Handelsman D J, Mackey M A, Howe C, Turner L, Conway A J
Andrology Unit, Royal Price Alfred Hospital, Sydney NSW, Australia.
Clin Endocrinol (Oxf). 1997 Sep;47(3):311-6. doi: 10.1046/j.1365-2265.1997.2521050.x.
To review 13 years of experience using fused crystalline testosterone implants for androgen replacement therapy in order to identify pattern of usage (including continuation rates) and adverse events emerging during therapy and factors associated with adverse events including implant extrusions.
Retrospective review of prospectively collected data on characteristics of patients and implant procedures performed as well as adverse events reported during routine follow-up.
Over 13 years 973 implant procedures using fused crystalline testosterone implants were performed in 221 men.
Continuation rates and adverse events such as extrusions, bleeding, infection or others were recorded and analysed in relationship to characteristics of the patient and the implant procedure performed.
Overall rate of adverse events (108/73, 11.1%) was significantly related to increased numbers of implants (4.2 +/- 0.1 vs 4.0 +/- 0.03, P = 0.031) and higher levels of physical activity at work (P = 0.030). The most common adverse effect was extrusion (83/973, 8.5%) which was related to occupational classification (P = 0.033) and increasing work activity (P = 0.044) and occurred more frequently than by chance in multiple (16 vs 3.3 expected) rather than single (65 vs 76.1 expected) episodes. Bleeding (22/973, 2.3%) was significantly associated with an increased number of implants (4.5 +/- 0.2 vs 4.0 +/- 0.03, P = 0.020) but even in the worst cases (3/22) it was of minor clinical importance. Infection was rare (6/973, 0.6%) but occurred more among thinner men. The overall continuation rate was 92.7% increasing from 86% after the first implantation to > 99% after the tenth implant.
This study demonstrates the very satisfactory clinical acceptability of testosterone pellet implants for androgen replacement therapy within a single unit with experienced operators. The only regular adverse effect is extrusion, which may be related to mechanical factors such as habitual work activity but also possibly procedural factors. Other adverse effects such as bleeding, infection and fibrosis were rare. An improved method of implant delivery would enhance this old but durable technology.
回顾13年来使用融合结晶睾酮植入物进行雄激素替代治疗的经验，以确定使用模式（包括持续率）以及治疗期间出现的不良事件，以及与不良事件相关的因素，包括植入物挤出。
对前瞻性收集的患者特征、植入手术数据以及常规随访期间报告的不良事件进行回顾性分析。
在13年期间，对221名男性进行了973次使用融合结晶睾酮植入物的植入手术。
记录并分析持续率和不良事件，如挤出、出血、感染或其他事件，并与患者特征和所进行的植入手术相关联。
总体不良事件发生率（108/973，11.1%）与植入物数量增加（4.2±0.1对4.0±0.03，P = 0.031）以及工作时较高的身体活动水平显著相关（P = 0.030）。最常见的不良反应是挤出（83/973，8.5%），这与职业分类（P = 0.033）和工作活动增加（P = 0.044）有关，并在多次（16例，预期3.3例）而非单次（65例，预期76.1例）发作中比偶然情况更频繁发生。出血（22/973，2.3%）与植入物数量增加显著相关（4.5±0.2对4.0±0.03，P = 0.020），但即使在最严重的情况下（3/22），其临床重要性也较小。感染很少见（6/973，0.6%），但在较瘦的男性中更常见。总体持续率为92.7%，从首次植入后的86%增加到第十次植入后的>99%。
本研究表明，在有经验的操作人员的单一单位内，睾酮丸植入物用于雄激素替代治疗具有非常令人满意的临床可接受性。唯一常见的不良反应是挤出，这可能与诸如习惯性工作活动等机械因素有关，但也可能与手术因素有关。其他不良反应，如出血、感染和纤维化很少见。改进的植入方法将提升这项古老但耐用的技术。
