Efficacy of needle-free administration of recombinant human growth hormone in adults with growth hormone deficiency

AIM: Needle-free administration of recombinant human growth hormone (rhGH) is effective in the treatment of growth hormone deficiency (GHD) in children, but has not been studied in adult patients. Therefore, we evaluated the efficacy of needle-free administration of rhGH in adults with GHD. METHODS: Insulin-like growth factor-I (IGF-I) concentrations were compared in newly diagnosed patients with GHD (n = 21) and in patients previously treated by subcutaneous injection of rhGH (switchers, n = 34), at baseline, 12 months and 24 months. RESULTS: In the new patients, IGF-I standard deviation scores (SDS) increased from - 1.82 +/- 0.46 to + 0.75 +/- 0.33 at 12 months and to + 0.65 +/- 0.41 at 24 months (P < or = 0.001 vs. baseline). In switchers, IGF-I SDS remained unchanged with values of + 0.98 +/- 0.32 at baseline, + 0.87 +/- 0.23 at 12 months and + 0.73 +/- 0.29 at 24 months (P = 0.696 vs. baseline). In new patients, the rhGH dose was 0.46 +/- 0.03 mg day(-1) at 12 months and 0.47 +/- 0.03 mg day(-1) at 24 months. In switchers, the rhGH dose was 0.53 +/- 0.04 mg day(-1) at baseline (s.c. injection), 0.52 +/- 0.03 mg day(-1) at 12 months and 0.48 +/- 0.03 mg day(-1) at 24 months (NS between the different time points). There was no difference in the dose of rhGH at 12 and 24 months between the two groups. Side-effects were generally minor and consisted of local tissue reactions. CONCLUSION: Administration of rhGH by needle-free, transdermal injection is effective in maintaining IGF-I concentrations in the normal range for age in adults with GHD, and is as effective as traditional subcutaneous injection of rhGH.     

国产与进口重组人生长激素治疗儿童原发性生长激素缺乏症的药物经济学分析

目的:比较国产与进口重组人生长激素治疗儿童原发性生长激素缺乏症的疗效和经济学效果,为临床用药提供依据。方法:采用二次文献研究方法,检索出符合纳入标准的国内文献共4篇,对国产重组人生长激素(A组)与进口重组人生长激素(B组)治疗儿童原发性生长激素缺乏症进行成本-效果分析,并对结果进行敏感度分析。结果:A、B组均有显著促身高增长作用,且无明显不良反应。治疗时间为6个月时,A、B组的单位效果成本分别为2660.5元/cm和13011.6元/cm;治疗时间为12个月时,A、B组的单位效果成本分别为3040.6元/cm和12775.0元/cm。敏感度分析结果表明,药品价格浮动不会影响分析结果。结论:国产与进口重组人生长激素在治疗儿童原发性生长激素缺乏症上效果相似,国产重组人生长激素更具价格优势。     

重组人生长激素治疗儿童特发性矮小症远期疗效分析

[摘要]目的：评价重组人生长激素（rhGH）治疗儿童特发性矮小症（ISS）的远期疗效及安全性。方法：连续收集2006年8月至2010年12月在我院就诊的ISS患儿。将愿意接受rhGH治疗的80例患儿纳入治疗组,给予每晚睡前皮下注射rhGH 0.15~0.18 IU/（kg·d）,疗程为6个月;另从拒绝接受rhGH治疗的患儿中选取80例年龄、性别及生长发育情况与治疗组患儿相仿的患儿设为对照组,保持自然生长并定期随访。治疗组患儿治疗结束后再随访5年观察治疗效果和不良反应情况。结果：治疗组72例、对照组76例完成5年随访,随访完成率为92.50%（148/160）。随访结束时,治疗组患儿身高从治疗前的（119.27±15.81）cm提高到（151.84±11.53）cm,生长速率从治疗前的每年（3.58±0.57）cm提高到每年（7.45±1.72）cm,且均高于对照组（P均<0.05）。治疗组不良反应/事件发生率为9.72%,予对症处理后不良反应均可消失。结论：rhGH治疗ISS的远期疗效显著,能提高患儿的身高和生长速率,不良反应/事件的发生率较低且可控。     

Clinical applications of recombinant human growth hormone in adults

The main function of growth hormone (GH) is to promote linear growth during childhood; however, GH secretion persists throughout life after cessation of skeletal growth. This hormone has important physiological functions apart from growth stimulation. Many aspects of the physiological and pharmacological actions of GH have been recently clarified. Accordingly, in the last years, especially since the introduction of recombinant human GH (rhGH), GH therapeutical applications have increased. In the last years, the main clinical application of rhGH has been to stimulate growth of growth-retarded GH deficient (GHD) children. More recently, rhGH therapy has been approved for other conditions associated with short stature, including Turner syndrome and end stage renal disease. In adults, the only therapeutic indications approved are the adult GHD syndrome and the AIDS-associated wasting. This review outlines the present knowledge of the physiological effects, clinical applications, therapeutic perspectives, side effects, precautions and contraindications of rhGH therapy in adults.     

Growth hormone replacement for adult growth hormone deficiency

Growth hormone deficiency (GHD) in childhood causes growth retardation, short stature and significant impairment of adult height. Growth hormone (GH) has been given successfully to these children for > 40 years but only since the introduction of recombinant DNA technology, has enough GH been available for paediatric needs and also for other indications. Adults with pituitary disease and hypopituitarism commonly develop GHD. Adult GHD is associated with an array of body composition alterations and metabolic abnormalities, as well as impaired physical performance and psychological well-being. None of these abnormalities are pathogenic for GHD but they constitute a characteristic clinical syndrome. GH substitution for adult GHD has been approved since 1996 in the US and most Western countries and since then, the clinical experience with this novel therapeutic modality is exponentially increased. GH replacement in this population has resulted in considerable clinical benefits. This article reviews the therapeutic principles, available GH formulations and current treatment guidelines for adult patients with GHD.     

Actively separated microneedle patch for sustained-release of growth hormone to treat growth hormone deficiency

Growth hormone deficiency (GHD) has become a serious healthcare burden, and presents a huge impact on the physical and mental health of patients. Here, we developed an actively separated microneedle patch (PAA/NaHCO₃-Silk MN) based on silk protein for sustained release of recombinant human growth hormone (rhGH). Silk protein, as a friendly carrier material for proteins, could be constructed in mild full-water conditions and ensure the activity of rhGH. After manually pressing PAA/NaHCO₃-Silk MN patch to skin for 1 min, active separation is achieved by absorbing the interstitial fluid (ISF) to trigger HCO₃^? in the active backing layer to produce carbon dioxide gas (CO₂). In rats, the MN patch could maintain the sustained release of rhGH for more than 7 days, and produce similar effects as daily subcutaneous (S.C.) injections of rhGH in promoting height and weight with well tolerated. Moreover, the PAA/NaHCO₃-Silk MN patch with the potential of painless self-administration, does not require cold chain transportation and storage possess great economic benefits. Overall, the PAA/NaHCO₃-Silk MN patch can significantly improve patient compliance and increase the availability of drugs, meet current unmet clinical needs, improve clinical treatment effects of GHD patients.     

重组人生长激素治疗ISS及GHD患儿的疗效及安全性分析

目的探讨重组人生长激素治疗特发性矮小症(ISS)及生长激素缺乏症(GHD)的临床疗效及安全性。方法选择2011年9月至2012年12月在我院采用重组人生长激素治疗的28例ISS及30例GHD患儿为研究对象,记录治疗前后患儿生长速率(GV)、体重、身高、骨龄、身高标准差计数(HtSDS)、胰岛素样生长因子-1(IGF-1)水平及不良反应发生率。结果治疗后患儿GV、HtSDS与治疗前比较差异有统计学意义(P<0.05);治疗后IGF-1水平显著升高(P<0.05);两组治疗前后体重、身高、骨龄均未见显著改变(P>0.05);ISS患儿GV与IGF-1水平未见相关性(r=0.235,P>0.05);GHD患儿GV与IGF-1水平显著相关(r=0.638,P<0.05);ISS及GHD患儿不良反应发生率12.1%,经处置后患儿均顺利完成治疗。结论重组人生长激素可促进ISS及GHD患儿生长,不会使骨龄明显提前,安全性好。     

重组人生长激素治疗青春后期特发性矮小临床观察

目的探讨基因重组人生长激素（rhGH）对青春后期特发性矮小的促生长效应。方法 11例青春后期矮小患儿,按性别分为2组,A组,男5例,骨龄14～15岁,B组,女6例,骨龄12.5～13.5岁,每晚睡前皮下注射rhGH,剂量0.15 IU/（kg.d）,疗程6个月。结果 2组患儿的身高分别由治疗前（148.6±2.6）cm、（139.6±2.9）cm增加到（153.6±2.1）cm、（143.8±2.5）cm,生长速率分别由治疗前（3.8±0.5）cm/年、（3.3±0.6）cm/年,提高到（9.8±1.7）cm/年、（8.4±1.8）cm/年,预测成年身高由治疗前（158.9±3.0）cm、（147.6±1.2）cm提高到（160.3±3.0）cm、（149.2±1.6）cm,与治疗前相比均有显著性差异（P〈0.05）,骨龄增加较治疗前相比无显著性差异（P〉0.05）。结论 rhGH治疗对青春后期特发性矮小儿童有促生长效应,疗效肯定,无明显不良反应。     

rhGH替代治疗对生长激素缺乏症患儿线性生长及空腹血糖的影响

目的:观察国产重组人生长激素(rhGH)替代治疗对生长激素缺乏症(GHD)患儿的治疗效果及短期替代治疗对空腹血糖(FBG)的影响.方法:用国产rhGH治疗确诊为GHD的患儿25例,剂量为0.1～0.15 U/(kg·d),每晚睡前皮下注射,每周6～7次.分别于治疗前及治疗3、6个月后进行随诊,由专人用同一量具测量患儿身高(Ht),体质量(Wt),计算体质指数(BMI)、身高标准差积分(HtSDS),禁食8h以上取上午8时空腹静脉血检测FBG.结果:rhGH治疗3、6个月后患儿HtSDS由-2.30±0.44分别增加至-1.77±1.23、-1.74±0.58(P＜0.05或P＜ 0.01),生长速率较治疗前明显提高(P＜0.01),FBG较治疗前增高(P＜0.05),但FBG尚均在正常范围.治疗3、6个月后的FBG均与初始治疗年龄呈正相关(r分别为0.418、0.456,P＜0.05).结论:国产rhGH短期替代治疗可以提高GHD患儿身高,治疗对空腹血糖有影响,初始治疗年龄较大者更应在治疗期间动态监测血糖.     

生长激素治疗过程中甲状腺功能的变化研究

目的观察基因重组人生长激素(rhGH)治疗生长激素缺乏症(GHD)患儿过程中甲状腺功能的变化。方法在应用rhGH前及用药后第1、3、6个月分别取清晨空腹血标本作T3、T4及TSH检测。结果GHD患儿与正常对照组相比,患儿组治疗前T3和T3/T4比值显著降低(P<0.05);rhGH治疗后1、3、6个月,T3和T3/T4比值与用药前相比,其水平明显升高,且差别均有显著性(P<0.05);在用药3个月时T4水平降低,与治疗前相比差别有统计学意义(P<0.05)。结论在rhGH治疗过程中应监测甲状腺功能的变化。     

重组人生长激素治疗青春期前特发性矮小儿童

目的:观察重组人生长激素(rhGH)治疗青春期前特发性矮小的疗效。方法:24例特发性矮小病儿分为2组,治疗组女孩10例,男孩2例,起始治疗年龄为(10.1±s1.9)a,予rhGH0.10～0.13U·kg-1·d-1,治疗时间(0.8±0.3)a。对照组女孩10例,男孩2例,起始观察年龄(9.9±1.7)a,未予rhGH治疗,观察时间(1.1±0.5)a。结果:治疗组治疗后生长的速率为(8.7±1.9)cm·a-1,对照组为(5.0±0.7)cm·a-1,2组差异有非常显著意义(P<0.01)。治疗组对骨龄的身高标准差值(HtSDSBA)增加0.4±0.4,预测成人身高(PHt)增加了(3.1±0.9)cm;对照组HtSDSBA减少0.3±0.5,PHt降低(0.9±1.7)cm,2组比较差异均有非常显著意义(P<0.01)。结论:rhGH对青春期前特发性矮小儿童的生长有促进作用,能改善其PHt。     

Tesamorelin,a human growth hormone releasing factor analogue

Background: The combination of clinical effectiveness with a variety of adverse side effects from the use of recombinant human growth hormone (rhGH) in therapy for growth hormone (GH)-deficient disorders has led to the development of human growth hormone releasing factor (GFR) analogues, which may be better tolerated. Tesamorelin, a synthetic GFR, has been developed as a potential treatment for a variety of conditions that may be associated with a relative deficiency of GH including HIV-related lipodystrophy. Objective: This article reviews the development of tesamorelin and its purported role in HIV-related lipodystrophy and other potential indications. Methods: Relevant articles and abstracts were obtained from searches of the medical and chemical literature databases and the references from published articles. Results/conclusion: A multicenter, randomized, placebo-controlled, Phase III clinical trial suggested that tesamorelin might be a beneficial treatment strategy for HIV-related lipodystrophy with a good safety profile and a positive effect on reducing visceral fat. Other potential indications for tesamorelin appear less promising from the current data.     

重组人生长激素治疗儿童生长激素缺乏症的临床观察

目的：探讨重组人生长激素（rhGH）对生长激素缺乏症（GHD）患儿的治疗效果及对甲状腺功能、血清胰岛素生长因子-1（IGF-1）、25羟维生素D（25（OH）D）水平的影响。方法：选取我院2013年1月至2017年12月我院门诊治疗的70例GHD患儿作为试验组,另外选取70名同龄健康儿童作为对照组,试验组采用rhGH治疗,分析试验组在治疗6个月、治疗12个月后的身高、身高标准差积分、生长速率、骨龄/实际年龄,检测试验组治疗前及治疗12个月后的血清游离三碘甲状腺原氨酸（FT3）、游离甲状腺激素（FT4）、促甲状腺激素（TSH）、IGF-1、25（OH）D水平,并与对照组进行比较。结果：在治疗6个月、12个月后,试验组患儿的身高、身高标准差积分、生长速率、骨龄/实际年龄测定值较治疗前均显著的增加,差异有统计学意义（P<0.05）;在治疗12个月后,试验组患儿的血清FT3、IGF-1、25（OH）D水平升高,差异具有统计学意义（P<0.05）,对照组的血清FT3高于试验组治疗前水平（P<0.05）,对照组的血清IGF-1、25（OH）D高于试验组治疗前及治疗后的水平（P<0.05）。结论：rhGH对GHD患儿的治疗效果显著,能明显改变患儿FT3、血清IGF-1、25（OH）D水平。     

ELISA法研究聚乙二醇重组人生长激素注射液单次给药人体药代动力学

目的 建立ELISA方法研究聚乙二醇重组人生长激素(PEG-rhGH)注射液单次给药人体药代动力学.方法 将30名健康受试者随机分成4组(其中两组为自身对照),分别单次皮下注射PEG-rhGH注射液(0.1 mg·kg-1、0.2 mg·kg-1、0.4 mg·kg-1)、注射用重组人生长激素(rhGH)(0.067mg· kg-1).ELISA法测定不同时间点PEG-rhGH、rhGH的血药浓度,并计算药代动力学参数.结果 PEG-rhGH、rhGH血药浓度分别在0.312 5～40.0000 ng·ml-1、0.312 5～10.0000 ng· ml-1范围内线性关系良好,最低检测性均为0.312 5ng· ml-1,批间、批内RSD均＜15％. PEG-rhGH(0.1、0.2、0.4 mg·kg-1)、rhGH(0.067mg· kg-1)的t1/2分别为:(31.70±4.70)h、(32.19±4.58)h、(30.39±5.93)h、(1.95±0.44)h,Tmax为:(22.20±9.82)h、(29.40±10.75)h、(40.80±8.39)h、(3.20±1.10)h,Cmax:(105.24±45.37)ng·ml-1、(379.09±109.61)ng·m1-1、(920.69±293.21)ng·ml-1、(30.17±3.20)ng·m1-1,CL/F:(26.97±13.86) ml· kg-1· h-1、(9.21±4.05) ml· kg-1· h-1、(6.29±2.87) ml· kg-1· h-1、(284.26±43.47)ml· kg-1· h-1,AUC0→∞:(4657.70±2337.30) ng· m1-1·h、(25279.58±9407.63) ng· ml-1·h、(74438.89±29 007.81) ng·ml-1·h、(240.97±39.40) ng·ml-1·h.结论 PEG-rhGH体内过程符合线性动力学特征,与rhGH相比,明显推迟达峰时间、延长半衰期、减慢清除率,具有长效特征.     

重组人生长激素治疗儿童生长激素缺乏症安全性和有效性的大样本临床研究

目的 采用大样本再评价注射用重组人生长激素(安苏萌)治疗儿童生长激素缺乏症(GHD)的安全性和有效性.方法 1012例GHD患者(观察组)按照0.1 IU·kg-1·d-1的剂量行睡前皮下注射安苏萌,疗程6个月,观察平均身高、生长速率、身高落后标准差、骨龄、生长激素(GH)抗体的变化以及不良反应的发生情况,并与106例未使用安苏萌治疗的GHD患儿(对照组)比较.结果 观察组患儿生长速率由(2.50±0.85) cm/年增至(13.44±4.27)cm/年,净增高速率为(10.94±3.69) cm/年.治疗前后差异均有统计学意义(P＜0.01).治疗后抗GH抗体的阳性率为13.34％,且对疗效无影响.少数患儿注射部位出现一过性红肿反应,未做处理可自行消失.结论 安苏萌治疗GHD的疗效显著,有明显地促进身高增长的效果,并且不会使青春发育提前,使用安全.     

重组人生长激素在老年人肺部感染治疗中的应用

目的 探讨重组人生长激素(rhGH)在老年患者肺部感染治疗中的应用价值.方法 53例肺部感染老年患者随机分为观察组(25例)和对照组(28例),观察组应用小剂量rhGH(0.1 U·Kg-1·d-1)于入院后第二天起每晚皮下注射,疗程10 d;对照组给予等量的注射用水;两组其他治疗相同,包括抗感染、氧疗、营养支持等.观察两组疗效、治疗前后体重指数(BMI)、血清生长激素、胰岛素样生长因子-1、白蛋白、瘦素水平等变化情况.结果 观察组总有效率88.0%,对照组为60.7%,两组比较差异有统计学意义(P＜0.05);观察组治疗后体重指数、血清白蛋白、生长激素、胰岛素样生长因子-1、瘦素水平分别为:(26.I±4.1)kg/m2、(38.4±6.6)g/L、(7.0±0.9)μg/L、(27.3±6.1)μg/L、(6.9±1.1)μg/L,与对照组治疗后的(21.8±3.4)kg/m2、(29.5±5.1)g/L、(4.0±0.4)μg/L、(22.0±3.8)μg/L、(3.8±0.8)μg/L相比较,差异均有统计学意义(均P＜0.05).结论 重组人生长激素辅助治疗老年人肺部感染,能改善患者的营养状态,提高治疗效果.     

重组人生长激素对小于胎龄儿血清胰岛素样生长因子1、胰岛素样生长因子结合蛋白3及身高均值标准差积分的影响

目的探讨血清胰岛素样生长因子1（IGF-1）、胰岛素样生长因子结合蛋白3（IGFBP-3）、两者比值及身高均值标准差积分（HtSDS）在重组人生长激素（rhGH）治疗小于胎龄儿（SGA）中的临床应用价值。方法对32例确诊为追赶生长失败的SGA患儿应用rhGH治疗（0．15～0．20u·b^-1·d^-1）,每晚睡前皮下注射,治疗3、6、9、12个月后进行随访,比较治疗前后的血清IGF-1、IGFBP-3,HtSDS、年生长速率（GV）的变化。结果GV治疗前为（4．1±0．5）cm／年,治疗后3、6、9、12个月分别升至（12．4±3．2）cm／年、（11．0±2．3）cm／年、（10．1±3．5）cm／年、（9．4±1．8）cm／年,显示治疗后追赶生长明显（F=51．35,P〈0．01）;HtSDS治疗前为（-2．81±0．64）,治疗后分别为（-2．55±0．73）、（-2．39±0．65）、（-2．21±0．58）和（-2．09±0．94）,显示治疗后身高与同年龄同性别正常儿童差距逐步缩小,与治疗前相比差异有统计学意义（F=4．99,P〈0．01）。IGF-1、IGFBP-3明显升高,各监测时间点和治疗前相比差异有统计学意义（F=34．52、14．04,均P〈0．01）,以IGF-1升高更明显,3个月之后维持在较高的水平,6个月达高峰;IGF-1／IGFBP-3比值和治疗前相比有所上升,但差异无统计学意义（F=1．82,P〉0．05）。rhGH治疗6个月内,血清IGF-1和身高标准差积分相对治疗前的变化（AHtSDS）存在显著正相关（r3=0．72,r6=0．91）,9个月后不存在相关性（r9=0．26,r12=0．33）。治疗期间未发生严重不良事件。结论rhGH治疗SGA后IGF-1、IGFBP-3升高,以IGF-1升高更明显,6个月内血清IGF-1和AHtSDS存在显著正相关,9个月后不存在相关。rhGH治疗小于胎龄儿是安全有效的。     

重组人生长激素在重度烧伤治疗中的临床应用价值

目的：探讨重组人生长素（ rhGH）在重度烧伤治疗中的应用价值。方法将36例重度烧伤患者按数字表法随机分为观察组和对照组,每组18例。两组均应用同样的抗感染治疗、营养支持及外科手术方法,治疗组给予rhGH皮下注射治疗,对照组每天注射等量的0．9％氯化钠注射液。比较两组肿瘤坏死因子α（TNF-α）和白细胞介素6（IL-6）的水平及创面愈合时间、住院时间等指标。结果两组治疗7 d、14 d后TNF-α水平和IL-6水平[（18．4±3．3）ng/L与（24．9±7．3）ng/L,（133．2±66．9）ng/L与（271．4±88．9）ng/L,（15.4±3．2）ng/L与（25．4±4．9） ng/L,（90．9±20．8） ng/L与（200．7±62．2） ng/L]差异均有统计学意义（t＝3．74、4．75、4．02、4．69,均P＜0．05）。观察组创面愈合时间和住院时间均显著短于对照组（t＝3．75、3.86、4．75、4．64,均P＜0．05）。结论 rhGH对重度烧伤患者伤口的愈合有很大促进作用,从而缩短了患者的住院时间,具有很好的临床效果。     

Cost-utility of somatropin (rDNA origin) in the treatment of growth hormone deficiency in children

ABSTRACT

Objective: The objective of this study was to generate estimates of cost-effectiveness/utility of somatropin (rDNA origin) in the treatment of growth hormone deficiency (GHD) in children

Methods: A decision-analytic model of the epidemiology and treatment of GHD in children was developed. Treatment of GHD was assessed in two hypothetical cohorts compared to no treatment – treatment with somatropin 0.030?mg/kg/day from ages 5 to 16 years, and treatment from ages 3 to 18 years. Costs (stated in 2005 US$) included those related to drug acquisition, endocrinologist consultations, and primary care office visits. Estimates of patient weight by age and sex were derived from published literature, as was the proportion of patients achieving normal height through somatropin treatment and pre/post-treatment patient utilities. Cost-effectiveness/utility was estimated over patients’ expected lifetimes, and was stated alternatively as discounted (3% per annum) US dollars per normal height year (NHY) gained, and cost per quality adjusted life-year (QALY) gained. Multivariate sensitivity analyses were conducted to ensure robustness of the model.

Results: The cost-effectiveness and cost-utility of treating children from ages 5 to 16 years with somatropin was estimated at approximately $8900 per NHY gained and $37?000 per QALY gained, respectively. Corresponding ratios pertaining to treatment of children from ages 3 to 18 years were $9300 per NHY gained and $42?600 per QALY gained. Findings were relatively insensitive to variation in most model parameters.

Conclusions: For both age cohorts, the cost-effectiveness/utility of somatropin in the treatment of GHD compares favorably to well-accepted threshold values. The use of somatropin represents reasonable value for money for the treatment of GHD in children.     

Effects of parenteral nutrition with and without GH on the GH/IGF-1 axis after hepatectomy in hepatocellular carcinoma with liver cirrhosis

Postoperative hepatic insulin-like growth factor-1 (IGF-1) production may be severely disturbed in patients with liver cirrhosis. Complex alterations in the GH/IGF-1 axis are thought to play an important role in the protein catabolism that complicates major surgical procedures. The aim of this study was to explore the effects of parenteral nutrition (PN) with and without growth hormone (GH) on the GH/IGF-1 axis after hepatectomy for hepatocellular carcinoma (HCC) with cirrhosis and evaluate the potential roles of recombinant human GH (rhGH) therapy. Twenty-four patients with HCC with cirrhosis who underwent hepatectomy were randomly divided into two groups: a PN group (n = 12) and an rhGH + PN group (n = 12). Liver function, serum GH, IGF-1 and IGFBP-3 were measured before the operation and at post-operative days (POD) 1 and 6. Insulin-like growth factor-1 and IGFBP-3 mRNA in the liver tissue was detected by RT-PCR. The liver Ki67 immunohistochemistry staining was studied. At the same time, 12 patients with cholelithiasis or liver hemangioma who underwent operation served as normal control group. On POD 6, serum prealbumin, GH, IGF-1, IGFBP-3, hepatic IGF-1 mRNA, IGFBP-3 mRNA and liver Ki67 LI were higher in the rhGH + PN group than in the PN group. There was no significant difference in the 6-and 12-month tumor-free survival rate and the median tumor-free survival time between the PN group and the rhGH + PN group (P>0.05). These data indicate that rhGH + PN could ameliorate the changes in the GH/IGF-1 axis after hepatectomy for HCC in the setting of cirrhosis.