Department of Reproductive Medicine, Lanzhou University Second Hospital, Lanzhou 730000, China.
Department of Reproductive Medicine, Lanzhou University Second Hospital, Lanzhou 730000, China.
J Reprod Immunol. 2023 Mar;156:103830. doi: 10.1016/j.jri.2023.103830. Epub 2023 Feb 16.
Published data regarding efficacy of intrauterine perfusion of recombinant human granulocyte colony-stimulating factor for patients with unexplained recurrent spontaneous abortion (URSA) is inconclusive. This study aims at evaluating the efficacy and safety of G-CSF in URSA.
Electronic databases were searched including Cochrane Library, PubMed, Embase, China Biology Medicine disc, China Science and Technology Journal Database, Wanfang Database and China National Knowledge Infrastructure Database (last search was performed on Sep 10th, 2022). A systematic review and meta-analysis was conducted with R-language software. Combined relative risk (RRs), and 95% confidence intervals (CIs) were calculated to estimate efficacy and safety.
Compared with placebo, the efficacy of G-CSF in the treatment of URSA patients was significant in conception rate (RR=1.34, 95%CI: 1.03-1.74, P = 0.028), and was none of significance in live birth rate (RR=1.35, 95%CI: 0.99-1.84, P = 0.06). Subgroup analysis showed that the ovulation-period-medication was the protective factor for conception rate, while "Ethnicity Asian" and "ovulation-period medication" were the protective factors for live birth rate. When it comes to the safety of rhG-CSF on URSA, meta-analysis showed that rhG-CSF had no significant effect on the incidence of adverse events (AEs) (RR=1.13, 95% CI: 0.89-1.43, P = 0.322), and subgroup analysis showed that the incidence of AEs in each subgroup did not increase significantly (P > 0.05).
Based on our meta-analysis, intrauterine perfusion of rhG-CSF in ovulation period is an effective and safe way to improve conception rate in URSA.
关于不明原因复发性自然流产（URSA）患者宫腔内灌注重组人粒细胞集落刺激因子（rhG-CSF）的疗效的已发表数据尚无定论。本研究旨在评估 rhG-CSF 在 URSA 中的疗效和安全性。
检索 Cochrane 图书馆、PubMed、Embase、中国生物医学文献数据库、中国科技期刊数据库、万方数据库和中国国家知识基础设施数据库（最后一次检索日期为 2022 年 9 月 10 日）。采用 R 语言软件进行系统评价和荟萃分析。合并相对风险（RR）及其 95%置信区间（CI）用于评估疗效和安全性。
与安慰剂相比，rhG-CSF 治疗 URSA 患者的妊娠率显著提高（RR=1.34，95%CI：1.03-1.74，P=0.028），活产率无显著差异（RR=1.35，95%CI：0.99-1.84，P=0.06）。亚组分析显示，排卵周期用药是妊娠率的保护因素，而“种族亚洲人”和“排卵周期用药”是活产率的保护因素。至于 rhG-CSF 对 URSA 的安全性，荟萃分析显示 rhG-CSF 对不良事件（AE）的发生率无显著影响（RR=1.13，95%CI：0.89-1.43，P=0.322），且各亚组的 AE 发生率均无显著增加（P>0.05）。
基于我们的荟萃分析，rhG-CSF 在排卵周期宫腔内灌注是提高 URSA 妊娠率的一种有效且安全的方法。
