Konkuk University, School of Medicine, Department of Anesthesiology and Pain Medicine, Chungju, South Korea.
Centre for Medical Evidence, Decision Integrity and Clinical Impact (MEDICI), University of Western Ontario, London, ON, Canada.
J Clin Anesth. 2017 Jun;39:57-63. doi: 10.1016/j.jclinane.2017.03.026. Epub 2017 Mar 30.
Although epidural analgesia is considered the gold standard for labor pain management, its use may be restricted in some conditions due to clinical contraindications or availability, and suitable alternatives may be required. The objective of this meta-analysis was to determine whether evidence from randomized trials suggests remifentanil PCA (R-PCA) results in significant differences in maternal satisfaction, analgesic efficacy, and safety compared with conventional epidural analgesia (EA).
We conducted a meta-analysis after systematically searching MEDLINE, EMBASE and Cochrane Library for all randomized controlled trials (RCTs) allocating parturients to R-PCA or EA and reporting at least one outcome of interest.
Eight randomized trials of R-PCA vs EA with 2351 patients were included.
The primary outcome of interest was maternal satisfaction. Secondary outcomes included visual analog pain score (VAS at 1, 2, 3h postoperatively), nausea, vomiting, pruritus, hypoxemia, acute respiratory depression or death (maternal or neonatal), need for Cesarean section, and neonatal Apgar score.
Meta-analysis of the randomized trials showed no significant differences between the R-PCA and EA groups for maternal satisfaction, VAS at 2 or 3h, nausea, vomiting, need for cesarean section, respiratory depression, umbilical pH, and neonatal Apgar score at 1min and 5min. However, incidence of hypoxemia was higher [OR 7.48, 95%CI 3.42-16.36] and VAS at 1h was slightly higher [WMD 1.33, 95%CI 0.30-2.36] with R-PCA versus EA. Pruritus was less frequent in the R-PCA group [OR 0.54, 95%CI 0.32-0.89]. Acute respiratory failure and death were not reported in any of the studies.
While no significant differences were detected for maternal satisfaction or for most clinical outcomes, this meta-analysis remains underpowered to rule out clinically-important differences due to the few existing randomized trials. For obstetric patients who are not candidates for EA, R-PCA may provide an alternative for analgesia in the peri-partum period, but caution is warranted particularly regarding hypoxemia, and suggests the need for increased surveillance and monitoring for R-PCA. Further adequately powered randomized trials with a focus on clinically-relevant maternal and neonatal outcomes are required to more accurately characterize the relative benefits and risks of R-PCA versus EA in this population.
尽管硬膜外镇痛被认为是分娩疼痛管理的金标准，但由于临床禁忌或可用性等原因，其使用可能会受到限制，因此可能需要合适的替代方法。本荟萃分析的目的是确定随机试验的证据是否表明瑞芬太尼患者自控镇痛（R-PCA）在产妇满意度、镇痛效果和安全性方面与传统硬膜外镇痛（EA）相比是否存在显著差异。
我们系统性地检索了 MEDLINE、EMBASE 和 Cochrane 图书馆，以查找所有将产妇分配到 R-PCA 或 EA 组并报告至少一个感兴趣结局的随机对照试验（RCT），然后对这些 RCT 进行荟萃分析。
纳入了 8 项 R-PCA 与 EA 的随机对照试验，共 2351 例患者。
主要结局指标为产妇满意度。次要结局指标包括术后 1、2、3 小时的视觉模拟疼痛评分（VAS）、恶心、呕吐、瘙痒、低氧血症、急性呼吸抑制或死亡（产妇或新生儿）、剖宫产需求以及新生儿 Apgar 评分。
对随机试验的荟萃分析显示，R-PCA 组与 EA 组在产妇满意度、术后 2 或 3 小时的 VAS、恶心、呕吐、剖宫产需求、呼吸抑制、脐动脉 pH 值以及 1 分钟和 5 分钟新生儿 Apgar 评分方面无显著差异。然而，R-PCA 组的低氧血症发生率更高[比值比（OR）7.48，95%置信区间（CI）3.42-16.36]，VAS 在 1 小时时也略高[加权均数差（WMD）1.33，95%CI 0.30-2.36]。瘙痒在 R-PCA 组中较少见[OR 0.54，95%CI 0.32-0.89]。在任何研究中均未报告急性呼吸衰竭和死亡。
虽然在产妇满意度或大多数临床结局方面未发现显著差异，但由于现有随机试验较少，本荟萃分析仍不足以排除临床重要差异。对于不适合 EA 的产科患者，R-PCA 可能是围产期镇痛的替代方法，但应特别注意低氧血症，并表明需要增加对 R-PCA 的监测和监测。需要进一步进行具有足够效力的、侧重于临床相关产妇和新生儿结局的随机试验，以更准确地描述 R-PCA 与 EA 在该人群中的相对益处和风险。
