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在另一项研究中,研究者对参加对照试验的母亲所生孩子的发育情况进行了评估。结果证实,无论其母亲在随机试验中接受了何种疗法,所有孩子在年龄2.5~5岁时均达到了同一发育目标。目前有一项验证性研究正在进行中,之后会针对婴儿开展一项相似的随访研究,大概在2018年完成,该研究预计将纳入580~750名婴儿。 Makena禁用于有以下任何一种情况的女性:当前或既往曾患有血栓症或血栓栓塞性疾病;已知患有乳腺癌或疑似乳腺癌,其他激素敏感性癌症,或有这些癌症的病史;未经诊断的与妊娠无关的异常阴道流血;妊娠期胆汁淤积性黄疸;肝脏良、恶性肿瘤或活动性肝病;高血压控制不良。 Makena由医护人员给药,于16~20孕周开始,每周肌注1次,一直持续至37孕周结束或至分娩以先发生者为准。 根据能够合理预测临床收益的替代终点收益在本批准令中是指降低在37孕周前分娩的风险,FDA基于加速审批法规批准了Makena这一具有应用前景的药物。根据上述法规,生产厂家必须在产品获批后开展进一步研究以证实其确实能产生临床收益。 FDA最初于1956年批准商品名为Delalutin的己酸羟孕酮用于孕妇,获准的适应证包括先兆流产。2000年,原生产厂家申请Delalutin撤市,撤市原因与安全性无关。 MAKENA Manufacturer:Ther-Rx Corporation Pharmacological Class:Progestin. Active Ingredient(s):Hydroxyprogesterone caproate 250mg/mL; for deep IM inj; contains castor oil, benzyl benzoate, benzyl alcohol. Indication(s):To reduce risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Not intended for use in patients with multiple gestations or other risk factors for preterm birth. Pharmacology:Hydroxyprogesterone is a synthetic progestin that is indicated to reduce the risk of preterm delivery in certain susceptible patients after the 16th week of pregnancy. After IM administration, hydroxyprogesterone caproate reaches peak levels in about 3–7 days. It is highly bound to plasma proteins and is extensively metabolized in the liver by several metabolic pathways. Both conjugated metabolites and free steroids are eliminated via urinary and fecal routes. Clinical Trials:A multicenter, randomized, double-blind, vehicle-controlled trial involving 463 pregnant women was conducted to assess the safety and efficacy of hydroxyprogesterone caproate in reducing the risk of spontaneous preterm birth. The study enrolled women 16 to 43 years of age with a history of singleton spontaneous preterm birth who were between 16 weeks 0 days and 20 weeks 6 days gestation with a singleton pregnancy. At the time of randomization, ultrasound was used to confirm gestational age and the absence of any known fetal abnormality. Women with prior progesterone treatment or heparin use were excluded, as were those with a history of thrombotic disease or maternal/obstetrical complications. Compared to treatment with the vehicle control, treatment with hydroxyprogesterone caproate reduced the proportion of women who delivered preterm at <37 weeks (–17.8%). The proportions of women who delivered at <35 weeks and <32 weeks were also lower in the group given the study drug (–9.4% and –7.7%, respectively). There was no overall survival advantage to treatment with the study drug due to a higher rate of stillbirth and miscarriage; studies are continuing. Legal Classification:Rx Adults:Begin treatment between 16 weeks 0 days and 20 weeks 6 days gestation. Inject slowly (over 1 minute or longer) into upper outer quadrant of gluteus maximus. 250mg IM once weekly. Continue until Week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever comes first. Children:Not applicable. Contraindication(s):Current or history of thrombosis or thromboembolic disorders. Breast or other hormone-sensitive cancers. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy. Hepatic adenoma or carcinoma. Uncontrolled hypertension. Warnings/Precautions:Conditions aggravated by fluid retention (eg, preeclampsia, migraine, asthma, seizures, cardiac or renal dysfunction). Monitor diabetics and for depression. Hepatic impairment. Discontinue if depression, thromboembolic events or allergic reactions occur. Reevaluate if jaundice or hypertension occurs. Not for use in stopping active preterm labor. Pregnancy (Cat. B) (limited data on 1st trimester use). Nursing mothers: not recommended; discontinue upon delivery. Interaction(s):May affect metabolism of drugs metabolized by CYP1A2, CYP2A6, or CYP2B6 (eg, theophylline, tizanidine, clozapine, nicotine, acetaminophen, efavirenz, bupropion, methadone). Adverse Reaction(s):Inj site reactions (pain, swelling, pruritus, nodule), urticaria, pruritus, GI upset; pregnancy-related fetal and maternal complications. How Supplied:Multidose vial (5mL)—1 Last Updated:4/14/2011 |
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己酸羟孕酮注射液|Makena(hydroxyprogesterone caproate)简介:
制造商: 热敏- Rx的公司 药理分类: 孕激素。 活性成分(补): 羟基己酸250mg/mL;深的IM损伤;含有蓖麻油,苯甲酸苄酯,苯甲醇。 指示(补): 为了减少与一个单胎妊娠的妇女谁拥有单身自发早产史的早 ... 关键字:己酸羟孕酮注射液
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