医学翻译学习-andexanet alfa治疗因子Ⅹa抑制剂相关出血的完整研究报告

关于“andexanet alfa治疗因子Ⅹa抑制剂相关出血的完整研究报告”一文医学翻译摘要学习情况，记录于此。

Full Study Report of Andexanet Alfa for Bleeding Associated with Factor Xa Inhibitors

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背景

BACKGROUND

andexanet alfa是人凝血因子Ⅹa的重组改构非活性形式，开发用于逆转因子Ⅹa抑制剂的作用。

Andexanet alfa is a modified recombinant inactive form of human factor Xa developed for reversal of factor Xa inhibitors.

笔记：

• 逗号之后，表述不够简明，过于贴原文
• reverasal中文处理为动词，是翻译的常见处理

方法

METHODS

我们评价了在给予因子Ⅹa抑制剂后18小时内发生急性大出血的352例患者。

We evaluated 352 patients who had acute major bleeding within 18 hours after administration of a factor Xa inhibitor.

患者接受了andexanet推注，随后接受了2小时输入。

The patients received a bolus of andexanet, followed by a 2-hour infusion.

笔记：

• 2小时输入 a 2-hour infusion

共同主要结局为andexanet治疗后抗因子Ⅹa活性的变化百分比，以及在输入结束后12小时，止血效果根据预设标准被裁定为优秀或良好的患者百分比。

The coprimary outcomes were the percent change in anti–factor Xa activity after andexanet treatment and the percentage of patients with excellent or good hemostatic efficacy at 12 hours after the end of the infusion, with hemostatic efficacy adjudicated on the basis of prespecified criteria.

试验在被证实有大出血并且基线抗因子Ⅹa活性至少为75 ng/mL（对于接受依诺肝素治疗的患者为≥0.25 IU/mL）的患者亚组中评估了疗效。

Efficacy was assessed in the subgroup of patients with confirmed major bleeding and baseline anti–factor Xa activity of at least 75 ng per milliliter (or ≥0.25 IU per milliliter for those receiving enoxaparin).

笔记：

• 大于等于，之前很少见到英文原文中亦有使用

结果

RESULTS

患者平均年龄为77岁，大多数患严重的心血管疾病。

Patients had a mean age of 77 years, and most had substantial cardiovascular disease.

出血主要为颅内出血（227例患者[64%]）或胃肠出血（90例患者[26%]）。

Bleeding was predominantly intracranial (in 227 patients [64%]) or gastrointestinal (in 90 patients [26%]).

在接受阿哌沙班治疗的患者中，中位抗因子Ⅹa活性从基线时的149.7 ng/mL降低至andexanet推注后的11.1 ng/mL（降低92%；95%置信区间[CI]，91%～93%）；在接受利伐沙班治疗的患者中，中位值从211.8 ng/mL降低至14.2 ng/mL（降低92%；95% CI，88%～94%）。

In patients who had received apixaban, the median anti–factor Xa activity decreased from 149.7 ng per milliliter at baseline to 11.1 ng per milliliter after the andexanet bolus (92% reduction; 95% confidence interval [CI], 91 to 93); in patients who had received rivaroxaban, the median value decreased from 211.8 ng per milliliter to 14.2 ng per milliliter (92% reduction; 95% CI, 88 to 94).

在可评价的249例患者中，204例（82%）达到了优秀或良好止血。

Excellent or good hemostasis occurred in 204 of 249 patients (82%) who could be evaluated.

笔记：

• 句子强调的内容放于主语

在30日内，49例患者（14%）死亡，34例（10%）发生了血栓性事件。

Within 30 days, death occurred in 49 patients (14%) and a thrombotic event in 34 (10%).

抗因子Ⅹa活性降低在总体患者中不能预测止血效果，但在颅内出血患者中能一定程度预测止血效果。

Reduction in anti–factor Xa activity was not predictive of hemostatic efficacy overall but was modestly predictive in patients with intracranial hemorrhage.

CONCLUSIONS

结论

In patients with acute major bleeding associated with the use of a factor Xa inhibitor, treatment with andexanet markedly reduced anti–factor Xa activity, and 82% of patients had excellent or good hemostatic efficacy at 12 hours, as adjudicated according to prespecified criteria. (Funded by Portola Pharmaceuticals; ANNEXA-4 ClinicalTrials.gov number, NCT02329327 .)

在发生因子Ⅹa抑制剂相关急性大出血的患者中，andexanet治疗显著降低了抗因子Ⅹa活性，并且根据预设标准，82%的患者在12小时达到优秀或良好的止血效果（由Portola Pharmaceuticals资助；ANNEXA-4在ClinicalTrials.gov注册号为NCT02329327）。