CAJ | 학술논문

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,IFN α-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(n=53)的60.46％、92.5％、92.3％比较,PegIFN α-2a组cEVR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(n=91)的53.8％、78.0％、68.9％比较,P＞ 0.05,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.
목적 탐토괄우아국병형간염병독(HCV)만성감염불동인군적개체화치료방안. 방법 채용전첨개방성림상연구,근거환자체질량(＜60kg화≥60kg)、년령(＜65세화65 ～ 75세)、질병상태(시부간경화)혹반발질병(여심장질병、당뇨병、갑상선질병등)선택불동류형/제량간우소연합리파위림방안치료.장169례만성병형간염(CHC)환자안조응용간우소류형분위보통간우소(IFN) α-2b조화취을이순간우소(PegIFN) α-2a조；안조응용IFN제량분위상규제량화소제량간우소조；소유병례균안천극체질량연합응용리파위림,근거병독학응답시간학정료정,대비분석불동치료방안병독학응답솔、불량반응발생솔급엄중정도. 결과 169례CHC환자중,IFN α-2b조(n=116)적쾌속병독학응답솔(RVR)、완전조기병독학응답솔(cEVR)화지속병독학응답솔(SVR)분별위48.7％、76.7％、53.6％,여PegIFNα-2a조(n=53)적60.46％、92.5％、92.3％비교,PegIFN α-2a조cEVR화SVR솔균현저고우IFNα-2b조.상규제량간우소조(n=78)적RVR、cEVR、SVR솔분별위58.9％、80.8％、58.3％,여소제량간우소조(n=91)적53.8％、78.0％、68.9％비교,P＞ 0.05,차이무통계학의의.결론 근거CHC환자기선특정、내수성화병독학응답출현시간우화항병독치료방안,가제고환자의종성、획득교고병독학응답솔,개선예후；동시가제고항병독약물적안전성、개선성본효익.
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 IFNα-2b treatment was given to 116 patients,and PegIFNα-2a was given to 53 patients.Compared to the IFNα-2b group,the PegIFNα-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 PegIFNα-2a group but the difference did not reach statistical significance (48.7％ vs.60.4％,P＞ 0.05).Seventy-eight patients received the routine dose,and 91 patients received the low dose; there 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.