利妥昔单抗对肝炎病毒感染的相关血管炎有效
2012-01-22 MedSci MedSci原创
最近，由美国国立卫生研究院（NIH）赞助的一项研究"A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C-associated cryoglobulinemic vasculitis"显示：对于抗病毒治疗未解缓的与丙型肝炎病毒(HCV)感染相关的冷球蛋白血症
最近，由美国国立卫生研究院（NIH）赞助的一项研究"A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C-associated cryoglobulinemic vasculitis"显示：对于抗病毒治疗未解缓的与丙型肝炎病毒(HCV)感染相关的冷球蛋白血症性血管炎（CV）患者，利妥昔单抗治疗有效且耐受性良好。相关研究结论于2011年12月6日在线发布于《关节炎与风湿病》Arthritis Rheum杂志。
该项研究为开放性、单中心随机对照试验，研究人员在抗病毒治疗未解缓的HCV感染相关的CV患者中将利妥昔单抗【每周375 mg/m2,共4 周】与HCV感染相关CV的最有效疗法(Best available therapy)进行了比较，主要终点是进入研究后6个月的缓解率。
结果：共有24例患者被纳入研究，两组患者基线时的疾病活动度及器官受累相似；研究6个月时，利妥昔单抗组10例（83%）患者缓解，对照组1例（8%）患者缓解，该结果达到了停止研究的标准(P<0.001)；达到主要终点时，利妥昔单抗治疗患者的中位缓解持续时间为7个月；研究中，未观察到利妥昔单抗对HCV血浆病毒血症或肝转氨酶水平的不良反应。
拓展阅读：
大剂量聚乙二醇干扰素-α和利巴韦林在无应答的丙肝患者中的应用与IL-28B基因型的关系
A randomized controlled trial of rituximab following failure of antiviral therapy for hepatitis C-associated cryoglobulinemic vasculitis.
Sneller MC, Hu Z, Langford CA.
OBJECTIVES:
To report on the results of a randomized controlled trial of rituximab in hepatitis C virus (HCV)-associated mixed cryoglobulinemic vasculitis.
METHODS:
We conducted an open-label single center randomized controlled trial of rituximab (375 mg/m(2) per week for 4 weeks) compared to best available therapy for treatment of patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy failed to induce remission. The primary endpoint was remission at 6 months from study entry.
RESULTS:
A total of 24 patients were enrolled. Baseline disease activity and organ involvement were similar in the two groups. Ten patients in the rituximab group (83%) were in remission at study month 6, compared with 1 patient in the control group (8%), a result that met criterion for stopping the study (P<0.001). The median duration of remission for rituximab-treated patients reaching the primary endpoint was 7 months. No adverse effect of rituximab on HCV plasma viremia or hepatic transaminase levels was observed.
CONCLUSIONS:
Therapy with rituximab was well tolerated and effective treatment for patients with HCV-associated cryoglobulinemic vasculitis in whom antiviral therapy fails to induce remission.
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