奥沙多龙对脊髓损伤患者慢性压力性溃疡愈合的影响：一项随机试验。

The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial.

机构信息

National Center of Excellence for the Medical Consequences of Spinal Cord Injury, Medical, Spinal Cord Injury and Research Services, James J. Peters Veterans Affairs Medical Center, Bronx, NY 10468, USA.

出版信息

Ann Intern Med. 2013 May 21;158(10):718-26. doi: 10.7326/0003-4819-158-10-201305210-00006.

DOI:10.7326/0003-4819-158-10-201305210-00006

PMID:23689765

Abstract

BACKGROUND

Anabolic steroids have been reported to improve wound healing.

OBJECTIVE

To determine whether oxandrolone increases the percentage of target pressure ulcers (TPUs) that heal compared with placebo and whether healed ulcers remain closed 8 weeks after treatment.

DESIGN

Parallel-group, placebo-controlled, randomized trial conducted from 1 August 2005 to 30 November 2008. Patients, clinical care providers, study personnel, and statisticians were blinded to treatment assignment. (ClinicalTrials.gov: NCT00101361).

SETTING

16 inpatient spinal cord injury (SCI) services at Veterans Affairs medical centers.

PATIENTS

1900 prescreened, 779 screened, and 212 randomly assigned inpatients with SCI and stage III or IV TPUs.

INTERVENTION

Oxandrolone, 20 mg/d (n = 108), or placebo (n = 104) until the TPU healed or 24 weeks.

MEASUREMENTS

The primary outcome was healed TPUs. The secondary outcome was the percentage of TPUs that remained healed at 8-week follow-up.

RESULTS

24.1% (95% CI, 16.0% to 32.1%) of TPUs in oxandrolone recipients and 29.8% (CI, 21.0% to 38.6%) in placebo recipients healed (difference, -5.7 percentage points [CI, -17.5 to 6.8 percentage points]; P = 0.40). At 8-week follow-up, 16.7% (CI, 9.6% to 23.7%) of oxandrolone recipients and 15.4% (CI, 8.5% to 22.3%) of placebo recipients retained a healed TPU (difference, 1.3 percentage points [CI, -8.8 to 11.2 percentage points]; P = 0.70). No serious adverse events were related to oxandrolone. Liver enzyme levels were elevated in 32.4% (CI, 23.6% to 41.2%) of oxandrolone recipients and 2.9% (CI, 0.0% to 6.1%) of placebo recipients (P < 0.001).

LIMITATIONS

Selection of severe wounds may have reduced treatment response. Approximately one third of patients did not complete the study in the treatment and placebo groups. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between the groups.

CONCLUSION

Oxandrolone showed no benefit over placebo for improving healing or the percentage of TPUs that remained closed after 8 weeks of treatment.

PRIMARY FUNDING SOURCE

U.S. Department of Veterans Affairs.

摘要

背景

已有报道称合成代谢类固醇可促进伤口愈合。

目的

确定羟甲烯龙是否比安慰剂更能提高目标压力性溃疡（TPU）的愈合率，以及治疗后 8 周时愈合的溃疡是否保持闭合。

设计

2005 年 8 月 1 日至 2008 年 11 月 30 日进行的平行分组、安慰剂对照、随机试验。患者、临床护理提供者、研究人员和统计人员对治疗分配均设盲。（ClinicalTrials.gov：NCT00101361）。

地点

退伍军人事务部医疗中心的 16 个住院脊髓损伤（SCI）服务处。

患者

经预筛选的 1900 名患者、筛选出的 779 名患者和随机分配的 212 名住院 SCI 合并 III 或 IV 期 TPU 患者。

干预措施

羟甲烯龙 20 mg/d（n = 108）或安慰剂（n = 104），直至 TPU 愈合或治疗 24 周。

测量指标

主要结局为愈合的 TPU。次要结局为治疗后 8 周时仍保持愈合的 TPU 的百分比。

结果

羟甲烯龙组中 24.1%（95%CI，16.0%至 32.1%）的 TPU 愈合，安慰剂组中 29.8%（CI，21.0%至 38.6%）的 TPU 愈合（差值，-5.7 个百分点[CI，-17.5 至 6.8 个百分点]；P = 0.40）。治疗后 8 周时，羟甲烯龙组中 16.7%（CI，9.6%至 23.7%）的 TPU 和安慰剂组中 15.4%（CI，8.5%至 22.3%）的 TPU 仍保持愈合（差值，1.3 个百分点[CI，-8.8 至 11.2 个百分点]；P = 0.70）。羟甲烯龙无严重不良事件。羟甲烯龙组中 32.4%（CI，23.6%至 41.2%）的患者和安慰剂组中 2.9%（CI，0.0%至 6.1%）的患者的肝酶水平升高（P < 0.001）。