Objective To evaluate the effectiveness and safety of different doses of interferon alfa (INF-α) in the treatment of chronic hepatitis C (CHC). Methods Such databases as MEDLINE, EMbase, CENTRAL, CBM, CNKI, VIP and WanFang Data were searched to collect the randomized controlled trials (RCTs) on different doses of INF-α in the treatment of CHC published before August, 2012. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and evaluated the quality of the included studies, and then meta-analysis was performed using RevMan 5.0 software. Results A total of 13 RCTs involving 1 442 patients were included. The results of meta-analysis on different doses of INF-α showed that, a) There was no significant difference in the complete response rate between the 3 MU dose group and the 1 MU dose group (RR=0.83, 95%CI 0.52 to 1.32, P=0.43), but there was significant difference in the sustained response rate between those 2 groups (RR=1.89, 95%CI 1.00 to 3.59, P=0.05); and b) No significant differences were found in the complete response rate among the 3 MU dose group, the 6 MU dose group, and the 1 MU dose group. Conclusion INF-α in dose of 3 MU, 3 times daily, is effective in treating CHC, but it would not rule out that higher dose takes more effective action. When INF-α is used to treat CHC, an individualized medication should be applied according to patients’ tolerance and economic status.
【摘要】 目的 探讨慢性丙型肝炎患者干扰素治疗前后血清自身抗体的合并状况。 方法 回顾性分析2005年2月-2008年2月66例慢性丙型肝炎患者应用干扰素治疗前后的检测结果，观察治疗前后自身抗体合并状况及与干扰素疗效的关系。 结果 ①66例慢性丙型肝炎患者中39例自身抗体阳性，阳性率59.1%（39/66），主要为ANA；②自身抗体的产生与年龄相关，而与性别、HCVRNA定量无关；③自身抗体阳性组干扰素应答率66.7% （26/39）明显高于阴性组40.7%（11/27），二者比较差异有统计学意义；④干扰素治疗后，自身抗体阴性组自身抗体检出率为44.4%（12/27），但滴度均lt;1∶320；治疗前抗甲状腺球蛋白抗体阳性患者会出现较高的甲状腺功能异常率。 结论 慢性丙型肝炎合并血清自身抗体阳性的患者干扰素应答率高于阴性组，但应注意抗甲状腺球蛋白抗体，以预测不良反应。【Abstract】 Objective To explore the consolidation of serum autoantibodies in chronic hepatitis C patients treated with interferon. Methods The clinical data of 66 patients with chronic hepatitis C treated with interferon from February 2005 to February 2008 were retrospectively analyzed. The relationship between the consolidation of serum autoantibodies and the effect of interferon was observed. Results ①There were 39 patients with positive autoantibodies; the positive rate was 59.1% (39/66) and ANA was the main antibody. ②The appearance of autoantibodies correlated with the patients′ ages but not with the sexes and CVRNA quantification. ③The interferon response rate in autoantibodies positive group was 66.7% (26/39) which was much higher than that in the negative group; the difference between the two groups was significant. ④After the interferon treatment, the autoantibody detection rate in autoantibody negative group was 44.4%(12/27)and the titer was lower than 1:320; before the treatment, the anti-thyroglobulin antibody-positive patients had a higher rate of thyroid dysfunction. Conclusion The interferon response rate in chronic hepatitis C patients with positive serum autoantibodies is higher than that in the patients with negative serum autoantibodies. Anti-thyroglobulin antibodies should be noted to predict the adverse effects.
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.
Objectives To determine the health benefit of elbasvir/grazoprevir versus peginterferon combing with ribavirin (PR regimen) for Chinese chronic hepatitis C patients with genotype 1b infection. Methods Markov cohort state-transition models were constructed to conduct cost utility analysis. Sensitivity analyses were performed based on base-case analysis. Results Elbasvir/grazoprevir was dominant versus PR, resulting in higher QALYs and lower costs for both noncirrhotic patients (13.867 5 QALYs, 82 090.82 RMB vs. 12.696 2 QALYs, 122 791.55 RMB) and cirrhotic patients (12.841 6 QALYs, 225 807.70 RMB vs. 8.892 4 QALYs, 326 545.01 RMB). Elbasvir/grazoprevir was economically dominant in nearly 100% among all patients within the range of threshold from 0 to 161 805 RMB/QALY. Conclusions Elbasvir/grazoprevir was dominant in treatment of genotype 1b chronic hepatitis C infection in China.