簡體 | 繁體   
                國內首家專科連鎖藥房，數十位執業藥師提供用藥指導！投訴熱線:(020)66843700
    
    
    

    


    
    

    

    

    


    

    


    

    

    





        
        
        
    
            
    
                
    
                    派羅欣專題 >> 派羅欣±拉米夫定治療HBeAg陰性慢性乙肝患者HBV-DNA抑制的2年隨訪結果
    
                
                
    
                    派羅欣±拉米夫定治療HBeAg陰性慢性乙肝患者HBV-DNA抑制的2年隨訪結果
    
                
    
                    
    來源： 百濟新特藥房網          發布時間：2007-9-20 14:59:00
    
                
    
                
    
                
                
    
                    
    
                    
    
                    
    
                        
    
                        
    
                        
      
                        
    
                    
    
                      
    


    


    

    　　背景：HbeAg慢性乙肝預后較差，治療應答率低且復發率高，尤其是核苷類似物治療更是如此。在一項大型國際研究中已證實接受派羅欣±拉米夫定治療較拉米夫定單藥治療停藥后24周的的應答率顯著增高。

    　　目的：評價派羅欣±拉米夫定治療停藥2年后病毒學和生化學應答的持久性。

    　　方法：在初期研究中，HbeAg陰性慢性乙肝患者接受的治療方案：派羅欣180μg，每周1次，聯合安慰劑（每日1次）或拉米夫定100mg（每日1次），共48周，并在停藥后6個月進行評價。在隨后的長期觀察性研究中，接受派羅欣聯合安慰劑的患者中有116例（116/177，66%），派羅欣聯合利巴韋林中有114例（114/179，64%）在停藥后第6、9、12、24個月接受評估，包括：HBV-DNA<20,000拷貝/毫升、<10,000拷貝/毫升、<400拷貝/毫升，和ALT復常<1倍正常值上限（30或>30～≤50IU/L）

    　　結果：HBV-DNA水平從停藥后第9月至第24月保持穩定，派羅欣單藥治療和派羅欣聯合拉米夫定治療患者病毒學應答無顯著差異。派羅欣單藥治療和派羅欣聯合拉米夫定治療患者停藥后第1年和第2年的ALT復常率分別為50% vs 45%，32% vs 28%。研究期間接受派羅欣單藥治療的患者有11例出現HbsAg轉陰，其中6例出現HbsAg抗體，在2年隨訪期間維持穩定。接受聯合治療的患者中14例出現HbsAg轉陰，6例出現HbsAg抗體，其中2例在隨訪期間維持穩定。

    　　結論：派羅欣治療，在停藥后隨訪2年期間有持久的ALT復常率和HBV-DNA抑制低于10,000拷貝/毫升，后者最近被證明可相當大地降低疾病并發癥和肝癌的危險。復發的患者在隨訪早期即出現復發。

    AASLD 2006 Abstract ID# 972

    Suppression of HBV-DNA in Patients with HBeAg-negative CHB Treated with Peginterferon Alfa-2a (40KD) ± Lamivudine: 2-Year Follow-up Results

    P. Marcellin1; F. Bonino2; G. K. Lau3; P. Farci4; C. Yurdaydin5; T. Piratvisuth6; K. Luo7; S. Gurel8; S. Hadziyannis9; Y. Wang10; M. Popescu11

    1. Service d'Hepatologie, Hopital Beaujon, University of Paris, Paris, France.
    2. Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Ospedale Maggiore di Milano Policlinico, Milan, Italy.
    3. Department of Medicine, Queen Mary Hospital, Hong Kong, China.
    4. Dipartimento di Scienze Mediche, Università di Cagliari, Monserrato, Italy.
    5. Department of Gastroenterology, University of Ankara, Ankara, Turkey.
    6. Department of Internal Medicine, Songklanagarind Hospital, Prince of Songkla University, Hat Yai, Thailand.
    7. Department of Infectious Diseases, Nanfang Hospital, Guangzhou, China.
    8. Department of Gastroenterology, University of Uludag, Bursa, Turkey. f
    9. Department of Medicine and Hepatology, Henry Dunant Hospital, Athens, Greece.
    10. Infectious Disease Department, Xinan Hospital, Chongqing, China.
    11. Pharmaceuticals Division, Roche, Basel, Switzerland.

    Background: HBeAg-negative chronic hepatitis B (CHB) is associated with poor prognosis, low rates of treatment response and high rates of relapse, especially following treatment with nucleos(t)ide analogues. Significantly higher response rates 24 weeks post-treatment have been demonstrated in patients receiving peginterferon alfa-2a +/- lamivudine, versus lamivudine alone, in a large multinational trial.

    Objective: To evaluate the durability of virological and biochemical response to peginterferon alfa-2a +/- lamivudine for up to 2 years post-treatment.

    Methods: In the initial study, HBeAg-negative CHB patients received 180μg peginterferon alfa-2a (40KD) once-weekly (qw) plus either placebo daily (qd) or 100 mg lamivudine (qd) for 48 weeks, and were assessed 6 months post-treatment. In a roll-over long-term observational study, 116/177 (66%) of those receiving peginterferon alfa-2a plus placebo, and 114/179 (64%) receiving the combination with lamivudine, were assessed for HBV-DNA suppression to <20,000 cp/mL, <10,000 cp/mL and <400 cp/mL and ALT normalisation <1 X ULN, (30 or >30–≤ 50 IU/L) at 6, 9, 12 and 24 months post-treatment.

    Results: HBV-DNA suppression at 1 and 2 years post-treatment is shown in the table below. HBV-DNA levels were stable from 9 months to 24 months post-treatment and there was no significant difference in the virological response between patients treated with peginterferon alfa-2a monotherapy and peginterferon alfa-2a plus lamivudine. ALT normalisation at 1 and 2 years post-treatment was 50% versus 45% and 32% versus 28% for patients treated with peginterferon alfa-2a monotherapy versus the combination with lamivudine, respectively. A total of 11/116 patients receiving peginterferon alfa-2a monotherapy lost HBsAg during the study, of whom six developed anti-HBs antibody, maintained over 2 years of follow-up. Of those receiving the combination with lamivudine, 14/114 lost HBsAg, and six developed anti-HBs antibody at some time during the study, which was maintained in two patients up to 2 years post-treatment.

    Conclusions: Peginterferon alfa-2a provides durable ALT normalisation and HBV-DNA suppression to less than 10,000 cp/mL, a level that has recently been associated with a considerably reduced risk of disease complications and hepatocellular cancer, for up to 2 years post-treatment. Patients who relapsed, did so in the early months of follow-up.
    
                    
    
                        
                    
    
                    
    
                        
    
                            
    
                            
    
                            
    
                                
      
                                    
    • 沒有相關記錄
      • 
                                
    
                            
    
                        
    
                        
    
                            
                        
    
                        
    
                        
    
                    
    
                    
    
                        TAG： 派羅欣 拉米夫定 HBeAg陰性  
    
                
    
                
                
    
                    
    
                        相關藥品
    
                    
    
                    
    
                
    
                
    
                    
    
                        
    
                            溫馨提示
                        
    
                        
    
                            
    
                        
    
                        
    
                    
    
                    
    
                        
    
                        
    
                        
    
                            
                        
    
                        
    
                        
    
                    
    
                    
    【我要挑錯】【關閉窗口】
    
                
    
                
    電子藥歷跟蹤
    
                
            
    
            
            
            
            
    
            
    
            
      專科病種索引：
    • 腫瘤科
    • 肝病科
    • 神經科
    • 精神科
    • 皮膚性病科
    • 眼科
    • 風濕免疫科
    • 心腦血管科
    • 糖尿病
    • 泌尿生殖科
    • 營養消化科
    • 醫療器械科
     
      藥品說明書索引：
    • 腫瘤科
    • 肝病科
    • 神經科
    • 精神科
    • 皮膚性病科
    • 眼科
    • 風濕免疫科
    • 心腦血管科
    • 糖尿病
    • 泌尿生殖科
    • 營養消化科
    • 醫療器械科
    
            
            
    
            
        
    
        
        
    
    
    
    
        
    
            互聯網藥品交易資格證|互聯網藥品信息服務資格證書|粵ICP備案號：粵ICP09020215
            
    
            Copyright@2011-2013 百濟新特網上藥店.百濟新特藥房網 m.358cha.cn 版權所有，并保留所有權利。
    
            客戶服務熱線：400-101-6868 投訴與建議：020-66843700
    
            本公司常年法律顧問：廣東信利盛達律師事務所
    
            本公司及客戶的合法均愛法律保護，任何侵犯本公司及客戶利益的任何單位和個人必將受到法律的追究。
        
    
        
    
            

            

            
        
    
        
    
            廣東網警廣東網警