CAJ | 학술논문

目的观察聚乙二醇干扰素(PegIFN)α-2a联合利巴韦林(RBV)治疗慢性丙型肝炎患者的疗效及其影响因素,探讨治疗时间及药物累积用量与疗效之间的关系.方法对117例慢性丙型肝炎患者给予PegIFN α-2a联合RBV抗病毒治疗,PegIFN α-2a每周1次,皮下注射135 μg或180 μg,RBV按体质量每日分次口服800～1200mg,共治疗48周.分别在用药前,用药后4、12、24、36、48周以及停药后24周检测HCV RNA载量,检测部分患者HCV基因型,观察病毒学应答情况并分析影响疗效的因素.计数资料的比较用x2检验,P＜0.05为差异有统计学意义.结果行基因型检测的29例患者中,1b型HCV感染21例,2a型HCV感染7例,1b和2a型混合HCV感染1例.117例患者中,88例获得了快速病毒学应答,96例(82.1%)获得了持续病毒学应答(SVR).年龄≤40岁、体质量＜75 kg、感染时间＜10年的患者可获得更好的疗效,SVR率明显高于年龄＞40岁、体质量≥75 kg、感染时间≥10年者(91.4%比72.9%,x2=6.796,P＜0.05;85%比50%,x2=5.433,P＜0.05;96.7%比77%,x2=5.852,P＜0.05).坚持全疗程的80%以上及PegIFN α-2a或RBV预计累积用量的80%以上可获得更好的疗效(x2值分别为16.971、16.971和43.212,P值均＜0.01).即使给予患者足够剂量的PegIFN α-2a(≥推荐剂量的80%),RBV减量(＜推荐剂量的80%)亦会使其SVR率下降[75.0%(27/36)比96.8%(60/62),x2=8.762,P＜0.01];获得快速病毒学应答的患者SVR率也明显下降[100.0%(51/51)比81.8%(18/22),x 2=6.614,P＜0.05].结论 PegIFN α-2a联合RBV治疗慢性丙型肝炎疗效显著,坚持80%PegIFN α-2a推荐剂量,80%以上RBV推荐剂量,以及80%推荐疗程可获得更好的疗效.
목적 관찰취을이순간우소(PegIFN)α-2a연합리파위림(RBV)치료만성병형간염환자적료효급기영향인소,탐토치료시간급약물루적용량여료효지간적관계.방법대117례만성병형간염환자급여PegIFN α-2a연합RBV항병독치료,PegIFN α-2a매주1차,피하주사135 μg혹180 μg,RBV안체질량매일분차구복800～1200mg,공치료48주.분별재용약전,용약후4、12、24、36、48주이급정약후24주검측HCV RNA재량,검측부분환자HCV기인형,관찰병독학응답정황병분석영향료효적인소.계수자료적비교용x2검험,P＜0.05위차이유통계학의의.결과 행기인형검측적29례환자중,1b형HCV감염21례,2a형HCV감염7례,1b화2a형혼합HCV감염1례.117례환자중,88례획득료쾌속병독학응답,96례(82.1%)획득료지속병독학응답(SVR).년령≤40세、체질량＜75 kg、감염시간＜10년적환자가획득경호적료효,SVR솔명현고우년령＞40세、체질량≥75 kg、감염시간≥10년자(91.4%비72.9%,x2=6.796,P＜0.05;85%비50%,x2=5.433,P＜0.05;96.7%비77%,x2=5.852,P＜0.05).견지전료정적80%이상급PegIFN α-2a혹RBV예계루적용량적80%이상가획득경호적료효(x2치분별위16.971、16.971화43.212,P치균＜0.01).즉사급여환자족구제량적PegIFN α-2a(≥추천제량적80%),RBV감량(＜추천제량적80%)역회사기SVR솔하강[75.0%(27/36)비96.8%(60/62),x2=8.762,P＜0.01];획득쾌속병독학응답적환자SVR솔야명현하강[100.0%(51/51)비81.8%(18/22),x 2=6.614,P＜0.05].결론 PegIFN α-2a연합RBV치료만성병형간염료효현저,견지80%PegIFN α-2a추천제량,80%이상RBV추천제량,이급80%추천료정가획득경호적료효.
Objective To evaluate the efficacy and to investigate the association between the length of the treatment period and the cumulative dose of pegylated interferon alpha-2a (PegIFN alpha-2a) plus ribavirin (RBV) and the effectiveness of antiviral therapy. Methods We analyzed data from 117 patients treated for 48 weeks with PEG-IFN alpha-2a (135 μ g or 180 μ g/week) plus weight-based RBV (800 mg/dfor patients ≤65 kg, 1000 mg/d for patients 65-75 kg and 1200 mg/d for patients ≥75 kg) under care at West China Hospital. HCV RNA was assessed at baseline, Week 4, 12 and 24, the end of treatment (EOT) and after 24 weeks follow-up (sustained virological response; SVR) with a test range of 1.0 x 103 to 5.0 x 107 IU/ml.Patients were stratified by age, gender, weight, route of transmission, duration of infection, baseline HCV RNA level and PegIFN alpha-2a or RBV dosage. Results HCV genotype was assessed in 29 patients (genotype 1b, 21; genotype 2a, 7; genotype 1b/2a, 1). Rapid virological response (RVR; HCV RNA negative at week 4), complete early virological response (cEVR; HCV RNA negative at week 12), EOT response, and SVR were achieved in 88 (75.2%), 110 (94%), 114 (97.4%) and 96 (82.1%) patients, respectively. Younger age, lower weight and shorter speculated infection years were associated with higher SVR rates (91.4% vs 72.9%, x2 = 6.796, P ＜ 0.05; 85% vs 50%, x2 = 5.433, P ＜ 0.05; 96.7% vs 77%, x2 = 5.852, P ＜ 0.05). SVR significantly increased with treatment length (38.5%, 66.7%, and 88.8% for ≤ 29 weeks, 29-38 weeks, and ≥38 weeks, respectively). SVR significantly increased with total cumulative treatment doses (38.5%, 66.7% and 88.8% for ≤ 60%, 60%-80% and ≥ 80% of PegIFN dose respectively; 33.3%, 85.3% and 96.8% for ≤ 60%,60%-80% and ≥ 80% in RBV dose respectively) in all patients. Less than 80% of standard dose of RBV was not sufficient even if given enough PegIFN (≥ 80% cumulative treatment dose) in patients who achieved RVR. Conclusion Chinese patients treated with peginterferon alpha-2a plus ribavirin have high rates of SVR.It is important to complete the target length of treatment and to continue the target dosage to achieve SVR.