Hofmann W P, Bock H, Weber C, Tacke W, Pfaff R, Kihn R, Moog G, Kellner H U, Schöfer M, Frick B, Berg P, Rambow A, Friedrich-Rust M, Herrmann E, Sarrazin C, Zeuzem S
Universitätsklinikum des Saarlandes, Kirrberger Strasse, 66421 Homburg/Saar.
Z Gastroenterol. 2006 Jan;44(1):25-31. doi: 10.1055/s-2005-858960.
The standard treatment for patients with chronic hepatitis C consists of pegylated interferon (PegIFN) alpha in combination with ribavirin. Information on treatment effectiveness outside clinical trials is sparse. To study community-based health care, a regional network supported by the German network of competence for hepatitis (Hep-Net) was created between gastroenterologists in private practice and a tertiary referral centre. A treatment register containing evidence-based guidelines was established and 212 consecutive patients who were treated with either PegIF Nalpha 2a/ribavirin (n = 126) or PegIFNalpha2b/ribavirin (n = 86) for 24 weeks (HCV genotype 2, 3) and 48 weeks (HCV genotype 1, 4, 5), respectively, were included and followed prospectively. Twenty-four weeks after cessation of antiviral treatment a sustained virological response was achieved in 54 % of the patients. By univariate analyses, infection with HCV genotypes 2 or 3 (p < 0.0001), younger age (p < 0.0001), normal gamma-glutamyltransferase levels before initiation of treatment (p = 0.003), and absence of language communication problems (p = 0.023) were associated with a sustained virological response. The presence of liver cirrhosis in patients with HCV genotype 1, 4, 5 infection was associated with lower sustained response rates (p = 0.025). Patients infected with HCV genotype 1 in whom the PegIFNalpha dose was reduced had higher virological relapse rates (p = 0.049). With regard to the treating physician, sustained virological response rates ranged from 26 - 67 % in patients infected with HCV genotype 1. Our study shows that virological response rates similar to those in international randomised clinical trials can be achieved by private practice gastroenterologists. The presented network allows characterization of the treatment outcome in chronic hepatitis C not only with regard to virus- and host-related factors but also on an individual physician basis.
慢性丙型肝炎患者的标准治疗方案是聚乙二醇化干扰素(PegIFN)α联合利巴韦林。关于临床试验之外治疗效果的信息较少。为研究基于社区的医疗保健情况,在德国肝炎专业能力网络(Hep-Net)的支持下,在私人执业胃肠病学家和一家三级转诊中心之间建立了一个区域网络。建立了一个包含循证指南的治疗登记册,纳入了212例连续接受PegIFNα 2a/利巴韦林(n = 126)或PegIFNα2b/利巴韦林(n = 86)治疗24周(丙型肝炎病毒基因型2、3)和48周(丙型肝炎病毒基因型1、4、5)的患者,并进行前瞻性随访。抗病毒治疗停止24周后,54%的患者实现了持续病毒学应答。单因素分析显示,感染丙型肝炎病毒基因型2或3(p < 0.0001)、年龄较轻(p < 0.0001)、治疗开始前γ-谷氨酰转移酶水平正常(p = 0.003)以及无语言沟通障碍(p = 0.023)与持续病毒学应答相关。丙型肝炎病毒基因型1、4、5感染患者中肝硬化的存在与较低的持续应答率相关(p = 0.025)。PegIFNα剂量降低的丙型肝炎病毒基因型1感染患者病毒学复发率较高(p = 0.049)。就治疗医生而言,丙型肝炎病毒基因型1感染患者的持续病毒学应答率在26%至67%之间。我们的研究表明,私人执业胃肠病学家能够实现与国际随机临床试验相似的病毒学应答率。所展示的网络不仅能够根据病毒和宿主相关因素,还能在个体医生层面上对慢性丙型肝炎的治疗结果进行特征描述。