两种风险评估模型对我国孕产妇罹患静脉血栓栓塞症的预测价值比较

Comparison of predictive value between two risk assessment models for venous thromboembolism in pregnant and puerperal women in China

摘要

目的 比较2015年英国皇家妇产科医师学会(RCOG)《妊娠期及产褥期静脉血栓栓塞症(VTE)诊治指南》和2021年《中国妊娠期及产褥期VTE预防和诊治专家共识》的VTE风险评估模型对我国孕产妇罹患VTE的预测价值,为优化我国产科VTE防治策略提供依据。方法 回顾性选取2018年1月至2022年6月于我院建档产检并分娩,且在妊娠期或产褥期发生VTE的孕产妇作为病例组(n=28),并选取同期建档产检并分娩且未发生VTE的孕产妇作为对照组(n=280).采用受试者工作特征(ROC)曲线评价两种模型预测VTE的价值。结果 本研究妊娠相关VTE患病率为0.49‰;两种评估模型的平均累积风险得分的比较结果均有统计学差异(t值分别为4.91、5.19,均P<0.05);RCOG指南及中国专家共识风险评估模型的曲线下面积(AUC)分别为0.783(95%CI:0.684~0.882)和0.794(95%CI:0.696~0.892);VTE组人群在妊娠期和产褥期阶段,RCOG指南及中国专家共识风险评估后的理论药物预防率比较后无显著性差异(P>0.05),对照组人群在妊娠期和产褥期阶段,遵循中国专家共识风险模型的药物预防率显著低于RCOG指南,差异有统计学意义(χ²值分别为23.3、20.7,P<0.05)。结论 本研究发现两种风险评估模型对孕产妇VTE均有一定的预测能力,中国专家共识风险评估模型的药物预防率低,药物预防成本低.

Abstract

Objective To compare predictive value of two venous thromboembolism (VTE) risk assessment models (RAMs)-Guidelines for Diagnosis and Treatment of Venous Thromboembolism (VTE) during Pregnancy and Puerperal Period issued by Royal College of Obstetricians and Gynaecologists (RCOG) in 2015 (in the following, called as RCOG guidelines RAM in brief) and Expert Consensus on Prevention, Diagnosis and Treatment of VTE during Pregnancy and Puerperal Period issued by Chinese Society of Obstetrics and Gynecology in 2021 (in the following, called as Chinese expert consensus RAM in brief). Methods From January 2018 to June 2022, 28 pregnant and puerperal women who registered, received prenatal examination and delivered in our hospital, and had VTE during pregnancy and puerperal period were selected as VTE group, and 280 pregnant and puerperal women who did not have VTE in the same period were selected as control group at a ratio of 1∶10. The risk of VTE was assessed by using the RCOG guidelines RAM and Chinese expert RAM respectively. Receiver operating characteristic (ROC) curve was used to analyze predictive values of the two risk assessment models for VTE in pregnant and puerperal women in China. Results A total of 28 hospitalized pregnant and puerperal women were diagnosed as pregnancy-related VTE, and total number of deliveries during the same period was 57401, the prevalence rate of VTE was 0.49‰. By the RCOG guidelines RAM, the average cumulative risk score in the VTE group was 3.3±2.0, and that in the control group was 1.4±1.4, there was a significant difference between the two groups (t=4.91, P<0.05). And by the Chinese expert consensus RAM, the average cumulative risk score in the VTE group was 2.5±1.6, and that in the control group was 0.9±1.0, there was a significant difference between the two groups (t=5.19, P<0.05). The areas under the curve (AUCs) of the two risk assessment models-the RCOG guidelines RAM and the Chinese expert consensus RAM were 0.783 (95%CI: 0.684-0.882, P<0.001) and 0.794 (95%CI: 0.696-0.892, P<0.001) respectively, there was no significant difference in AUC between the two assessment models (P=0.595). In the VTE group, both in pregnancy and puerperal period, there were no significant differences in theoretical pharmaceutical prophylaxis rate between the RCOG guidelines RAM and the Chinese expert consensus RAM (both P>0.05), while in the control group, the pharmaceutical prophylaxis rate by the Chinese expert consensus RAM was lower than that by the RCOG guidelines RAM both in pregnancy and puerperal period, and the differences were statistically significant (χ²=23.3 and 20.7 respectively, both P<0.05). Conclusion The two RAMs both have certain prediction ability for maternal VTE. Compared to the RCOG guidelines RAM, the risk factors predicted by the Chinese expert consensus RAM for VTE during pregnancy and puerperal period are lesser, the pharmaceutical prophylaxis rate and the cost are significantly lower. It can be considered that the Chinese expert consensus RAM is more suitable for the population in China.

关键词

孕产妇 / 静脉血栓栓塞症 / 风险评估模型 / 预测

Key words

pregnant and puerperal women / venous thromboembolism / risk assessment model / prediction

参考文献

[1] American College of Obstetricians and Gynecologists Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 196: Thromboembolism in Pregnancy[J]. Obstet Gynecol, 2018, 132(1): e1-e17.

[2] Royal College of Obstetricians and Gynaecologists. Reducing the risk of venous thromboembolism during pregnancy and the puerperium [EB/OL]. Green-top Guideline No. 37a, 2015. Available from: https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf.

[3] 中华医学会妇产科学分会产科学组. 妊娠期及产褥期静脉血栓栓塞症预防和诊治专家共识[J]. 中华妇产科杂志, 2021, 56(4): 236-243.

[4] 中华医学科会呼吸病学分会肺栓塞与肺血管学组, 中国医师协会呼吸医师分会肺栓塞与肺血管病工作委员会, 全国肺栓与肺血管病防治协作组. 肺血栓栓塞症诊治与预防指南[J]. 中华医学杂志, 2018, 98(14): 1060-1086.

[5] Krenitsky N, Friedman A M, Yu K, et al. Trends in venous thromboembolism and associated risk factors during delivery hospitalizations from 2000 to 2018[J]. Obstet Gynecol, 2022, 139(2): 223-234.

[6] Zhou Q, Zhao Z, Xu J, et al. Hospital variation and associated organizational factors of pregnancy-related venous thrombo-embolism in China[J]. Clin Appl Thromb Hemost, 2022, 28: 10760296221076148.

[7] Luo X, Shan D, Zhang L, et al. Incidence of maternal venous thromboembolism in China: A systematic review and meta-analysis[J]. Int J Gynaecol Obstet, 2023, 163(1): 75-88.

[8] 全国妇幼卫生监测办公室. 2021年度全国妇幼健康监测主要结果分析报告[R]. 全国妇幼健康监测及年报通讯, 2023, 113(3): 1-6.

[9] 刘兴会, 陈锰. 降低中国可避免的孕产妇死亡[J]. 中国实用妇科与产科杂志, 2020, 36(1): 54-56.

[10] Queensland Clinical Guidelines. VTE prophylaxis in pregnancy and the puerperium [R/OL]. (2020-03-01) [2021-11-21]. https://www.health.qld.gov.au/data/assets/pdf_file/0011/140024/g-vte.pdf.

[11] 上海市母婴安全专家委员会, 上海市医学会围产医学专科分会, 上海市医学会妇产科专科分会产科学组, 等. 上海市产科静脉血栓栓塞症防治的专家共识[J]. 上海医学, 2020, 43(11): 640-650.

[12] Chen Y, Dai Y, Song J, et al. Establishment of a risk assessment tool for pregnancy-associated venous thromboembolism and its clinical application: protocol for a prospective observational study in Beijing[J]. BMC Pregnancy Childbirth, 2019, 19(1): 294.

[13] 崔宇童, 李笑天, 周琼洁. 综合医院与专科医院孕产妇VTE防治现状的调查[J]. 中华妇产科杂志, 2021, 56(5): 310-316.

[14] 李芷馨, 陈奕. 妊娠及产褥期静脉血栓栓塞症风险评估及预防指南推荐比较分析[J]. 中国妇产科临床杂志, 2020, 21(5): 553-555.

[15] Brouwers M C, Kho M E, Browman G P, et al. AGREE II: advancing guideline development, reporting and evaluation in healthcare[J]. CMAJ, 2010, 182(18): E839-E842.

[16] 汪宇纾, 孙熙木, 高红, 等. 妊娠期和产褥期相关静脉血栓栓塞症防治指南及共识质量评价和内容比较[J]. 中国实用妇科与产科杂志, 2022, 38(12): 1224-1230.

[17] 洪珊珊, 林志强, 黄晓威, 等. 妊娠期深静脉血栓形成预防指南的质量评价[J]. 长治医学院学报, 2023, 37(3): 192-197.

[18] Ge Y Z, Zhang C, Cai Y Q, et al. Application of the RCOG risk assessment model for evaluating postpartum venous thromboembolism in Chinese women: a case-control study[J]. Med Sci Monit, 2021, 27: e929904.

[19] Luo X, Zhang W, Zhou R, et al. Comparison of risk assessments for venous thromboembolism during the puerperium[J]. Heliyon, 2023, 9(2): e13568.

[20] O'Shaughnessy F, Donnelly J C, Bennett K, et al. Prevalence of postpartum venous thromboembolism risk factors in an Irish urban obstetric population[J]. Thromb Haemost, 2019, 17(11): 1875-1885.

[21] KOTASKA A. Postpartum heparin thromboprophylaxis: more harm than good[J]. Obstet Gynecol, 2021, 138(4): 527-529.

[22] 贺依林, 杨慧霞. 妊娠期及产褥期静脉血栓栓塞症的预防与治疗的相关问题[J]. 中国临床医生杂志, 2022, 50(7): 769-771.

[23] 方婧, 戴毅敏, 顾宁, 张群, 王志群. 通过41例产科静脉血栓评价不同指南的推荐差异[J]. 中国妇幼健康研究, 2019, 30(8): 941-945.

[24] Knight M, Tuffnell D, Kenyon S, et al. Saving lives, improving mothers' care-surveillance of maternal deaths in the UK 2011-13 and lessons learned to inform maternity care from the UK and Ireland confidential enquiries into maternal deaths and morbidity 2009-13[M]. Oxford: University of Oxford, 2015.

基金资助

国家自然科学基金(82304088)

首都特色临床应用研究(Z181100001718091)