聚乙二醇干扰素α-2a治疗慢性丙型肝炎疗效观察

Effect of Peginterferon Alpha-2a in the Treatment of Chronic Hepatitis C

目的：观察聚乙二醇干扰素α-2a（PEG-IFNα-2a）治疗慢性丙型肝炎的临床疗效和安全性。方法：85例慢性丙型肝炎患者随机分为两组，观察组（43例）予PEG-IFNα-2a180μg，皮下注射，每周1次，同时口服利巴韦林900～1200mg·d-1；对照组（42例）接受普通干扰素α-2b500MU，皮下注射，1周3次，利巴韦林用法同观察组。48周治疗结束后随访24周，检测基线及治疗4，12，48周及治疗结束后24周时的血清HCVRNA和ALT水平，比较两组快速病毒学应答（RNA）率、早期病毒学应答（EVR）率、治疗终点病毒学应答（ETVR）率、持续病毒学应答（SVR）率以及ALT复常率与不良反应。结果：EVR、ETVR、SVR观察组分别为76.7%、86.0%和79.1%，明显高于对照组的54.8%、66.7%和57.1%，差异有统计学意义（P＜0.05）。观察组治疗12周及48周时ALT复常率分别为81.4%和90.7%，明显高于对照组（P＜0.05）。观察组白细胞计数下降和血小板减少的发生率高于对照组（P＜0.05），中性粒细胞计数减少的发生率明显高于对照组（P＜0.01），其他不良反应两组相近，未出现与聚乙二醇干扰素α-2a相关的新的不良反应。结论：PEG-IFNα-2a对慢性丙型肝炎患者的疗效优于普通干扰素，并具有较好的安全性和耐受性。

Objective： To investigate the efficacy and safety of peginterferon alpha-2a plus ribavirin in the treatment of chronic hepatitis C. Methods： Totally 85 patients with chronic hepatitis C were randomly divided into the observation group and the control group. Each patient in the observation group was injected subcutaneously peginterferon alpha-2a with the dose of 180μg once a week plus ribavirin 900-1 200 mg/d, po, and each patient in the control was treated subcutaneously with 5 MU standard interferon alpha-2b three times a week plus the same used ribavirin. After the 48-week treatment, 24-week fellow-up was carried out. HCV RNA and ALT were detected at the baseline, 4th week, 12th week and 48th week during the treatment, and 24th week after the treatment, respectively. The rate of rapid virological response （RVR）, early virological response （EVR）, end of treatment virological response （ETVR）, sustained virological response （SVR）, ALT normalization and adverse reactions were respectively assessed. Results：The rates of EVR,ETVR and SVR in the observation group were 76.7%（33/43）, 86.0%（37/43） and 79.1%（34/43）, respectively, which were significantly higher than those in the control group ［54.8%（23/43）, 66.7%（28/43） and 57.1%（24/43），respectively］ （P＜0.05）. The ALT normalization rate at 12th and 48th week after the treatment in the observation group was 81.4% and 90.7%, respectively, which were higher than those in the control group ［64.3% and 71.4%, respectively］（P＜0.05）. The rate of white cell counts and platelet underlying （58.1% and 39.5%） in the observation group were also higher than those in the control group （35.7% and 19.0%）（P＜0.05）. The decreased rate of neutrophil （58.1%） in the observation group was higher than that in the control group（19.0%）（P＜0.01）. The other adverse reactions in the two groups were similar, and there was no new or unique adverse event related to peginterferon. Conclusion：Peginterferon alpha 2a has better effect than the standard interferon alpha 2b in the treatment of patients with chronic hepatitis C with promising tolerance.