Adverse events associated with testosterone replacement in middle-aged and older men: A meta-analysis of randomized, placebo-controlled trials
Adverse events associated with testosterone replacement in middle-aged and older men: A meta-analysis of randomized, placebo-controlled trials
复制标题
DOI：
10.1093/gerona/60.11.1451
复制
发表时间：
2005-11-01
影响因子：
5.1
通讯作者：
Bhasin, S
中科院分区：
文献类型：
--
作者：
Calof, OM;Singh, AB;Bhasin, S
背景我们对随机临床试验进行了荟萃分析，以确定老年男性睾酮替代治疗相关不良事件的风险。检索MEDLINE数据库，检索时间为1966年至2004年4月，使用睾酮作为索引词;范围包括人类、男性、≥ 45岁和随机对照试验。在417项研究中，19项符合纳入标准：睾酮替代至少90天，男性>= 45岁，睾酮水平低或正常，随机对照试验，医学稳定的男性。优势比（OR）采用随机效应模型进行汇总，假设研究间的结果不均匀，并根据样本量进行加权。在19项符合入选标准的研究中，651名男性接受睾酮治疗，433名男性接受安慰剂治疗。睾酮治疗男性的所有前列腺事件的合并发生率显著高于安慰剂治疗男性（OR = 1.78，95%置信区间[Cl]，1.07-2.95）。睾酮组的前列腺癌、前列腺特异性抗原（PSA）>4 ng/ml和前列腺活检的发生率在数值上高于安慰剂组，尽管两组之间的差异没有统计学意义。睾酮治疗的男性红细胞压积>50%的可能性几乎是安慰剂治疗男性的四倍（OR = 3.69，95%CI，1.82-7.51）。心血管事件、睡眠呼吸暂停或死亡的发生率在两组之间无显著差异。与wits安慰剂相比，老年男性中睾酮替代与前列腺事件和红细胞压积>50%的检测风险显著较高相关;红细胞压积升高是睾酮替代相关的最常见不良事件。这些数据再次证实，需要监测血细胞比容，PSA和前列腺的数字检查在睾酮替代老年男性。
Background. We performed a meta-analysis of randomized clinical trials to determine the risks of adverse events associated with testosterone replacement in older men.Methods. The MEDLINE database was searched front 1966 to April 2004, using testosterone as the indexing term; limits included human, male, >= 45 years old, and randomized controlled trial. Of the 417 studies thus identified, 19 met the inclusion criteria: testosterone replacement for at least 90 days, men >= 45 years old with low or low-normal testosterone level, randomized controlled trial, and medically stable men. Odds ratios (ORs) were pooled using a random effects model, assuming heterogeneous results across studies, and were weighted for sample size.Results. In the 19 studies that met eligibility criteria, 65 1 men were treated with testosterone and 433 with placebo. The combined rate of all prostate events was significantly greater in testosterone-treated men than in placebo-treated men (OR = 1.78, 95% confidence interval [Cl], 1.07-2.95). Rates of prostate cancer, prostate-specific antigen (PSA) >4 ng/ml, and prostate biopsies were numerically higher in the testosterone group than in the placebo group, although differences between the groups were not individually statistically significant. Testosterone-treated men were nearly four times as likely to have hematocrit >50% as placebo-treated men (OR = 3.69, 95% CI, 1.82-7.51). The frequency of cardiovascular events, sleep apnea or death was not significantly different between the two groups.Conclusions. Testosterone replacement in older men was associated with a significantly higher risk of detection of prostate events and of hematocrit >50% than wits placebo; hematocrit increase was the most frequent adverse event associated with testosterone replacement. These data reaffirm the need to monitor hematocrit, PSA, and digital examination of the prostate during testosterone replacement in older men.