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低分子肝素联合阿司匹林治疗 RSA 的临床疗效及不良反应：Meta 分析和系统评价。

Clinical efficacy and adverse effects of LMWH combined with ASA in the treatment of RSA: A meta-analysis and systematic review.

机构信息

Yinchuan Maternal and Child Health Care Hospital, Yinchuan, Ningxia, China.

General Hospital of Ningxia Medical University, Yinchuan, Ningxia, China.

出版信息

Medicine (Baltimore). 2024 Sep 13;103(37):e39603. doi: 10.1097/MD.0000000000039603.

DOI:10.1097/MD.0000000000039603
PMID:39287269
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11404929/
Abstract

BACKGROUND

The incidence of recurrent spontaneous abortion (RSA) in the clinic shows an increasing trend year by year, and the coagulation status of this group of patients is mostly relatively abnormal. Currently, commonly used drugs in clinical practice include Aspirin (ASA) and low molecular weight heparin (LMWH), but their optimal treatment remains controversial. We aimed to evaluate the clinical efficacy and adverse effects of LMWH combined with ASA in the treatment of RSA.

METHODS

Randomized controlled trials of LMWH combined with ASA for RSA were searched in the databases of PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure, Wanfang, VIP, and Chinese Biomedical Literature Service System from the construction of the database to June 2024. Data were analyzed using Review Manager 5.3 and Stata software. Dichotomous variables were analyzed using relative risk (RR) and 95% confidence interval (CI) as their statistics. The included literature was assessed for bias and risk of bias of eligible studies using Cochrane risk of bias tool. The risk of bias was evaluated based on the evaluation criteria recommended by the Cochrane Guidance Manual for Systematic Evaluation.

RESULTS

A total of 32 papers with a total of 3397 patients with RSA were finally included. LMWH combined with ASA treatment significantly improved the live birth rate (RR = 1.31, 95% CI: [1.19, 1.45], P < .00001), the rate of preterm stillbirths (RR = 0.23, 95% CI: [0.13, 0.40], P < .00001), rate of term delivery (RR = 1.55, 95% CI: [1.43, 1.67], P < .00001), rate of miscarriage (RR = 0.42, 95% CI: [0.36, 0.48], P < .00001), incidence of petechiae (RR = 0.44, 95% CI: [0.26, 0.72], P = .001), and incidence of thrombocytopenia (RR = 0.61, 95% CI: [0.39, 0.96], P = .03). In contrast, the incidence of preterm live births (RR = 1.07, 95% CI: [0.90, 1.28], P = .44), adverse reactions (RR = 0.77, 95% CI: [0.59, 1.00], P = .05), gingival bleeding (RR = 1.12, 95% CI: [0.65, 1.93], P = .69), and gastrointestinal reactions (RR = 0.87, 95% CI: [0.64, 1.17], P = .35) were not significant.

CONCLUSION

LMWH combined with ASA treatment might improve pregnancy outcomes and reduces the incidence of adverse events in patients with RSA.

摘要

背景

临床上复发性自然流产（RSA）的发生率呈逐年上升趋势，该组患者的凝血状态大多较为异常。目前，临床上常用的药物包括阿司匹林（ASA）和低分子肝素（LMWH），但它们的最佳治疗方案仍存在争议。我们旨在评估 LMWH 联合 ASA 治疗 RSA 的临床疗效和不良反应。

方法

检索建库至 2024 年 6 月PubMed、EMBASE、Cochrane 图书馆、中国知网、万方、维普及中国生物医学文献服务系统中关于 LMWH 联合 ASA 治疗 RSA 的随机对照试验。采用 Review Manager 5.3 和 Stata 软件进行数据分析。二分类变量采用相对危险度（RR）和 95%置信区间（CI）作为其统计量。采用 Cochrane 偏倚风险工具评估纳入文献的偏倚和合格研究的风险偏倚。根据 Cochrane 系统评价指南推荐的评估标准评估偏倚风险。

结果

最终纳入 32 篇文献，共计 3397 例 RSA 患者。LMWH 联合 ASA 治疗可显著提高活产率（RR=1.31，95%CI：[1.19，1.45]，P<0.00001）、早产死胎率（RR=0.23，95%CI：[0.13，0.40]，P<0.00001）、足月分娩率（RR=1.55，95%CI：[1.43，1.67]，P<0.00001）、流产率（RR=0.42，95%CI：[0.36，0.48]，P<0.00001）、瘀斑发生率（RR=0.44，95%CI：[0.26，0.72]，P=0.001）和血小板减少发生率（RR=0.61，95%CI：[0.39，0.96]，P=0.03）。相反，早产活产率（RR=1.07，95%CI：[0.90，1.28]，P=0.44）、不良反应发生率（RR=0.77，95%CI：[0.59，1.00]，P=0.05）、牙龈出血发生率（RR=1.12，95%CI：[0.65，1.93]，P=0.69）和胃肠道反应发生率（RR=0.87，95%CI：[0.64，1.17]，P=0.35）无显著差异。

结论

LMWH 联合 ASA 治疗可能改善 RSA 患者的妊娠结局，并降低不良反应发生率。

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