Mostafa Tarek, Badra Gamal, Abdallah Mahmoud
Department of Clinical Pharmacy, Tanta University Faculty of Pharmacy, Tanta, Egypt.
Turk J Gastroenterol. 2015 Mar;26(2):163-9. doi: 10.5152/tjg.2015.7782.
BACKGROUND/AIMS: This study aimed to evaluate the efficacy and the immunomodulatory effect of rifaximin as another promising prophylactic therapy against spontaneous bacterial peritonitis (SBP) in cirrhotics.
Seventy cirrhotic patients with ascites were included in the study. Patients were divided into two groups in a randomized single-blind fashion. Group one (n=40) received rifaximin and group two (n=30) received norfloxacin (control group). The treatment duration was 6 months. Serum levels of tumor necrosis factor alpha (TNF-α), interleukin-6 ( IL-6), and interleukin-10 (IL-10) were the primary inflammatory markers of the study to evaluate the effect of the medications used.
Three months after treatment, five cases on norfloxacin therapy showed SBP, whereas all cases on rifaxmine therapy were free from SBP. In addition, there was no significant difference between patients on rifaximin and norfloxacin therapy with respect to TNF-α, IL-6, and IL-10 serum levels (p>0.05). Furthermore, patients on both rifaximin and norfloxacin therapies showed a statistically significant decrease in TNF-α and IL-6 serum levels compared with their baseline levels (p=0.000 and p=0.000, respectively). In contrast, serum IL-10 showed a statistically significant increase in both groups in comparison with its baseline level (p>0.00). Six-month after treatment, patients on rifaximin therapy showed more effective remission from SBP than those on norfloxacin therapy.
In conclusion, the use of rifaximin not only prevents bacterial translocation but also modulates the immune response of the inflammatory and the anti-inflammatory cytokines in SBP patients. However, the efficacy and the immunomodulatory effect of rifaximin in the prophylaxis of SBP in cirrhotics needs further prospective large-scale, double-blind studies.
背景/目的：本研究旨在评估利福昔明作为另一种有前景的预防肝硬化患者自发性细菌性腹膜炎（SBP）的治疗方法的疗效和免疫调节作用。
70例肝硬化腹水患者纳入本研究。患者以随机单盲方式分为两组。第一组（n = 40）接受利福昔明治疗，第二组（n = 30）接受诺氟沙星治疗（对照组）。治疗持续时间为6个月。血清肿瘤坏死因子α（TNF-α）、白细胞介素-6（IL-6）和白细胞介素-10（IL-10）水平是本研究评估所用药物效果的主要炎症标志物。
治疗3个月后，5例接受诺氟沙星治疗的患者发生SBP，而所有接受利福昔明治疗的患者均未发生SBP。此外，接受利福昔明和诺氟沙星治疗的患者在TNF-α、IL-6和IL-10血清水平方面无显著差异（p>0.05）。此外，与基线水平相比，接受利福昔明和诺氟沙星治疗的患者TNF-α和IL-6血清水平均有统计学显著下降（分别为p = 0.000和p = 0.000）。相比之下，两组血清IL-10与其基线水平相比均有统计学显著升高（p>0.00）。治疗6个月后，接受利福昔明治疗的患者SBP缓解效果优于接受诺氟沙星治疗的患者。
总之，使用利福昔明不仅可预防细菌移位，还可调节SBP患者炎症和抗炎细胞因子的免疫反应。然而，利福昔明在预防肝硬化患者SBP方面的疗效和免疫调节作用需要进一步的前瞻性大规模双盲研究。
