N-乙酰半胱氨酸治疗早发性子痫前期的随机对照试验：研究方案
A randomized controlled trial of N-acetylcysteine in the treatment of early-onset preeclampsia: Study Protocol.
摘要(中文译文)
尽管产科护理取得了显著进展，子痫前期的发生率仍然是重大的公共卫生挑战，预防疾病进展的有效策略仍然有限，尤其是在资源匮乏的环境中。N-乙酰半胱氨酸（NAC）是一种抗氧化剂和谷胱甘肽前体，已显示出抗炎和血管舒张作用，使其成为药物重定位的有前景的候选药物。然而，缺乏来自充分把握度的随机对照试验的有力证据。本研究将评估NAC对尼日利亚拉各斯早发型子痫前期孕妇疾病进展时间的影响。这是一项概念验证、双盲、随机、对照试验的研究方案，将于2026年4月至2028年7月在尼日利亚拉各斯两所教学医院的产科病房进行。在基线时，153名年龄18岁及以上、在妊娠24-34周被诊断为早发型子痫前期的性活跃女性将被随机分配接受每日口服含600 mg NAC的片剂或外观和给药方案相匹配的安慰剂片剂，此外从诊断（随机化）至妊娠34周或分娩（以先发生者为准）期间接受标准产前护理。主要终点是早发型子痫前期进展为重度疾病的时间（以天计）。数据分析将基于意向性治疗原则进行。将使用Kaplan-Meier估计和Log-rank检验计算和比较治疗组的疾病进展时间，同时使用采用向后条件法的Cox比例风险模型比较治疗组之间的主要终点，并通过风险比（HRs）和95%置信区间（95%CIs）对其他协变量进行调整以提高精确度。还将进行亚组分析，以评估显著协变量对NAC影响疾病进展的差异效应。统计显著性报告为P < 0.05。本研究将评估每日口服NAC与安慰剂相比治疗早发型子痫前期孕妇的疗效。如果被证明有效，NAC可提供一种安全、可负担且可扩展的干预措施，以减轻子痫前期的负担，尤其是在资源受限的环境中。
Abstract
Despite significant advancements in obstetric care, the incidence of preeclampsia remains a substantial public health challenge, and effective strategies to prevent the disease progression remain limited, particularly in low-resource settings. N-acetylcysteine (NAC), an antioxidant and glutathione precursor, has demonstrated anti-inflammatory and vasodilatory effects, making it a promising candidate for repurposing. However, robust evidence from well-powered randomized controlled trials is lacking. This study will evaluate the impact of NAC on the time-to-disease progression in pregnant women with early-onset preeclampsia in Lagos, Nigeria. This is the study protocol for a proof-of-concept, double-blind, randomized, controlled trial to be conducted between April 2026 to July 2028 at the maternity units of the two teaching hospitals in Lagos, Nigeria. At baseline, n = 153 sexually active women aged 18 years or older diagnosed with early-onset preeclampsia at 24-34 weeks' gestation will be randomised to receive either daily oral tablet containing 600 mg of NAC or a placebo tablet that is matched for appearance and the dosing regimen in addition to standard antenatal care from diagnosis (randomisation) until either 34 weeks' gestation or delivery, whichever comes first. The primary endpoint is the time-to-progression (in days) of early-onset preeclampsia to severe disease. The data analysis will be conducted on an intention-to-treat basis. Kaplan-Meier estimates with a Log-rank test will be used to calculate and compare the time-to-disease progression for the treatment groups, while Cox proportional hazard models with a backwards conditional method will be used to compare the primary endpoint between the treatment arms while adjusting for other covariates for precision using hazard ratios (HRs) and 95% confidence intervals (95%CIs). Subgroup analyses will also be performed to assess the differential effects of significant covariates on the impact of NAC on disease progression. Statistical significance will be reported as P < 0.05. This study will evaluate the efficacy of daily oral NAC compared to placebo in treating pregnant women with early-onset preeclampsia. If proven effective, NAC could offer a safe, affordable, and scalable intervention to reduce the burden of preeclampsia, particularly in resource-constrained settings.
如何引用
AMA
Kehinde S Okunade, Adebola A Adejimi, Muisi A Adenekan, Iyabo Y Ademuyiwa, Hameed Adelabu, Fatimah M Habeebu-Adeyemi, et al. A randomized controlled trial of N-acetylcysteine in the treatment of early-onset preeclampsia: Study Protocol.. PloS one. 2026; doi:10.1371/journal.pone.0347695.
APA
Kehinde S Okunade, Adebola A Adejimi, Muisi A Adenekan, Iyabo Y Ademuyiwa, Hameed Adelabu, Fatimah M Habeebu-Adeyemi, et al (2026). A randomized controlled trial of N-acetylcysteine in the treatment of early-onset preeclampsia: Study Protocol.. PloS one. https://doi.org/10.1371/journal.pone.0347695
GB/T 7714
Kehinde S Okunade, Adebola A Adejimi, Muisi A Adenekan, Iyabo Y Ademuyiwa, Hameed Adelabu, Fatimah M Habeebu-Adeyemi, et al. A randomized controlled trial of N-acetylcysteine in the treatment of early-onset preeclampsia: Study Protocol.[J]. PloS one, 2026 doi:10.1371/journal.pone.0347695.
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