佩昔利单抗对急性心肌梗死患者或接受冠状动脉搭桥手术患者死亡率的影响：一项系统综述。

Effect of pexelizumab on mortality in patients with acute myocardial infarction or undergoing coronary artery bypass surgery: a systematic overview.

作者信息

Mahaffey Kenneth W, Van de Werf Frans, Shernan Stanton K, Granger Christopher B, Verrier Edward D, Filloon Thomas G, Todaro Thomas G, Adams Peter X, Levy Jerrold H, Hasselblad Vic, Armstrong Paul W

机构信息

Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA.

出版信息

Am Heart J. 2006 Aug;152(2):291-6. doi: 10.1016/j.ahj.2006.03.027.

DOI:10.1016/j.ahj.2006.03.027

PMID:16875911

Abstract

BACKGROUND

Recent trials evaluating the C5 complement inhibitor, pexelizumab, have shown that modulation of inflammation during ischemia/reperfusion in patients with acute myocardial infarction (MI) or undergoing coronary artery bypass graft (CABG) surgery may improve clinical outcomes.

METHODS

We performed a systematic overview of individual patient data from all completed randomized controlled trials of pexelizumab to evaluate the effect on all-cause mortality at 30 and 180 days after treatment. We used a random effects model and included all 5916 patients randomized in 4 clinical trials. Patients received placebo, pexelizumab bolus only or pexelizumab bolus followed by a 24-hour infusion.

RESULTS

A significant reduction in mortality at 30 days was observed in patients treated with bolus plus infusion (n = 2476) compared with placebo (n = 2492) (2.9% vs 4.2%; relative risk [RR], 0.70; 95% confidence interval [CI], 0.52-0.95; P = .02), with no interaction according to disease state of CABG or acute MI (P for interaction .33). A trend toward a reduction in mortality was observed in patients who received bolus plus infusion or bolus only (n = 3429) compared with placebo (n = 2476) (3.5% vs 4.2%; RR, 0.85; 95% CI, 0.66-1.0975; P = .215), but not in patients who received bolus only (n = 937) compared with placebo (n = 937) (5.2% vs 5.4%; RR, 0.96; 95% CI, 0.66-1.41; P = .918). The mortality benefit with bolus plus infusion compared with placebo persisted through 180 days (P = .05).

CONCLUSIONS

Pexelizumab reduced 30-day mortality in this systematic evaluation. Bolus plus infusion dose is being studied in ongoing trials in acute MI and CABG populations.

摘要

背景

近期评估C5补体抑制剂培昔利珠单抗的试验表明，在急性心肌梗死（MI）患者或接受冠状动脉旁路移植术（CABG）手术的患者中，调节缺血/再灌注期间的炎症反应可能会改善临床结局。

方法

我们对培昔利珠单抗所有已完成的随机对照试验的个体患者数据进行了系统综述，以评估治疗后30天和180天全因死亡率的影响。我们使用随机效应模型，纳入了4项临床试验中随机分组的所有5916例患者。患者接受安慰剂、仅培昔利珠单抗推注或培昔利珠单抗推注后再进行24小时输注。

结果

与安慰剂组（n = 2492）相比，接受推注加输注治疗的患者（n = 2476）在30天时死亡率显著降低（2.9%对4.2%；相对风险[RR]，0.70；95%置信区间[CI]，0.52 - 0.95；P = 0.02），根据CABG或急性MI的疾病状态无交互作用（交互作用P值为0.33）。与安慰剂组（n = 2476）相比，接受推注加输注或仅推注治疗的患者（n = 3429）有死亡率降低的趋势（3.5%对4.2%；RR，0.85；95% CI，0.66 - 1.0975；P = 0.215），但仅接受推注治疗的患者（n = 937）与安慰剂组（n = 937）相比无此趋势（5.2%对5.4%；RR，0.96；95% CI，0.66 - 1.41；P = 0.918）。与安慰剂相比，推注加输注的死亡率获益持续至180天（P = 0.05）。