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羊膜腔输液与中孕期 PROM 标准处理的比较:观察性研究和 RCT 的系统评价和荟萃分析。

Amnioinfusion vs. standard management for the second trimester PPROM: a systematic review and meta-analysis of observational studies and RCTs.

机构信息

Department of Obstetrics and Gynecology, School of Medicine, Koc University, Istanbul, Turkey.

Department of Obstetrics and Gynecology, Zeynep Kamil Women and Children Diseases Training and Research Hospital, Istanbul, Turkey.

出版信息

J Matern Fetal Neonatal Med. 2023 Dec;36(2):2230511. doi: 10.1080/14767058.2023.2230511.

Abstract

OBJECTIVE

This meta-analysis aims to review the effect of serial transabdominal amnioinfusion (TAI) on short-term and long-term perinatal outcomes in mid-trimester preterm premature rupture of membranes (PPROM).

METHODS

Literature searches of PubMed, Web of Sciences, Scopus, and Cochrane Library were performed from their inception to April 2022. Studies comparing conventional treatment with serial TAI in women with proven PPROM at less than 26 + 0 weeks of gestation with oligohydramnios were included. Studies that included oligohydramnios due to other reasons such as fetal growth retardation or renal anomalies were excluded. Risk of bias in observational studies was assessed using the tool of the Cochrane Review group identified as risk of bias in non-randomized studies - of interventions. The risk of bias assessments for RCTs were performed according to the Cochrane risk-of-bias tool for randomized trials. An score was used to assess the heterogeneity of included studies. The analyses were performed by using random-effect model, and the results were expressed as relative risk (RR) or mean difference with 95% confidence intervals (CIs).

RESULTS

Overall, eight relevant studies including five observational studies ( = 252; 130 women allocated to the intervention) and three RCTs ( = 183; 93 women allocated to the intervention) were eligible. The pooled latency period was 21.9 days (95% CI, 13.1-30.8) and 5.8 days (95% CI, -11.6-23.2) longer in the TAI group in the observational studies and RCTs, respectively. The perinatal mortality rate reduced in the intervention group when tested in observational studies (RR 0.68; 95% CI, 0.51-0.92), but not in RCTs (RR 0.79; 95% CI, 0.56-1.13). The rate of long-term healthy survival was higher in the children whose mothers were treated with the TAI (35.7%) than those were treated with the standard management (28.6%) (RR 1.30, 95% CI 0.47-3.60, "best case scenario").

CONCLUSIONS

The efficacy of serial TA on early PPROM associated morbidity and mortality is not attested. Additional randomized control trials with adequate power are needed.

摘要

目的

本荟萃分析旨在回顾中孕期胎膜早破(PPROM)时行序贯经腹羊膜腔灌注(TAI)对短期和长期围产结局的影响。

方法

从建库至 2022 年 4 月,对 PubMed、Web of Sciences、Scopus 和 Cochrane Library 进行文献检索。纳入比较经证实的孕 26 周+0 天前胎膜早破且羊水过少的孕妇采用常规治疗与序贯 TAI 的研究。排除因胎儿生长受限或肾脏异常等其他原因导致羊水过少的研究。采用 Cochrane 评价组制定的工具评估观察性研究的偏倚风险,确定为非随机干预研究的偏倚风险。对 RCT 的偏倚风险评估按照 Cochrane 随机试验偏倚风险工具进行。采用 评分评估纳入研究的异质性。采用随机效应模型进行分析,结果表示为相对风险(RR)或均数差值及 95%置信区间(CI)。

结果

共纳入八项相关研究,包括五项观察性研究( = 252;130 名孕妇接受干预)和三项 RCT( = 183;93 名孕妇接受干预)。序贯 TAI 组的潜伏期分别延长了 21.9 天(95%CI,13.1-30.8)和 5.8 天(95%CI,-11.6-23.2)。在观察性研究中,干预组的围产儿死亡率降低(RR 0.68;95%CI,0.51-0.92),但在 RCT 中未降低(RR 0.79;95%CI,0.56-1.13)。接受 TAI 治疗的母亲所生儿童的长期健康存活率更高(35.7%),而接受标准治疗的母亲所生儿童的长期健康存活率更低(28.6%)(RR 1.30,95%CI 0.47-3.60,“最佳情况”)。

结论

目前尚无证据表明序贯 TAI 对早期 PPROM 的发病率和死亡率有效。需要进行更多具有足够效能的随机对照试验。

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