Pár Alajos, Tornai István, Szalay Ferenc
Pécsi Tudományegyetem, Altalános Orvostudományi Kar I. Belgyógyászati Klinika, Pécs.
Orv Hetil. 2007 May 6;148(18):819-26. doi: 10.1556/OH.2007.28114.
In the past decade several multicentre, prospective, randomised trials revealed a significant progress in the therapy for chronic viral hepatitis, but limited and controversial data are available regarding the real value of the antiviral treatment in the everyday routine clinical praxis.
A nation-wide retrospective analysis has been made of the antiviral therapy for patients with hepatitis B and C, who represented the entire patient population necessitating treatment in Hungary during a seven-year period. In addition, results of a prospective study for chronic hepatitis C patients were also presented.
A total of 220 patients with chronic hepatitis B treated with standard interferon alpha (112), pegylated interferon alpha-2a (23), or lamivudine (85) were investigated and assessed for the HBeAg seroconversion and/or undetectable HBV-DNA. Out of 2442 chronic hepatitis C patients, 333 were treated with standard interferon monotherapy, 1122 with standard interferon + ribavirin and 987 with pegylated interferon plus ribavirin combination for 6-12 months. In a prospective study, 69 patients with chronic hepatitis C were enrolled and treated with pegylated interferon alpha-2a plus ribavirin. The rate of sustained virological response, the predictors of outcome and the adverse effects of treatment were evaluated.
For HBV patients standard IFN provided 31%, PEG-IFN 30% and lamivudine 31-33% sustained virological response rate, respectively. In chronic hepatitis C, a continuous improvement was noted in sustained virological response, from 13% by interferon monotherapy, to 31% by pegylated interferon plus ribavirin combination, in the nation-wide retrospective study, while even a 48% sustained virological response was achieved in the prospective trial. The most important predictors of outcome were the 4-week "rapid" and the 12-week "early" virological responses, then the female sex, age, BMI and adherence. The most frequent complications of the antiviral treatment were cytopenias, haemolysis and depression, 9% of patients experienced adverse effects.
The efficacy of antiviral treatment unlike HBV infection, in chronic HCV hepatitis gradually improved in our every-day clinical praxis, but the results are far poorer than those achieved in a prospective study. To manage the growing populations of hard-to-treat patients with chronic viral hepatitis, there is a need for more effective treatment modalities, including optimized, individualized dosing and novel antivirals.
在过去十年中,多项多中心、前瞻性、随机试验显示慢性病毒性肝炎治疗取得了显著进展,但关于抗病毒治疗在日常临床实践中的实际价值的数据有限且存在争议。
对乙型和丙型肝炎患者的抗病毒治疗进行了全国性回顾性分析,这些患者代表了匈牙利七年内需要治疗的全部患者群体。此外,还介绍了一项针对慢性丙型肝炎患者的前瞻性研究结果。
共调查和评估了220例接受标准干扰素α(112例)、聚乙二醇化干扰素α-2a(23例)或拉米夫定(85例)治疗的慢性乙型肝炎患者的HBeAg血清学转换和/或HBV-DNA检测不到情况。在2442例慢性丙型肝炎患者中,333例接受标准干扰素单药治疗,1122例接受标准干扰素+利巴韦林治疗,987例接受聚乙二醇化干扰素加利巴韦林联合治疗6至12个月。在一项前瞻性研究中,69例慢性丙型肝炎患者入组并接受聚乙二醇化干扰素α-2a加利巴韦林治疗。评估持续病毒学应答率、预后预测因素和治疗不良反应。
对于乙肝患者,标准干扰素的持续病毒学应答率为31%,聚乙二醇化干扰素为30%,拉米夫定为31%-33%。在慢性丙型肝炎中,在全国性回顾性研究中,持续病毒学应答持续改善,从干扰素单药治疗的13%提高到聚乙二醇化干扰素加利巴韦林联合治疗的31%,而在前瞻性试验中甚至达到了48%的持续病毒学应答率。最重要的预后预测因素是4周“快速”和12周“早期”病毒学应答,其次是女性、年龄、BMI和依从性。抗病毒治疗最常见的并发症是血细胞减少、溶血和抑郁,9%的患者出现不良反应。
与乙肝感染不同,在我们的日常临床实践中,慢性丙肝肝炎抗病毒治疗的疗效逐渐提高,但结果远低于前瞻性研究。为了管理日益增多的难治性慢性病毒性肝炎患者群体,需要更有效的治疗方式,包括优化、个体化给药和新型抗病毒药物。