一项多中心、开放标签、随机、平行分组、优效性试验，旨在比较熊去氧胆酸与利福平在治疗严重早发型妊娠期肝内胆汁淤积症女性患者中的疗效：TURRIFIC 随机试验。
A multi-centre, open label, randomised, parallel-group, superiority Trial to compare the efficacy of URsodeoxycholic acid with RIFampicin in the management of women with severe early onset Intrahepatic Cholestasis of pregnancy: the TURRIFIC randomised trial.
机构信息
Robinson Research Institute, The University of Adelaide, 55 King William Road, North Adelaide, 5006, South Australia, Australia.
Obstetric Medicine, Women's and Babies' Division, Women's and Children's Hospital, 72 King William Road, North Adelaide, South Australia, 5006, Australia.
出版信息
BMC Pregnancy Childbirth. 2021 Jan 12;21(1):51. doi: 10.1186/s12884-020-03481-y.
BACKGROUND
Severe early onset (less than 34 weeks gestation) intrahepatic cholestasis of pregnancy (ICP) affects 0.1% of pregnant women in Australia and is associated with a 3-fold increased risk of stillbirth, fetal hypoxia and compromise, spontaneous preterm birth, as well as increased frequencies of pre-eclampsia and gestational diabetes. ICP is often familial and overlaps with other cholestatic disorders. Treatment options for ICP are not well established, although there are limited data to support the use of ursodeoxycholic acid (UDCA) to relieve pruritus, the main symptom. Rifampicin, a widely used antibiotic including in pregnant women, is effective in reducing pruritus in non-pregnancy cholestasis and has been used as a supplement to UDCA in severe ICP. Many women with ICP are electively delivered preterm, although there are no randomised data to support this approach.
METHODS
We have initiated an international multicentre randomised clinical trial to compare the clinical efficacy of rifampicin tablets (300 mg bd) with that of UDCA tablets (up to 2000 mg daily) in reducing pruritus in women with ICP, using visual pruritus scores as a measuring tool.
DISCUSSION
Our study will be the first to examine the outcomes of treatment specifically in the severe early onset form of ICP, comparing "standard" UDCA therapy with rifampicin, and so be able to provide for the first-time high-quality evidence for use of rifampicin in severe ICP. It will also allow an assessment of feasibility of a future trial to test whether elective early delivery in severe ICP is beneficial.
TRIAL IDENTIFIERS
Australian New Zealand Clinical Trials Registration Number (ANZCTR): 12618000332224p (29/08/2018). HREC No: HREC/18/WCHN/36. EudraCT number: 2018-004011-44. IRAS: 272398. NHMRC registration: APP1152418 and APP117853.
背景
严重早发型（不足 34 周妊娠）妊娠肝内胆汁淤积症（ICP）在澳大利亚影响 0.1%的孕妇，与死产、胎儿缺氧和损伤、自发性早产风险增加 3 倍以及子痫前期和妊娠糖尿病的发生频率增加相关。ICP 常为家族性的，并与其他胆汁淤积性疾病重叠。尽管有有限的数据支持熊去氧胆酸（UDCA）用于缓解瘙痒（主要症状），但 ICP 的治疗选择尚未得到很好的确定。UDCA 是一种广泛使用的抗生素，包括在孕妇中使用，在非妊娠性胆汁淤积中有效减轻瘙痒，并已被用于严重 ICP 的 UDCA 补充剂。许多 ICP 妇女被择期早产，尽管没有随机数据支持这种方法。
方法
我们已经启动了一项国际多中心随机临床试验，以比较利福平片（300mg，每日 2 次）与 UDCA 片（每日高达 2000mg）在减轻 ICP 妇女瘙痒方面的临床疗效，使用视觉瘙痒评分作为测量工具。
讨论
我们的研究将首次专门检查严重早发型 ICP 的治疗结果，比较“标准”UDCA 治疗与利福平，并首次为严重 ICP 中使用利福平提供高质量证据。它还将评估未来试验的可行性，以测试在严重 ICP 中择期早期分娩是否有益。
试验标识符
澳大利亚和新西兰临床试验注册中心（ANZCTR）：12618000332224p（2018 年 8 月 29 日）。HREC 编号：HREC/18/WCHN/36。EudraCT 编号：2018-004011-44。IRAS：272398。NHMRC 注册：APP1152418 和 APP117853。
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