Pellegrini Luciano, Belcaro Gianni, Dugall Mark, Corsi Marcello, Luzzi Roberta, Hosoi Masayuki
Irvine3 Labs, Chieti, Italy -
Minerva Gastroenterol Dietol. 2016 Sep;62(3):245-52.
The aim of this registry study was to evaluate Robuvit® (French oak wood extract) supplementation in the evolution of moderate functional hepatic failure (MTHF) due to alcohol. Recent studies have indicated the protective effect of oak wood (QR) extracts on liver injury. This registry included patients with MTHF characterized by: decreased albumin levels; increased total bilirubin, altered hepatic functions enzymes, increased oxidative stress, negative viral hepatitis markers.
The two groups resulted divided into a best management (BM) group and a comparative group (BM + Robuvit®): 23 Robuvit® patients and 21 comparable controls completed the 12-week registry. At inclusion, blood parameters in the two groups were comparable.
During the observation period, the increase in albumin levels was significantly (P<0.05 at 6 weeks) faster and higher in the Robuvit® group in comparison with controls. The decrease in ALT-SGPT and AST-ASAT were significantly more important in the supplement group (P<0.05 at 6 and 12 weeks). Alkaline phosphatase was significantly lower at 6 and 12 weeks in Robuvit® patients; (Robuvit® group's values were significantly better; P<0.05). Total bilirubin improved more in Robuvit® subjects at 6 weeks. Results were statistically significant in comparison with controls (P<0.05). Also, direct bilirubin values were higher in the Robuvit® group at 6 and 12 weeks (P<0.05). Gamma GT values were normalized at 6 and 12 weeks in the Robuvit® group. There was a less important decrease in controls (P<0.05) without normalization at 12 weeks. Plasma free radicals, high at inclusion, showed a more significant decrease in Robuvit® subjects (at 6 and 12 weeks), with normalization at 12 weeks. Persisting high values in controls were observed even at 12 weeks (P<0.05). Erythrocytes sedimentation rate (ESR) decreased in both groups with a more important decrease in the Robuvit® group (P<0.05). Hepatitis markers were negative when repeated at 6 and 12 weeks.
In conclusion, observations from this pilot, supplement registry study indicate a significant protective activity of the supplementation with Robuvit®, associated with a very good safety profile, in patients with temporary alcoholic hepatic failure. The activity of Robuvit® seems to be mediated by its anti-inflammatory activity associated to its important action on oxidative stress.
本登记研究的目的是评估补充Robuvit®（法国橡木提取物）对酒精所致中度功能性肝衰竭（MTHF）病情发展的影响。近期研究表明橡木提取物对肝损伤具有保护作用。本登记研究纳入的MTHF患者具有以下特征：白蛋白水平降低；总胆红素升高、肝功能酶异常、氧化应激增加、病毒性肝炎标志物阴性。
两组患者分为最佳治疗组（BM）和比较组（BM + Robuvit®）：23例使用Robuvit®的患者和21例对照者完成了为期12周的登记研究。纳入时，两组的血液参数具有可比性。
在观察期内，与对照组相比，Robuvit®组白蛋白水平升高显著更快且更高（6周时P<0.05）。补充组中ALT - SGPT和AST - ASAT的降低更为显著（6周和12周时P<0.05）。Robuvit®组患者在6周和12周时碱性磷酸酶显著更低；（Robuvit®组的值显著更好；P<0.05）。Robuvit®组患者在6周时总胆红素改善更明显。与对照组相比，结果具有统计学意义（P<0.05）。此外，Robuvit®组在6周和12周时直接胆红素值更高（P<0.05）。Robuvit®组在6周和12周时γ - GT值恢复正常。对照组下降幅度较小（P<0.05），12周时未恢复正常。血浆自由基在纳入时较高，Robuvit®组患者下降更显著（6周和12周时），12周时恢复正常。即使在12周时，对照组仍观察到持续的高值（P<0.05）。两组红细胞沉降率（ESR）均下降，Robuvit®组下降更显著（P<0.05）。6周和12周重复检测时肝炎标志物均为阴性。
总之，这项初步补充登记研究的观察结果表明，补充Robuvit®对暂时性酒精性肝衰竭患者具有显著的保护作用，且安全性良好。Robuvit®的作用似乎是通过其抗炎活性及其对氧化应激的重要作用介导的。
