Emberton Mark, Fitzpatrick John M, Garcia-Losa Manuel, Qizilbash Nawab, Djavan Bob
Division of Surgery and Interventional Science, University College London, London, UK.
BJU Int. 2008 Sep;102(8):981-6. doi: 10.1111/j.1464-410X.2008.07717.x. Epub 2008 Jun 28.
To systematically review the placebo arms of randomized trials of medical therapy for benign prostatic hyperplasia (BPH) and thus estimate rates of progression.
We searched PubMed, the Cochrane Trials Register and the USA Food and Drug Administration website. Retrieved citations were reviewed in two stages: a title and abstract screen, followed by a review of selected full-length articles. The inclusion criterion for studies were trials of BPH with >100 patients in the placebo group.
From 1774 citations screened, 16 eligible studies were found with a total of 12 158 patients. The range of mean baseline age was 62.6-66.5 years, for prostate volume 33.9-61.0 mL and for maximum urinary flow 8.6-11.6 mL/s. With studies spanning 12-48 months, the rates of surgery were 1-10% and for acute urinary retention 0.4-6.6%. Most studies showed progression, based on a worsening in clinical outcomes of the change from baseline in prostate volume and maximum urinary flow. Statistical heterogeneity prevented a quantitative synthesis of the data.
This systematic review confirms BPH disease progression in the form of increased prostate volume, reduction in maximum urinary flow rate and an increase in the risk of acute urinary retention and surgery. To provide quantitative estimates of effect, access to data from individual participants would be required.
系统评价良性前列腺增生（BPH）药物治疗随机试验中的安慰剂组，从而估计疾病进展率。
我们检索了PubMed、Cochrane试验注册库和美国食品药品监督管理局网站。检索到的文献分两个阶段进行审查：标题和摘要筛选，随后对选定的全文进行审查。纳入研究的标准为安慰剂组患者超过100例的BPH试验。
在筛选的1774篇文献中，发现16项符合条件的研究，共12158例患者。平均基线年龄范围为62.6 - 66.5岁，前列腺体积为33.9 - 61.0 mL，最大尿流率为8.6 - 11.6 mL/s。研究持续时间为12 - 48个月，手术率为1% - 10%，急性尿潴留率为0.4% - 6.6%。基于前列腺体积和最大尿流率相对于基线变化的临床结局恶化情况，大多数研究显示疾病进展。统计异质性妨碍了对数据进行定量综合分析。
本系统评价证实了BPH以前列腺体积增大、最大尿流率降低以及急性尿潴留和手术风险增加的形式出现疾病进展。为了提供效应的定量估计，需要获取个体参与者的数据。
