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癸酸诺龙对接受透析患者的合成代谢作用:一项随机对照试验。

Anabolic effects of nandrolone decanoate in patients receiving dialysis: a randomized controlled trial.

作者信息

Johansen K L, Mulligan K, Schambelan M

机构信息

Department of Medicine, San Francisco General Hospital, University of California, USA.

出版信息

JAMA. 1999 Apr 14;281(14):1275-81. doi: 10.1001/jama.281.14.1275.

DOI:10.1001/jama.281.14.1275
PMID:10208142
Abstract

CONTEXT

Patients receiving dialysis commonly experience malnutrition, reduced muscle mass (sarcopenia), and fatigue for which no effective treatment has been identified. Anabolic steroids are known to increase muscle mass and strength in healthy individuals, but their effect on the sarcopenia and fatigue associated with long-term dialysis has not been evaluated.

OBJECTIVE

To assess the effects of an anabolic steroid, nandrolone decanoate, on lean body mass (LBM), functional status, and quality of life in dialysis patients.

DESIGN

Randomized, double-blind, placebo-controlled trial conducted between April 1996 and July 1997.

SETTING

Hospital-based outpatient dialysis unit.

PATIENTS

Twenty-nine patients undergoing dialysis for at least 3 months.

INTERVENTION

Nandrolone decanoate, 100 mg (n = 14), or placebo (n = 15) by intramuscular injection once a week for 6 months.

MAIN OUTCOME MEASURES

Weight, LBM, fatigue, grip strength, walking and stair-climbing times, and treadmill performance after 3 and 6 months of treatment.

RESULTS

Lean body mass increased significantly in patients given nandrolone compared with patients given placebo (mean change [SD], +4.5 [2.3] kg; P<.001 compared with baseline). This effect was significantly greater than the change in LBM in the placebo group (mean change [SD], +1.9 [1.6] kg; P = .003 compared with baseline; P = .005 compared with nandrolone group). Serum creatinine levels increased in the nandrolone group (+168 [203] mmol/L [1.9 [2.3] mg/dL]; P = .02) but not in the placebo group (-4.0 [177] mmol/L [0.04 [2.0] mg/dL]; P = .95), suggesting an increase in muscle mass. Time to complete the walking and stair-climbing test decreased from 36.5 to 32.7 seconds in the nandrolone group, while those in the placebo group increased from 38.7 to 42.1 seconds (P = .05). Peak oxygen consumption increased in the individuals in the nandrolone group who performed treadmill tests, but not to a statistically significant degree. Grip strength did not change in either group.

CONCLUSIONS

Treatment with nandrolone for 6 months resulted in a significant increase in LBM associated with functional improvement in patients undergoing dialysis.

摘要

背景

接受透析的患者通常会出现营养不良、肌肉量减少(肌肉减少症)和疲劳等情况,目前尚未发现有效的治疗方法。已知合成代谢类固醇可增加健康个体的肌肉量和力量,但它们对长期透析相关的肌肉减少症和疲劳的影响尚未得到评估。

目的

评估合成代谢类固醇癸酸诺龙对透析患者瘦体重(LBM)、功能状态和生活质量的影响。

设计

1996年4月至1997年7月进行的随机、双盲、安慰剂对照试验。

地点

医院门诊透析单元。

患者

29名接受透析至少3个月的患者。

干预措施

癸酸诺龙100毫克(n = 14)或安慰剂(n = 15),每周一次肌肉注射,共6个月。

主要观察指标

治疗3个月和6个月后的体重、LBM、疲劳、握力、步行和爬楼梯时间以及跑步机性能。

结果

与接受安慰剂的患者相比,接受癸酸诺龙治疗的患者瘦体重显著增加(平均变化[标准差],+4.5[2.3]千克;与基线相比P<.001)。这种效果显著大于安慰剂组LBM的变化(平均变化[标准差],+1.9[1.6]千克;与基线相比P = .003;与癸酸诺龙组相比P = .005)。癸酸诺龙组血清肌酐水平升高(+168[203]毫摩尔/升[1.9[2.3]毫克/分升];P = .02),而安慰剂组未升高(-4.0[177]毫摩尔/升[0.04[2.0]毫克/分升];P = .95),提示肌肉量增加。癸酸诺龙组完成步行和爬楼梯测试的时间从36.5秒降至32.7秒,而安慰剂组从38.7秒增至42.1秒(P = .05)。进行跑步机测试的癸酸诺龙组个体的峰值耗氧量增加,但未达到统计学显著程度。两组的握力均未改变。

结论

癸酸诺龙治疗6个月可使透析患者的LBM显著增加,并伴有功能改善。

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