Selective androgen receptor modulation for muscle weakness in chronic obstructive pulmonary disease: a randomised control trial.
Selective androgen receptor modulation for muscle weakness in chronic obstructive pulmonary disease: a randomised control trial.
复制标题
作者：
选择性雄激素受体调节剂（SARM）通过雄激素受体增加肌肉质量。这项2A期试验研究了SARM（GSK 2881078）联合运动对慢性阻塞性肺疾病（COPD）和身体功能受损患者腿部力量的影响。47名绝经后女性和50名男性COPD患者（1秒用力呼气量30%-65%预测值;短期体能成套测验评分：3-11）入组一项随机双盲、安慰剂对照试验。患者以1：1的比例随机接受安慰剂或口服GSK 2881078（女性：1.0 mg;男性：2.0 mg），每日一次，持续13周，同时进行家庭锻炼计划，包括力量训练和体力活动。主要终点是90天时腿部力量较基线的变化（最大重复一次;绝对（kg）和相对（%变化））和多个安全性结局。次要终点包括瘦体重、身体功能和患者报告的结局。GSK 2881078增加了男性的腿部力量。治疗组和安慰剂组之间较基线的校正平均变化和校正平均百分比变化的差异为：女性，8.0 kg（90% CI −2.5至18.4）和5.2%（90% CI −4.7至15.0）;男性分别为11.8 kg（90% CI −0.5至24.0）和7.0%（90% CI 0.5至13.6）。瘦体重增加，但未观察到患者报告结局的变化。高密度脂蛋白胆固醇可逆性降低和肝转氨酶一过性升高是主要的治疗相关安全性结果。GSK 2881078耐受性良好，短期治疗增加COPD男性患者的腿部力量（以预测百分比表示）超过单纯体育训练。 NCT 03359473。
Selective androgen receptor modulators (SARMs) increase muscle mass via the androgen receptor. This phase 2A trial investigated the effects of a SARM, GSK2881078, in conjunction with exercise, on leg strength in patients with chronic obstructive pulmonary disease (COPD) and impaired physical function. 47 postmenopausal women and 50 men with COPD (forced expiratory volume in 1 s 30%–65% predicted; short physical performance battery score: 3–11) were enrolled into a randomised double-blind, placebo control trial. Patients were randomised 1:1 to once daily placebo or oral GSK2881078 (females: 1.0 mg; males: 2.0 mg) for 13 weeks with a concurrent home-exercise programme, involving strength training and physical activity. Primary endpoints were change from baseline in leg strength at 90 days (one-repetition maximum; absolute (kg) and relative (% change)) and multiple safety outcomes. Secondary endpoints included lean body mass, physical function and patient-reported outcomes. GSK2881078 increased leg strength in men. The difference in adjusted mean change from baseline and adjusted mean percentage change from baseline between treatment and placebo were: for women, 8.0 kg (90% CI −2.5 to 18.4) and 5.2% (90% CI −4.7 to 15.0), respectively; for men, 11.8 kg (90% CI −0.5 to 24.0) and 7.0% (90% CI 0.5 to 13.6), respectively. Lean body mass increased, but no changes in patient-reported outcomes were observed. Reversible reductions in high-density lipoprotein-cholesterol and transient elevations in hepatic transaminases were the main treatment-related safety findings. GSK2881078 was well tolerated and short-term treatment increased leg strength, when expressed as per cent predicted, in men with COPD more than physical training alone. NCT03359473.
登录
查看更多内容
DOI：
10.1183/09031936.00104909
发表时间：
2010-07
期刊：
The European respiratory journal
影响因子：
--
作者：
Seymour JM;Spruit MA;Hopkinson NS;Natanek SA;Man WD;Jackson A;Gosker HR;Schols AM;Moxham J;Polkey MI;Wouters EF
通讯作者：
Wouters EF
影响因子：
10
作者：
Mohan, Divya;Forman, Julia R.;Polkey, Michael I.
通讯作者：
Polkey, Michael I.
影响因子：
3.7
作者：
Demeyer H;Burtin C;Hornikx M;Camillo CA;Van Remoortel H;Langer D;Janssens W;Troosters T
通讯作者：
Troosters T
影响因子：
6.7
作者：
Fermont JM;Mohan D;Fisk M;Bolton CE;Macnee W;Cockcroft JR;McEniery C;Fuld J;Cheriyan J;Tal-Singer R;Müllerova H;Wood AM;Wilkinson IB;Polkey MI;ERICA consortium
通讯作者：
ERICA consortium
癌症恶病质干预试验的监管指南请求。
DOI：
10.1002/jcsm.12083
发表时间：
2015-12
期刊：
Journal of cachexia, sarcopenia and muscle
影响因子：
--
作者：
Fearon K;Argiles JM;Baracos VE;Bernabei R;Coats A;Crawford J;Deutz NE;Doehner W;Evans WJ;Ferrucci L;Garcia JM;Gralla RJ;Jatoi A;Kalantar-Zadeh K;Lainscak M;Morley JE;Muscaritoli M;Polkey MI;Rosano G;Rossi-Fanelli F;Schols AM;Strasser F;Vellas B;von Haehling S;Anker SD
通讯作者：
Anker SD