Jensen P B, Hansen T B, Oxhøj H, Froberg K, Ekelund B, Nielsen F T, Pedersen F B
Department of Nephrology, Odense University Hospital, Denmark.
Br J Clin Pract Suppl. 1996 Aug;85:47-51.
In a double-blind, placebo-controlled trial of recombinant human growth hormone (rhGH) comprising 20 chronic enfeebled haemodialysed patients, the clinical benefit of daily growth hormone treatment for six months was evaluated. Nine patients (five male, four female) were treated with rhGH 4 i.u./m2/day and eleven with placebo (seven male, four female). Their mean age was 46.5 years (range 18-68). No difference in mean age was found between the groups. A significant increase in insulin-like growth factor I (IGF-I) was observed in the rhGH-treated group (200 to 527ng/ml, p = 0.01), while a decrease was noticed in the placebo group (285 to 219ng/ml, p = 0.02). S-GH did not change significantly in either group, and there were no differences between the two groups in terms of weight, haemoglobin, s-albumin, -urea or -creatinine, which all remained unchanged during the trial. Patients' lean body mass, as measured by DXA-scanning, increased significantly in the rhGH-treated group (43.4 to 46.7kg, p = 0.004), while no change was observed in the placebo group (44.9 to 45.2kg, p = 0.76). The changes in lean body mass between the two groups were significant, p = 0.001. Left ventricular muscle mass increased significantly (227 to 286g, p = 0.03) in the rhGH-treated group, but not in the placebo group (292 to 253g, p = 0.3). The changes in left ventricular muscle mass between the two groups were significant (p = 0.02). The maximal working capacity decreased slightly and insignificantly in both groups, when measured by bicycle ergometry. Isometric muscle contraction force and endurance did not change significantly in either group. Patients' opinion about the influence of the treatment on their general well-being and working capacity, evaluated blindly on a subjective scale, improved significantly in the rhGH-treated group (9.7 to 12.6, p = 0.02), while no change was experienced in the placebo group (9.9 to 10.7, p = 0.2). No difference was however demonstrable between the two groups (p = 0.4). Thus we conclude that adult patients in long-term haemodialysis treated with rhGH experienced an increase in their lean body mass and left ventricular muscle mass. This increase in muscle mass did not, however, improve muscle contraction force or endurance when measured objectively. The rhGH-treated patients nevertheless had a subjective feeling of a slight improvement in their general wellbeing.
在一项针对20例慢性衰弱血液透析患者的重组人生长激素(rhGH)双盲、安慰剂对照试验中,评估了每日生长激素治疗6个月的临床益处。9例患者(5例男性,4例女性)接受rhGH 4国际单位/平方米/天治疗,11例接受安慰剂治疗(7例男性,4例女性)。他们的平均年龄为46.5岁(范围18 - 68岁)。两组之间平均年龄无差异。rhGH治疗组观察到胰岛素样生长因子I(IGF - I)显著增加(从200至527ng/ml,p = 0.01),而安慰剂组则出现下降(从285至219ng/ml,p = 0.02)。两组中血清生长激素(S - GH)均无显著变化,两组在体重、血红蛋白、血清白蛋白、尿素或肌酐方面也无差异,这些指标在试验期间均保持不变。通过双能X线吸收法(DXA)扫描测量,rhGH治疗组患者的瘦体重显著增加(从43.4至46.7kg,p = 0.004),而安慰剂组未观察到变化(从44.9至45.2kg,p = 0.76)。两组之间瘦体重的变化具有显著性,p = 0.001。rhGH治疗组左心室肌肉质量显著增加(从227至286g,p = 0.03),而安慰剂组未增加(从292至253g,p = 0.3)。两组之间左心室肌肉质量的变化具有显著性(p = 0.02)。通过自行车测力计测量,两组的最大工作能力均略有下降且不显著。两组等长肌肉收缩力和耐力均无显著变化。通过主观量表对患者关于治疗对其总体健康和工作能力影响的看法进行盲法评估,rhGH治疗组显著改善(从9.7至12.6,p = 0.02),而安慰剂组无变化(从9.9至10.7,p = 0.2)。然而,两组之间无明显差异(p = 0.4)。因此,我们得出结论,接受rhGH治疗的长期血液透析成年患者瘦体重和左心室肌肉质量增加。然而,客观测量时,肌肉质量的增加并未改善肌肉收缩力或耐力。尽管如此,接受rhGH治疗的患者主观感觉总体健康略有改善。