聚乙二醇干扰素α-2a联合利巴韦林治疗慢性丙型肝炎和代偿期丙型肝炎肝硬化的对比研究

Comparative Analysis of Peg Interferon α-2a in Combination with Ribavirin in the Treatment of Patients with Chronic Hepatitis C and Hepatitis C Cirrhosis at Compensation Stage

目的研究聚乙二醇干扰素（Peg interferon,PEG-IFN）α-2a联合利巴韦林（ribavirin,RBV）治疗慢性丙型肝炎和代偿期丙肝肝硬化的疗效及药物不良反应,为临床合理用药提供参考。方法回顾性分析60例接受PEG-IFNα-2a联合RBV抗病毒治疗的住院病例,分为两组：对照组（30例慢性丙型肝炎）与治疗组（30例代偿期丙肝肝硬化）。总疗程48~72周,随访24周。比较两组患者的病毒学应答率及不良反应发生率。结果对照组和治疗组快速病毒学应答（rapid virus response,RVR）、早期病毒学应答（early virus response,EVR）、治疗结束时病毒学应答（end-treatment virus response,ETVR）、无病毒学应答（no response,NR）、复发（relapse）均无统计学差异,而治疗组持续病毒学应答（SVR）率（53.3%）较对照组（80.0%）低（P〈0.05）。两组患者治疗过程中未发生死亡或严重不良反应,除血液系统、神经精神症状及腹水的发生率治疗组明显高于对照组外（P〈0.05）,其余不良反应发生率差异均无统计学意义（P〉0.05）。结论在掌握适应证和预防措施的情况下,PEG-IFN联合RBV治疗慢性丙肝安全有效的,大部分患者可以按预定方案完成治疗。对于丙肝肝硬化患者,临床使用小剂量PEG-IFN联合RBV较为安全,也有一定疗效。丙肝肝硬化患者在抗病毒治疗中较慢性丙肝更易出现血液系统、神经精神系统的不良反应及肝功能失代偿。治疗过程应密切观察并处理各种不良反应,提高患者的耐受性和依从性。

Objective To perform the comparatively study of clinical efficacy and adverse drug reactions of Peg interferon alfa-2a in combination with ribavirin in the treatment of patients with chronic hepatitis C and hepatitis C cirrhosis at compensation stage, the clinical efficacy and safety were discussed, to provide a reference for clinical rational drug use. Methods A total 60 patients received PEG-IFN α-2a in combination with ribavirin anti-HCV therapy, were divided into two groups.- control group （30 patients with chronic hepatitis C） and treatment group （30 patients with hepatitis C cirrho- sis at compensation stage）. The total antiviral treatment course were 48 to 72 weeks and the follow-up was 24 weeks. Virological response rate between two groups were compared and incidence of side effects were observed.Results The rapid virus response （RVR） ,early virus response （EVR） , end-treatment virus response （ETVR） , no response （NR） , relapse in two groups were not significantly different, but SVR in treatment group （53.3%） was lower than control group （80.0% ,P〈0.05） . There was no death or serious adverse reactions in two groups, but the treatment group had a higher incidence of the abnormal peripheral blood cells, neuropsychiatric symptoms and ascites than control group （P〈0.05） . The other adverse reactions had no signifi- cant difference （P〉0.05） .Conclusion Under the indica- tions and preventive measures, PEG-IFN and ribavirin treatment of chronic hepatitis C are safe and effective, the majority patients could regularly complete treatment plan. The use of low-dose peg IFN and RBV in hepatitis C cirrhosis at compensation stage are safe. Although SVR rates are lower than hepatitis C patients, 53.3% of patients could still obtain SVR. Hepatitis C cirrhosis in anti-HCV therapy are more likely to have blood system, neuropsyehiatric adverse reactions and liver decompensation. To improve patient tolerability and compliance, a variety of adverse reactions should be closely observed and treated.