Glycyrrhizin in patients who failed previous interferon alpha-based therapies: biochemical and histological effects after 52 weeks.
Glycyrrhizin in patients who failed previous interferon alpha-based therapies: biochemical and histological effects after 52 weeks.
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DOI：
10.1111/j.1365-2893.2011.01579.x
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发表时间：
2012-08
影响因子：
2.5
通讯作者：
European SNMC Study Group
中科院分区：
文献类型：
--
作者：
Manns MP;Wedemeyer H;Singer A;Khomutjanskaja N;Dienes HP;Roskams T;Goldin R;Hehnke U;Inoue H;European SNMC Study Group
慢性丙型肝炎患者往往对以干扰素为基础的治疗无效。这项III期研究旨在证实甘草酸苷在干扰素+利巴韦林治疗无效者中的有效性和安全性。对379名患者进行了随机、双盲、安慰剂对照的甘草酸苷比较，分别静脉注射5×/或3×/周和5×/周的安慰剂，为期12周，随后进行了甘草酸苷静脉注射的随机开放比较。每周5次/次，而不是每周3次/次，共40周。主要终点是：(1)与基线相比，12周双盲期后≥50%丙氨酸氨基转移酶(ALT)下降的患者比例；(2)52周后坏死性炎症改善的患者比例。12周后≥下降50%的患者中，甘草酸苷5×/周组(28.7%，P<；0.0001)和甘草酸3×/周组(29.0%，P<；0.0001)显著高于安慰剂组(7.0%)。52周后坏死炎症改善率分别为44.9%(5×/周)和46.0%(3×/周)。与安慰剂相比，甘草酸苷在治疗12周后表现出显著更高的ALT降低，在52周治疗后坏死性炎症和纤维化得到改善。总体而言，甘草甜素治疗耐受性良好。
Chronic hepatitis C patients often fail to respond to interferon-based therapies. This phase III study aimed at confirming the efficacy and safety of glycyrrhizin in interferon + ribavirin-based therapy non-responders. A randomised, double-blind, placebo-controlled, comparison of glycyrrhizin, administered intravenously 5×/or 3×/week, and 5×/week placebo for 12 weeks to 379 patients, was followed by a randomised, open comparison of glycyrrhizin i.v. 5×/versus 3×/week for 40 weeks. Primary endpoints were: (1) the proportion of patients with ≥50% ALT (alanine aminotransferase) reduction after 12 weeks double-blind phase, and (2) the proportion of patients with improvement of necro-inflammation after 52 weeks as compared with baseline. The proportion of patients with ALT reduction ≥50% after 12 weeks was significantly higher with 5×/week glycyrrhizin (28.7%, P < 0.0001) and 3×/week glycyrrhizin (29.0%, P < 0.0001) compared with placebo (7.0%). The proportion of patients with improvement in necro-inflammation after 52 weeks was 44.9% with 5×/week and 46.0% with 3×/week, respectively. Glycyrrhizin exhibited a significantly higher ALT reduction compared to placebo after 12 weeks of therapy and an improvement of necro-inflammation and fibrosis after 52-weeks treatment. Generally, glycyrrhizin treatment was well tolerated.
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