A Proof of Principle Randomised Placebo-Controlled Trial for Use of Statins to Ameliorate Early Onset Preeclampsia

使用他汀类药物改善早发性先兆子痫的随机安慰剂对照试验原理证明

• 批准号: G0701824/2
• 负责人: Asif Ahmed
• 金额: $ 24.74万
• 依托单位: Aston University
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2012
• 资助国家: 英国
• 起止时间: 2012 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=G0701824%2F2
• 关键词: Proof; Principle; Randomised; Placebo; Controlled

Preeclampsia (PE) is a potentially dangerous condition of pregnancy in which the mother?s blood pressure is higher than normal and there is protein in the urine. About 1 in 100 women experience preeclampsia before 32 weeks of pregnancy. The only effective treatment is to deliver the baby prematurely, but this has serious consequences for the baby. Watchful waiting, often employed clinically to allow the baby?s lungs to mature, risks progression of disease severity in the mother. A cheap and effective therapy for prevention of preeclampsia complications is urgently needed.It is not known what causes preeclampsia but recently some blood molecules (called anti-angiogenic factors) known to affect blood flow are higher in women with PE. These anti-angiogenic factors when given to pregnant animals mimic preeclampsia. Drugs called statins, which lower cholesterol, reduce the levels of these molecules. It is not known whether statins can reduce the severity and complications of preeclampsia.We will test the idea that statins can reduce these molecules in preeclamptic women before 32 weeks of pregnancy and decrease the severity of preeclampsia. Doctors from six hospitals will seek consent from these women. Those who are suitable and agree, will be randomly divided into two groups. One group will get a daily dose of statin. The other will get a dummy sugar pill (placebo). We hope to recruit 128 women. Neither the women nor their doctors will know what group they are in. In this way, we can be confident that any differences between the two groups are due to treatment. Women will stay in hospital and be closely monitored, and if the preeclampsia gets worse, their baby will be delivered.This trial is unique because it is the first to test whether statins can reduce the severity of preeclampsia and because statins are not prescribed normally to pregnant women. There is some concern that statins may cause congenital defects in the baby, but we have found no convincing evidence to support this. Furthermore, we believe it is safe to give statins later in pregnancy once the baby?s organs have already developed. However, all side effects and complications will be closely monitored.If this small trial shows that the severity of preeclampsia is reduced, and there are few side effects, a bigger trial will be organised to determine if statins can increase the length of pregnancy and reduce the number of premature deliveries.

先兆子痫（PE）是一种潜在的危险的怀孕条件，其中母亲？他的血压比正常高，尿中有蛋白质。大约每100名妇女中就有1名在怀孕32周前经历先兆子痫。唯一有效的治疗方法是早产，但这对婴儿有严重的后果。观察等待，临床上经常雇用让婴儿？的肺发育成熟，母亲的疾病严重程度有进展的风险。目前尚不清楚是什么原因导致先兆子痫，但最近一些已知影响血流的血液分子（称为抗血管生成因子）在PE女性中较高。这些抗血管生成因子在给予怀孕动物时模拟先兆子痫。降低胆固醇的他汀类药物降低了这些分子的水平。目前尚不清楚他汀类药物是否可以降低先兆子痫的严重程度和并发症，我们将测试他汀类药物可以在妊娠32周前减少先兆子痫妇女的这些分子并降低先兆子痫的严重程度。来自六家医院的医生将征求这些妇女的同意。那些适合并同意的人将被随机分为两组。其中一组每天服用他汀类药物。另一个将得到一个假糖丸（安慰剂）。我们希望招募128名女性。妇女和她们的医生都不知道她们属于哪一组。这样，我们可以确信两组之间的任何差异都是由于治疗造成的。妇女将留在医院接受密切监测，如果先兆子痫恶化，她们的孩子就会出生。这项试验是独一无二的，因为它是第一个测试他汀类药物是否可以降低先兆子痫的严重程度，而且因为他汀类药物通常不会开给孕妇。有人担心他汀类药物可能会导致婴儿先天性缺陷，但我们没有发现令人信服的证据支持这一点。此外，我们认为，一旦婴儿出生，在怀孕后期给予他汀类药物是安全的。的器官已经发育。然而，所有的副作用和并发症将被密切监测，如果这个小规模的试验表明先兆子痫的严重程度降低，并且副作用很少，将组织一个更大的试验，以确定他汀类药物是否可以增加怀孕时间并减少早产的数量。