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随机临床试验中程序化间歇性硬膜外推注技术维持分娩镇痛的可推广性:一项前瞻性单中心队列研究。

Generalisability of randomised trials of the programmed intermittent epidural bolus technique for maintenance of labour analgesia: a prospective single centre cohort study.

机构信息

University of Basel, Basel, Switzerland.

Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.

出版信息

Br J Anaesth. 2019 Aug;123(2):e434-e441. doi: 10.1016/j.bja.2019.02.016. Epub 2019 Mar 28.

Abstract

BACKGROUND

Several randomised controlled trials show that maintenance of labour epidural analgesia with programmed intermittent epidural bolus reduces the maternal motor block compared with maintenance with a continuous infusion. However, these trials were usually restricted to healthy nulliparous parturients. To assess the generalisability of these randomised controlled trials to 'real-world' conditions, we compared maternal motor function (modified Bromage score) over time between healthy nulliparous and parous women using routinely collected quality-control data.

METHODS

After ethical approval, all parturients receiving programmed intermittent epidural bolus labour analgesia between June 2013 and October 2014 were included in this prospective cohort study. Bupivacaine 0.1% with fentanyl 2 μg ml was used allowing for patient-controlled bolus every 20 min. The maternal motor function (primary outcome) was regularly assessed from insertion of the epidural catheter until delivery.

RESULTS

Of the 839 parturients included, 553 (66%) were nulliparous and 286 (34%) were parous. The parous women had a shorter median duration of epidural analgesia (3 h 59 min vs 5 h 45 min) and a higher incidence of spontaneous delivery (66% vs 37%). The probability of being in a certain Bromage category at birth was similar in nulliparous and parous women in a general additive model adjusting for duration of epidural analgesia, number of rescue top-ups, and number of catheter manipulations (cumulative odds ratio: 1.18; 95% confidence interval: 0.98-1.41). Parous women required a higher time-weighted number and volume of rescue top-ups.

CONCLUSIONS

The results of the randomised controlled trials on a reduced motor block with programmed intermittent epidural bolus seem generalisable to parturients typically not included in these trials.

摘要

背景

几项随机对照试验表明,与持续输注相比,使用程控间歇硬膜外推注维持分娩硬膜外镇痛可减少产妇运动阻滞。然而,这些试验通常仅限于健康的初产妇。为了评估这些随机对照试验对“真实世界”条件的普遍性,我们使用常规收集的质量控制数据比较了健康初产妇和经产妇的产妇运动功能(改良 Bromage 评分)随时间的变化。

方法

在获得伦理批准后,我们将 2013 年 6 月至 2014 年 10 月期间接受程控间歇硬膜外推注分娩镇痛的所有产妇纳入本前瞻性队列研究。使用 0.1%布比卡因加 2μg/ml 芬太尼,允许患者每 20 分钟自控推注一次。产妇的运动功能(主要结局)从硬膜外导管插入到分娩时定期评估。

结果

在纳入的 839 名产妇中,553 名(66%)为初产妇,286 名(34%)为经产妇。经产妇的硬膜外镇痛持续时间较短(3 小时 59 分钟 vs 5 小时 45 分钟),自然分娩率较高(66% vs 37%)。在调整硬膜外镇痛持续时间、救援推注次数和导管操作次数的一般加性模型中,初产妇和经产妇在出生时处于特定 Bromage 类别的概率相似(累积优势比:1.18;95%置信区间:0.98-1.41)。经产妇需要更高的时间加权救援推注次数和体积。

结论

程控间歇硬膜外推注减少运动阻滞的随机对照试验结果似乎适用于通常不包括在这些试验中的产妇。

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