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系统评价:生长激素在健康老年人中的安全性和有效性。

Systematic review: the safety and efficacy of growth hormone in the healthy elderly.

作者信息

Liu Hau, Bravata Dena M, Olkin Ingram, Nayak Smita, Roberts Brian, Garber Alan M, Hoffman Andrew R

机构信息

Stanford University, Stanford, California 94305-6019, USA.

出版信息

Ann Intern Med. 2007 Jan 16;146(2):104-15. doi: 10.7326/0003-4819-146-2-200701160-00005.

DOI:10.7326/0003-4819-146-2-200701160-00005
PMID:17227934
Abstract

BACKGROUND

Human growth hormone (GH) is widely used as an antiaging therapy, although its use for this purpose has not been approved by the U.S. Food and Drug Administration and its distribution as an antiaging agent is illegal in the United States.

PURPOSE

To evaluate the safety and efficacy of GH therapy in the healthy elderly.

DATA SOURCES

The authors searched MEDLINE and EMBASE databases for English-language studies published through 21 November 2005 by using such terms as growth hormone and aging.

STUDY SELECTION

The authors included randomized, controlled trials that compared GH therapy with no GH therapy or GH and lifestyle interventions (exercise with or without diet) with lifestyle interventions alone. Included trials provided GH for 2 weeks or more to community-dwelling participants with a mean age of 50 years or more and a body mass index of 35 kg/m2 or less. The authors excluded studies that evaluated GH as treatment for a specific illness.

DATA EXTRACTION

Two authors independently reviewed articles and abstracted data.

DATA SYNTHESIS

31 articles describing 18 unique study populations met the inclusion criteria. A total of 220 participants who received GH (107 person-years) completed their respective studies. Study participants were elderly (mean age, 69 years [SD, 6]) and overweight (mean body mass index, 28 kg/m2 [SD, 2]). Initial daily GH dose (mean, 14 microg per kg of body weight [SD, 7]) and treatment duration (mean, 27 weeks [SD, 16]) varied. In participants treated with GH compared with those not treated with GH, overall fat mass decreased (change in fat mass, -2.1 kg [95% CI, -2.8 to -1.35] and overall lean body mass increased (change in lean body mass, 2.1 kg [CI, 1.3 to 2.9]) (P < 0.001), and their weight did not change significantly (change in weight, 0.1 kg [CI, -0.7 to 0.8]; P = 0.87). Total cholesterol levels decreased (change in cholesterol, -0.29 mmol/L [-11.21 mg/dL]; P = 0.006), although not significantly after adjustment for body composition changes. Other outcomes, including bone density and other serum lipid levels, did not change. Persons treated with GH were significantly more likely to experience soft tissue edema, arthralgias, carpal tunnel syndrome, and gynecomastia and were somewhat more likely to experience the onset of diabetes mellitus and impaired fasting glucose.

LIMITATIONS

Some important outcomes were infrequently or heterogeneously measured and could not be synthesized. Most included studies had small sample sizes.

CONCLUSIONS

The literature published on randomized, controlled trials evaluating GH therapy in the healthy elderly is limited but suggests that it is associated with small changes in body composition and increased rates of adverse events. On the basis of this evidence, GH cannot be recommended as an antiaging therapy.

摘要

背景

人生长激素(GH)被广泛用作抗衰老疗法,尽管其用于此目的尚未获得美国食品药品监督管理局的批准,且在美国作为抗衰老药物进行销售是违法的。

目的

评估GH疗法在健康老年人中的安全性和有效性。

数据来源

作者检索了MEDLINE和EMBASE数据库,以查找截至2005年11月21日发表的英文研究,检索词包括生长激素和衰老。

研究选择

作者纳入了随机对照试验,这些试验比较了GH疗法与非GH疗法,或GH与生活方式干预(有或无饮食的运动)与单独的生活方式干预。纳入的试验为社区居住的参与者提供了2周或更长时间的GH,这些参与者的平均年龄为50岁或以上,体重指数为35kg/m2或更低。作者排除了评估GH作为特定疾病治疗方法的研究。

数据提取

两位作者独立审阅文章并提取数据。

数据综合

31篇描述18个独特研究人群的文章符合纳入标准。共有220名接受GH治疗的参与者(107人年)完成了各自的研究。研究参与者为老年人(平均年龄69岁[标准差6])且超重(平均体重指数28kg/m2[标准差2])。初始每日GH剂量(平均,每千克体重14μg[标准差7])和治疗持续时间(平均,27周[标准差16])各不相同。与未接受GH治疗的参与者相比,接受GH治疗的参与者总体脂肪量减少(脂肪量变化,-2.1kg[95%可信区间,-2.8至-1.35]),总体瘦体重增加(瘦体重变化,2.1kg[可信区间,1.3至2.9])(P<0.001),且体重无显著变化(体重变化,0.1kg[可信区间,-0.7至0.8];P=0.87)。总胆固醇水平降低(胆固醇变化,-0.29mmol/L[-11.21mg/dL];P=0.006),尽管在调整身体成分变化后不显著。其他结局,包括骨密度和其他血脂水平,未发生变化。接受GH治疗的人更有可能出现软组织水肿、关节痛、腕管综合征和男性乳房发育,并且更有可能出现糖尿病和空腹血糖受损。

局限性

一些重要结局的测量频率低或存在异质性,无法进行综合分析。大多数纳入研究的样本量较小。

结论

关于评估GH疗法在健康老年人中的随机对照试验的文献有限,但表明其与身体成分的微小变化和不良事件发生率增加有关。基于这一证据,不推荐将GH作为抗衰老疗法。

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