Martí-Carvajal Arturo J, Peña-Martí Guiomar E, Comunián-Carrasco Gabriella
Iberoamerican Cochrane Network, Valencia, Edo. Carabobo, Venezuela, 2001.
Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD007722. doi: 10.1002/14651858.CD007722.pub2.
Idiopathic thrombocytopenic purpura (ITP) is a common hematologic disorder caused by immune-mediated thrombocytopenia. The magnitude of the maternal-fetal risk of ITP during pregnancy is controversial. Labour management of pregnant women with ITP remains controversial. Management of ITP during pregnancy is complex because of the disparity between maternal and fetal platelet counts.
To assess the effectiveness and safety of corticosteroids, intravenous immunoglobulin, vinca alkaloids, danazol, dapsone, and any other types of pharmacological treatments for the treatment of idiopathic thrombocytopenic purpura during pregnancy.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (February 2009), LILACS (1982 to 8 February 2009), ClinicalTrials.gov (8 February 2009), Current Controlled Trials (16 February 2009), Google Scholar (16 February 2009) and ongoing and unpublished trials cited in the reference lists of relevant articles.
Randomised controlled trials (RCTs) on any medical treatments for idiopathic thrombocytopenia purpura during pregnancy.
Two review authors independently evaluated methodological quality and extracted trial data. Any disagreement was resolved by discussion or by consulting a third review author.
This review included one RCT in which 38 women (41 pregnancies) were randomised, with only 26 women (28 pregnancies) being analysed.This RCT comparing the effect of betamethasone (1.5 mg/day) with no medication found no statistically significant difference in neonatal thrombocytopenia (risk ratio (RR) 1.12, 95% confidence interval (CI) 0.62 to 2.05) and neonatal bleeding (RR 1.00, 95% CI 0.24 to 4.13). Review authors conducted an intention-to-treat analysis which showed similar findings: RR 1.18, 95% CI 0.57 to 2.45 and RR 1.05, 95% CI 0.24 to 4.61, respectively. Maternal death, perinatal mortality, postpartum haemorrhage and neonatal intracranial haemorrhage were not studied by this RCT.
AUTHORS' CONCLUSIONS: Current evidence indicates that compared to no medication, betamethasone did not reduce the risk of neonatal thrombocytopenia and neonatal bleeding in ITP during pregnancy. There is insufficient evidence to support the use of betamethasone for treating ITP. This Cohrane review does not provide evidence about other medical treatments for ITP during pregnancy. This systematic review also identifies the need for well-designed, adequately powered randomised clinical trials for this medical condition during pregnancy. Unless randomised clinical trials provide evidence of a treatment effect and the trade off between potential benefits and harms are established, policy-makers, clinicians, and academics should not use betamethasone for ITP in pregnant women. Any future trials on medical treatments for treating ITP during pregnancy should test a variety of important maternal, neonatal or both outcome measures, including maternal death, perinatal mortality, postpartum haemorrhage and neonatal intracranial haemorrhage.
特发性血小板减少性紫癜(ITP)是一种由免疫介导的血小板减少引起的常见血液系统疾病。孕期ITP母婴风险的程度存在争议。ITP孕妇的分娩管理也仍存在争议。由于母体和胎儿血小板计数的差异,孕期ITP的管理较为复杂。
评估皮质类固醇、静脉注射免疫球蛋白、长春花生物碱、达那唑、氨苯砜以及其他任何类型的药物治疗在孕期治疗特发性血小板减少性紫癜的有效性和安全性。
我们检索了Cochrane妊娠与分娩组试验注册库(2009年2月)、拉丁美洲及加勒比地区卫生科学数据库(1982年至2009年2月8日)、ClinicalTrials.gov(2009年2月8日)、当前对照试验库(2009年2月16日)、谷歌学术(2009年2月16日)以及相关文章参考文献列表中引用的正在进行和未发表的试验。
关于孕期特发性血小板减少性紫癜任何药物治疗的随机对照试验(RCT)。
两位综述作者独立评估方法学质量并提取试验数据。任何分歧通过讨论或咨询第三位综述作者解决。
本综述纳入一项RCT,其中38名女性(41次妊娠)被随机分组,仅26名女性(28次妊娠)接受分析。该RCT比较了倍他米松(1.5毫克/天)与不治疗的效果,发现新生儿血小板减少(风险比(RR)1.12,95%置信区间(CI)0.62至2.05)和新生儿出血(RR 1.00,95%CI 0.24至4.13)方面无统计学显著差异。综述作者进行的意向性分析显示了类似结果:RR分别为1.18,95%CI 0.57至2.45和RR 1.05,95%CI 0.24至4.61。该RCT未研究母体死亡、围产儿死亡率、产后出血和新生儿颅内出血情况。
当前证据表明,与不治疗相比,倍他米松并未降低孕期ITP新生儿血小板减少和新生儿出血的风险。没有足够证据支持使用倍他米松治疗ITP。本Cochrane综述未提供关于孕期ITP其他药物治疗的证据。该系统评价还指出,需要针对孕期这种疾病开展设计良好、样本量充足的随机临床试验。除非随机临床试验提供治疗效果的证据并确定潜在益处与危害之间的权衡,否则政策制定者、临床医生和学者不应将倍他米松用于孕妇ITP的治疗。未来任何关于孕期ITP药物治疗的试验都应测试各种重要的母体、新生儿或两者的结局指标,包括母体死亡、围产儿死亡率、产后出血和新生儿颅内出血。