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硫酸镁预防重度子痫前期妇女子痫:随机对照试验(PIPES试验)

Prophylactic magnesium sulphate in prevention of eclampsia in women with severe preeclampsia: randomised controlled trial (PIPES trial).

作者信息

Keepanasseril Anish, Maurya Dilip Kumar, Manikandan K, Suriya J Yavana, Habeebullah Syed, Raghavan S Soundara

机构信息

a Department of Obstetrics and Gynecology , Jawaharlal Institute of Post-graduate Medical Education and Research , Puducherry , India.

出版信息

J Obstet Gynaecol. 2018 Apr;38(3):305-309. doi: 10.1080/01443615.2017.1351931. Epub 2017 Oct 3.

Abstract

Optimum dose, route and duration of use of prophylactic magnesium sulphate in women with severe pre-eclampsia is still controversial. We compared the efficacy and safety of 'low-dose Dhaka' regime with 'Loading dose only' regime for seizure prophylaxis in severe preeclampsia using a randomised controlled trial in 402 women. The incidence of eclampsia in the 'low-dose Dhaka' regime group was 1.49% and that in the 'Loading dose only regime' was 2.98% (p = .321). In the low-dose Dhaka regime, injection site abscess and respiratory depression occurred in one woman each. Neonatal outcomes such as Apgar score at 5 minutes (5.0% vs. 8.05% p = .251) and perinatal mortality (20.4% vs. 21.9%, p = .724) were similar in both groups. Loading dose only regime may be considered an effective alternative regime for the prevention of eclampsia in women with severe preeclampsia. Impact statement What is already known on this subject: Efficacy of therapeutic short regime magnesium sulphate in eclampsia has already been reported. Data regarding prophylactic short regime in women with preeclampsia is sparse. What the results of this study add: We have shown that short regime of magnesium sulphate using only the loading dose in the prevention of seizure in preeclampsia is an effective alternative to the low-dose Dhaka regime. What the implications are of these findings for clinical practice and/or further research: The short regime is less resource-intensive. Further larger studies are needed to confirm the efficacy of this short regime and to establish its cost-effectiveness.

摘要

对于重度子痫前期女性,预防性使用硫酸镁的最佳剂量、途径和使用时长仍存在争议。我们在402名女性中进行了一项随机对照试验,比较了“低剂量达卡方案”和“仅负荷剂量方案”预防重度子痫前期惊厥的疗效和安全性。“低剂量达卡方案”组的子痫发病率为1.49%,“仅负荷剂量方案”组为2.98%(p = 0.321)。在低剂量达卡方案中,各有一名女性出现注射部位脓肿和呼吸抑制。两组的新生儿结局相似,如5分钟时的阿氏评分(5.0%对8.05%,p = 0.251)和围产期死亡率(20.4%对21.9%,p = 0.724)。仅负荷剂量方案可被视为预防重度子痫前期女性子痫的一种有效替代方案。影响声明关于该主题已知的信息:已报道了硫酸镁治疗短疗程方案在子痫中的疗效。关于子痫前期女性预防性短疗程方案的数据稀少。本研究结果补充了什么:我们已表明,在预防子痫前期惊厥方面,仅使用负荷剂量的硫酸镁短疗程方案是低剂量达卡方案的有效替代方案。这些发现对临床实践和/或进一步研究的意义是什么:短疗程方案资源消耗较少。需要进一步开展更大规模的研究来证实该短疗程方案的疗效并确定其成本效益。

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