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撤稿:特拉唑嗪用于良性前列腺增生症。

WITHDRAWN: Terazosin for benign prostatic hyperplasia.

作者信息

Wilt Timothy J, Howe R William, Rutks Indy, Macdonald Roderick

机构信息

General Internal Medicine (111-0), VAMC, One Veterans Drive, Minneapolis, Minnesota, USA, 55417.

出版信息

Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD003851. doi: 10.1002/14651858.CD003851.pub2.

DOI:10.1002/14651858.CD003851.pub2
PMID:21901686
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10680428/
Abstract

BACKGROUND

Lower urinary tract symptoms associated with benign prostatic obstruction (BPO) occur in up to 70% of men over the age of 60 years. To relieve these bothersome symptoms, treatment options include alpha-antagonists, also know as alpha-blockers.

OBJECTIVES

We conducted a systematic review to evaluate the effectiveness and adverse effects of the alpha-blocker, terazosin, for treatment of urinary symptoms associated with BPO.

SEARCH STRATEGY

Trials were searched in computerized general and specialized databases (MEDLINE, Cochrane Library), by checking bibliographies, and by contacting manufacturers and researchers.

SELECTION CRITERIA

Studies were included if they (1) were randomized trials of at least 1 month duration, and (2) included men with symptomatic BPO and compared terazosin with placebo or active controls.

DATA COLLECTION AND ANALYSIS

Study, patient characteristics and outcomes data were extracted in duplicate onto standardized forms utilizing a prospectively developed protocol. The main outcome measure for comparing the effectiveness of terazosin with placebo or other BPO medications was change in urological symptoms as measured by validated symptom scores. Secondary outcomes included urodynamic measures. The main outcome measure for adverse effects was the number of men reporting side effects. We also evaluated the number of men withdrawing from treatment and the number withdrawing due to adverse effects.

MAIN RESULTS

Seventeen studies involving 5151 subjects met inclusion criteria (placebo-controlled (n = 10); alpha-blockers (n = 7); finasteride alone or in combination with terazosin as well as placebo (1); microwave therapy (TUMT) (1). Study duration ranged from 4 to 52 weeks. Mean age was 65 years and 82% of men were white. Baseline urologic symptom scale scores and flow rates demonstrated that men had moderate BPO. Efficacy outcomes were rarely reported in a fashion that allowed for data pooling but indicated that terazosin improved symptom scores and flow rates more than placebo or finasteride and similarly to other alpha antagonists. The pooled mean percentage improvements for the Boyarsky symptom score was 37% for terazosin versus 15% for placebo (n = 4 studies). The mean percentage improvement for the American Urological Association symptom score (AUA) was 38% compared to 17% and 20% for placebo and finasteride, respectively (n = 2 studies). The pooled mean improvement in the International Prostate Symptom Score (IPSS) (40%) was similar to tamsulosin (43%). Peak urine flow rates improved greater with terazosin (22%), than placebo (11%) and finasteride (15%) but did not differ significantly from the other alpha-blockers. The percentage of men discontinuing terazosin was comparable to men receiving placebo and finasteride but was greater then with other alpha-antagonists. Adverse effects were greater than placebo and included dizziness, asthenia, headache, and postural hypotension.

AUTHORS' CONCLUSIONS: The available evidence suggests that terazosin improves urinary symptoms and flow measures associated with BPO. Effectiveness is superior to placebo or finasteride, similar to other alpha-blockers but less than TUMT. Adverse effects were generally mild but more frequent than other alpha-blockers and associated with between a two-to-four fold increase in treatment discontinuation.

摘要

背景

与良性前列腺梗阻(BPO)相关的下尿路症状在60岁以上男性中发生率高达70%。为缓解这些令人烦恼的症状,治疗选择包括α-拮抗剂,也称为α-阻滞剂。

目的

我们进行了一项系统评价,以评估α-阻滞剂特拉唑嗪治疗与BPO相关的尿路症状的有效性和不良反应。

检索策略

通过检索计算机化的综合和专业数据库(MEDLINE、Cochrane图书馆)、查阅参考文献以及联系制造商和研究人员来查找试验。

入选标准

纳入的研究需满足以下条件:(1)为至少持续1个月的随机试验;(2)纳入有症状性BPO的男性,并将特拉唑嗪与安慰剂或活性对照进行比较。

数据收集与分析

利用预先制定的方案,将研究、患者特征和结局数据一式两份提取到标准化表格中。比较特拉唑嗪与安慰剂或其他BPO药物有效性的主要结局指标是通过经过验证的症状评分衡量的泌尿系统症状变化。次要结局包括尿动力学指标。不良反应的主要结局指标是报告有副作用的男性人数。我们还评估了退出治疗的男性人数以及因不良反应而退出的人数。

主要结果

17项涉及5151名受试者的研究符合纳入标准(安慰剂对照试验10项;α-阻滞剂对照试验7项;非那雄胺单独或与特拉唑嗪联合以及安慰剂对照试验1项;微波治疗(经尿道微波热疗)对照试验1项)。研究持续时间为4至52周。平均年龄为65岁,82%为白人男性。基线泌尿系统症状量表评分和流速表明男性患有中度BPO。疗效结局很少以允许数据合并的方式报告,但表明特拉唑嗪比安慰剂或非那雄胺更能改善症状评分和流速,与其他α-拮抗剂相似。特拉唑嗪组Boyarsky症状评分的合并平均改善百分比为37%,而安慰剂组为15%(4项研究)。美国泌尿外科学会症状评分(AUA)的平均改善百分比分别为38%,安慰剂组为17%,非那雄胺组为20%(2项研究)。国际前列腺症状评分(IPSS)的合并平均改善率(40%)与坦索罗辛(43%)相似。特拉唑嗪组的最大尿流率改善幅度(22%)大于安慰剂组(11%)和非那雄胺组(15%),但与其他α-阻滞剂无显著差异。停用特拉唑嗪的男性百分比与接受安慰剂和非那雄胺的男性相当,但高于其他α-拮抗剂。不良反应比安慰剂多,包括头晕、乏力、头痛和体位性低血压。

作者结论

现有证据表明特拉唑嗪可改善与BPO相关的尿路症状和流速指标。有效性优于安慰剂或非那雄胺,与其他α-阻滞剂相似,但低于经尿道微波热疗。不良反应一般较轻,但比其他α-阻滞剂更频繁,且导致治疗中断的人数增加了两到四倍。

相似文献

1
WITHDRAWN: Terazosin for benign prostatic hyperplasia.撤稿:特拉唑嗪用于良性前列腺增生症。
Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD003851. doi: 10.1002/14651858.CD003851.pub2.
2
Terazosin for benign prostatic hyperplasia.特拉唑嗪用于治疗良性前列腺增生。
Cochrane Database Syst Rev. 2002(4):CD003851. doi: 10.1002/14651858.CD003851.
3
Terazosin for treating symptomatic benign prostatic obstruction: a systematic review of efficacy and adverse effects.特拉唑嗪治疗有症状的良性前列腺梗阻:疗效和不良反应的系统评价
BJU Int. 2002 Feb;89(3):214-25.
4
WITHDRAWN: Tamsulosin for benign prostatic hyperplasia.撤回:坦索罗辛用于良性前列腺增生。
Cochrane Database Syst Rev. 2011 Sep 7;2011(9):CD002081. doi: 10.1002/14651858.CD002081.pub2.
5
Finasteride for benign prostatic hyperplasia.非那雄胺用于良性前列腺增生症。
Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD006015. doi: 10.1002/14651858.CD006015.pub3.
6
Tamsulosin for benign prostatic hyperplasia.坦索罗辛用于良性前列腺增生症。
Cochrane Database Syst Rev. 2003(1):CD002081. doi: 10.1002/14651858.CD002081.
7
Doxazosin for treating lower urinary tract symptoms compatible with benign prostatic obstruction: a systematic review of efficacy and adverse effects.多沙唑嗪治疗与良性前列腺梗阻相关的下尿路症状:疗效和不良反应的系统评价
BJU Int. 2004 Dec;94(9):1263-70. doi: 10.1111/j.1464-410X.2004.05154.x.
8
Pygeum africanum for benign prostatic hyperplasia.非洲臀果木治疗良性前列腺增生症。
Cochrane Database Syst Rev. 2002;1998(1):CD001044. doi: 10.1002/14651858.CD001044.
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Serenoa repens for benign prostatic hyperplasia.用于良性前列腺增生的锯叶棕。
Cochrane Database Syst Rev. 2009 Apr 15(2):CD001423. doi: 10.1002/14651858.CD001423.pub2.
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Naftopidil for the treatment of lower urinary tract symptoms compatible with benign prostatic hyperplasia.萘哌地尔用于治疗与良性前列腺增生相关的下尿路症状。
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