Department of Researches, National Institute of Gastroenterology, Havana, Cuba.
BMJ Open. 2011 Jan 1;1(2):e000140. doi: 10.1136/bmjopen-2011-000140.
Viusid is a nutritional supplement with recognised antioxidant and immunomodulatory properties which could have beneficial effects on cirrhosis-related clinical outcomes such as survival, disease progression and development of hepatocellular carcinoma (HCC). This study evaluated the efficacy and safety of viusid in patients with HCV-related decompensated cirrhosis.
A randomised double-blind and placebo-controlled study was conducted in a tertiary care academic centre (National Institute of Gastroenterology, Havana, Cuba). The authors randomly assigned 100 patients with HCV-related decompensated cirrhosis to receive viusid (three oral sachets daily, n=50) or placebo (n=50) during 96 weeks. The primary outcome of the study was overall survival at 96 weeks, and the secondary outcomes included time to disease progression, time to HCC diagnosis, time to worsening of the prognostic scoring systems Child-Pugh and Model for End-Stage Liver Disease, and time to a new occurrence or relapse for each one of the main clinical complications secondary to portal hypertension at 96 weeks.
Viusid led to a significant improvement in overall survival (90%) versus placebo (74%) (HR 0.27, 95% CI 0.08 to 0.92; p=0.036). A similar improvement in disease progression was seen in viusid-treated patients (28%), compared with placebo-treated patients (48%) (HR 0.47, 95% CI 0.22 to 0.89; p=0.044). However, the beneficial effects of viusid were wholly observed among patients with Child-Pugh classes B or C, but not among patients with Child-Pugh class A. The cumulative incidence of HCC was significantly reduced in patients treated with viusid (2%) as compared with placebo (12%) (HR 0.15, 95% CI 0.019 to 0.90; p=0.046). Viusid was well tolerated.
The results indicate that treatment with viusid leads to a notable improvement in overall clinical outcomes such as survival, disease progression and development of HCC in patients with HCV-related decompensated cirrhosis. Trial registration number http://ClinicalTrials.gov (NCT00502086).
Viusid 是一种具有公认的抗氧化和免疫调节特性的营养补充剂，可能对与肝硬化相关的临床结局（如生存、疾病进展和肝细胞癌[HCC]的发展）有有益的影响。本研究评估了 Viusid 在 HCV 相关失代偿性肝硬化患者中的疗效和安全性。
这是一项在三级保健学术中心（古巴哈瓦那国家胃肠病学研究所）进行的随机、双盲、安慰剂对照研究。作者将 100 例 HCV 相关失代偿性肝硬化患者随机分为 Viusid 组（每日口服 3 袋，n=50）或安慰剂组（n=50），接受 96 周的治疗。该研究的主要终点是 96 周时的总生存率，次要终点包括疾病进展时间、HCC 诊断时间、预后评分系统 Child-Pugh 和终末期肝病模型的恶化时间，以及在 96 周时，门静脉高压引起的每个主要临床并发症的新发生或复发时间。
与安慰剂组（74%）相比，Viusid 显著提高了总生存率（90%）（HR 0.27，95%CI 0.08 至 0.92；p=0.036）。Viusid 治疗组（28%）的疾病进展改善情况与安慰剂治疗组（48%）相似（HR 0.47，95%CI 0.22 至 0.89；p=0.044）。然而，Viusid 的有益作用仅见于 Child-Pugh 分级为 B 或 C 的患者，而不是 Child-Pugh 分级为 A 的患者。Viusid 治疗组 HCC 的累积发生率明显低于安慰剂组（2%与 12%）（HR 0.15，95%CI 0.019 至 0.90；p=0.046）。Viusid 耐受性良好。
结果表明，Viusid 治疗可显著改善 HCV 相关失代偿性肝硬化患者的总体临床结局，如生存、疾病进展和 HCC 的发生。试验注册编号：http://ClinicalTrials.gov（NCT00502086）。
