慢性丙型肝炎个体化治疗方案的临床研究  

Study of using an individualized treatment strategy to treat patients with chronic hepatitis C

作　　者：南月敏[1] 郑欢伟[2] 孙殿兴[3] 安春绵[4] 李友生[5] 孔丽[1] 戴二黑[2] 张玉果[1] 赵素贤[1] 苏珊珊[1] 贾彦红[1] 

机构地区：[1]河北医科大学第三医院中西医结合肝病科,石家庄050051 [2]石家庄市第五医院 [3]中国人民解放军白求恩国际和平医院 [4]邢台市人民医院 [5]邯郸市传染病医院

出　　处：《中华肝脏病杂志》2013年第1期23-26,共4页Chinese Journal of Hepatology

基　　金：河北省科学技术研究与发展计划项目（10276102D）

摘　　要：目的探讨适于我国丙型肝炎病毒（HCV）慢性感染不同人群的个体化治疗方案。方法采用前瞻开放性临床研究，根据患者体质量（〈60kg和≥60kg）、年龄（〈65岁和65～75岁）、疾病状态（是否肝硬化）或伴发疾病（如心脏疾病、糖尿病、甲状腺疾病等）选择不同类型／剂量干扰素联合利巴韦林方案治疗。将169例慢性丙型肝炎（CHC）患者按照应用干扰素类型分为普通干扰素（IFN）α-2b组和聚乙二醇干扰素（PegIFN）α-2a组；按照应用IFN剂量分为常规剂量和小剂量干扰素组；所有病例均按千克体质量联合应用利巴韦林，根据病毒学应答时间确定疗程，对比分析不同治疗方案病毒学应答率、不良反应发生率及严重程度。结果169例CHC患者中，IFNα-2b组（n=116）的快速病毒学应答率（RVR）、完全早期病毒学应答率（cEVR）和持续病毒学应答率（SVR）分别为48．7％、76．7％、53．6%与PegIFNα-2a组（刀=53）的60．46％、92．5％、92．3％比较，PegIFNα-2a组姗和SVR率均显著高于IFNα-2b组。常规剂量干扰素组（n=78）的RVR、cEVR、SVR率分别为58．9％、80．8%、58．3％，与小剂量干扰素组（力=91）的53．8％、78．0％、68．9％比较，JD〉O．05，差异无统计学意义。结论根据CHC患者基线特征、耐受性和病毒学应答出现时间优化抗病毒治疗方案，可提高患者依从性、获得较高病毒学应答率，改善预后；同时可提高抗病毒药物的安全性、改善成本效益。Objective To investigate the outcomes of chronic hepatitis C （CHC） patients treated with antiviral regimens of interferon （IFN） plus ribavirin （RBV） using individualized doses and durations. Methods This study was designed as an open-label, prospective clinical trial to analyze the virological responses of 169 CHC patients who received individualized dosages of IFNα-2b or pegylated （Peg）IFNα-2a combined with RBV based on their weight （ 〈 60 kg or ≥ 60 kg）, age （ 〈 65 years or 65-75 years）, morbid state （liver cirrhosis or not）, and complications （such as heart disease, diabetes, thyroid disorder）. Treatment duration was calculated using the time required to induce HCV RNA negativity. The rates of virological response and adverse effects among the different groups were compared. Results The IFNct-2b treatment was given to 116 patients, and PeglFNα- 2a was given to 53 patients. Compared to the IFNα-2b group, the PeglFNct-2a group showed significantly higher rates of complete early virological response （cEVR; 76.7% vs. 92.5%,P 〈 0.05） and sustained virological response （SVR; 53.6% vs. 92.3%, P 〈 0.05） among the patients who had completed their course of treatment; the rapid virological response （RVR） rate was also higher for the PeglFNα-2a group but the difference did not reach statistical siznificance （48.7% vs. 60.4%, P〉 0.05）. Seventv-eight vatients received the routine dose. and 91 patients received the low dose; them were no significant differences between these two groups for RVR （53.8% vs. 58.9%, P 〉 0.05）, cEVR （78.0% vs. 80.8%, P 〉 0.05）, or SVR （65.5% vs. 58.3%, P 〉 0.05）. Conclusion Use of an individualized antiviral treatment strategy designed according to the patient＇s baseline condition, early viral kinetics, and tolerability to adverse reactions can achieve a high rate of SVR, as well as improve the safety, prognosis, and cost-effectiveness associated with treating CHC patients.

关 键 词：肝炎  丙型 慢性 干扰素Α 利巴韦林 优化方案 

分 类 号：R512.63[医药卫生—内科学]