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英国利物浦大学和利物浦妇女医院Angharad Care团队对预防高危单胎妊娠妇女自发早产的干预措施进行了一项系统回顾和网络荟萃分析。相关论文发表在2022年2月15日出版的《英国医学杂志》上。

该研究旨在比较卧床休息、宫颈环扎术（McDonald、Shirodkar或未指明类型的环扎术）、宫颈托、鱼油或ω-脂肪酸、营养补充剂（锌）、孕酮（肌肉注射、口服或阴道）、预防性抗生素、预防性宫缩抑制剂或组合干预，与安慰剂或无治疗（对照组）相比，预防单胎妊娠、有自然早产史或宫颈短的女性自发早产的效果。

研究组在Cochrane妊娠和分娩组的试验数据库、Cochrane对照试验中央登记册、Medline、Embase等大型数据库中检索研究因自发性早产史或宫颈长度短而具有高自发性早产风险孕妇的随机对照试验，采用贝叶斯网络荟萃分析进行系统回顾。

根据已发表的早产研究核心结果，研究组分析了7种孕产妇结局和11种胎儿结局。对于<34周早产和围产期死亡的结局，给出了相对疗效（优势比和95%可信区间）和证据的确定性。

61项试验（17273名孕妇）为至少一种结果的分析提供了数据。对于<34周的早产（40项试验，13310名孕妇） ，以安慰剂或无治疗作为对照，使用阴道孕酮后早产风险显著降低（优势比0.50，证据高度确定）。Shirodkar环扎显示出最大效应量（0.06），但证据的确定性较低。

17OHPC（17α-羟基孕酮己酸酯；0.68，中等确定度）、宫颈托（0.65，中等确定度）和鱼油或ω-脂肪酸（0.30，中等确定度）与安慰剂或不治疗相比，也有可能降低34周以下的早产率。对于围产期死亡的胎儿结局（30项试验，12119名孕妇），以安慰剂或无治疗作为对照，阴道孕酮是唯一一种有明显益处的治疗方法（0.66，中等确定度）。

17OHPC（0.78，中等确定度）、McDonald环扎术（0.59，中等确定度）和未指明类型的环扎术（0.77，中等确定度）有可能降低围产期死亡率，但置信区间不排除危害的可能性。与对照组相比，只有孕酮治疗与新生儿呼吸窘迫综合征、新生儿败血症、坏死性小肠结肠炎和新生儿重症监护病房入院率的降低有关。

研究结果表明，阴道孕酮应被视为有自然早产史或宫颈短而有自然早产的风险的单胎妊娠妇女的预防性治疗选择。未来的随机对照试验应使用阴道孕酮作为对照，以确定更好的治疗或联合治疗。

附：英文原文

Title: Interventions to prevent spontaneous preterm birth in women with singleton pregnancy who are at high risk: systematic review and network meta-analysis

Author: Angharad Care, Sarah J Nevitt, Nancy Medley, Sarah Donegan, Laura Good, Lynn Hampson, Catrin Tudur Smith, Zarko Alfirevic

Issue&Volume: 2022/02/15

Abstract:

Objectives To compare the efficacy of bed rest, cervical cerclage (McDonald, Shirodkar, or unspecified type of cerclage), cervical pessary, fish oils or omega fatty acids, nutritional supplements (zinc), progesterone (intramuscular, oral, or vaginal), prophylactic antibiotics, prophylactic tocolytics, combinations of interventions, placebo or no treatment (control) to prevent spontaneous preterm birth in women with a singleton pregnancy and a history of spontaneous preterm birth or short cervical length.

Design Systematic review with bayesian network meta-analysis.

Data sources The Cochrane Pregnancy and Childbirth Group’s Database of Trials, the Cochrane Central Register of Controlled Trials, Medline, Embase, CINAHL, relevant journals, conference proceedings, and registries of ongoing trials.

Eligibility criteria for selecting studies Randomised controlled trials of pregnant women who are at high risk of spontaneous preterm birth because of a history of spontaneous preterm birth or short cervical length. No language or date restrictions were applied.

Outcomes Seven maternal outcomes and 11 fetal outcomes were analysed in line with published core outcomes for preterm birth research. Relative treatment effects (odds ratios and 95% credible intervals) and certainty of evidence are presented for outcomes of preterm birth <34 weeks and perinatal death.

Results Sixty one trials (17273 pregnant women) contributed data for the analysis of at least one outcome. For preterm birth <34 weeks (40 trials, 13310 pregnant women) and with placebo or no treatment as the comparator, vaginal progesterone was associated with fewer women with preterm birth <34 weeks (odds ratio 0.50, 95% credible interval 0.34 to 0.70, high certainty of evidence). Shirodkar cerclage showed the largest effect size (0.06, 0.00 to 0.84), but the certainty of evidence was low. 17OHPC (17α-hydroxyprogesterone caproate; 0.68, 0.43 to 1.02, moderate certainty), vaginal pessary (0.65, 0.39 to 1.08, moderate certainty), and fish oil or omega 3 (0.30, 0.06 to 1.23, moderate certainty) might also reduce preterm birth <34 weeks compared with placebo or no treatment. For the fetal outcome of perinatal death (30 trials, 12119 pregnant women) and with placebo or no treatment as the comparator, vaginal progesterone was the only treatment that showed clear evidence of benefit for this outcome (0.66, 0.44 to 0.97, moderate certainty). 17OHPC (0.78, 0.50 to 1.21, moderate certainty), McDonald cerclage (0.59, 0.33 to 1.03, moderate certainty), and unspecified cerclage (0.77, 0.53 to 1.11, moderate certainty) might reduce perinatal death rates, but credible intervals could not exclude the possibility of harm. Only progesterone treatments are associated with reduction in neonatal respiratory distress syndrome, neonatal sepsis, necrotising enterocolitis, and admission to neonatal intensive care unit compared with controls.

Conclusion Vaginal progesterone should be considered the preventative treatment of choice for women with singleton pregnancy identified to be at risk of spontaneous preterm birth because of a history of spontaneous preterm birth or short cervical length. Future randomised controlled trials should use vaginal progesterone as a comparator to identify better treatments or combination treatments.

DOI: 10.1136/bmj-2021-064547

Source: https://www.bmj.com/content/376/bmj-2021-064547

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