NANDROLONE DECANOATE IN HIV-INFECTED MEN W/ MILD TO MOD WEIGHT LOSS WITH RHGH

诺龙癸酸在 HIV 感染男性中使用 RHGH 实现轻度至 MOD 减肥效果

• 批准号: 7355254
• 负责人: Thomas Storer
• 金额: $ 1.39万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-02-01 至 2007-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7355254
• 关键词: NANDROLONE; DECANOATE; HIV; INFECTED; MEN

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Objective: We compared the effectiveness of a biweekly regimen of 150 mg nandrolone with placebo in HIV-infected men with mild to moderate weight loss and contrasted its effects against a Food and Drug Administration-approved regimen of recombinant human (rh)GH. Methods: In this placebo-controlled, randomized, 12-wk trial, placebo and nandrolone (150 mg im biweekly) were administered double blind, and rhGH (6 mg sc daily) was administered in an open-label manner. Participants were HIV-infected men with 5-15% weight loss over 6 months and on stable antiretroviral therapy for more than 12 wk. Lean body mass (LBM), muscle performance, physical function, endurance, hormone levels, insulin sensitivity, sexual function, quality of life, and appetite were assessed at baseline and after 12 wk. Results: Nandrolone administration was associated with a greater increase in LBM (+1.6 ¿ 0.3 kg) by dual-energy x-ray absorptiometry scan than placebo (+0.4 ¿ 0.3 kg; P < 0.05); however, the change in LBMs with nandrolone was not significantly different from rhGH (+2.5 ¿ 0.3 kg). Nandrolone administration was also associated with significantly greater gains in fat-free mass (+1.6 ¿ 0.3 kg), body cell mass (+1.0 ¿ 0.2 kg), and intracellular water (+0.9 ¿ 0.2 kg) than placebo; these changes in the nandrolone group were not significantly different from the rhGH group. rhGH administration was associated with greater loss of whole body fat mass and higher frequency of drug-related adverse effects and treatment discontinuations than nandrolone and placebo and a greater increase in extracellular water than nandrolone. Nandrolone treatment was associated with greater improvements in perception of health than rhGH and sexual function than placebo. The cachexia/anorexia scores, health care resource use, and insulin sensitivity did not significantly change. Conclusion: We conclude that nandrolone is superior to placebo and not significantly different from a Food and Drug Administration-approved regimen of rhGH in improving lean body mass in HIV-infected men with mild to moderate weight loss.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。目的：我们比较了150 mg诺龙与安慰剂两周一次治疗方案在轻度至中度体重减轻的HIV感染男性中的有效性，并将其效果与美国食品和药物管理局批准的重组人（rh）GH方案进行了对比。研究方法：在这项安慰剂对照、随机、12周试验中，安慰剂和诺龙（150 mg im，每两周一次）双盲给药，rhGH（6 mg sc，每日一次）以开放标签方式给药。参与者是HIV感染的男性，在6个月内体重减轻5 - 15%，并接受稳定的抗逆转录病毒治疗超过12周。在基线和12周后评估瘦体重（LBM）、肌肉性能、身体功能、耐力、激素水平、胰岛素敏感性、性功能、生活质量和食欲。结果如下：与安慰剂（+0.4 <$0.3 kg; P <0.05）相比，诺龙给药与双能X线吸收测定扫描的LBM（+1.6 <$0.3 kg）增加更大相关;然而，诺龙的LBM变化与rhGH（+2.5 <$0.3 kg）无显著差异。与安慰剂相比，诺龙给药还与去脂质量（+1.6 <$0.3 kg）、体细胞质量（+1.0 <$0.2 kg）和细胞内水（+0.9 <$0.2 kg）的显著增加相关;诺龙组的这些变化与rhGH组无显著差异。与诺龙和安慰剂相比，rhGH给药与全身脂肪量更大的损失和更高频率的药物相关不良反应和治疗中止相关，并且与诺龙相比，细胞外水增加更大。与rhGH相比，诺龙治疗与健康感知的改善以及与安慰剂相比的性功能改善相关。恶病质/厌食评分、医疗资源使用和胰岛素敏感性没有显著变化。结论：我们的结论是，诺龙在改善轻度至中度体重减轻的艾滋病毒感染男性的瘦体重方面优于安慰剂，并且与美国食品和药物管理局批准的rhGH方案没有显着差异。上级。