Objective To assess the efficacy between Peginterferon α-2a and common Interferon in HBeAg positive chronic hepatitis B. Methods MEDLINE, EBSCO, PubMed, CNKI, WangFang were searched from the beginning to May 2009, and the references of eligible studies were manually screened. Randomized controlled trials comparing Peginterferon-alpha2a with common interferon in HBeAg positive chronic hepatitis B were eligible for inclusion. Jadad score method was adopted to evaluate the methodological quality of included studies. Meta analysis was conducted by RevMan 5.0 software supplied by the Cochrane Collaboration. Subgroup analyses were used in treatment and observation course. Results Six randomized controlled trials were included (n=688). The treatment duration of 48 weeks and 24 weeks were reported in four and two studies, respectively. We carried out subgroup analysis according to treatment. Meta-analysis showed that Peginterferon-alpha2a (180 ug/d, 48 W) could significantly clear HBeAg, clear HBVDNA, normalize ALT and HBeAg seroconversion compared with common Interferon (Plt;0.05). Peginterferon-alpha2a (180 ug/d, 24 W) could effectively clear HBV DNA [P=0.04, RR=1.44, 95%CI (1.01, 2.05)], but was not effective in loss of HBeAg, HBeAg seroconversion and ALT normalization (Pgt;0.05). Conclusion The efficacy of 48 weeks treatment with Peginterferon α-2a is better than common Interferon. The efficacy of 24 weeks treatment with Peginterferon α-2a is only better in HBV-DNA negative rate than common Interferon. However, because the methodological quality of included studies is not high, this conclusion should be carefully considered in clinical use.
目的:观察聚乙二醇干扰素(PEG-INFa)联合利巴韦林治疗慢性丙型肝炎临床疗效。方法:共收集42例慢性丙型肝炎患者,其中治疗组24例,采用聚乙二醇干扰素180ug皮下注射,每周1次;对照组18例,采用IFNa2b(赛若金)500万u皮下注射,隔日1次。两组均联合利巴韦林治疗,剂量均为800~1200mg/d口服,总疗程为48周。分别于治疗12周、24周、48周及治疗结束后24周评价疗效,并观察药物副反应。结果:所有患者均完成治疗,在治疗12周时,治疗组早期应答率83.3%,对照组应答率50.0%;在治疗24周时,治疗组应答率87.5%,对照组应答率61.1%;在治疗48周时,治疗组完全应答率87.5%,对照组完全应答率55.6%;治疗结束后24周,治疗组持续应答率75.0%,对照组持续应答率44.4%。主要副反应为不同程度发热,头痛,肌肉关节酸痛,白细胞,血红蛋白及血小板下降,部分患者出现脱发,皮疹皮肤瘙痒,失眠,抑郁等症状,予对症处理后好转,未影响治疗。结论:PEG干扰素联合利巴韦林治疗慢性丙型肝炎疗效优于普通干扰素,副反应两者无明显差别,患者可以耐受。
ObjectiveTo evaluate the effect of autoantibody on the efficacy and safety of pegylated interferonα-2a (Peg-IFNα-2a) and ribavirin on chronic hepatitis C (HCV). MethodsWe enrolled 106 chronic HCV infected patients, who were divided into autoantibody-positive group and negative group based on the baseline autoantibody detection. The patients were treated for 48 weeks. The anti-viral response and adverse effects were observed. Data analyses were reported using the SPSS 20.0 statistical package. ResultsThe prevalence of any autoantibody in chronic hepatitis C patients amounted to 31.1%, and serum anti-nuclear antibody was positive in 24 patients. Difference in age, sex, serum alanine transaminase level, aspartate transaminase level, total bilirubin level, thyroid function and HCV RNA level between autoantibody-positive group and negative group was not significant (P > 0.05). The level of hemoglobin in autoantibody-positive group was significantly lower than the negative group (P=0.018). Of the 106 patients, 82 patients achieved sustained virological response (SVR), 56 achieved rapid virological response (RVR), 98 achieved ealy virological response (EVR) and 8 were non-responders. There were no significant differences between RVR, EVR and SVR in autoantibody-positive group and negative group (P > 0.05). The most common adverse effects in this study were fatigue, weight loss, hair loss and fever, and no significant differences in adverse effects were observed between the two groups (P > 0.05). ConclusionAutoantibody positivity may not affect the treatment response and is safe in chronic HCV infected patients with combination therapy of pegylated interferonα-2a plus ribavirin.
ObjectiveTo systematically review the efficacy of peginterferon alpha (PEG-IFNα) initially combined with lamivudine (LAM) or adefovir (ADV) in treatment of HBeAg-positive chronic hepatitis B (CHB) patients. MethodsWe electronically searched databases including The Cochrane Library (Issue 11, 2014), PubMed, CBM, CNKI, VIP, and WanFang Data from inception to December 2014, to collect randomized controlled trials (RCTs) about PEG-IFNα initially combined with LAM or ADV for HBeAg-positive CHB. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.2 software. ResultsA total of 11 RCTs involving 2031 patients were included. The results of meta-analysis showed that: After 48 weeks of treatment, the HBsAg seroconversion rate of the PEG-IFNα plus ADV group was significantly higher than that of the PEG-IFNα monotherapy group (8.6% vs. 0%, OR=7.73, 95%CI 1.53 to 39.05, P=0.01) or the ADV monotherapy group (8.5% vs. 0%, OR=7.75, 95%CI 1.07 to 56.23, P=0.04); and the HBsAg seroclearance rate in the combination therapy group was significantly higher than that of the ADV monotherapy group (10.5% vs. 1.2%, OR=5.56, 95%CI to 2.14 to 14.47, P=0.0004). After 52 weeks of treatment, the HBsAg seroconversion rate of the PEG-IFNα plus LAM group was significantly higher than that of the PEG-IFNα monotherapy group (11.6% vs. 5.6%, OR=2.21, 95%CI 1.04 to 4.72, P=0.04). After 26 weeks of follow-up, no significant differences were found between the combination therapy group and the PEG-IFNα monotherapy group in HBsAg seroclearance rate and HBsAg seroconversion rate (all P values >0.05). ConclusionCurrent evidence shows that, compared with PEG-IFNα, LAM, or ADV monotherapy, PEG-IFNα plus LAM or ADV could improve the HBsAg seroclearance or seroconversion rate after 48-52 weeks of treatment for HBeAg-positive CHB, but this effect is still limited. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
ObjectivesTo systematically review the efficacy and safety of pegylated interferon α-2a (Peg-IFNα-2a) combined with entecavir (ETV) versus Peg-IFNα-2a alone in treatment of HBeAg-positive chronic hepatitis B (CHB) patients.MethodsThe Cochrane Library, PubMed, Web of Science, EMbase, CNKI, VIP and WanFang Data databases were electronically searched to collect randomized controlled trials (RCTs) on Peg-IFNα-2a combined with ETV for HBeAg-positive CHB from inception to March, 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 12 RCTs involving 1 130 patients were included. The results of meta-analysis showed that: compared with Peg-IFNα-2a monotherapy, Peg-IFNα-2a combined with ETV could improve the rate of serum HBV-DNA clearance (RR=2.55, 95%CI 1.83 to 3.55, P<0.000 01), ALT normalization (RR=2.37, 95%CI 1.76 to 3.20, P<0.000 01) and HBeAg seroconversion (RR=2.88, 95%CI 1.18 to 7.03, P=0.02) after 12 weeks of treatment. Additionally, it could improve the rate of serum HBV-DNA clearance (RR=2.10, 95%CI 1.74 to 2.53, P<0.000 01), AST normalization (RR=1.87, 95%CI 1.15 to 3.04, P=0.01), ALT normalization (RR=1.70, 95%CI 1.46 to 1.99, P<0.000 01), serum HBeAg clearance (RR=2.14, 95%CI 1.62 to 2.83, P<0.000 01), HBeAg seroconversion (RR=2.51, 95%CI 1.65 to 3.82, P<0.000 01) and serum HBsAg clearance (RR=2.78, 95%CI 1.06 to 7.31, P=0.04) after 24 weeks of treatment. It could also improve the rate of serum HBV-DNA clearance (RR=1.63, 95%CI 1.32 to 2.02, P<0.000 01), AST normalization (RR=2.75, 95%CI 1.82 to 4.16, P<0.000 01), ALT normalization (RR=1.47, 95%CI 1.33 to 1.63, P<0.000 01), serum HBeAg clearance (RR=1.65, 95%CI 1.42 to 1.91, P<0.000 01), HBeAg seroconversion (RR=1.91, 95%CI 1.51 to 2.41, P<0.000 01) and serum HBsAg clearance (RR=1.57, 95%CI 1.07 to 2.31, P=0.02) after 48 weeks of treatment. There was no statistically significance of adverse reactions in groups.ConclusionsCurrent evidence shows that Peg-IFNα-2a combined with ETV is superior to Peg-IFNα-2a monotherapy in the treatment of HBeAg-positive CHB, and does not increase the incidence of adverse reactions. Due to the limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusion.