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检查指征下的单胎妊娠宫颈环扎术时的辅助治疗:系统评价和荟萃分析。

Adjunct Therapy at Time of Examination-Indicated Cervical Cerclage in Singleton Pregnancies: A Systematic Review and Meta-analysis.

机构信息

Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, Utah.

Department of Obstetrics and Gynecology, Intermountain Healthcare, Murray, Utah.

出版信息

Am J Perinatol. 2022 Dec;39(16):1719-1725. doi: 10.1055/a-1877-9078. Epub 2022 Jun 16.

Abstract

OBJECTIVE

Physical examination-indicated cerclage for cervical insufficiency prolongs gestation, but evidence on the addition of adjuncts to further prolong latency is limited. The aim of this systematic review and meta-analysis was to compare gestational latency between those who did and did not receive adjunct antibiotic or tocolytic therapy at the time of examination-indicated cerclage.

STUDY DESIGN

Electronic databases (1966-2020) were searched for randomized controlled trials (RCTs) and cohort studies comparing adjunct antibiotic or tocolytic use versus nonuse at time of examination-indicated cerclage, defined as placement for cervical dilation ≥1 cm, in a current singleton pregnancy. Studies including individuals with intra-amniotic infection, cerclage in place, nonviable gestation, or ruptured membranes were excluded. The primary outcome was latency from cerclage placement to delivery. Secondary outcomes included preterm birth, preterm premature rupture of membranes, birth weight, and neonatal survival. Risk of bias was assessed using standardized tools. Heterogeneity was assessed using and tests. Results were pooled and analyzed using a random-effects model. This study is registered with The International Prospective Register of Systematic Reviews (PROSPERO) with registration no.: CRD42021216370.

RESULTS

Of 923 unique records, 163 were reviewed in full. Three met inclusion criteria: one RCT and two retrospective cohorts. The included RCT ( = 50) and one cohort ( = 142) compared outcomes with and without adjunct use of antibiotic and tocolytic, while the second cohort ( = 150) compared outcomes with and without adjunct tocolytic, with a subpopulation also receiving antibiotics. The RCT was nested within one of the cohorts, and therefore only one of these two studies was utilized for any given outcome to eliminate counting individuals twice. Risk of bias was "critical" for one cohort study, "moderate" for the other cohort study, and "some concerns" for the RCT. Gestational latency could not be pooled and meta-analyzed. Adjunct tocolytic-antibiotic therapy was not associated with a decrease in risk of preterm delivery <28 weeks (relative risk [RR] = 0.90, 95% confidence interval [CI]: 0.65-1.26;  = 0.0,  = 0.0%) or neonatal survival to discharge (RR = 1.11, 95% CI: 0.91-1.35;  = 0.05,  = 0.0%).

CONCLUSION

There is not enough evidence to robustly evaluate the use of adjunct tocolytics or antibiotics at time of examination-indicated cerclage to prolong latency.

KEY POINTS

· Limited data on adjunct antibiotic tocolytics at cerclage.. · Widely variable practices at time of cerclage identified.. · Role of adjunct therapies at time of examination-indicated cerclage remains unclear..

摘要

目的

体格检查指征性宫颈环扎术可延长妊娠时间,但有关进一步延长潜伏期时附加辅助药物治疗的证据有限。本系统评价和荟萃分析的目的是比较体格检查指征性宫颈环扎术中使用和不使用辅助抗生素或宫缩抑制剂治疗的患者之间的潜伏期差异。

研究设计

检索了电子数据库(1966 年至 2020 年)中比较体格检查指征性宫颈环扎术(定义为宫颈扩张≥1cm 时进行的当前单胎妊娠)时使用和不使用辅助抗生素或宫缩抑制剂治疗的随机对照试验(RCT)和队列研究。排除了存在羊膜腔内感染、环扎术已放置、不可存活妊娠或胎膜破裂的患者。主要结局是从宫颈环扎术到分娩的潜伏期。次要结局包括早产、早产胎膜早破、出生体重和新生儿存活率。使用标准化工具评估偏倚风险。使用 和 检验评估异质性。使用随机效应模型对结果进行汇总和分析。本研究已在国际前瞻性系统评价注册库(PROSPERO)注册,注册号为:CRD42021216370。

结果

在 923 条独特记录中,有 163 条进行了全文审查。有 3 项研究符合纳入标准:一项 RCT 和两项回顾性队列研究。纳入的 RCT(n=50)和一项队列研究(n=142)比较了使用和不使用辅助抗生素和宫缩抑制剂的结局,而第二项队列研究(n=150)比较了使用和不使用辅助宫缩抑制剂的结局,其中一个亚组还接受了抗生素治疗。该 RCT 嵌套在其中一个队列研究中,因此对于任何给定的结局,仅使用其中两项研究之一来消除重复计数个体。一项队列研究的偏倚风险为“关键”,另一项队列研究的偏倚风险为“中度”,RCT 的偏倚风险为“存在一些关注”。潜伏期无法进行汇总和荟萃分析。辅助宫缩抑制剂-抗生素治疗与 28 周前早产风险降低无关(相对风险[RR] = 0.90,95%置信区间[CI]:0.65-1.26; = 0.0, = 0.0)或新生儿存活率到出院(RR = 1.11,95%CI:0.91-1.35; = 0.05, = 0.0)。

结论

目前尚无足够证据可靠地评估体格检查指征性宫颈环扎术中使用辅助宫缩抑制剂或抗生素来延长潜伏期。

关键点

· 宫颈环扎术时使用辅助抗生素的有限数据。· 宫颈环扎术时的实践存在广泛差异。· 体格检查指征性宫颈环扎术时辅助治疗的作用仍不清楚。

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