University of Miami, Miller School of Medicine, Miami, Florida.
Brady Urological Institute, Johns Hopkins Medicine, Baltimore, Maryland.
J Urol. 2022 Jan;207(1):44-51. doi: 10.1097/JU.0000000000002188. Epub 2021 Aug 27.
We sought to compare testosterone formulations and determine the degree that hematocrit increases vary by testosterone therapy formulation. As head-to-head trials are rare, network meta-analysis of the contemporary studies is the only way to compare hematocrit changes by testosterone type, including topical gels and patches, injectables (both short-acting and long-acting) and oral tablets.
We conducted a thorough search of listed publications in Scopus®, PubMed®, Embase®, Cochrane CENTRAL, and ClinicalTrials.gov. A total of 29 placebo-controlled randomized trials (3,393 men) met inclusion criteria for analysis of mean hematocrit change after testosterone therapy. Randomized controlled trial data for the following formulations of testosterone were pooled via network meta-analysis: gel, patch, oral testosterone undecanoate, intramuscular testosterone undecanoate, and intramuscular testosterone enanthate/cypionate.
All types of testosterone therapies result in statistically significant increases in mean hematocrit when compared with placebo. Meta-analysis revealed all formulations, including gel (3.0%, 95% CI 1.8-4.3), oral testosterone undecanoate (4.3%, 0.7-8.0), patch (1.4%, 0.2-2.6), intramuscular testosterone enanthate/cypionate (4.0%, 2.9-5.1), and intramuscular testosterone undecanoate (1.6%, 0.3-3.0) result in statistically significant increases in mean hematocrit when compared with placebo. When comparing all formulations against one another, intramuscular testosterone cypionate/enanthate were associated with a significantly higher increase in mean hematocrit compared to patch, but no differences in hematocrit between other formulations were detected.
All types of testosterone are associated with increased hematocrit; however, the clinical concern of this increase remains questionable, warranting future studies. This is the first network meta-analysis to quantify mean hematocrit change and compare formulations, given the absence of head-to-head trials.
我们旨在比较不同睾酮制剂，并确定睾酮疗法制剂引起的红细胞压积升高程度。由于头对头试验较为罕见，因此，对于睾酮类型引起的红细胞压积变化，包括局部凝胶和贴剂、注射剂（短效和长效）和口服片剂，仅能通过对当代研究的网络荟萃分析来进行比较。
我们在 Scopus®、PubMed®、Embase®、Cochrane CENTRAL 和 ClinicalTrials.gov 中进行了全面的文献检索。共有 29 项安慰剂对照随机试验（3393 名男性）符合纳入标准，可分析睾酮治疗后平均红细胞压积的变化。通过网络荟萃分析对以下睾酮制剂的随机对照试验数据进行了汇总：凝胶、贴剂、口服十一酸睾酮、肌肉内十一酸睾酮和肌肉内睾酮庚酸/丙酸酯。
与安慰剂相比，所有类型的睾酮治疗均导致平均红细胞压积的统计学显著升高。荟萃分析显示，所有制剂，包括凝胶（3.0%，95%CI 1.8-4.3）、口服十一酸睾酮（4.3%，0.7-8.0）、贴剂（1.4%，0.2-2.6）、肌肉内睾酮庚酸/丙酸酯（4.0%，2.9-5.1）和肌肉内十一酸睾酮（1.6%，0.3-3.0），与安慰剂相比均导致平均红细胞压积的统计学显著升高。当将所有制剂相互比较时，与贴剂相比，肌肉内睾酮丙酸酯/庚酸酯与平均红细胞压积的显著升高相关，但未发现其他制剂之间的红细胞压积差异。
所有类型的睾酮均与红细胞压积升高相关；然而，这种升高的临床意义仍存在疑问，需要进一步研究。鉴于缺乏头对头试验，这是首次进行网络荟萃分析以量化平均红细胞压积变化并比较制剂。
