Waters D, Danska J, Hardy K, Koster F, Qualls C, Nickell D, Nightingale S, Gesundheit N, Watson D, Schade D
Department of Medicine/Endocrinology, University of New Mexico School of Medicine, Albuquerque 87131-5271, USA.
Ann Intern Med. 1996 Dec 1;125(11):865-72. doi: 10.7326/0003-4819-125-11-199612010-00001.
To increase lean body mass and improve health status in patients with wasting associated with the acquired immunodeficiency syndrome (AIDS) by treatment with recombinant human growth hormone (rhGH), recombinant human insulin-like growth factor 1 (rhIGF-1), or both.
Randomized, double-blind, placebo-controlled clinical trial.
University of New Mexico Clinical Research Center and University of Texas Southwestern Medical Center.
60 patients with AIDS and wasting as defined by the Centers for Disease Control and Prevention. Patients were divided into four groups of 15 patients each.
Group 1 received 1.4 mg of rhGH once daily plus placebo twice daily; group 2 received 5 mg of rhIGF-1 twice daily plus placebo once daily; group 3 received 5 mg of rhIGF-1 twice daily plus 1.4 mg of rhGH once daily; and group 4 received placebo three times daily.
Body weight, body composition, muscle strength, protein catabolism, quality of life, and immune status were assessed at baseline, and changes in these variables were measured at 6 and 12 weeks.
At 6 weeks, lean body mass had increased and total fat mass had decreased in the groups receiving rhGH, rhIGF-1, or both. Group 3 had the greatest changes in lean body mass (mean +/- SE, 3.2 +/- 0.59 kg; P < 0.001); only in this group were changes in body mass maintained at 12 weeks. Only patients in group 1 had improvement in muscular strength of the knees and upper body (P = 0.04) and quality of life (P = 0.01). Immunologic function did not improve in any group.
Growth factor therapy had significantly increased lean body mass and decreased fat mass by 6 weeks, but these improvements persisted for 12 weeks only in group 3. Growth factor therapy at the dosages used in this study is not recommended because the magnitude of weight gain was modest and improvements in quality-of-life measures varied.
通过使用重组人生长激素（rhGH）、重组人胰岛素样生长因子1（rhIGF-1）或两者联合治疗，增加与获得性免疫缺陷综合征（AIDS）相关的消瘦患者的瘦体重并改善其健康状况。
随机、双盲、安慰剂对照临床试验。
新墨西哥大学临床研究中心和德克萨斯大学西南医学中心。
60例符合美国疾病控制与预防中心定义的患有AIDS且消瘦的患者。患者被分为四组，每组15例。
第1组每天一次接受1.4mg rhGH加每天两次安慰剂；第2组每天两次接受5mg rhIGF-1加每天一次安慰剂；第3组每天两次接受5mg rhIGF-1加每天一次1.4mg rhGH；第4组每天三次接受安慰剂。
在基线时评估体重、身体组成、肌肉力量、蛋白质分解代谢、生活质量和免疫状态，并在第6周和第12周测量这些变量的变化。
在第6周时，接受rhGH、rhIGF-1或两者联合治疗的组中，瘦体重增加而总脂肪量减少。第3组瘦体重变化最大（均值±标准误，3.2±0.59kg；P<0.001）；仅在该组中，体重变化在第12周时得以维持。仅第1组患者的膝关节和上身肌肉力量（P = 0.04）及生活质量（P = 0.01）有所改善。任何组的免疫功能均未改善。
生长因子治疗在6周时显著增加了瘦体重并减少了脂肪量，但这些改善仅在第3组中持续了12周。不推荐本研究中使用的剂量的生长因子治疗，因为体重增加幅度不大且生活质量指标的改善存在差异。
