粒细胞集落刺激因子治疗前壁心肌梗死后干细胞动员：CAPITAL STEM MI 随机试验。
Granulocyte colony-stimulating factor therapy for stem cell mobilization following anterior wall myocardial infarction: the CAPITAL STEM MI randomized trial.
机构信息
Division of Cardiology (Hibbert, Hayley, Beanlands, Le May, Davies, So, Marquis, Labinaz, Froeschl, O'Brien, Burwash, Wells, Pourdjabbar, Simard, Glover), Department of Medicine, University of Ottawa Heart Institute, Ottawa, Ont.; Libin Cardiovascular Institute (O'Brien), Calgary, Alta.; Division of Hematology (Atkins), Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, Ont.
出版信息
CMAJ. 2014 Aug 5;186(11):E427-34. doi: 10.1503/cmaj.140133. Epub 2014 Jun 16.
BACKGROUND
Small studies have yielded divergent results for administration of granulocyte colony-stimulating factor (G-CSF) after acute myocardial infarction. Adequately powered studies involving patients with at least moderate left ventricular dysfunction are lacking.
METHODS
Patients with left ventricular ejection fraction less than 45% after anterior-wall myocardial infarction were treated with G-CSF (10 μg/kg daily for 4 days) or placebo. After initial randomization of 86 patients, 41 in the placebo group and 39 in the G-CSF group completed 6-month follow-up and underwent measurement of left ventricular ejection fraction by radionuclide angiography.
RESULTS
Baseline and 6-week mean ejection fraction was similar for the G-CSF and placebo groups: 34.8% (95% confidence interval [CI] 32.6%-37.0%) v. 36.4% (95% CI 33.5%-39.2%) at baseline and 39.8% (95% CI 36.2%-43.4%) v. 43.1% (95% CI 39.2%-47.0%) at 6 weeks. However, G-CSF therapy was associated with a lower ejection fraction at 6 months relative to placebo (40.8% [95% CI 37.4%-44.2%] v. 46.0% [95% CI 42.7%-44.3%]). Both groups had improved left ventricular function, but change in left ventricular ejection fraction was lower in patients treated with G-CSF than in those who received placebo (5.7 [95% CI 3.4-8.1] percentage points v. 9.2 [95% CI 6.3-12.1] percentage points). One or more of a composite of several major adverse cardiac events occurred in 8 patients (19%) within each group, with similar rates of target-vessel revascularization.
INTERPRETATION
In patients with moderate left ventricular dysfunction following anterior-wall infarction, G-CSF therapy was associated with a lower 6-month left ventricular ejection fraction but no increased risk of major adverse cardiac events. Future studies of G-CSF in patients with left ventricular dysfunction should be monitored closely for safety.
TRIAL REGISTRATION
ClinicalTrials.gov, no. NCT00394498.
背景
小样本研究对于急性心肌梗死后粒细胞集落刺激因子（G-CSF）的给药结果存在分歧。缺乏涉及至少中度左心室功能障碍患者的充分有力的研究。
方法
前壁心肌梗死后左心室射血分数（LVEF）<45%的患者接受 G-CSF（10μg/kg，每日 1 次，连续 4 天）或安慰剂治疗。在最初对 86 例患者进行随机分组后，安慰剂组 41 例和 G-CSF 组 39 例完成了 6 个月的随访，并接受放射性核素血管造影测量 LVEF。
结果
G-CSF 组和安慰剂组的基线和 6 周时平均 LVEF 相似：基线时分别为 34.8%（95%置信区间[CI]32.6%-37.0%）和 36.4%（95% CI 33.5%-39.2%），6 周时分别为 39.8%（95% CI 36.2%-43.4%）和 43.1%（95% CI 39.2%-47.0%）。然而，与安慰剂相比，G-CSF 治疗与 6 个月时的 LVEF 降低相关（40.8%[95% CI 37.4%-44.2%]与 46.0%[95% CI 42.7%-44.3%]）。两组左心室功能均有所改善，但 G-CSF 治疗组的 LVEF 改善程度低于安慰剂组（5.7[95% CI 3.4-8.1]个百分点比 9.2[95% CI 6.3-12.1]个百分点）。两组各有 8 例（19%）患者发生 1 项或多项主要不良心脏事件的复合事件，靶血管血运重建的发生率相似。
结论
在前壁梗死后中度左心室功能障碍的患者中，G-CSF 治疗与 6 个月时较低的 LVEF 相关，但无主要不良心脏事件风险增加。应密切监测左心室功能障碍患者的 G-CSF 安全性。
试验注册
ClinicalTrials.gov，NCT00394498。
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