Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
J Matern Fetal Neonatal Med. 2020 Jun;33(12):1965-1973. doi: 10.1080/14767058.2018.1533948. Epub 2018 Dec 17.
It is unknown whether observational studies comparing laparotomy versus peritoneal drainage for surgical treatment of necrotizing enterocolitis (NEC) in preterm infants differ from randomized controlled trials (RCTs) of the same interventions. Further, in the absence of sufficient RCT evidence, it is uncertain how best to use existing observational data to guide clinical decision making. We performed a systematic review and meta-analysis of articles comparing laparotomy versus peritoneal drainage for preterm infants with NEC. Two authors independently searched PubMed and the Cochrane Database of Systematic Reviews, from 1 January 1990 to 1 May 2017 and selected articles that: (1) included low birthweight (<2500 g) or preterm (<37-week gestation) infants, (2) compared laparotomy versus peritoneal drainage for NEC, and (3) reported all-cause mortality (primary outcome) in both groups. The same two authors extracted data about study outcomes and about study quality, which was assessed using the Consolidated Standards of Reporting Trials (CONSORT) checklist for reporting of RCTs and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklist for reporting of observational studies. Random-effects meta-analysis was used to generate weighted odds ratios (OR). Twenty-five observational studies and two RCTs met all eligibility criteria. Outcomes were reported for 16,288 patients: 16,103 from observational studies and 185 from RCTs. Meta-analysis of observational studies demonstrated significantly lower mortality after laparotomy, as compared to peritoneal drainage (pooled OR 0.54, 95% CI 0.34-0.84). In contrast, RCTs demonstrated no difference in mortality (pooled OR 0.85, 95% CI 0.47-1.54). In analyses, observational studies were separated into two subgroups: low versus high quality of reporting, based on the STROBE checklist. Observational studies with low quality of reporting significantly favored laparotomy (pooled OR 0.38, 95% CI 0.18-0.81). In contrast and similar to RCTs, observational studies with high quality of reporting showed no difference in mortality (pooled OR 0.67, 95% CI 0.37-1.19). Neither RCTs nor observational studies with high quality of reporting demonstrate differences in mortality when preterm infants with surgical NEC are managed with laparotomy or peritoneal drainage. While RCTs remain a gold standard for evaluation of therapies, results from high quality observational studies may approximate the results of RCTs and might guide clinical practice until adequate RCT evidence is available.
尚不清楚比较剖腹术与经皮引流治疗早产儿坏死性小肠结肠炎（NEC）的观察性研究与相同干预措施的随机对照试验（RCT）是否存在差异。此外，在缺乏足够 RCT 证据的情况下，尚不确定如何最好地利用现有的观察性数据来指导临床决策。我们对比较剖腹术与经皮引流治疗早产儿 NEC 的文章进行了系统评价和荟萃分析。两名作者独立检索了 PubMed 和 Cochrane 系统评价数据库，检索时间为 1990 年 1 月 1 日至 2017 年 5 月 1 日，并选择了以下文章：（1）纳入低出生体重（<2500g）或早产（<37 周妊娠）婴儿；（2）比较剖腹术与经皮引流治疗 NEC；（3）报告两组的全因死亡率（主要结局）。两名作者使用 CONSORT 报告 RCT 的清单和 STROBE 报告观察性研究的清单，分别提取研究结局和研究质量的数据。使用随机效应荟萃分析生成加权比值比（OR）。25 项观察性研究和 2 项 RCT 符合所有纳入标准。16288 例患者的结局得到报告：16103 例来自观察性研究，185 例来自 RCT。观察性研究的荟萃分析表明，与经皮引流相比，剖腹术后死亡率显著降低（汇总 OR 0.54，95%CI 0.34-0.84）。相比之下，RCT 并未显示死亡率有差异（汇总 OR 0.85，95%CI 0.47-1.54）。在敏感性分析中，根据 STROBE 清单，将观察性研究分为低质量报告和高质量报告两个亚组。低质量报告的观察性研究显著倾向于剖腹术（汇总 OR 0.38，95%CI 0.18-0.81）。相比之下，与 RCT 相似，高质量报告的观察性研究显示死亡率无差异（汇总 OR 0.67，95%CI 0.37-1.19）。在接受手术治疗的早产儿 NEC 患者中，无论是 RCT 还是高质量报告的观察性研究均未显示死亡率存在差异。虽然 RCT 仍然是评估治疗方法的金标准，但高质量观察性研究的结果可能接近 RCT 的结果，并可能在获得足够的 RCT 证据之前指导临床实践。
