目的:觀察聚乙二醇干擾素(PEG-INFa)聯合利巴韋林治療慢性丙型肝炎臨床療效。方法:共收集42例慢性丙型肝炎患者,其中治療組24例,采用聚乙二醇干擾素180ug皮下注射,每周1次;對照組18例,采用IFNa2b(賽若金)500萬u皮下注射,隔日1次。兩組均聯合利巴韋林治療,劑量均為800~1200mg/d口服,總療程為48周。分別于治療12周、24周、48周及治療結束后24周評價療效,并觀察藥物副反應。結果:所有患者均完成治療,在治療12周時,治療組早期應答率83.3%,對照組應答率50.0%;在治療24周時,治療組應答率87.5%,對照組應答率61.1%;在治療48周時,治療組完全應答率87.5%,對照組完全應答率55.6%;治療結束后24周,治療組持續應答率75.0%,對照組持續應答率44.4%。主要副反應為不同程度發熱,頭痛,肌肉關節酸痛,白細胞,血紅蛋白及血小板下降,部分患者出現脫發,皮疹皮膚瘙癢,失眠,抑郁等癥狀,予對癥處理后好轉,未影響治療。結論:PEG干擾素聯合利巴韋林治療慢性丙型肝炎療效優于普通干擾素,副反應兩者無明顯差別,患者可以耐受。
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 探討慢性丙型肝炎患者干擾素治療前后血清自身抗體的合并狀況。 方法 回顧性分析2005年2月-2008年2月66例慢性丙型肝炎患者應用干擾素治療前后的檢測結果，觀察治療前后自身抗體合并狀況及與干擾素療效的關系。 結果 ①66例慢性丙型肝炎患者中39例自身抗體陽性，陽性率59.1%（39/66），主要為ANA；②自身抗體的產生與年齡相關，而與性別、HCVRNA定量無關；③自身抗體陽性組干擾素應答率66.7% （26/39）明顯高于陰性組40.7%（11/27），二者比較差異有統計學意義；④干擾素治療后，自身抗體陰性組自身抗體檢出率為44.4%（12/27），但滴度均lt;1∶320；治療前抗甲狀腺球蛋白抗體陽性患者會出現較高的甲狀腺功能異常率。 結論 慢性丙型肝炎合并血清自身抗體陽性的患者干擾素應答率高于陰性組，但應注意抗甲狀腺球蛋白抗體，以預測不良反應。【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.
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.
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.