用于良性前列腺增生的β-谷甾醇。
Beta-sitosterols for benign prostatic hyperplasia.
作者信息
Wilt T, Ishani A, MacDonald R, Stark G, Mulrow C, Lau J
机构信息
General Internal Medicine, Department of Veterans Affairs Coordinating Center of the, One Veterans Drive, Minneapolis, Minnesota 55417, USA.
出版信息
Cochrane Database Syst Rev. 2000;1999(2):CD001043. doi: 10.1002/14651858.CD001043.
OBJECTIVES
This systematic review aimed to assess the effects of beta-sitosterols (B-sitosterol) on urinary symptoms and flow measures in men with of benign prostatic hyperplasia (BPH).
SEARCH STRATEGY
Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers.
SELECTION CRITERIA
Trials were eligible for inclusion provided they (1) randomized men with BPH to receive B-sitosterol preparations in comparison to placebo or other BPH medications, and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements.
DATA COLLECTION AND ANALYSIS
Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. Main outcome measure for comparing the effectiveness of B-sitosterols with placebo and standard BPH medications was the change in urologic symptom scale scores. Secondary outcomes included changes in nocturia as well as urodynamic measures (peak and mean urine flow, residual volume, prostate size). Main outcome measure for side effects was the number of men reporting side effects.
MAIN RESULTS
519 men from 4 randomized, placebo-controlled, double-blind trials, (lasting 4 to 26 weeks) were assessed. 3 trials used non-glucosidic B-sitosterols and one utilized a preparation that contained 100% B-sitosteryl-B-D-glucoside. B-Sitosterols improved urinary symptom scores and flow measures. The weighted mean difference (WMD) for the IPSS was -4.9 IPSS points (95%CI = -6.3 to -3.5, n = 2 studies). The WMD for peak urine flow was 3.91 ml/sec (95%CI = 0.91 to 6.90, n = 4 studies) and the WMD for residual volume was -28.62 ml (95%CI = -41. 42 to -15.83, n = 4 studies). The trial using 100% B-sitosteryl-B-D-glucoside (WA184) show improvement in urinary flow measures. B-sitosterols did not reduce prostate size. Withdrawal rates for men assigned to B-sitosterol and placebo were 7.8% and 8. 0%, respectively.
REVIEWER'S CONCLUSIONS: The evidence suggests non-glucosidic B-sitosterols improve urinary symptoms and flow measures. Their long term effectiveness, safety and ability to prevent BPH complications are not known.
目的
本系统评价旨在评估β-谷甾醇对良性前列腺增生（BPH）男性患者的泌尿症状及尿流指标的影响。
检索策略
通过计算机检索综合及专业数据库（MEDLINE、EMBASE、Cochrane图书馆、Phytodok），查阅参考文献，并联系药品制造商及研究人员来查找相关试验。
入选标准
符合以下条件的试验可纳入：（1）将BPH男性患者随机分组，使其接受β-谷甾醇制剂，与安慰剂或其他BPH药物进行比较；（2）纳入临床结局，如泌尿系统症状量表、症状或尿动力学测量结果。
数据收集与分析
至少两名独立评审员使用标准表格提取有关患者、干预措施及结局的信息。比较β-谷甾醇与安慰剂及标准BPH药物疗效的主要结局指标为泌尿系统症状量表评分的变化。次要结局包括夜尿变化以及尿动力学指标（尿流峰值和平均尿流率、残余尿量、前列腺大小）。副作用的主要结局指标为报告有副作用的男性患者数量。
主要结果
对来自4项随机、安慰剂对照、双盲试验（持续4至26周）的519名男性患者进行了评估。3项试验使用了非糖苷型β-谷甾醇，1项试验使用了含100%β-谷甾醇-β-D-葡萄糖苷的制剂。β-谷甾醇改善了泌尿症状评分及尿流指标。国际前列腺症状评分（IPSS）的加权平均差（WMD）为-4.9个IPSS评分点（95%置信区间=-6.3至-3.5，n = 2项研究）。尿流峰值的WMD为3.91 ml/秒（95%置信区间=0.91至6.90，n = 4项研究），残余尿量的WMD为-28.62 ml（95%置信区间=-41.42至-15.83，n = 4项研究）。使用100%β-谷甾醇-β-D-葡萄糖苷（WA184）的试验显示尿流指标有所改善。β-谷甾醇并未使前列腺体积缩小。分配至β-谷甾醇组和安慰剂组的男性患者的退出率分别为7.8%和8.0%。
综述作者结论
有证据表明非糖苷型β-谷甾醇可改善泌尿症状及尿流指标。其长期疗效、安全性及预防BPH并发症的能力尚不清楚。
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