聚乙二醇干扰素α-2b联合病毒唑治疗慢性丙型肝炎的临床观察

聚乙二醇干扰素α-2b联合病毒唑治疗慢性丙型肝炎的临床观察

【摘要】 目的 评价聚乙二醇干扰素α-2b联合病毒唑治疗慢性丙型病毒性肝炎的临床效果及用药安全性,探讨临床慢性丙型肝炎的抗病毒方法。方法 选择68例慢性丙型肝炎患者随机分成联合治疗组与对照组,联合治疗组38例,给予聚乙二醇干扰素α-2b 80 μg,1次/周皮下注射,加上病毒唑450 mg,3次/d,疗程为6个月;对照组30例,用甘乐能干扰素α-2b 3Mu隔日肌内注射1次,加上病毒唑450 mg,3次/d,疗程6个月。两组停药后随访6个月。分别观察两组慢性丙肝患者治疗前后的临床症状、体征改善状况,生化应答率、病毒应答率和临床不良反应。 结果 治疗结束时联合治疗组显效率、有效率和总有效率分别是71.05%、18.42%和89.47%;对照组分别是66.67%、16.67%和83.34%;两组比较差异无统计学意义(P＞0.05)。随访6个月联合治疗组的持续应答率为47.37%,而对照组为16.67%,两组有统计学意义(P＜0.01)。两组副作用均有发热、乏力、胃肠道症状、白细胞下降、肌肉酸痛等(P＞0.05)。结论 聚乙二醇干扰素α-2b联合病毒唑治疗慢性丙型肝炎,可迅速缓解患者的症状体征,促进HCV-RNA的阴转,临床用安全,停药6个月后的持续完全应答显著优于甘乐能干扰素。

【Abstract】 Objective To evaluate the efficacy of consensus peginterferon alfa-2b combined with ribavirin therapy for chronic hepatitis C(CHC).Methods Sixty-eight patients with CHC were randomly divided into combined curative group(n=38,PEG and ribavirin)and control group(n=30,interferon α-2b and ribavirin),treated for 6 months and followed by a follow-up of 6 months.The end of treatment response(ETR)and end of follow-up response(sustained response,SR)were evaluated based on the main symptoms and signs and the serum ALT normalization and seronegative of HCV-RNA.Results The excellence rate,effective power and the total effective rate in combined curative group were percent of 71.0、percent of 18.42 and percent of 89.47 in turn at the end of treatment,but which in control group were percent of 66.67、percent of 16.67 and percent of 83.34,there was no significant deviation(P＞0.05).After 6 monththe rate of SR in combined curative group was percent of 47.37,while the rate was percent of 16.67 in control group(P＜0.01).The side effects in two groups were similar which had fever ,anergy,gastrointestinal symptom,leucocyte reduce,muscular soreness,and so on.Conclusion The combined treatment with Peginterferon alfa-2b and ribavirin was not only safe but also improve the forward effects.

【Key words】 Peginterferon alfa-2b;Ribavirin;Chronic hepatitis C

丙型肝炎病毒感染人体后,大多数转为慢性。目前普遍认为干扰素治疗丙型肝炎有效。我们选用聚乙二醇干扰素α-2b加病毒唑来治疗慢性丙型肝炎,对其疗效及安全性进行评价,探讨丙肝的临床抗病毒方法。

1 资料与方法

1.1 一般资料 68例慢性丙型肝炎患者为2005~2008年住院或门诊患者,男36例,女32例,年龄18~57岁,平均32岁; 所有患者血清抗-HCV和HCV-RNA阳性, ALT升高超过

正常值上限2倍以上、10倍以下,病程1年以上。排除以下情况:①血清总胆红素＞50 ummol/L,HB＜10 g/L,WBC＜4.0×109/L;②HBV、HGV、TTV重叠感染;③曾接受干扰素或免疫调节剂、肾上腺皮质激素治疗;④自身免疫性肝病,遗传性肝病;⑤妊娠、精神病、甲状腺功能异常、糖尿病、肾脏疾病、心脏病、高血压病及其他严重并发症;⑥近期嗜洒或药瘾者。符合以上标准的慢性丙型肝炎患者68例,随机分成两组:联合治疗组38例,对照组30例。两组治疗病例在年龄、病程、病情的严重程度差异无统计学意义(P＞0.05),具有可比性。

1.2 治疗方法 联合治疗组给予聚乙二醇干扰素α-2b(PEG)80 μg,1次/周皮下注射,加用病毒唑450 mg,3次/d,口服,疗程6个月;对照组用甘乐能干扰素α-2b 3Mu,隔日肌内注射1次,加上病毒唑450 mg,3次/d,疗程6个月。

1.3 观察指标及检测方法 观测治疗前及治疗开始后1、3、6个月的血清生化:ALT、AST、TBiL、白蛋白及治疗后每个月的血常规;定量测定HCV-RNA,HCV-RNA用荧光定量PCR,采用美国Biotronic公司AG9600AmpLisensor Assay系统及试剂合。

1.4 疗效的判断标准 疗程结束时应答(ETR):①显效:症状、体征明显改善,ALT、AST复常,HCV-RNA阴转;②有效:症状、体征明显改善,ALT、AST复常,HCV-RNA未阴转;③无效:未达到以上标准者。停药后6个月持续应答(SR):完全应答,ALT、AST正常,HCV-RNA阴性。