体重对急性缺血性卒中阿替普酶疗效的影响：ENCHANTED 试验
本研究为 ENCHANTED 试验事后分析，评估体重是否影响低剂量与标准剂量静脉阿替普酶疗效，以及体重与临床结局的关联。结果显示体重未显著改变两种剂量对功能恢复、死亡和症状性颅内出血的疗效差异。低体重与更差的功能结局和死亡相关，但不增加症状性颅内出血风险。
要点
- 体重不影响低剂量与标准剂量阿替普酶在急性缺血性卒中中的疗效比较。
- 体重低于约 74 kg 的患者 90 天不良功能结局和死亡风险更高。
- 低体重不增加溶栓后症状性颅内出血风险。
核心结论
- 无证据表明体重会改变低剂量与标准剂量静脉阿替普酶在急性缺血性卒中患者中的疗效比较。
- 低体重可预测不良结局，但不增加急性缺血性卒中溶栓治疗后症状性颅内出血风险。
研究设计与样本
- ENCHANTED 试验的事后分析，该试验为国际部分析因随机对照试验。
- 阿替普酶剂量组纳入 3206 例患者，平均年龄 66.6 岁，女性占 37.9%。
- 全队列纳入 4458 例患者，平均年龄 66.7 岁，女性占 37.8%。
主要发现
- 体重未显著改变低剂量与标准剂量阿替普酶对功能恢复的影响，P交互=0.60。
- 体重未显著改变两种剂量对死亡的影响，P交互=0.56。
- 体重未显著改变两种剂量对症状性颅内出血的影响，P交互=0.46。
- 连续体重与 90 天改良 Rankin 量表评分呈非线性关系，拐点约为 74 kg。
- 体重低于 74 kg 的患者不良功能结局风险更高，比值比 1.41，95%CI 1.06–1.87，P=0.017。
关键数值与推荐
- 不良功能结局定义为 90 天改良 Rankin 量表评分 2 至 6 分，对照为 0 至 1 分。
- 低剂量阿替普酶为 0.6 mg/kg，标准剂量为 0.9 mg/kg。
临床怎么用
- 临床选择阿替普酶剂量时无需因患者体重差异而调整低剂量与标准剂量的决策。
- 对低体重急性缺血性卒中患者应关注其更高的不良功能结局和死亡风险。
以上解读依据论文摘要（全文未开放获取或许可不允许翻译转载）。
原文
Stroke, Volume 57, Issue 10, Page 2991-2999, October 1, 2026. BACKGROUND:The prognostic significance of body weight in patients receiving thrombolysis for acute ischemic stroke remains uncertain. This study aimed to determine whether body weight modifies the comparative effects of low- versus standard-dose intravenous alteplase and to evaluate the associations of body weight and clinical outcomes in patients with acute ischemic stroke.METHODS:A post hoc analysis of the ENCHANTED trial (Enhanced Control of Hypertension and Thrombolysis Stroke Study), an international partial-factorial randomized controlled trial comparing low-dose (0.6 mg/kg) versus standard-dose (0.9 mg/kg) intravenous alteplase and intensive (target systolic blood pressure 130–140 mm Hg) versus guideline-recommended (target systolic blood pressure <180 mm Hg) treatment. The primary outcome was poor functional outcome at 90 days, defined as a modified Rankin Scale score of 2 to 6 (versus 0–1). For the first objective, the exposure was defined as alteplase dose and body weight, whereas for the second objective, body weight alone was considered as the exposure. Logistic regression models were performed to analyze the association between body weight and outcome. The association shape between treatment effect and body weight was evaluated using restricted cubic splines.RESULTS:Among 3206 patients (mean age, 66.6 years; female 37.9%) in the alteplase-dose arm, body weight did not significantly modify the comparative effects of low- versus standard-dose alteplase on functional recovery (Pinteraction=0.60), death (Pinteraction=0.56), or symptomatic intracerebral hemorrhage (Pinteraction=0.46). In the full cohort of 4458 patients (mean age 66.7 years; female 37.8%), a nonlinear relationship was observed between continuous body weight and 90-day modified Rankin Scale score, with an inflection point at ≈74 kg. Patients weighing <74 kg had a significantly higher likelihood of poor functional outcome (odds ratio, 1.41 [95% CI, 1.06–1.87];P=0.017) and death (1.65 [95% CI, 1.04–2.61]; 0.03), but not an increase in symptomatic intracerebral hemorrhage.CONCLUSIONS:There was no evidence of effect modification by body weight on the effectiveness of low- versus standard-dose intravenous alteplase in patients with acute ischemic stroke. Low body weight predicts a poor outcome but not an increased risk of symptomatic intracerebral hemorrhage after thrombolysis treatment for acute ischemic stroke.REGISTRATION:U
引用
- Stroke：Body Weight in Relation to the Effectiveness of Intravenous Alteplase in Acute Ischemic Stroke: The ENCHANTED Trial
供执业医师工作参考，不替代临床判断；数值与分级以指南原文为准。