伟哥促进胎儿生长试验:11名婴儿死亡 试验终止

2018-07-25 14:36

小弈编译

(本文为小弈自动翻译)

[(Title)] Viagra trial for pregnant women halted after 11 babies die.


A Dutch trial with Sildenafil, sold under the brand name Viagra, has been immediately halted after 11 babies of mothers using the medication died.

在11名孕期服用伟哥的母亲生产的婴儿死亡后,荷兰药企宣布终止以壮阳药伟哥促进胎儿生长的试验计划。

When the trial was stopped, roughly half of 183 pregnant women involved in the study were taking Sildenafil, participating hospital Amsterdam University's Academic Medical Centre (AMC) said.

参与此项研究的183名孕妇中,约有半数正在接受阿姆斯特丹大学学术医学中心的调查。

The study started in 2015 and involved 11 hospitals. It was designed to look at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.

此项研究始于2015年,涉及11家医院,它旨在研究母亲血液流量增加胎儿发育的可能产生的有益影响。

About 15 women who took the medication have not yet given birth.

约有15名服用药物的妇女尚未分娩。

"Previous studies have shown that Sildenafil would have a positive effect on the growth of babies. The first results of the current study showed that there may be adverse effects for the baby after birth," the AMC said.

AMC说:“以前的研究表明,伟哥会对婴儿生长产生积极的影响,目前的初步研究表明,婴儿出生后可能会产生不良影响。

The results showed 17 babies were born with lung conditions and 11 died. Among the roughly equal control group, just three babies had lung problems and none died.

结果显示,17个婴儿出生时患有肺部疾病,11个死亡,在大致相同的对照组中,只有3个婴儿出现肺病,没有婴儿死亡。

Among the women taking Sildenafil, 11 of the babies died due to "a possibly related lung condition" that caused high blood pressure in the lungs and may have resulted from reduced oxygen levels.

在服用Sildenafil的妇女中,11名婴儿死于"可能是相关肺病",造成肺部高血压,可能是氧气浓度降低所致。

An interim analysis found the chance of blood vessel disease in the lungs "appears to be greater and the chance of death after birth seems to have increased".

一项临时分析发现,肺部血管疾病的机会"似乎更大,出生后死亡的机会似乎增加了"。

"The researchers found no positive effect for the children on other outcomes," the AMC said.

AMC说:“研究人员发现,这些婴儿的其他测试结果未发现正面影响。”

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the small number of trials with pregnant women has limited our knowledge of medicines in pregnant women.

伦敦卫生与热带医学学院药物流行病学教授斯蒂芬埃文斯表示,少数孕妇试验限制了我们对孕妇用药的知识。

"There have been other studies in this area, both involving preliminary work using animals and using pregnant women, and there was no indication that the treatment was dangerous based on previous research," he said.

“在一领域还有其他研究,包括使用动物和孕妇进行初步实验,并且根据以前的研究,没有迹象表明治疗是危险的,”他说。

Viagra was originally developed by Pfizer but is now off patent and available as a generic.

伟哥最初是由辉瑞开发的,但目前专利权已过期,其他厂商可以合法制造同种药物。

Pfizer had no immediate comment.

辉瑞对此没有立即发表评论。

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