美国阿拉巴马大学伯明翰分校妇女生殖健康中心Akila Subramaniam团队研究了更具选择性与标准风险分层的产后肝素化学预防对患者预后的影响。该研究于2024年6月27日发表在《美国医学会杂志》上。

2016年，研究组机构根据美国妇产科学会的指南采用了妊娠相关静脉血栓栓塞（VTE）预防方案，该指南建议基于风险分层算法的产后肝素化学预防（依诺肝素）。针对使用该方案增加的伤口血肿而VTE没有显著降低的情况，2021年采用了更具选择性的风险分层方法。

为了评价以肝素为基础的产科血栓预防（依诺肝素）方案的选择性风险分层方法的效果，研究组对2016年1月1日至2018年12月31日（初始方案）以及2021年12月1日和2023年5月31日期间（更具选择性的方案）在美国东南部一家三级护理中心分娩的17489名患者进行了一项回顾性观察性研究。排除因妊娠期活动性VTE或高VTE风险而接受门诊抗凝治疗的患者。暴露因素为标准风险分层和更具选择性的产后VTE化学预防方案。主要结局是在手术后6周内对伤口血肿进行临床诊断。次要结局为产后6周内VTE的新诊断。研究组比较了各组之间的基线特征和结果，并使用原始方案组作为参考，估计了主要和次要结局的95%置信区间的校正优势比。

在17489例纳入分析的患者中，12430例（71%）属于原始方案组，5029例（29%）属于更具选择性组。化学预防率从16%（原始方案）下降到8%（更具选择性的方案）。更具选择性组中患者更有可能年龄较大、已婚、患有肥胖或其他合并症（高血压、糖尿病、心脏病）。与初始方案相比，更具选择性的方案与任何伤口血肿的减少有关（0.7%对0.3%；校正比值比[aOR]，0.38；95%置信区间，0.21-0.67），特别是由于浅表伤口血肿的发生率较低（0.6%对0.3%；aOR，0.43；95%可信区间，0.24-0.75）。VTE或个别类型的VTE没有显著增加（0.1%对0.1%；aOR，0.40；95%CI，0.12-1.36）。

研究结果表明，依诺肝素血栓预防VTE方案的更具选择性的风险分层方法与伤口血肿发生率降低有关，且不会增加产后VTE发生率。

附：英文原文

Title: A More Selective vs a Standard Risk-Stratified, Heparin-Based, Obstetric Thromboprophylaxis Protocol

Author: Macie L. Champion, Christina T. Blanchard, Michelle Y. Lu, Ashley E. Shea, Anna I. Lively, J. Morgan Jenkins, Samantha E. Howell, Grace M. Lee, Brian M. Casey, Ashley N. Battarbee, Akila Subramaniam

Issue&Volume: 2024-06-27

Abstract:

Importance  In 2016, our institution adopted a pregnancy-related venous thromboembolism (VTE) prophylaxis protocol based on American College of Obstetricians and Gynecologists guidelines that recommended postpartum heparin-based chemoprophylaxis (enoxaparin) based on a risk-stratified algorithm. In response to increased wound hematomas without significant reduction in VTE using this protocol, a more selective risk-stratified approach was adopted in 2021.

Objective  To evaluate outcomes of the more selective risk-stratified approach to heparin-based obstetric thromboprophylaxis (enoxaparin) protocol.

Design, Setting, and Participants  Retrospective observational study of 17489 patients who delivered at a single tertiary care center in the southeast US between January 1, 2016, and December 31, 2018 (original protocol), and between December 1, 2021, and May 31, 2023 (more selective protocol). Patients receiving outpatient anticoagulation for active VTE or high VTE risk during pregnancy were excluded.

Exposure  Standard risk-stratified and more selective postpartum VTE chemoprophylaxis protocols.

Main Outcomes and Measures  The primary outcome was clinical diagnosis of wound hematoma up to 6 weeks pos tpartum. The secondary outcome was new diagnosis of VTE up to 6 weeks post partum. We compared baseline characteristics and outcomes between groups and estimated adjusted odds ratios with 95% CIs of primary and secondary outcomes using the original protocol group as reference.

Results  Of 17489 patients included in the analysis, 12430 (71%) were in the original protocol group and 5029 (29%) were in the more selective group. Rates of chemoprophylaxis decreased from 16% (original protocol) to 8% (more selective protocol). Patients in the more selective group were more likely to be older, be married, and have obesity or other comorbidities (hypertension, diabetes, cardiac disease). Compared with the original protocol, the more selective protocol was associated with a decrease in any wound hematoma (0.7% vs 0.3%; adjusted odds ratio [aOR], 0.38; 95% CI, 0.21-0.67), specifically due to a lower rate of superficial wound hematomas (0.6% vs 0.3%; aOR, 0.43; 95% CI, 0.24-0.75). There was no significant increase in VTE or individual types of VTE (0.1% vs 0.1%; aOR, 0.40; 95% CI, 0.12-1.36).

Conclusions and Relevance  A more selective risk-stratified approach to an enoxaparin thromboprophylaxis protocol for VTE was associated with decreased rates of wound hematomas without increased rates of postpartum VTE.

DOI: 10.1001/jama.2024.8684

Source: https://jamanetwork.com/journals/jama/fullarticle/2820391