Ni Lei, Sun Xue-Qian, Zhao Dong-Xu, Zhu Zi-Wei
Department of Hematology.
Department of Immunology.
Medicine (Baltimore). 2019 Feb;98(8):e14619. doi: 10.1097/MD.0000000000014619.
Previous clinical studies reported low molecular weight heparin (LMWH) monotherpay has been utilized for the treatment of recurrent abortion (RCA) with antiphospholipid system (APS). However, its efficacy is still inconclusive. This systematic review aims to assess its efficacy and safety for patients with RCA and APS.
A systematic literature search for article up to February 2019 will be conducted in 9 databases: Cochrane Library, EMBASE, MEDILINE, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Information, and Wanfang Data. Inclusion criteria are randomized control trials of LMWH monotherpay for patients with RCA and APS. The Cochrane risk of bias tool will be used to evaluate the methodological quality for each qualified study. The summary results will be showed by using fixed-effects and random-effects models for pooling the data based on the heterogeneity of included studies.
This systematic review will assess the clinical efficacy and safety of LMWH monotherpay in treating RCA with APS. The primary outcome is pregnancy loss. The secondary outcomes include frequency of preterm delivery, live birth rates, maternal and fetal complications, as well as adverse events.
The findings of this study will summarize the present evidence to judge whether LMWH monotherpay is an effective therapy for patients with RCA and APS.
The findings of this study will be published by through peer-reviewed journals. This study does not needs ethic documents, because it will not analyze individual patient data.
PROSPERO CRD42019121064.
既往临床研究报道,低分子肝素(LMWH)单药治疗已用于抗磷脂综合征(APS)所致复发性流产(RCA)的治疗。然而,其疗效仍不明确。本系统评价旨在评估其对RCA合并APS患者的疗效和安全性。
截至2019年2月,将在9个数据库中进行系统文献检索:考克兰图书馆、EMBASE、医学索引数据库、护理学与健康照护领域累积索引数据库、补充与替代医学数据库、中国生物医学文献数据库、中国知网、维普资讯和万方数据。纳入标准为LMWH单药治疗RCA合并APS患者的随机对照试验。将使用考克兰偏倚风险工具评估每项合格研究的方法学质量。根据纳入研究的异质性,将使用固定效应模型和随机效应模型合并数据来呈现汇总结果。
本系统评价将评估LMWH单药治疗RCA合并APS的临床疗效和安全性。主要结局为流产。次要结局包括早产频率、活产率、母婴并发症以及不良事件。
本研究结果将总结现有证据,以判断LMWH单药治疗是否为RCA合并APS患者的有效治疗方法。
本研究结果将通过同行评审期刊发表。本研究不需要伦理文件,因为它不会分析个体患者数据。
国际前瞻性系统评价注册库CRD42019121064。