Kelleher S, Conway A J, Handelsman D J
Department of Andrology, Concord Hospital and ANZAC Research Institute, University of Sydney, Sydney, New South Wales 2139, Australia.
Eur J Endocrinol. 2002 Apr;146(4):513-8. doi: 10.1530/eje.0.1460513.
Testosterone pellet implantation is a safe, effective and convenient form of depot androgen replacement, with extrusion of pellets following about 10% of procedures the most frequent adverse effect. This study aimed to determine whether extrusion rate could be reduced by antibiotic impregnation of pellets immediately prior to implantation.
Prospective, randomised, parallel-group, open-label study design in a single centre. One hundred and eighty-six androgen-deficient men (400 implantation procedures) were randomised into either a group who had their pellets soaked for approximately 2 min in gentamicin solution prior to implantation, or a control group who had the standard implantation procedure.
Extrusion, infection and/or bruising were evaluated prospectively by self-report from the participants, and retrospectively at subsequent implantation. Other variables (site, shaving, skin preparation, operator, pellet batch, bruising) were collected at implantation time.
The extrusion rate was 20% lower (odds ratio=0.80, 95% confidence interval (CI) 0.40-1.62) but not statistically different between the two groups (extrusion rate 23/205 (11.2%) for the control group vs 18/195 (9.2%) for the antibiotic-soak group, P=0.42). One operator experienced more total (P=0.0002) and infection-related (P=0.0008) extrusions and marginally more bruising (P=0.06) than other operators. The operator effect did not appear to be explained by differences in experience or implantation style. There was a 4.6-fold excess (95% CI 1.6-18.6) of multiple (19 vs 4 expected) over single (22 vs 10 expected) and no (359 vs 386 expected) extrusions. Extrusion was not related to batch number (P=0.15), location (P=0.15), shaving (P=0.32), old or new site (P=0.59), or the presence of suppuration or not (P=0.42); however, povidone-iodine skin disinfectant had statistically fewer extrusions than mixed alcohol solution.
Antibiotic impregnation prior to implantation does not significantly decrease testosterone pellet extrusion rate. An operator effect, not due to experience or procedural style, an excess of multiple extrusions and disinfectant effects were confirmed. Neither location, nor preparation of the site, nor pellet batch, influences extrusion rate.
睾酮植入剂是一种安全、有效且便捷的长效雄激素替代方式，约10%的手术会出现植入剂挤出的情况，这是最常见的不良反应。本研究旨在确定在植入前对植入剂进行抗生素浸渍是否能降低挤出率。
在单一中心进行的前瞻性、随机、平行组、开放标签研究设计。186名雄激素缺乏男性（400次植入手术）被随机分为两组，一组在植入前将植入剂在庆大霉素溶液中浸泡约2分钟，另一组为对照组，采用标准植入程序。
通过参与者的自我报告对挤出、感染和/或瘀伤进行前瞻性评估，并在后续植入时进行回顾性评估。在植入时收集其他变量（部位、剃须、皮肤准备、操作者、植入剂批次、瘀伤）。
挤出率低20%（优势比=0.80，95%置信区间（CI）0.40 - 1.62），但两组之间无统计学差异（对照组挤出率为23/205（11.2%），抗生素浸泡组为18/195（9.2%），P = 0.42）。一名操作者的总挤出情况（P = 0.0002）和与感染相关的挤出情况（P = 0.0008）更多，瘀伤也略多（P = 0.06）。操作者效应似乎无法用经验或植入方式的差异来解释。多次挤出（19例，预期4例）比单次挤出（22例，预期10例）多4.6倍（95%CI 1.6 - 18.6），且无挤出情况（359例，预期386例）。挤出与批次号（P = 0.15）、位置（P = 0.15）、剃须（P = 0.32）、新老部位（P = 0.59）或是否存在化脓（P = 0.42）无关；然而，聚维酮碘皮肤消毒剂的挤出情况在统计学上比混合酒精溶液少。
植入前进行抗生素浸渍并不能显著降低睾酮植入剂的挤出率。证实了操作者效应（并非由于经验或操作方式）、多次挤出过多以及消毒剂的影响。部位、部位准备或植入剂批次均不影响挤出率。
