Lee P D, Pivarnik J M, Bukar J G, Muurahainen N, Berry P S, Skolnik P R, Nerad J L, Kudsk K A, Jackson L, Ellis K J, Gesundheit N
Department of Pediatrics, Baylor College of Medicine, Houston, Texas 77030, USA.
J Clin Endocrinol Metab. 1996 Aug;81(8):2968-75. doi: 10.1210/jcem.81.8.8768860.
Loss of body mass, or wasting, is a major cause of morbidity and a contributor to mortality in human immunodeficiency virus-1 (HIV-1) infection. Dietary supplements and appetite adjuvants have had limited effectiveness in treating this condition. GH and insulin-like growth factor I (IGF-I) have been shown to be anabolic in many catabolic conditions, and limited data suggest similar efficacy in HIV wasting. In addition, it appears that GH and IGF-I may have complementary anabolic effects with opposing glucoregulatory effects. We report results from a 12-week randomized, placebo-controlled trial of combination recombinant human GH (rhGH; Nutropin; 0.34 mg, sc, twice daily) and rhIGF-I (5.0 mg, sc, twice daily) in individuals with HIV wasting and without active opportunistic infection, cancer, or gastrointestinal disease. A total of 142 subjects (140 males and 2 females) were randomized using a 2:1, double blind treatment scheme and assigned to receive either active treatment or placebo injections. Eighty subjects completed the 12-week protocol. Nutritional intake and demographic and clinical characteristics did not differ between the groups at any study time point. At 3 weeks, the treatment group had a significantly larger weight increase (P = 0.0003), but this difference was not observed at any later time point. Similarly, fat-free mass, calculated from skinfold measurements, increased transiently in the treatment group at 6 weeks (P = 0.002). No significant differences in isokinetic muscle strength or endurance testing or in quality of life were observed between the groups. Resting heart rate was significantly higher in the treatment group at each time point post-baseline. GH and IGF-binding protein-3 levels did not change; however, IGF-I levels were higher in the treatment group at 6 and 12 weeks. There were no significant between-group differences in any of the measured biochemical or immunological parameters. rhGH plus rhIGF-I treatment was associated with an increased incidence of peripheral edema and other side-effects, possibly related to fluid retention. We conclude that the combination of rhIGF-I and low dose rhGH used in this study had no significant anabolic effect in HIV wasting.
体重减轻或消瘦是人类免疫缺陷病毒1型（HIV-1）感染中发病的主要原因及死亡的一个因素。膳食补充剂和食欲辅助剂在治疗这种情况方面效果有限。生长激素（GH）和胰岛素样生长因子I（IGF-I）在许多分解代谢状态下已显示出合成代谢作用，有限的数据表明在HIV消瘦中也有类似疗效。此外，GH和IGF-I似乎可能具有互补的合成代谢作用以及相反的血糖调节作用。我们报告了一项为期12周的随机、安慰剂对照试验的结果，该试验针对患有HIV消瘦且无活动性机会性感染、癌症或胃肠道疾病的个体，联合使用重组人生长激素（rhGH；健高素；0.34毫克，皮下注射，每日两次）和rhIGF-I（5.0毫克，皮下注射，每日两次）。总共142名受试者（140名男性和2名女性）采用2:1双盲治疗方案进行随机分组，并被分配接受活性治疗或安慰剂注射。80名受试者完成了12周的方案。在任何研究时间点，两组之间的营养摄入、人口统计学和临床特征均无差异。在3周时，治疗组体重增加显著更大（P = 0.0003），但在任何后续时间点均未观察到这种差异。同样，根据皮褶测量计算的去脂体重在治疗组6周时短暂增加（P = 0.002）。两组之间在等速肌力或耐力测试或生活质量方面未观察到显著差异。基线后各时间点治疗组静息心率显著更高。GH和IGF结合蛋白-3水平未改变；然而，治疗组在6周和12周时IGF-I水平更高。在任何测量的生化或免疫参数方面，两组之间均无显著差异。rhGH加rhIGF-I治疗与外周水肿及其他副作用的发生率增加相关，可能与液体潴留有关。我们得出结论，本研究中使用的rhIGF-I和低剂量rhGH联合在HIV消瘦中没有显著的合成代谢作用。
