第七章 陈新月RGT策略+96周实验20120729.ppt

* 再者，在核苷(酸)类似物的长期治疗过程中，耐药问题非常突出。 在一项随机研究中，644例患者分别接受拉米夫定（430例）或安慰剂（214例）治疗，在430例接受拉米夫定治疗的患者中，近一半(209例，49%)发生了YMDD变异。发生了YMDD变异的患者疾病进展的比例为11%，而未发生变异者这一比例仅为5%。这一研究提示，患者应用核苷类似物容易出现耐药，而耐药的出现会影响核苷类药物的疗效。 21％；13％；5％。数据再确认一遍 . * 目的：强调派罗欣延长治疗可提高持久免疫控制。 话述：巫善明教授在2008年亚太肝病年会（APASL）上发表的临床试验：49例中国HBeAg阳性慢性乙型肝炎患者接受派罗欣治疗48周，并延长疗程至96周。结果显示派罗欣延长治疗至72周和96周的HBeAg清除率分别为51％和53％，较48周常规治疗提高。 3.3 Per Protocol Population (PP) The Per Protocol analysis population is defined to include patients (i) who satisfy all key study inclusion and exclusion criteria, and (ii) who receive at least four weeks of study medication, that is at least 4 doses of PEG-IFN. Patients who receive treatment other than that intended will be analyzed according to treatment received. Treatment received will be defined as defined in Section 3.5. Note also that: 3.5 Definition of Treatment Received For the Per Protocol Population and the Safety Population patients who receive treatment other than that intended will be analyzed according to treatment received. The definition of treatment received for dose and duration is as follows. Duration Received Duration of treatment will be based on the last date that study medication was taken. Patients that received less than or equal to 28 weeks of treatment will be analysed according to the 24 week treatment arm. Patients that received greater than 28 weeks of treatment will be analysed according to the 48 week treatment arm. This allows a 4-week window for patients who missed doses and ran slightly behind treatment schedule. This means that some patients randomized to 48 weeks were analysed as 24 weeks because only received =24 weeks Rx. 江家骥教授在2008年美国肝病年会（AASLD）上发表的临床试验：65例HBeAg阳性慢性乙型肝炎患者接受派罗欣治疗48 周后，部分应答者接受24 周的派罗欣延长治疗至72周（16例） ，或单纯随访至治疗结束后24周（15例）。结果显示，派罗欣72周延长治疗期间HBeAg与HBsAg定量持续下降。 Preliminary results suggest a benefit of extending therapy Extending PEGASYS therapy provided sustained immune control in more patients Analyses are underway to investigate: Which pati