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一项关于胶原蛋白海绵和外用氨甲环酸在脊柱后路融合手术中效果的随机对照试验。

A randomized controlled trial on the effects of collagen sponge and topical tranexamic acid in posterior spinal fusion surgeries.

作者信息

Xu Derong, Zhuang Qianyu, Li Zheng, Ren Zhinan, Chen Xin, Li Shugang

机构信息

Department of Orthopedic Surgery, Peking Union Medical College Hospital, No.1 Shuai Fu Yuan, Wang Fu Jing Street, Beijing, 100730, China.

出版信息

J Orthop Surg Res. 2017 Nov 6;12(1):166. doi: 10.1186/s13018-017-0672-2.

Abstract

BACKGROUND

This is a randomized controlled trial research to assess the hemostatic efficacy of gelatin sponge, collagen sponge, and topical use of tranexamic acid (TXA) on postoperative blood loss in posterior spinal fusion surgeries.

METHODS

We recruited patients with spinal degenerative diseases into the study from November 2013 to October 2016. All the participants were assigned to 3 groups using a simple, equal-probability randomization scheme: group A is a control group utilizing gelatin sponge, while groups B and C are experimental groups, applying collagen hemostatic sponge and topical TXA respectively. Postoperative blood loss, rates of transfusion, and hospitalization were compared among the 3 groups.

RESULTS

In our study, the volume of drainage and blood content in drainage on the first postoperative day (POD 1) of patients in the experimental groups were significantly less than those in the control group, as well as rates of transfusion and postoperative hospitalization (P < 0.05). When compared with the control group, the volume of drainage decreased by 22.7% in group B and 56.2% in group C, while the blood content in drainage decreased by 28.8 and 75% respectively.

CONCLUSIONS

In this study, collagen and topical use of TXA have both proven to be effective and safe for patients undergoing posterior spinal fusion surgeries, while TXA has exhibited better efficacy. The total amount of perioperative blood loss reduced significantly without increasing incidence of related complications.

TRIAL REGISTRATION

A randomized controlled trial for effects of collagen sponge and topical tranexamic acid in posterior lumbar fusion surgeries. ChiCTR-IIR-17010785.

摘要

背景

这是一项随机对照试验研究,旨在评估明胶海绵、胶原海绵以及局部使用氨甲环酸(TXA)对后路脊柱融合手术术后失血的止血效果。

方法

我们于2013年11月至2016年10月招募患有脊柱退行性疾病的患者参与本研究。所有参与者采用简单、等概率随机化方案分为3组:A组为使用明胶海绵的对照组,而B组和C组为实验组,分别应用胶原止血海绵和局部TXA。比较3组之间的术后失血量、输血率和住院时间。

结果

在我们的研究中,实验组患者术后第1天(POD 1)的引流量和引流液中的血液含量均显著低于对照组,输血率和术后住院时间也显著低于对照组(P < 0.05)。与对照组相比,B组引流量减少了22.7%,C组减少了56.2%,而引流液中的血液含量分别减少了28.8%和75%。

结论

在本研究中,胶原和局部使用TXA对接受后路脊柱融合手术的患者均已证明是有效且安全的,而TXA表现出更好的疗效。围手术期总失血量显著减少,且未增加相关并发症的发生率。

试验注册

胶原海绵和局部氨甲环酸在后路腰椎融合手术中作用的随机对照试验。ChiCTR-IIR-17010785。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/159d/5674845/c0e8e12d0835/13018_2017_672_Fig1_HTML.jpg

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