Zeng Xin, Tang Xia Jiao, Sheng Xia, Ni Wu, Xin Hai Guang, Chen Wei Zhong, Jiang Cai Feng, Lin Yong, Shi Jian, Shi Bin, Chen Yue Xiang, Yuan Zong Li, Xie Wei Fen
Department of Gastroenterology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.
Department of Infectious Disease, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China.
J Dig Dis. 2015 Nov;16(11):665-74. doi: 10.1111/1751-2980.12294.
To evaluate the efficacy, safety and tolerability of different doses of rifaximin in Chinese patients with liver cirrhosis.
This random prospective study included a screening visit, a 2-week treatment period and a subsequent 4-week observation phase. Patients with liver cirrhosis were randomly assigned to a low-dose rifaximin group, a high-dose rifaximin group and the control group in a ratio of 1:1:1. The low-dose and high-dose groups received 400 mg or 600 mg rifaximin per 12 h for 2 weeks, respectively. All other therapeutic strategies remained unchanged in the three groups as long as possible.
In total, 60 patients with liver cirrhosis were screened and 43 of them met the eligibility criteria. After 2-week treatment serum endotoxin levels in the low-dose (1.1 ± 0.8 EU/mL) and high-dose rifaximin groups (1.0 ± 0.8 EU/mL) were significantly lower than that in the control group (2.5 ± 1.8 EU/mL), while no significant difference was found between the two rifaximin-treated groups. The effect of high-dose rifaximin on endotoxemia lasted for at least 4 weeks after drug withdrawal. A significant reduction in the abundance of the Veillonellaceae taxa and an increase in the abundance of Bacteroidaceae were shown after 2 weeks of rifaximin therapy. The incidence of adverse events and severe adverse events was similar among the three groups.
Low-dose (800 mg/day) rifaximin could be analogous to high-dose (1200 mg/day) rifaximin to reduce the serum endotoxin level after 2 weeks of treatment.
评估不同剂量利福昔明对中国肝硬化患者的疗效、安全性和耐受性。
这项随机前瞻性研究包括一次筛查访视、为期2周的治疗期以及随后4周的观察阶段。肝硬化患者按1:1:1的比例随机分为低剂量利福昔明组、高剂量利福昔明组和对照组。低剂量组和高剂量组分别每12小时服用400mg或600mg利福昔明,持续2周。只要有可能,三组的所有其他治疗策略均保持不变。
总共筛查了60例肝硬化患者,其中43例符合纳入标准。治疗2周后,低剂量(1.1±0.8EU/mL)和高剂量利福昔明组(1.0±0.8EU/mL)的血清内毒素水平显著低于对照组(2.5±1.8EU/mL),而两个利福昔明治疗组之间未发现显著差异。高剂量利福昔明对内毒素血症的作用在停药后至少持续4周。利福昔明治疗2周后,韦荣氏菌科菌群丰度显著降低,拟杆菌科菌群丰度增加。三组不良事件和严重不良事件的发生率相似。
低剂量(800mg/天)利福昔明在治疗2周后降低血清内毒素水平的效果可能与高剂量(1200mg/天)利福昔明相似。