Shirley Ryan Ability Lab, Chicago, IL, USA.
Department of Physical Medicine and Rehabilitation, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
NeuroRehabilitation. 2020;46(3):355-368. doi: 10.3233/NRE-192992.
Endocrinopathy, including hypogonadism, is common following traumatic brain injury (TBI). Prior evidence suggests hypogonadism is associated with poorer function.
Determine the feasibility, safety, and efficacy of testosterone (T) therapy in hypogonadal men following TBI in acute rehabilitation.
Randomized, double blind, placebo-controlled pilot trial.
Inpatient rehabilitation brain injury unit.
Men ages 18 -65, post moderate to severe TBI receiving inpatient rehabilitation.
Transdermal T gel or placebo.
Revised FIM™ score, strength, adverse events.
Of 498 screened, 70 participants were enrolled, and 22 meeting all criteria were randomized into placebo (n = 10) or physiologic T therapy (n = 12). There was no significant difference between groups in rate of improvement on the FIM™ (intercepts t = -0.31, p = 0.7593, or slopes t = 0.61, p = 0.5472). The Treatment group demonstrated the greatest absolute improvement in FIM™ scores and grip strength compared to Placebo or Normal T groups. There was no difference in adverse events between groups. Percentage of time with agitation or aggression was highest in the Placebo group.
Although there were no significant differences in rates of recovery, treatment group subjects showed greater absolute functional and strength improvement compared to the Placebo or Normal T groups.
内分泌疾病，包括性腺功能减退症，在创伤性脑损伤（TBI）后很常见。先前的证据表明，性腺功能减退症与功能较差有关。
确定在急性康复期间，对 TBI 后的低促性腺激素血症男性进行睾丸激素（T）治疗的可行性、安全性和疗效。
随机、双盲、安慰剂对照的试验。
住院康复脑损伤病房。
年龄在 18-65 岁之间、患有中度至重度 TBI 并正在接受住院康复治疗的男性。
透皮 T 凝胶或安慰剂。
修订后的 FIM™评分、力量、不良事件。
在筛选出的 498 名患者中，有 70 名患者入组，22 名符合所有标准的患者被随机分为安慰剂（n=10）或生理 T 治疗（n=12）组。FIM™评分的改善率（截距 t=-0.31，p=0.7593，或斜率 t=0.61，p=0.5472）在两组之间无显著差异。与安慰剂或正常 T 组相比，治疗组的 FIM™评分和握力的绝对改善最大。两组之间的不良事件无差异。在安慰剂组中，出现激动或攻击行为的时间百分比最高。
尽管恢复率没有显著差异，但治疗组患者的绝对功能和力量改善明显大于安慰剂组或正常 T 组。
