Department of Urology, Klinikum Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
Eur Urol. 2013 Aug;64(2):228-43. doi: 10.1016/j.eururo.2013.01.018. Epub 2013 Jan 25.
Several drugs are approved for the treatment of lower urinary tract symptoms (LUTS) in men, but these are mostly used by clinicians as monotherapies. The combination of different compounds, each of which targets a different aspect of LUTS, seems appealing. However, only few clinical trials have evaluated the effects of combination therapies.
This systematic review analyzes the efficacy and adverse events of combination therapies for male LUTS.
PubMed and Cochrane databases were used to identify clinical trials and meta-analyses on male LUTS combination therapy. The search was restricted to studies of level of evidence ≥ 1b. A total of 49 papers published between January 1988 and March 2012 were identified.
The α1-adrenoceptor antagonist (α1-blocker)/5α-reductase inhibitor (5-ARI) combination provides the most data. This combination seems to be more efficacious in terms of several outcome variables in patients whose prostate volume is between 30 ml and 40 ml when treatment is maintained for >1 yr; when given for <1 yr, α1-blockers alone are just as effective. The combination of α1-blocker/5-ARI shows a slightly increased rate of adverse events. It remains unknown whether its safety and superiority over either drug as monotherapy are sustained after >6 yr. The α1-blocker/muscarinic receptor antagonist (antimuscarinic) combination was most frequently assessed as an add-on therapy to already existing α1-blocker therapy. Inconsistent data derive from heterogeneous study populations and different study designs. Currently, the α1-blocker/antimuscarinic combination appears to be a second-line add-on for patients with insufficient symptom relief after monotherapy. The combination seems to be safe in men with postvoid residual <200 ml. However, there are no trials >4 mo concerning safety and efficacy of this combination. The α1-blocker/phosphodiesterase type 5 inhibitor combination is a new treatment option with only preliminary reports. More studies are needed before definitive conclusions can be drawn.
An α1-blocker/5-ARI combination is beneficial for patients whose prostate volume is between 30 ml and 40 ml when medical treatment is intended for >1 yr. Based on short-term follow-up studies, add-on of antimuscarinics to α1-blockers is an option when postvoid residual is <200 ml.
有几种药物被批准用于治疗男性下尿路症状（LUTS），但这些药物大多仅被临床医生用作单一疗法。将不同化合物组合使用，每种化合物针对 LUTS 的不同方面，这似乎很有吸引力。然而，只有少数临床试验评估了联合疗法的效果。
本系统评价分析了男性 LUTS 联合疗法的疗效和不良反应。
使用 PubMed 和 Cochrane 数据库确定了男性 LUTS 联合治疗的临床试验和荟萃分析。检索仅限于证据水平≥1b 的研究。共确定了 1988 年 1 月至 2012 年 3 月期间发表的 49 篇论文。
α1-肾上腺素能受体拮抗剂（α1 阻滞剂）/5α-还原酶抑制剂（5-ARI）联合治疗提供了最多的数据。对于前列腺体积在 30ml 至 40ml 之间且治疗持续时间超过 1 年的患者，这种联合治疗在几个结局变量方面似乎更有效；治疗持续时间不到 1 年时，单独使用α1 阻滞剂同样有效。α1 阻滞剂/5-ARI 联合治疗的不良反应发生率略有增加。尚不清楚其安全性和作为单一疗法的优越性是否在超过 6 年后仍然存在。α1 阻滞剂/毒蕈碱受体拮抗剂（抗毒蕈碱）联合治疗最常被评估为已有α1 阻滞剂治疗的附加治疗。不一致的数据源于异质的研究人群和不同的研究设计。目前，对于单一疗法治疗后症状缓解不足的患者，α1 阻滞剂/抗毒蕈碱联合治疗似乎是二线附加治疗。对于残余尿量<200ml 的男性，联合治疗似乎是安全的。然而，目前还没有关于这种联合治疗的安全性和疗效的超过 4 个月的试验。α1 阻滞剂/磷酸二酯酶 5 抑制剂联合治疗是一种新的治疗选择，仅有初步报告。需要更多的研究才能得出明确的结论。
对于前列腺体积在 30ml 至 40ml 之间且预计治疗时间超过 1 年的患者，α1 阻滞剂/5-ARI 联合治疗有益。基于短期随访研究，当残余尿量<200ml 时，α1 阻滞剂加用抗毒蕈碱是一种选择。
