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

子痫前期（PE）是一种有潜在危险的妊娠状况，其中母亲？S血压高于正常水平，尿液中含有蛋白质。大约百分之一的女性在怀孕32周之前会经历先兆子痫。唯一有效的治疗方法是早产，但这会对婴儿造成严重后果。观察等待，临床上常采用让宝宝？母亲的肺部发育不成熟，有疾病严重程度进展的风险。迫切需要一种廉价而有效的治疗方法来预防子痫前期并发症。目前尚不清楚导致子痫前期的原因，但最近一些已知会影响血流的血液分子（称为抗血管生成因子）在PE女性中含量更高。这些抗血管生成因子当给怀孕的动物类似先兆子痫。降低胆固醇的他汀类药物会降低这些分子的水平。目前尚不清楚他汀类药物是否能降低子痫前期的严重程度和并发症。我们将测试他汀类药物是否可以在怀孕32周之前减少子痫前期妇女体内的这些分子，并降低子痫前期的严重程度。来自六家医院的医生将征求这些妇女的同意。那些合适且同意的人，将被随机分为两组。一组每天服用他汀类药物。另一组将得到一个假糖丸（安慰剂）。我们希望招募128名女性。这些妇女和她们的医生都不知道她们属于哪一类。通过这种方式，我们可以确信两组之间的任何差异都是由于治疗引起的。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减轻先兆子痫的严重程度，因为他汀类药物通常不给孕妇开处方。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来支持这一点。此外，我们认为在怀孕后期给他汀类药物是安全的。他的器官已经发育好了。然而，所有的副作用和并发症将密切监测。如果这个小型试验表明，先兆子痫的严重程度减轻了，而且几乎没有副作用，那么将组织一个更大的试验，以确定他汀类药物是否可以延长妊娠期，减少早产的数量。

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.