Department of Hepatology, National Institute of Gastroenterology, 25th Avenue, 503, Vedado, Havana 10400, Cuba.
World J Gastroenterol. 2010 Jun 7;16(21):2638-47. doi: 10.3748/wjg.v16.i21.2638.
To investigate the efficacy of Viusid, a nutritional supplement, as an antioxidant and an immunomodulator in patients with chronic hepatitis C.
Sixty patients with chronic hepatitis C who were non-responders to standard antiviral treatment were randomly assigned to receive Viusid (3 sachets daily, n = 30) or placebo (n = 30) for 24 wk. The primary outcome was the change in serum malondialdehyde and 4-hydroxyalkenals (lipid peroxidation products). Secondary outcomes were changes in serum tumor necrosis factor-alpha (TNF-alpha), interferon-gamma (IFN-gamma) and interleukin-10 (IL-10).
Statistically significant reductions in serum 4-hydroxyalkenals and malondialdehyde levels were observed in both groups in comparison with pretreatment values, but the patients who received Viusid showed a more marked reduction as compared with the control group (P = 0.001). TNF-alpha levels significantly increased from 6.9 to 16.2 pg/mL (P < 0.01) in the patients who received placebo in comparison with almost unchanged levels, from 6.6 to 7.1 pg/mL (P = 0.26), in the patients treated with Viusid (P = 0.001). In addition, IL-10 levels were markedly increased in the patients treated with Viusid (from 2.6 to 8.3 pg/mL, P = 0.04) in contrast to the patients assigned to placebo (from 2.8 to 4.1 pg/mL, P = 0.09) (P = 0.01). Likewise, the administration of Viusid markedly increased mean IFN-gamma levels from 1.92 to 2.89 pg/mL (P < 0.001) in comparison with a reduction in mean levels from 1.80 to 1.68 pg/mL (P = 0.70) in the placebo group (P < 0.0001). Viusid administration was well tolerated.
Our results indicate that treatment with Viusid leads to a notable improvement of oxidative stress and immunological parameters in patients with chronic hepatitis C.
研究 Viusid(一种营养补充剂)作为抗氧化剂和免疫调节剂在慢性丙型肝炎患者中的疗效。
将 60 名对标准抗病毒治疗无反应的慢性丙型肝炎患者随机分为 Viusid 组(每天 3 袋,n = 30)或安慰剂组(n = 30),疗程 24 周。主要终点是血清丙二醛和 4-羟烯醛(脂质过氧化产物)的变化。次要终点是血清肿瘤坏死因子-α(TNF-α)、干扰素-γ(IFN-γ)和白细胞介素-10(IL-10)的变化。
与治疗前相比,两组患者血清 4-羟烯醛和丙二醛水平均显著降低,但 Viusid 组患者的降低更为明显(P = 0.001)。与 Viusid 治疗组患者的 TNF-α水平几乎不变(从 6.6 至 7.1pg/mL,P = 0.26)相比,安慰剂组患者的 TNF-α水平从 6.9 增加至 16.2pg/mL(P < 0.01)(P = 0.001)。此外,与安慰剂组患者(从 2.8 至 4.1pg/mL,P = 0.09)相比,Viusid 治疗组患者的 IL-10 水平显著升高(从 2.6 至 8.3pg/mL,P = 0.04)(P = 0.01)。同样,与安慰剂组患者的 IFN-γ水平从 1.80 降低至 1.68pg/mL(P = 0.70)相比,Viusid 组患者的 IFN-γ水平从 1.92 升高至 2.89pg/mL(P < 0.001)(P < 0.0001)。Viusid 的治疗耐受良好。
我们的结果表明,Viusid 治疗可显著改善慢性丙型肝炎患者的氧化应激和免疫参数。