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严重肾衰竭患者的依诺肝素剂量调整:抗Xa因子浓度与安全性

Enoxaparin dosage adjustment in patients with severe renal failure: antifactor xa concentrations and safety.

作者信息

Lachish Tamar, Rudensky Bernard, Slotki Itzchak, Zevin Shoshana

机构信息

Department of Internal Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.

出版信息

Pharmacotherapy. 2007 Oct;27(10):1347-52. doi: 10.1592/phco.27.10.1347.

DOI:10.1592/phco.27.10.1347
PMID:17896889
Abstract

STUDY OBJECTIVE

To evaluate the safety and efficacy, by measuring antifactor Xa levels, of enoxaparin 1 mg/kg subcutaneously once every 24 hours in patients with severe renal failure.

DESIGN

Prospective study.

SETTING

Emergency, internal medicine, geriatrics, and cardiology departments of a medical center in Israel.

PATIENTS

Nineteen patients with stage 4 or 5 chronic kidney disease who required full anticoagulation.

INTERVENTION

Patients received enoxaparin 1 mg/kg subcutaneously every 24 hours for 2 or more days, as determined by a treating physician.

MEASUREMENTS AND MAIN RESULTS

Data on patients' demographic and clinical characteristics were collected. Blood samples for peak and trough antifactor Xa levels were obtained during the enoxaparin treatment period. Of the 19 study patients, 14 (74%) had peak antifactor Xa levels within the recommended range for full anticoagulation of 0.5-1.0 U/ml after their first enoxaparin dose; no concentration exceeded 1.0 U/ml. The mean peak antifactor Xa level was not significantly different after the first enoxaparin dose compared with the second and third doses. The mean +/- SD trough antifactor Xa level, thought to be an indicator of drug accumulation, was 0.12 +/- 0.12 U/ml; its clinical significance and target range are still unknown. No major bleeding events were noted.

CONCLUSION

Enoxaparin 1 mg/kg once every 24 hours in patients with stage 4 or 5 chronic kidney disease who required full anticoagulation was safe, and this dose did not exceed recommended concentrations. The significance of enoxaparin trough levels remains unclear and should be investigated in future studies. Other dosing regimens of enoxaparin for specific patient populations should also be assessed for safety and efficacy.

摘要

研究目的

通过测量抗Xa因子水平,评估每24小时皮下注射1mg/kg依诺肝素对严重肾衰竭患者的安全性和有效性。

设计

前瞻性研究。

地点

以色列一家医疗中心的急诊科、内科、老年病科和心脏病科。

患者

19例4期或5期慢性肾病且需要充分抗凝的患者。

干预措施

由主治医生决定,患者每24小时皮下注射1mg/kg依诺肝素,持续2天或更长时间。

测量指标及主要结果

收集患者的人口统计学和临床特征数据。在依诺肝素治疗期间采集血样,测定抗Xa因子的峰浓度和谷浓度。19例研究患者中,14例(74%)在首次注射依诺肝素后,抗Xa因子峰浓度处于充分抗凝推荐范围0.5 - 1.0 U/ml内;无浓度超过1.0 U/ml。首次注射依诺肝素后的平均抗Xa因子峰浓度与第二次和第三次注射后相比,无显著差异。平均±标准差抗Xa因子谷浓度被认为是药物蓄积的指标,为0.12±0.12 U/ml;其临床意义和目标范围仍不清楚。未观察到重大出血事件。

结论

对于需要充分抗凝的4期或5期慢性肾病患者,每24小时皮下注射1mg/kg依诺肝素是安全的,且该剂量未超过推荐浓度。依诺肝素谷浓度的意义仍不明确,应在未来研究中进行调查。还应评估依诺肝素针对特定患者群体的其他给药方案的安全性和有效性。

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