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     2006年8月29号，纽约，WHITE PLAINS 。 

     今天，March of Dimes催促FDA官员尽快地批准能够预防早产的商业孕酮疗法。 

     March of Dimes的医疗主管Nancy Green博士证明，FDA生殖健康咨询委员会即将讨论是否批准“Gestiva”的使用，也就是众所周知的17α－羟孕酮或17－P。 

     “孕酮注射液的研究有希望减少有早产史的孕妇再发早产的几率”Green博士说，“我们希望FDA批准这个药物以便帮助这些妇女摆脱早产的困扰。”

     在全国，每年几乎有50万婴儿过早地出生，这些婴儿有较大的风险会患上终身发育障碍类疾病，如大脑性瘫痪、智力发育迟缓、慢性肺病和视力听力丧失等。医学研究所估计，2005年早产相关性花费已经超过260亿美元。 

     在第二次妊娠中期，该孕酮注射液每周使用一次。该药广泛使用之前需要FDA批准。 

     对于高妊娠风险的妇女，如曾经有自发性早产史的妇女，产科医师经常使用孕酮来治疗。2003年时，使用孕酮的产科医师占38％，而2005年时已达67％。 

     大量地研究表明，对于有早产史的妇女，与对照组相比，17-P可以将早产发生率下降33个百分点。March of Dimes估计如果所有可以使用孕酮的妇女都接受其治疗的话，2003年内大约可以阻止10000名妇女发生早产。 

     虽然没有证据表明17-P会对婴儿有副反应，March of Dimes还是建议没有早产史的妇女谨慎的使用该药。 

     Green建议FDA监控该药对婴儿可能产生的副反应。考虑到其有效性，她还推荐FDA批准Gestiva只应用于有早产史的妇女。 

     March of Dimes: Drug to prevent preterm birth needs prompt FDA approval 

     WHITE PLAINS, N.Y., AUGUST 29, 2006 – The March of Dimes today urged Food and Drug Administration officials to promptly approve a commercial progesterone therapy that appears to prevent some premature births. 

     Dr. Nancy Green, March of Dimes medical director, testified before the FDA Advisory Committee for Reproductive Health Drugs, which met to discuss "Gestiva," also known as 17 alpha-hydroxyprogesterone or 17-P. 

     "Studies of progesterone injections offer promise that the risk of recurrent preterm births will be reduced in a select group of women who already had a baby born too soon," said Dr. Green. "We hope the FDA will approve the licensing of this drug so those women can be helped by this treatment." 

     Nationwide, nearly a half million babies are born too soon each year and babies who survive face risks of lifelong developmental challenges, such as cerebral palsy, mental retardation, chronic lung disease, and vision and hearing loss. The Institute of Medicine estimates the national cost of premature birth in 2005 exceeded $26 billion. 

     Progesterone is given as weekly injections during the second half of pregnancy. FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid. 

     Obstetricians who treat women with a high risk pregnancy, such as those with a history of spontaneous preterm birth, often offer progesterone treatments. A 2005 survey found 67 percent of these obstetricians use progesterone compared to 38 percent in 2003. 

     A large study found that for women who had a previous premature baby 17-P reduced the preterm birth rate by 33 percent compared to a control group. The March of Dimes estimated that if all women eligible for the progesterone therapy had received it, nearly 10,000 premature births might have been prevented in 2003. 

     While there is no evidence that 17-P has an adverse effect on infants, the March of Dimes remains cautious about its use and is concerned that women without a previous premature baby are receiving the injections. 

     Dr. Green asked the FDA to monitor the drug for possible adverse effects on infants. She also recommended the FDA direct that, given what is known about its efficacy, Gestiva should only be used by women with a history of spontaneous premature birth.

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