Gerner Patrick, Posselt Hans-Georg, Krahl Andreas, Ballauff Antje, Innerhofer Albina, Binder Christa, Wenzl Tobias G, Zense Matthias, Hector Ariadne, Dockter Gerhard, Adam Rüdiger, Neubert Jenny, Classen Martin, van Gemmern Robert, Wirth Stefan
Children's Hospital, Duisburg-Essen University, Klinik 2, Essen 45122, Germany.
World J Gastroenterol. 2008 Dec 21;14(47):7208-13. doi: 10.3748/wjg.14.7208.
To evaluate the safety and efficacy of Vitamin E in children with chronic hepatitis B.
We randomly assigned patients with chronic hepatitis B, positive for hepatitis B e antigen (HBeAg), to receive either Vitamin E or placebo once daily for 6 mo in a 3:1 ratio and double-blind manner. The primary end point was HBeAg seroconversion, defined as the loss of HBeAg, undetectable levels of serum hepatitis B virus DNA, and the appearance of antibodies against HBeAg 12 mo after therapy.
At baseline visit, 49 patients had normal and 43 had increased serum aminotransferase levels. Twenty-nine patients did not respond to previous treatment with interferon-alpha or lamivudine. Seventy-six children completed the study; 16 were non-compliant (n = 7), lost to follow-up (n = 7), or started another antiviral treatment (n = 3). Intention-to-treat analysis showed HBeAg seroconversion in 16 children (23.2%) treated with Vitamin E and two (8.7%) in the placebo group (P = 0.13). Vitamin E was well tolerated.
There is only a tendency that Vitamin E may promote HBeAg seroconversion. Therefore larger studies are needed to clarify the role of antioxidants in the therapy of chronic hepatitis B.
评估维生素E对慢性乙型肝炎儿童的安全性和疗效。
我们将乙肝e抗原（HBeAg）阳性的慢性乙型肝炎患者按3:1的比例随机分配，接受维生素E或安慰剂治疗，每日一次，为期6个月，采用双盲方式。主要终点是HBeAg血清学转换，定义为治疗12个月后HBeAg消失、血清乙肝病毒DNA检测不到以及出现抗HBeAg抗体。
在基线访视时，49例患者血清转氨酶水平正常，43例升高。29例患者对先前的α干扰素或拉米夫定治疗无反应。76名儿童完成了研究；16名不符合要求（n = 7）、失访（n = 7）或开始了另一种抗病毒治疗（n = 3）。意向性分析显示，维生素E治疗组有16名儿童（23.2%）实现了HBeAg血清学转换，安慰剂组有2名（8.7%）（P = 0.13）。维生素E耐受性良好。
维生素E仅有一种可能促进HBeAg血清学转换的趋势。因此，需要开展更大规模的研究来阐明抗氧化剂在慢性乙型肝炎治疗中的作用。
