摘要
目的:观察聚乙二醇干扰素联合拉米夫定治疗慢性乙型肝炎的临床疗效和安全性。方法:将80例慢性乙型肝炎患者随机均分为观察组和对照组。所有患者均给予常规治疗,在此基础上对照组患者给予拉米夫定100 mg,1次/日,饭前或饭后服用;观察组患者在对照组治疗的基础上给予聚乙二醇干扰素注射液180μg,皮下注射,1次/周。观察组患者均根据患者个体情况调整聚乙二醇干扰素的用药剂量。两组患者疗程均为48周。观察两组患者临床疗效,治疗6个月、12个月时的乙肝病毒脱氧核糖核酸(HBV-DNA)阴转率、乙型肝炎病毒e抗原(HBe Ag)阴转率、HBe Ag转化率、丙氨酸氨基转移酶(ALT)复常率和并发症发生率及并发症评分,记录不良反应发生情况。结果:两组患者治疗6个月时HBV-DNA阴转率、HBe Ag阴转率和HBe Ag转化率比较,差异均无统计学意义(P>0.05);治疗12个月时HBV-DNA阴转率、HBe Ag阴转率和HBe Ag转化率均显著高于对照组,两组比较差异均有统计学意义(P<0.05);观察组患者总有效率、ALT复常率显著高于对照组,两组比较差异均有统计学意义(P<0.05);两组患者并发症发生率、并发症评分比较,差异无统计学意义(P>0.05)。两组患者治疗期间均未见明显不良反应发生。结论:聚乙二醇干扰素联合拉米夫定治疗慢性乙型肝炎较单用拉米夫定疗效更显著,安全性相似。
OBJECTIVE:To observe the clinical efficacy and safety of polyethylene glycol interferon combined with lamivudine in the treatment of chronic hepatitis B(CHB). METHODS:80 CHB patients were randomly divided into observation group and control group. All patients were given conventional treatment. On this basis,control group was given lamivudine 100 mg,once a day,before meals or after meals. Observation group was additionally given Polyethylene glycol interferon injection 180 μg subcutaneously once a week on the basis of control group. The dose of polyethylene glycol interferon was adjusted in observation group according to individual condition. Treatment course of 2 groups lasted for 48 weeks. Clinical efficacies of 2 groups were observed,and HBV-DNA negative conversion rate,HBe Ag negative conversion rate,rate of HBe Ag conversion,ALT recovery rate and the incidence of complications were observed after 6 months and 12 months of treatment. The occurrence of ADR was also recorded.RESULTS:There was no statistical significance in HBV-DNA negative conversion rate,HBe Ag negative conversion rate and HBe Ag conversion rate between 2 groups after 6 months of treatment(P〉0.05);there was statistical significance in above index between 2 groups after 12 months of treatment(P〈0.05). Total effective rate and ALT recovery rate of observation group were significantly higher than those of control group;there was statistical significance(P〈0.05). There was no statistical significance in the incidence and score of complications between 2 groups(P〉0.05). No obvious ADR was found in 2 groups during treatment.CONCLUSIONS:Polyethylene glycol interferon combined with lamivudine is more effective and safer than lamivudine alone in the treatment of CHB.
出处
《中国药房》
CAS
CSCD
2014年第48期4543-4545,共3页
China Pharmacy
关键词
聚乙二醇干扰素
拉米夫定
慢性乙型肝炎
疗效
Polyethylene glycol interferon; Lamivudine; Chronic hepatitis B; Therapeutic efficacy