthony C H, Tejani Aaron M

机构信息

BSc(Pharm), is with the Providence Crosstown Clinic, Vancouver, British Columbia.

BSc(Pharm), ACPR, PharmD, MSc, is with Lower Mainland Pharmacy Services, Vancouver, British Columbia.

出版信息

Can J Hosp Pharm. 2017 Mar-Apr;70(2):113-119. doi: 10.4212/cjhp.v70i2.1643. Epub 2017 Apr 28.

DOI:10.4212/cjhp.v70i2.1643

PMID:28487578

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5407420/

Abstract

BACKGROUND

Finasteride and dutasteride are competitive inhibitors of 5α-reductase enzymes and are commonly used to treat symptomatic benign prostatic hyperplasia (BPH).

OBJECTIVE

To compare the efficacy and safety of finasteride and dutasteride in terms of clinically important outcomes.

DATA SOURCES

A literature search was performed using the search terms "prostatic hyperplasia", "prostatic hypertrophy", "dutasteride", "finasteride", "quality of life", "adverse drug reaction", and "mortality". The Embase, PubMed, Cochrane Central Register of Controlled Trials, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature databases were searched from inception to December 2015.

STUDY SELECTION AND DATA EXTRACTION

Randomized controlled trials, quasi-randomized trials, and systematic reviews comparing finasteride with dutasteride, either as monotherapy or in combination with α-blockers, for treatment of men with BPH were included. The outcomes of interest included need for prostate-related surgery, episodes of acute urinary retention, withdrawals due to adverse events, number of patients experiencing serious adverse events, mortality, and sexual dysfunction.

DATA SYNTHESIS

Four studies involving a total of 1879 patients were included in the analysis. There were no significant differences in any of the clinically important outcomes examined: for prostate-related surgery, odds ratio (OR) 2.01 (95% confidence interval [CI] 0.18-22.24); for episodes of acute urinary retention, OR 1.47 (95% CI 0.68-3.19); for number of withdrawals due to adverse events, OR 1.10 (95% CI 0.68-1.75); for total number of patients experiencing adverse events, OR 0.94 (95% CI 0.78-1.14); for number of patients experiencing serious adverse events, OR 1.31 (95% CI 0.87-1.97); and for sexual dysfunction, OR 0.83 (95% CI 0.64-1.08).

CONCLUSION

There is insufficient evidence to suggest that either finasteride or dutasteride offers an advantage in efficacy or safety over the other, in terms of clinically important outcomes.

摘要

背景

非那雄胺和度他雄胺是5α-还原酶的竞争性抑制剂，常用于治疗有症状的良性前列腺增生（BPH）。

目的

比较非那雄胺和度他雄胺在临床重要结局方面的疗效和安全性。

数据来源

使用检索词“前列腺增生”“前列腺肥大”“度他雄胺”“非那雄胺”“生活质量”“药物不良反应”和“死亡率”进行文献检索。检索了Embase、PubMed、Cochrane对照试验中心注册库、国际药学文摘、护理及相关健康文献累积索引以及拉丁美洲和加勒比健康科学文献数据库，检索时间从建库至2015年12月。

研究选择和数据提取

纳入比较非那雄胺与度他雄胺作为单一疗法或与α受体阻滞剂联合使用治疗BPH男性患者的随机对照试验、半随机试验和系统评价。感兴趣的结局包括前列腺相关手术的需求、急性尿潴留发作、因不良事件退出研究、发生严重不良事件的患者数量、死亡率和性功能障碍。

数据综合

分析纳入了4项研究，共1879例患者。在任何一项所检查的临床重要结局方面均无显著差异：前列腺相关手术，比值比（OR）2.01（95%置信区间[CI]0.18 - 22.24）；急性尿潴留发作，OR 1.47（95%CI 0.68 - 3.19）；因不良事件退出研究的数量，OR 1.10（95%CI 0.68 - 1.75）；发生不良事件的患者总数，OR 0.94（95%CI 0.78 - 1.14）；发生严重不良事件的患者数量，OR 1.31（95%CI 0.87 - 1.97）；性功能障碍，OR 0.83（95%CI 0.64 - 1.08）。