小剂量生长激素补充在中老年男性中的应用研究

目的 :探讨小剂量生长激素补充在中老年男性中应用的疗效和安全性。　方法 :从门诊患者中选择 30例4 2～ 77岁有更年期症状、血睾酮水平正常的中老年男性参加本试验 ,每例患者均接受连续 6个月的生长激素补充 ,0 .0 4U/ (kg·次 ) ,每周 3次 ,皮下注射。治疗前、后均检查血脂、血糖、血睾酮、血胰岛素样生长因子 (IGF 1 )、血前列腺特异性抗原 (PSA)、男性更年期症状评分、腹围、体重、握力、尿流率、国际前列腺症状评分 (IPSS)、前列腺体积以及治疗中的不良反应。　结果 :治疗后 ,血IGF 1水平显著上升 ;血睾酮水平无明显变化 ;血总胆固醇在用药 6个月后显著下降 ;男性更年期症状评分显著下降 ;握力增加 ,腹围减少 ,体重无明显变化 ;尿流率、IPSS、血PSA、甘油三酯、血糖以及前列腺体积在治疗前后均无明显变化。　结论 :短期小剂量生长激素补充可使部分中老年男性更年期症状得以改善 ,无明显不良反应     

联合应用重组人生长激素和胰岛素样生长因子-1对烫伤大鼠创面愈合及蛋白质代谢影响的实验研究

目的　了解联合应用重组人生长激素(rhGH)和胰岛素样生长因子-1(IGF-1)对烫伤大鼠创面愈合及蛋白质代谢的影响。方法　Wistar大鼠40只,深Ⅱ度烫伤,随机分成四组,分别接受rhGH(每天0.1 U/kg 称A组)、rhGH加IGF-1(每天rhGH 0.1U/kg 加IGF-1 2.0 m g/kg称C组)、IGF-1(每天2.0 m g/kg 称B组)和林格氏液(每天2 m l/kg 称D组)治疗2 周后,分析比较各组大鼠一般状况、创面愈合时间和蛋白质代谢情况。结果　治疗2 周后C、A 组体重开始增加,4 周后C组体重是A组的1.65 倍,而D组在4～5 周后才开始增加;C组创面愈合天数为(17.1±4.4)天,A组为(20.5±4.8)天,D组为(29.7±6.3)天,C组创面愈合时间明显短于D组,而B组则差异不明显;C组蛋白质升高比A 组和B组明显,有统计学意义(P< 0.01)。结论　联合应用rhGH和IGF-1 比单纯应用rhGH 或IGF-1 对缩短创面愈合时间、促进蛋白质合成均有明显的效果     

重组生长激素对肾病综合征大鼠血清蛋白的影响

目的:观察基因重组生长激素(rhGH)对肾病综合征大鼠(NS大鼠)血清总蛋白、白蛋白和胰岛素样生长因子-1(IGF-1)的作用.方法:制备阿霉素大鼠NS模型,设正常组(6只)、模型组 (12只)和rhGH治疗组 (12只).以放射免疫法(RIA)测血清IGF-1水平,用酶联免疫吸附试验测尿微量白蛋白浓度(Alb),S-丽春红测 24 h尿蛋白定量,全自动生化仪测量血清总蛋白和白蛋白.结果:模型组大鼠血清蛋白、血清IGF-1浓度均显著低于正常组.rhGH治疗4周时血清IGF-1和血清蛋白与模型组大鼠同期相比显著上升;而rhGH治疗组与模型组同期尿蛋白排出无统计学差异.结论:NS时,尿蛋白排出量增加和血清GH/IGF-1轴紊乱导致血清蛋白水平下降,外源性rhGH在不增加尿蛋白排出的情况下可提高NS血清IGF-1和蛋白水平.     

小剂量生长激素补充对中老年男性性功能障碍患者的影响

目的 探讨小剂量生长激素补充对中老年男性性功能障碍患者的疗效和安全性。方法 30例42-77岁有性功能障碍、血睾酮水平正常的中老年男性随机分成A、B两组。A组病人按0.04U/Kg/次,每周3次,皮下注射rhGH,连续用药3个月;B组病人先给予安慰剂1个月,然后再按A组给药方案应用rhGH 3个月。记录治疗前、后各项有关指标。结果 A、B两组应用rhGH后,每月晨间勃起次数由10.25.3次增加到19.44.8次(P<0.01);成功阴道插入次数由1.61.1次增加到3.82.2次(P<0.01);男性更年期症状总评分及性功能症状评分显著下降;IIEF-5评分显著上升;而B组患者在应用安慰剂的第1个月,各项指标均无明显变化。结论 小剂量生长激素补充可使部分中老年男性性功能显著改善,无明显副作用,但由于其是一种促进全身代谢的激素,使用仍应谨慎。     

益肾活血法对肾虚型LOH患者睾酮分泌指数的影响

目的:探讨中医益肾活血法对肾虚型迟发性性腺功能减退症(LOH)患者睾酮分泌指数的影响及治疗机制。方法:采用中国中老年男子健康研究会(CHISAM)认可的《男性更年期自我评定表》进行症状评分,检测血清总睾酮(TT)、黄体生成素(LH)的水平,并依据TT/LH计算出TSI(睾酮分泌指数)值,筛选出60例肾虚型LOH患者入组,按2∶1随机分为中药组和对照组。中药组用男更宁汤剂治疗;对照组用十一酸睾酮口服治疗,疗程均为12周。观察治疗后第4、8、12周两组患者心理学分量表评分、躯体分量表评分、性分量表评分、TT、LH和TSI的变化。结果:①中药组与对照组治疗前LH的水平分别为(5.32±2.08)、(5.36±2.07)IU/L,治疗12周后为(4.89±1.46)、(4.81±1.75)IU/L,两组治疗前后差异具有显著性(P均<0.05);两组治疗前心理学分量表评分分别为(5.2±1.3)、(4.8±2.2)分,治疗12周后分别为(2.7±1.4)、(2.9±1.2)分,两组治疗前后差异均具有显著性(P均<0.05);两组躯体分量表评分分别为(6.9±2.5)、(7.1±2.7)分,治疗12周后分别为(2.9±1.6)、(3.1±1.5)分,两组治疗前后差异具有显著性(P均<0.05);两组性分量表评分分别为(10.2±3.3)、(9.8±3.1)分,治疗12周分别为(4.5±2.9)、(4.8±3.0)分,两组治疗前后差异有显著性(P均<0.05);②两组治疗前TT分别为(11.13±0.69)、(10.99±0.74)nmol/L,治疗12周后分别为(14.55±0.75)、(14.74±0.83)nmol/L,差异有显著性(P均<0.05);两组治疗前TSI分别为(2.14±0.65)、(2.05±0.73)nmol/IU,治疗12周后分别为(2.99±0.72)、(3.11±0.65)nmol/IU,差异有显著性(P均<0.05);③中药组治疗12周后LH、TT、TSI、心理学分量表评分、躯体分量表评分、性分量表评分分别为(4.89±1.46)IU/L、(14.55±0.75)nmol/L、(2.99±0.72)nmol/IU、(2.7±1.4)分、(2.9±1.6)分、(4.5±2.9)分,对照组治疗12周后分别为(4.81±1.75)IU/L、(14.74±0.83)nmol/L、(3.11±0.65)nmol/IU、(2.9±1.2)分、(3.1±1.5)分、(4.8±3.0)分,两组间对比差异无显著性(P均>0.05)。④整个治疗过程,两组均无不良事件发生。结论:益肾活血法治疗肾虚型LOH可显著改善患者临床症状,同时使TT水平、TSI水平升高,疗效与补充雄激素治疗相当;男更宁汤通过下丘脑-垂体-性腺轴发挥作用可能是其治疗LOH的主要机制之一。     

庆大霉素局部注射治疗女性尿道综合征的临床研究

目的:研究在"女性前列腺"局部注射抗生素对女性尿道综合征的疗效,为其探索一种有效的治疗方法。方法:选择2009年7月至2010年12月在我院门诊就诊的患者,共入选163例。根据就诊顺序前瞻性随机分为A、B、C 3组,A组58例为实验组,B组55例、C组50例为对照组。A、B、C 3组均进行同样的常规治疗,除此之外A、B组同时采取局部注射治疗,A组注射庆大霉素8万单位(2 ml)+2%利多卡因2 ml的混合药液,B组注射生理盐水2 ml+2%利多卡因2 ml的混合药液。注射方法两组完全一致。浸润性注射在尿道后壁尿道旁腺及其周围,每周治疗2次,6次为1疗程。根据患者自主症状评分的改变评定疗效。疗程结束后第2、4周重复症状评分,症状消失为治愈,分值减少>1/2为为显效,分值减少>1/4分为有效,分值减少<1/4或者反增加为无效。结果:疗程结束后第2周症状评分,疗效A组(有效率为77.5%)明显高于B组(有效率为67.3%)和C组(有效率为68.0%),差异有显著性(P<0.05),而B、C组间无明显差异(P>0.05)。疗程结束后第4周复查,A组有效率略有下降,仍然高于B组和C组,差异有显著性(P<0.05)。结论:"女性前列腺"局部注射庆大霉素治疗女性尿道综合征有一定效果。     

血管紧张素Ⅱ对大鼠增生前列腺细胞增殖和凋亡的影响

目的了解血管紧张素Ⅱ对良性前列腺增生(BPH)大鼠前列腺细胞增殖和凋亡的作用。方法成年雄性Wistar大鼠随机分为正常组(A组),BPH模型组(B组)和BPH+血管紧张素转化酶抑制剂依那普利组(C组),每组10只。B组在双侧睾丸切除后1周开始皮下注射丙酸睾酮并灌饲生理盐水,C组在双侧睾丸切除术后1周开始皮下注射丙酸睾酮并灌饲依那普利。4周后观察各组大鼠前列腺重量和组织学变化,Ki-67免疫组化染色及TUNEL染色测定前列腺上皮和间质细胞的增殖和凋亡指数。结果3组大鼠前列腺指数[前列腺湿重(mg)／体重(g)]分别为1．54±0．09,1．65±0．07和1．59±0．09,B组大鼠前列腺指数显著大于A组和C组(P<0．05)。光镜显示B组前列腺上皮细胞增生明显,C组上皮细胞明显萎缩。A组上皮和间质细胞增殖率分别为(1．4±0．4)％和(1．1±0．4)％,B组为(3．0±0．4)％和(1．4±0．4)％,C组为(2．1±0．5)％和(1．2±0．5)％,B组上皮细胞增殖率显著高于A组和C组(P<0．05),而3组间质细胞的增殖率比较差异无统计学意义(P>0．05);3组上皮细胞凋亡率分别为(1．2±0．5)％,(1．1±0．3)％和(1．1±0．5)％(P>0．05)。结论血管紧张素Ⅱ在大鼠BPH组织中表达上调。血管紧张素Ⅱ可能影响大鼠前列腺细胞的增殖,但对细胞凋亡影响不明显。     

保留动脉显微手术联合麒麟丸治疗双侧精索静脉曲张致少弱精子症

目的:探讨保留睾丸动脉显微手术联合服用麒麟丸治疗双侧精索静脉曲张(VC)合并少弱精子症的临床疗效。方法:60例双侧精索静脉曲张并少弱精子症患者,随机分为两组,单纯手术组30例,显微手术联合服用麒麟丸组30例,疗程12周,每次服用6 g,每日3次,观察治疗后第4、8、12周两组患者精子浓度、精液量、精子活力(a+b级)、畸形精子百分率、血清Inh B、LH、TT和FSH水平变化,并计算睾酮分泌指数(TSI=TT/LH)。结果:患者均手术成功,术后症状消失,精子浓度、精液量、精子活力明显提高,畸形精子百分率明显降低,术后血清Inh B、TT、TSI明显改善,FSH、LH含量降低,与术前比较,差异有统计学意义(P﹤0.01)。手术联合服用麒麟丸组治疗12周后血清Inh B、LH、TT及TSI分别为(138.96±22.26)ng/L、(3.17±0.12)IU/L、(13.98±3.02)nmol/L、(4.41±0.53)nmol/IU,单纯手术组治疗12周后分别为(129.54±22.23)ng/L、(3.59±0.11)IU/L、(12.68±3.12)nmol/L、(3.53±0.51)nmol/IU,两组间对比差异有显著性(P﹤0.05)。手术联合服用麒麟丸组受孕22例,受孕率为73.4%,比单纯手术组受孕11例、受孕率为36.6%效果显著(P﹤0.05)。结论:保留睾丸动脉显微手术联合服用麒麟丸治疗双侧精索静脉曲张所致少弱精子症,对于术后精液质量改善明显、疗效满意。     

安特尔、保列治治疗PADAM合并BPH 42例体会

目的：年龄和雄激素是前列腺增生的二个条件，中、老年男性部分雄激素缺乏激素补充治疗是否对前列腺肥大患者有不良影响尚无定论，本文对前列腺肥大合并部分雄激素缺乏患者的治疗方法进行了探讨。方法：对2000年7月到2002年3月在我院男科门诊就诊，确诊为前列腺肥大和部分雄激素缺乏综合征的患者给予保列治、安特尔联合治疗，并且对相关指标：游离睾酮、最大尿流率、前列腺症状积分、男子更年期症状积分、前列腺超声等进行观察。结果：治疗前后前列腺症状积分、尿流率、游离睾酮、男子更年期症状积分均有显著意义的改善，而血脂、EKG、PSA则无变化。结论：保列治、安特尔治疗PADAM合并BPH是安全、有效的。     

二仙汤治疗男性更年期综合征临床研究

目的探讨二仙汤治疗肾虚证男性更年期综合征的疗效。方法采用Bosphorus心理系将症状量化的方法，对男性更年期综合征症状进行评分，将病人随机分为2组，Ⅰ组服用十一酸睾酮（安特尔），Ⅱ组经中医辨证为肾虚证服用二仙汤组。结果十一酸睾酮治疗组和二仙汤治疗组治疗后症状比治疗前均有明显的改善，应用安特尔治疗后血F-T明显升高（P〈0．01），而二仙汤服用3个月后F—T无明显改变（P〉0．05）。结论 二仙汤治疗男性更年期综合征，作用是补肾益气，调和阴阳平衡，特别适用于患有前列腺疾病的中老年人。     

Low-dose recombinant human growth hormone increases body weight and lean body mass in patients with short bowel syndrome.

OBJECTIVE: The authors investigate the effects of low dose recombinant human growth hormone (rhGH) on body composition and absorptive capacity in patients with short bowel syndrome from Crohn's disease. SUMMARY BACKGROUND DATA: Patients with short bowel syndrome usually are malnourished because of malabsorption. The anabolic effects of high doses of rhGH have been tested in different clinical catabolic conditions, recently including patients with short bowel syndrome. The authors have investigated the effects of low-dose rhGH in short bowel syndrome in a placebo-controlled crossover clinical trial. METHODS: Ten patients were treated with daily subcutaneous doses of rhGH/placebo (0.5 international units/kg-1 per week-1 = 0.024 mg/kg-1 per day-1) for 8 weeks in a randomized, double-blind, placebo-controlled crossover clinical trial with a minimum of 12 weeks wash-out. Absorptive capacity and biochemical parameters were investigated in a metabolic ward before treatment and during first and last week of treatment. Body composition was determined by DEXA-Scan (Lunar DPX, Scanexport Medical, Helsingborg, Sweden), impedance analysis, and whole body potassium counting. RESULTS: Low-dose rhGH doubled serum levels of insulin-like growth factor-1 (IGF-1) and increased body weight, lean body mass, and total body potassium by 5% (p < 0.05). Fat-free mass and total body water increased by 6% (p = 0.008). Increases in IGF-1 levels correlated with increases in fat-free mass (r = 0.77, p < 0.02). No significant changes in absorptive capacity of water, energy, or protein were detected. CONCLUSION: Eight weeks of low-dose rhGH treatment leads to increases in body weight, lean body mass, and fat-free mass in patients with short bowel syndrome, correlated to increases in IGF-1 levels.     

The modulation of prostate cancer risk with alpha-tocopherol: a pilot randomized, controlled clinical trial

PURPOSE: Studies suggest that vitamin E may decrease the risk of prostate cancer. The Prevention Research Veteran Affairs E-vitamin Nutrition Trial is a randomized, double-blind, placebo controlled study designed to assess the effects of vitamin E supplementation on biomarkers associated with prostate cancer risk in peripheral blood and prostate tissue. MATERIALS AND METHODS: A total of 44 patients with increased prostate specific antigen (PSA) and/or abnormal digital rectal examination on initial evaluation were randomized to receive 400 IU vitamin E (22) vs placebo (22). Serum vitamin E, PSA, dehydroepiandrosterone, testosterone and insulin-like growth factor-1 (IGF-1) were measured in the 2 groups at baseline and then at 3-month intervals. Results are reported in 28 patients (placebo in 14 and vitamin E in 14) who completed the treatment as specified by the protocol. RESULTS: Serum Vitamin E was significantly higher in patients on vitamin E supplementation. alpha-Tocopherol supplementation did not affect the levels of PSA, serum androgens (testosterone and dehydroepiandrosterone) or (IGF-1). CONCLUSIONS: Serum alpha-tocopherol is increased by oral supplementation of vitamin E. We found that alpha-tocopherol supplementation has no effect on serum androgens, IGF-1 or PSA. The lack of an effect of vitamin supplementation on PSA avoids any bias in the diagnosis of prostate cancer in vitamin E treated patients. Our results suggest that a decrease in prostate cancer risk with alpha-tocopherol is likely to occur through a mechanism that is nonhormonal and independent of IGF-1.     

糖皮质激素诱导胰岛素样生长因子1降低对原发性肾病综合征患者骨代谢的影响

目的 观察糖皮质激素（GC）治疗的原发性肾病综合征（PNS）患者胰岛素样生长因子1（IGF-1）变化,探讨其水平改变对PNS患者骨代谢的影响及意义。 方法 以本院2008年1月至2009年8月临床资料完整的PNS患者39例为对象。口服泼尼松0.8~1.0 mg&#8226;kg-1&#8226;d-1,完全缓解2周后,以每2周减去原剂量的5％～10％的方式减量。最终每日或隔日5～10 mg维持（总疗程>24周）。测定应用激素前、治疗第4、8、12、24周末血白蛋白、24 h尿蛋白量、血清钙、磷、甲状旁腺激素（PTH）、25羟基维生素D3（25-（OH）D3）、骨钙素（BGP）、I型胶原吡啶交联C终端肽（CTx）及尿钙/肌酐;双能X线骨密度仪检测患者骨密度（BMD）;酶联免疫法测定血清IGF-1水平。使用Pearson 相关分析探讨IGF-1与骨代谢改变的关系。 结果 36例完成随访,并具备完整临床数据。治疗第4、8、12和24周与治疗前比较,患者血钙、25-（OH）D3水平均呈时间依赖性升高（P < 0.05）,相关分析提示,与尿蛋白量呈负相关 （r=-0.749,r=-0.831,P < 0.05）。骨形成指标血BGP、IGF-1水平呈时间依赖性降低（P < 0.05）,骨吸收指标CTx逐渐升高,至第12周起差异有统计学意义（P < 0.05）。第4周各部位BMD与治疗前差异均无统计学意义;第8周起腰椎（L1~L4）BMD值较治疗前显著下降（P < 0.05）;第 24 周,股骨颈和股骨干的BMD与治疗前差异有统计学意义（P < 0.05）。PNS患者经糖皮质激素治疗后,IGF-1与BMD和BGP呈正相关（r=0.495和r=0.896,均P < 0.05）,与血CTx呈负相关（r=-0.697,P < 0.05）。 结论 糖皮质激素呈时间依赖性导致PNS患者血清IGF-1水平降低。IGF-1下降与患者早期骨形成指标降低、骨吸收指标增高及后期骨密度下降相关。IGF-1途径可能参与GC 引起的PNS患者骨代谢改变。IGF-1有望成为反映或预测糖皮质激素诱导的骨质疏松的新型生化指标。     

Treatment of male hypogonadism with testosterone undecanoate injected at extended intervals of 12 weeks: a phase II study

This paper reports the result of an open-label, non-randomized clinical trial investigating the efficacy and safety of an injectable preparation of testosterone undecanoate (TU) dissolved in castor oil and given over a 3.2-year period. In a previous study we demonstrated that injections of TU every 6 weeks resulted in satisfactory substitution but a tendency toward testosterone accumulation. Here we investigate prolonged TU treatment at extended injection intervals in 7 hypogonadal men. Injections were given at gradually increasing intervals between the fifth and 10th injection, and from then on every 12 weeks. Steady state kinetics were obtained after the 13th injection. Well-being, sexual activity, clinical chemistry, prostate volume, and prostate-specific antigen (PSA) and serum hormone levels were monitored. Patients were clinically well-adjusted throughout the study. Before the next injection, testosterone, dihydrotestosterone, and estradiol levels were mostly within the normal range and showed a tendency to decrease with increasing injection intervals. Body weight, hemoglobin, serum lipids, PSA, and prostate volume did not change significantly during the 3.2 years of treatment. PSA levels were always within the normal limit. Maximal testosterone levels during steady state kinetics were measured after 1 week with 32.0 +/- 11.7 nmol/L (mean +/- SD). Before the last injection, mean testosterone concentrations were 12.6 +/- 3.7 nmol/L. Compared with conventional testosterone enanthate or cypionate treatment requiring injection intervals of 2-3 weeks and resulting in supraphysiological serum testosterone levels, injections of TU at intervals of up to 3 months offer an excellent alternative for substitution therapy of male hypogonadism.     

Serum measurements of testosterone, insulin-like growth factor 1, and insulin-like growth factor binding protein-3 in the diagnosis of prostate cancer among Korean men

Aim： To investigate the relationships of serum testosterone, insulin-like growth factor （IGF）- 1 and IGF-binding protein （IGFBP）-3 levels with prostate cancer risk and also with known prognostic parameters of prostate cancer in Korean men who received radical retropubic prostatectomy （RRP） for clinically-localized prostate cancer. Methods： Serum levels of total testosterone, free testosterone, IGF-1 and IGFBP-3 were determined in 592 patients who subsequently received prostate biopsy. Results were compared between patients who eventually received RRP for prostate cancer （n = 159） and those who were not diagnosed with prostate cancer from biopsy （control group, n = 433）. Among the prostate cancer only patients, serum hormonal levels obtained were analyzed in relation to serum prostate specific antigen （PSA）, pathological T stage and pathological Gleason score. Results： Prostate cancer patients and the control group demon- strated no significant differences regarding serum levels of total testosterone, free testosterone, IGF-I and IGFBP-3 across the different age groups. Among the cancer only patients, no significant associations were observed for serum levels of total testosterone, free testosterone, IGF-1 and IGFBP-3 levels with pathological T stage, pathological Oleason score and preoperative PSA. Conclusion： Our data indicate that simple quantifications of serum testosterone and IGF-1 along with IGFBP-3 levels might not provide useful clinical information in the diagnosis of clinically localized prostate cancer in Korean men. Also, our results suggest that serum levels of testosterone, IGF-1 and IGFBP-3 might not be significantly associated with known prognostic factors of clinically localized prostate cancer in Korean men. （Asian J Androl 2008 Mar; 10： 207-213）     

重组人生长激素对严重烧伤后机体代谢的影响

目的　探讨重组人生长激素 (rhGH)对严重烧伤患者代谢的影响。　方法　烧伤患者2 4例 ,随机分为rhGH治疗组和对照组 ,每组 12例。分别于伤后第 3～ 17天皮下注射rhGH(9U/d)和等量等渗盐水。于伤后第 3、10、17天抽血检测血清生长激素 (GH)、胰岛素样生长因子 (IGF 1)、胰岛素样生长因子结合蛋白 3(IGFBP 3)、血清蛋白、血浆胰岛素、血浆胰高血糖素及血糖值 ,进行对比分析。　结果　伤后第 10、17天 ,rhGH治疗组血清GH、IGF 1、IGFBP 3、血清前白蛋白及转铁蛋白值均明显高于对照组 (P <0 .0 5～ 0 .0 1) ,两组各时相点血清白蛋白、血浆胰岛素、胰高血糖素及血糖浓度比较差异无显著性意义 (P >0 .0 5 )。　结论　严重烧伤后应用小剂量rhGH能促进机体蛋白质合成 ,对血糖无影响     

Phase II study of abarelix depot for androgen independent prostate cancer progression during gonadotropin-releasing hormone agonist therapy

PURPOSE: We determine the clinical efficacy of the gonadotropin-releasing hormone (Gn-RH) antagonist abarelix in patients with androgen independent prostate cancer, and measure its effect on serum follicle-stimulating hormone (FSH) and testosterone. MATERIALS AND METHODS: A total of 20 patients with prostate cancer progression during Gn-RH agonist therapy received 100 mg. abarelix depot by intramuscular injection on days 1, 15 and 29, and then every 28 days for up to 24 weeks. Gn-RH agonist therapy was not continued. Patients who met criteria for prostate specific antigen (PSA) response after 24 weeks of therapy could receive treatment for up to 52 weeks. PSA response was the primary end point and was defined as a 50% decrease confirmed 4 weeks later. Secondary end points of this study were the effect of therapy on serum FSH and testosterone. RESULTS: No patient met the criteria for PSA response. At the end of the 6 cycles of therapy 2 patients remained stable without PSA progression or other signs of disease progression. Median time to progression was 8 weeks (95% CI 5.7-10.3). Mean serum FSH decreased by more than 50% from a baseline of 5.7 IU/l. (95% CI 4.2-7.1) and remained suppressed throughout the observation period. Mean serum testosterone did not change after 4 and 8 weeks of therapy and remained in the anorchid range. Treatment was well tolerated with no grade 3 or higher toxicity. CONCLUSIONS: Treatment of androgen independent prostate cancer with abarelix decreases circulating FSH and maintains anorchid testosterone but does not result in clinical responses.     

The effect of recombinant human growth hormone treatment on bone and mineral metabolism in haemodialysis patients

Background: Uraemia and chronical haemodialysis are associated with an abnormal growth hormone (GH)-insulin-like growth factor (IGF) axis which may contribute to malnutrition and renal bone disease. Short-term studies have shown a beneficial effect of treatment with recombinant human growth hormone (rhGH) on nutritional status in patients on haemodialysis. In the present study, we evaluated the effect of rhGH on bone and mineral metabolism. Methods: Twenty chronic malnourished patients on haemodialysis took part in a double-blind, placebo controlled trial with subcutaneous injections of rhGH (4 IU/m²/day) or placebo for 6 months. Results: During rhGH treatment, serum IGF-1 increased 264±52% (mean±SEM) (P<0.008). There were no significant changes in biochemical markers of mineral metabolism (serum ionized calcium, phosphate and parathyroid hormone). Among markers of bone metabolism, there was a significant increase in serum procollagen type I C-terminal propeptide (maximum 155±8%, P<0.001) and no significant changes in serum alkaline phosphatase. Bone densitometry showed a significant decrease in whole body bone mineral content (95.7±1.2%) after 6 months treatment. Conclusion: The effects of 6 months treatment with rhGH seen in this study are best explained by a GH- or IGF-1-induced increased bone turnover. Long-term treatment in larger cohorts followed by bone densitometry and, preferentially, bone histomorphometry are needed to evaluate whether this is a beneficial effect in haemodialysis patients.