【罂粟摘要】氨甲环酸在高危患者髋膝关节置换术中应用的安全性

2021-07-07 罂粟花

随着氨甲环酸在全髋和膝关节置换术中的应用日益增多，安全性问题仍然存在。

氨甲环酸在高危患者髋膝关节置换术中应用的安全性

贵州医科大学高鸿教授课题组

翻译：任文鑫编辑：佟睿审校：曹莹

背景

随着氨甲环酸在全髋和膝关节置换术中的应用日益增多，安全性问题仍然存在。本研究利用全国性的声明数据，考察了氨甲环酸在预先存在合并症的患者中的使用情况。假设使用氨甲环酸与有合并症的髋关节和膝关节置换术患者的并发症风险增加无关。

方法

在765,011例全髋/膝关节置换手术中（2013年至2016年，首席医疗索赔），评估了三个高危组的氨甲环酸使用情况：第一组有静脉血栓栓塞、心肌梗塞、癫痫发作或缺血性中风/短暂性缺血发作病史的患者（n = 27,890）；第二组有肾病（n = 44,608）；第三组有心房颤动（n = 45,952）。主要观察指标是输血和新发生的 "综合并发症"（静脉血栓栓塞、心肌梗塞、癫痫发作和缺血性中风/短暂性脑缺血发作）。高危组分别测定氨甲环酸的使用与预后之间的关系。报告了优势比和Bonferroni校正的99.9%CI。

结果

总体而言，404974名患者（52.9%）接受了氨甲环酸治疗，在高危人群I（27890人中13004人[46.6%]）、II（44608人中22424人[50.3%]）和III（45952人中22379人[48.7%]）中的频率相似。使用氨甲环酸与高危组I（13004例中721例[5.5%]，14886例中2293例[15.4%]；优势比0.307；99.9%可信区间，0.258至0.366），高危组II（2045/22424[9.1%]对5159/22184[23.3%]；优势比0.315；99.9%可信区间（CI）为0.263~0.378），高危组III输血几率降低相关（1325/22379[5.9%]对3773/23573[16.0%]；优势比0.321；99.9%置信区间，0.266～0.389）；所有调整后比较P<0.001。在高危组I（13004例中有129例[1.0%]，14886例中有239例[1.6%]；优势比，0.89，99.9%CI，0.49-1.59），高危组II（22424例中238例[1.1%]对22184例中369例[1.7%]；优势比0.98；99.9%可信区间为0.58-1.67），高危组III中复合并发症的发生率没有增加（22379例中187例为0.8%，23573例中290例为1.2%）；优势比0.93；99.9%置信区间，0.54～1.61）；所有调整后的比较P>0.999。

结论

尽管氨甲环酸能有效减少输血，但无论患者在基线检查时的高危状态如何，氨甲环酸都不会增加并发症。

英文原文

ABSTRACT

Safety of Tranexamic Acid in Hip and Knee Arthroplasty in High-risk Patients

Background: With increasing use of tranexamic acid in total hip and knee arthroplasties, safety concerns remain. Using national claims data, this study examined tranexamic acid use in patients with preexisting comorbidities. The hypothesis was that tranexamic acid use is not associated with increased complication risk in hip and knee arthroplasty patients with comorbidities.

Methods: Among 765,011 total hip/knee arthroplasties (2013 to 2016, Premier Healthcare claims), tranexamic acid use was assessed in three highrisk groups: group I with patients with a history of venous thromboembolism, myocardial infarction, seizures, or ischemic stroke/transient ischemic attack (n = 27,890); group II with renal disease (n = 44,608); and group III with atrial fibrillation (n = 45,952). The coprimary outcomes were blood transfusion and new-onset “composite complications” (venous thromboembolism, myocardial infarction, seizures, and ischemic stroke/transient ischemic attack). Associations between tranexamic acid use and outcomes were measured separately by high-risk group. The odds ratios and Bonferroni-adjusted 99.9% CIs are reported.

Results: Overall, 404,974 patients (52.9%) received tranexamic acid, with similar frequencies across high-risk groups I (13,004 of 27,890 [46.6%]), II (22,424 of 44,608 [50.3%]), and III (22,379 of 45,952 [48.7%]). Tranexamic

acid use was associated with decreased odds of blood transfusion in high-risk groups I (721 of 13,004 [5.5%] vs. 2,293 of 14,886 [15.4%]; odds ratio, 0.307; 99.9% CI, 0.258 to 0.366), group II (2,045 of 22,424 [9.1%] vs. 5,159 of 22,184 [23.3%]; odds ratio, 0.315; 99.9% CI, 0.263 to 0.378), and group III (1,325 of 22,379 [5.9%] vs. 3,773 of 23,573 [16.0%]; odds ratio, 0.321; 99.9% CI, 0.266 to 0.389); all adjusted comparisons P < 0.001. No increased odds of composite complications were observed in high-risk group I

(129 of 13,004 [1.0%] vs. 239 of 14,886 [1.6%]; odds ratio, 0.89, 99.9% CI, 0.49 to 1.59), group II (238 of 22,424 [1.1%] vs. 369 of 22,184 [1.7%]; odds ratio, 0.98; 99.9% CI, 0.58 to 1.67), and group III (187 of 22,379 [0.8%] vs. 290 of 23,573 [1.2%]; odds ratio, 0.93; 99.9% CI, 0.54 to 1.61); all adjusted

comparisons P > 0.999.

Conclusions: Although effective in reducing blood transfusions, tranexamic acid is not associated with increased complications, irrespective of patient high-risk status at baseline.