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.
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.
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DOI：
10.1186/s12884-020-03481-y
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发表时间：
2021-01-12
影响因子：
3.1
通讯作者：
Williamson C
中科院分区：
文献类型：
--
作者：
Hague WM;Callaway L;Chambers J;Chappell L;Coat S;de Haan-Jebbink J;Dekker M;Dixon P;Dodd J;Fuller M;Gordijn S;Graham D;Heikinheimo O;Hennessy A;Kaaja R;Khong TY;Lampio L;Louise J;Makris A;Markus C;Marschall HU;Middleton P;Mol BW;Morris J;Newnham JP;Ovadia C;Peek M;Shand A;Stark M;Thornton J;Timonen S;Walker S;Warrilow D;Williamson C
在澳大利亚，有0.1%的孕妇患有严重早发性妊娠期肝内胆汁淤积症(孕周不到34 )，并与死产、胎儿缺氧和宫内窘迫、自然早产以及先兆子痫和妊娠期糖尿病的风险增加3倍相关。肝内胆汁淤积症通常是家族性的，并与其他胆汁淤积性疾病重叠。尽管有有限的数据支持使用熊去氧胆酸(UDCA)来缓解主要症状瘙痒，但治疗妊娠肝内胆汁淤积症的治疗方案还没有确定下来。利福平是一种广泛使用的抗生素，包括在孕妇中，它在非妊娠胆汁淤积症中有效地减少瘙痒，并已被用作严重妊娠期肝内胆汁淤积症的UDCA的补充。许多患有妊娠肝内胆汁淤积症的妇女选择早产，尽管没有随机数据支持这种方法。我们已经启动了一项国际多中心随机临床试验，以视觉瘙痒评分作为衡量工具，比较利福平片剂(300mgbd)和乌拉地平片(每天最多2000mgBd)在减少妊娠期肝内胆汁淤积症妇女瘙痒方面的临床疗效。我们的研究将首次对重度早发性妊娠肝内胆汁淤积症的治疗结果进行研究，将“标准”UDCA疗法与利福平进行比较，从而首次为利福平治疗重症妊娠肝内胆汁淤积症提供高质量的证据。它还将允许对未来试验的可行性进行评估，以测试选择性早期分娩对重度妊娠肝内胆汁淤积症是否有益。澳大利亚新西兰临床试验注册号(ANZCTR)：12618000332224p(2018年8月29日)。人权委员会编号：HREC/18/WCHN/36。EudraCT编号：2018年-004011-44。IRAS：272398。NHMRC注册：APP1152418和APP117853。网上版载有补充材料，可在10.1186/s12884-020-03481-y查阅。
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. 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. 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. 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. The online version contains supplementary material available at 10.1186/s12884-020-03481-y.
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影响因子：
5.1
作者：
Agarwal, Mukesh M.;Boulvain, Michel;Samad, Noorjahan
通讯作者：
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影响因子：
13.5
作者：
Glantz, A;Marschall, HW;Mattsson, LÅ
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影响因子：
13.5
作者：
Marschall, Hanns-Ulrich;Shemer, Elisabeth Wikstrom;Stephansson, Olof
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影响因子：
4.8
作者：
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通讯作者：
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DOI：
10.1016/s1470-032(03)02973
发表时间：
2003-05-01
影响因子：
5.8
作者：
Gorelik, J;Shevchuk, AI;Williamson, C
通讯作者：
Williamson, C