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氧化再生纤维素与局部应用氨甲环酸在全膝关节置换术中的止血效果——一项前瞻性随机对照试验

Hemostatic effect of oxidized regenerated cellulose vs. topical tranexamic acid in total knee arthroplasty-a prospective randomized controlled trial.

作者信息

Li Bowei, Pan Wenjie, Ma Jianbing, Huang Yuanchi

机构信息

Department of Knee Joint Surgery, Xi'an Honghui Hospital, Xi'an Jiaotong University, Xi'an, Shaanxi, China.

出版信息

Front Surg. 2025 Jan 7;11:1515610. doi: 10.3389/fsurg.2024.1515610. eCollection 2024.

Abstract

AIMS

This study compared the hemostatic effects and complications of oxidized regenerated cellulose (ORC) and topical TXA in total knee arthroplasty (TKA), thus providing a reference for the use of ORC as an alternative hemostatic agent to TXA in TKA.

METHODS

A total of 105 patients were included in this study and randomized into blank control, ORC, and TXA groups. The primary outcomes were total blood loss, hemoglobin drop (Hb drop), transfusion rates, and incidence of thrombosis. The secondary outcomes included operation time, tourniquet duration, coagulation parameters, inflammation markers, and complication rates.

RESULTS

Total blood loss was 1,002.47 ± 308.58 ml and 964.68 ± 273.00 ml in the ORC and TXA groups, respectively, both significantly lower than that in the blank control group (1,168.94 ± 405.04 ml) (  = 0.043 and  = 0.014, respectively). Hb Drop was statistically insignificantly different between the ORC (36.03 ± 12.17 g/L) and TXA (34.32 ± 10.19 g/L) groups ( = 0.555). There was no statistically significant difference in transfusion rate, operation time, tourniquet duration, coagulation parameters, inflammation markers, and complication rates among the three groups.

CONCLUSION

In conclusion, our prospective randomized controlled trial (RCT) highlights that, oxidized regenerated cellulose (ORC) can reduce postoperative invisible blood loss in total knee arthroplasty and achieve a hemostatic effect similar to topical tranexamic acid (TXA). This provides a safe and effective hemostatic option for patients with severe underlying diseases or contraindications to tranexamic acid.

CLINICAL TRIAL REGISTRATION

https://www.chictr.org.cn/bin/project/edit?pid=186370, identifier (ChiCTR2200066633).

摘要

目的

本研究比较氧化再生纤维素(ORC)和局部应用氨甲环酸(TXA)在全膝关节置换术(TKA)中的止血效果及并发症,为ORC作为TKA中TXA的替代止血剂的应用提供参考。

方法

本研究共纳入105例患者,随机分为空白对照组、ORC组和TXA组。主要结局指标为总失血量、血红蛋白下降(Hb下降)、输血率和血栓形成发生率。次要结局指标包括手术时间、止血带使用时间、凝血参数、炎症标志物和并发症发生率。

结果

ORC组和TXA组的总失血量分别为1,002.47±308.58ml和964.68±273.00ml,均显著低于空白对照组(1,168.94±405.04ml)(分别为P = 0.043和P = 0.014)。ORC组(36.03±12.17g/L)和TXA组(34.32±10.19g/L)之间的Hb下降无统计学显著差异(P = 0.555)。三组之间的输血率、手术时间、止血带使用时间、凝血参数、炎症标志物和并发症发生率无统计学显著差异。

结论

总之,我们的前瞻性随机对照试验(RCT)表明,氧化再生纤维素(ORC)可减少全膝关节置换术后的隐性失血,并达到与局部应用氨甲环酸(TXA)相似的止血效果。这为患有严重基础疾病或对氨甲环酸有禁忌证的患者提供了一种安全有效的止血选择。

临床试验注册

https://www.chictr.org.cn/bin/project/edit?pid=186370,标识符(ChiCTR2200066633)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7e24/11747695/555c52f26df6/fsurg-11-1515610-g001.jpg

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