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围手术期补充睾酮可增加前交叉韧带重建术健康男性的瘦体重:一项随机对照试验

Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.

作者信息

Wu Brian, Lorezanza Dan, Badash Ido, Berger Max, Lane Christianne, Sum Jonathan C, Hatch George F, Schroeder E Todd

机构信息

Keck School of Medicine, University of Southern California, Los Angeles, California, USA.

出版信息

Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.

DOI:10.1177/2325967117722794
PMID:28840147
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5555502/
Abstract

BACKGROUND

Rehabilitation after repair of the anterior cruciate ligament (ACL) is complicated by the loss of leg muscle mass and strength. Prior studies have shown that preoperative rehabilitation may improve muscle strength and postoperative outcomes. Testosterone supplementation may likewise counteract this muscle loss and potentially improve clinical outcomes.

PURPOSE

The purpose was to investigate the effect of perioperative testosterone administration on lean mass after ACL reconstruction in men and to examine the effects of testosterone on leg strength and clinical outcome scores. It was hypothesized that testosterone would increase lean mass and leg strength and improve clinical outcome scores relative to placebo.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 1.

METHODS

Male patients (N = 13) scheduled for ACL reconstruction were randomized into 2 groups: testosterone and placebo. Participants in the testosterone group received 200 mg of intramuscular testosterone weekly for 8 weeks beginning 2 weeks before surgery. Participants in the placebo group received saline following the same schedule. Both groups participated in a standard rehabilitation protocol. The primary outcome was the change in total lean body mass at 6 and 12 weeks. Secondary outcomes were extensor muscle strength, Tegner activity score, and Knee injury and Osteoarthritis Outcome Score.

RESULTS

There was an increase in lean mass of a mean 2.7 ± 1.7 kg at 6 weeks postoperatively in the testosterone group compared with a decrease of a mean 0.1 ± 1.5 kg in the placebo group ( .01). Extensor muscle strength of the uninjured leg also increased more from baseline in the testosterone group (+20.8 ± 25.6 Nm) compared with the placebo group (-21.4 ± 36.7 Nm) at 12 weeks ( = .04). There were no significant between-group differences in injured leg strength or clinical outcome scores. There were no negative side effects of testosterone noted.

CONCLUSION

Perioperative testosterone supplementation increased lean mass 6 weeks after ACL reconstruction, suggesting that this treatment may help minimize the effects of muscle atrophy associated with ACL injuries and repair. This study was not powered to detect differences in strength or clinical outcome scores to assess the incidence of testosterone-related adverse events.

CLINICAL RELEVANCE

Supraphysiological testosterone supplementation may be a useful adjunct therapy for counteracting muscle atrophy after ACL reconstruction. Further investigation is necessary to determine the safety profile and effects of perioperative testosterone administration on leg strength and clinical outcomes after surgery.

REGISTRATION

NCT01595581 (ClinicalTrials.gov).

摘要
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/84a1d05d5fa0/10.1177_2325967117722794-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/a6aa53cc56bd/10.1177_2325967117722794-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/3fd4e107ce59/10.1177_2325967117722794-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/425ce23dc76e/10.1177_2325967117722794-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/d1b4635e5def/10.1177_2325967117722794-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/84a1d05d5fa0/10.1177_2325967117722794-fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/a6aa53cc56bd/10.1177_2325967117722794-fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/3fd4e107ce59/10.1177_2325967117722794-fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/425ce23dc76e/10.1177_2325967117722794-fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/d1b4635e5def/10.1177_2325967117722794-fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/872e/5555502/84a1d05d5fa0/10.1177_2325967117722794-fig5.jpg

背景

前交叉韧带(ACL)修复术后的康复因腿部肌肉质量和力量的丧失而变得复杂。先前的研究表明,术前康复可能会提高肌肉力量和术后效果。补充睾酮同样可能抵消这种肌肉流失,并有可能改善临床效果。

目的

本研究旨在调查围手术期给予睾酮对男性ACL重建术后瘦体重的影响,并研究睾酮对腿部力量和临床结果评分的影响。研究假设是,相对于安慰剂,睾酮会增加瘦体重和腿部力量,并改善临床结果评分。

研究设计

随机对照试验;证据等级为1级。

方法

计划进行ACL重建的男性患者(N = 13)被随机分为两组:睾酮组和安慰剂组。睾酮组的参与者在手术前2周开始,每周接受200mg肌肉注射睾酮,共8周。安慰剂组的参与者按照相同的时间表接受生理盐水注射。两组均参与标准的康复方案。主要结果是6周和12周时全身瘦体重的变化。次要结果包括伸肌力量、Tegner活动评分以及膝关节损伤和骨关节炎结果评分。

结果

睾酮组术后6周的瘦体重平均增加2.7±1.7kg,而安慰剂组平均减少0.1±1.5kg(P = 0.01)。在12周时,睾酮组未受伤腿部的伸肌力量相对于基线增加得更多(+20.8±25.6 Nm),而安慰剂组则减少(-21.4±36.7 Nm)(P = 0.04)。受伤腿部的力量或临床结果评分在组间没有显著差异。未观察到睾酮的负面副作用。

结论

围手术期补充睾酮可使ACL重建术后6周的瘦体重增加,这表明该治疗可能有助于减轻与ACL损伤和修复相关的肌肉萎缩的影响。本研究的样本量不足以检测力量或临床结果评分的差异,也无法评估与睾酮相关的不良事件的发生率。

临床意义

超生理剂量的睾酮补充可能是抵消ACL重建术后肌肉萎缩的一种有用的辅助治疗方法。有必要进一步研究以确定围手术期给予睾酮的安全性以及对术后腿部力量和临床结果的影响。

注册信息

NCT01595581(ClinicalTrials.gov)

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