重组复合干扰素治疗慢性丙型肝炎的临床研究.doc

重组复合干扰素治疗慢性丙型肝炎的临床研究重组复合干扰素治疗慢性丙型肝炎的临床研究2011-02-27 姚光弼傅希贤徐道振郝连杰皇甫玉珊苏纯信田庚善 【摘要】目的比较两种剂量的重组复合干扰素(Consensus Interferon, CIFN)和重组干扰素-2a(IFN -2a)治疗慢性丙型肝炎患者的疗效和安全性。方法187例初治的慢性丙型肝炎(丙肝)患者，随机分成三组，分别接受：CIFN 15 g(A组)61例、9 g(B组)65例和IFN -2a 3 MU(C组)61例，1周3次，共24周，在完成治疗后继续随访24周。本试验以治疗结束时和随访时丙氨酸转氨酶(ALT)复常和丙型肝炎病毒核糖核酸(HCV RNA)逆转录-聚合酶链反应(RT-PCR)检查阴转考核药物近期和远期疗效，同时观察不良反应。结果180例完成24周治疗，分别为CIFN 15g组56例，9 g组63例和IFN -2a组61例。经24周治疗后，A、B、C三组的ALT复常率分别为76.9%、68.3%和57.4%，HCV RNA的阴转率分别为89.6%、73.6%和60.4%，A组和C组比较差异均有显著性(P0.05和P0.01)。在48周时，A、B、C三组的ALT复常率分别为78.8%、63.9%和55.0%，HCV RNA的阴转率分别为75.0%、65.4%和54.7%，A组和C组比较差异均有显著性(P0.01和P0.05)。三组患者近期显效率分别为70.8%、54.7%和34.0%；远期显效率分别为64.6%、51.9%和43.4%。A组的近期和远期疗效均显著高于C组(P0.01和P0.05)。三组患者治疗期间药物不良反应发生的类型、频率和严重程度无统计学显著差异。结论CIFN 15 g和9 g对治疗慢性丙肝安全有效，15 g剂量组的近期和远期疗效优于IFN -2a 3 MU。 【关键词】肝炎，丙型，慢性；重组复合干扰素；重组干扰素-2a； 丙氨酸转氨酶；丙型肝炎病毒核糖核酸 Clinical trial of consensus interferon for chronic hepatitis C YAO Guangbi， FU Xixian, XU Daozhen, et al. （Shanghai Jing An Qu Central Hospital, Shanghai 200040, China） 【Abstract】ObjectiveThe randomized study was conducted to determine the safety and efficacy of consensus interferon (CIFN) in the treatment of chronic hepatitis C at two doses compared with that of interferon alfa-2a (IFN -2a).Methods187 patients were randomized to receive CIFN 15 g, CIFN 9 g or 3 MU interferon -2a. Patients received subcutaneous injections tiw for 24 weeks followed by 24 weeks of observation. Normalization rate of serum alanine aminotransferase (ALT) and seroconversion rate of HCV RNA by (RT-PCR) were detected to evaluate the efficacy. The categories and severity of adverse events were registered. Results180 patients completed full course of treatment, 56 cases of which were treated with CIFN 15 g,63 cases with CIFN 9 g and 61 cases with 3MU IFN -2a, respectively. After 24 weeks treatment, ALT normalization rate for 15 g CIFN, 9 g and 3MU IFN -2a were 76.9%, 68.3% and 57.4%. HCV RNA seroconversion rate were 89.6%, 73.6% and 60.4%. There were significant statistical difference of both ALT normalization rate and HCV RNA seroconversion rate between CIFN 15 g and IFN -2a 3MU treated patients (P0.05 and P0.01). After 48 weeks therapy, ALT normalization rate for those three groups were 78.8%, 63.9% and 55.0%, the HCV RNA seroconversion rate were 75.0%, 65.4% and 54.7%. It also showed significant statistical difference between CIFN 15 g and 3MU IFN -2a group (P0.01 and P0.05). The short-term and long-term complete response rate in the patients treated with CIFN 15 g (70.8% and 64.6%, respectively) were higher than in the patients treated with IFN -2a 3 MU (34.0% and 43.4%, respectively; P0.01 and P35 mol/L，白蛋白176 mol/L，过去一年内曾接受干扰素、抗病毒药、激素、免疫调节剂或抗癌药者，有甲状腺或精神病史，酗酒或药瘾，怀孕或哺乳妇女或育龄妇女无有效节育措施者均予排除。所有患者系作者所在的医院，于1995年12月至1996年12月内选择。 二、治疗用药 CIFN为水针剂，每安瓿含15 g或9 g。CIFN治疗单位采用g，应用WISH-VSV检测系统，1 gCIFN相当于0.51.0106 IU的干扰素(批号为419L4A,41