关于中国《慢性乙型肝炎防治指南（2010年版）》的修改建议

2015-09-09 宁琴韩梅芳吴迪中国医学论坛报

2010年版指南缺少对于核苷(酸)类似物(NUC)经治并取得一定疗效的慢性乙型肝炎(CHB)患者进一步优化抗病毒治疗方案的推荐，而这部分经治患者在临床上占相当大比例;并且仅有干扰素初治患者的干扰素抗病毒疗效的预测因素推荐，不适用于长期经核苷(酸)类似物治疗并序贯联合干扰素的CHB患者。        核苷(酸)类似物经治的CHB患者干扰素序贯联合治

2010年版指南缺少对于核苷(酸)类似物(NUC)经治并取得一定疗效的慢性乙型肝炎(CHB)患者进一步优化抗病毒治疗方案的推荐，而这部分经治患者在临床上占相当大比例;并且仅有干扰素初治患者的干扰素抗病毒疗效的预测因素推荐，不适用于长期经核苷(酸)类似物治疗并序贯联合干扰素的CHB患者。

核苷(酸)类似物经治的CHB患者干扰素序贯联合治疗方案

修改建议建议增加核苷(酸)类似物经治的CHB患者，获得部分病毒学/血清学应答[包括HBVDNA阴转和(或)HBeAg阴转]，可考虑序贯或联合PEG-IFN治疗，已有研究显示，该治疗方案具有良好的安全性，并有望改善疗效，获得更高水平的血清学应答。

修改理由 ①随着核苷(酸)类似物抗病毒治疗的广泛普及，经治CHB患者的优化治疗已成为临床的难点与热点。核苷(酸)类似物长期治疗可导致治疗费用高、耐药率增加以及依从性降低，从而影响治疗疗效。

②由于PEG-IFN与核苷(酸)类似物的作用机制及特点不同，两者适时的序贯/联合使用可提高核苷(酸)类似物经治慢乙肝患者的抗病毒疗效。研究表明序贯或联合使用PEG-IFN可有效缩短、终止核苷(酸)类似物长期治疗。OSST研究采用序贯联合方式，即恩替卡韦(ETV)单药治疗9个月以上、继而PEG-IFN和ETV重叠使用8周、之后PEG-IFN继续单药使用48周，该序贯联合方式较对照组ETV单药治疗的方式显著提高血清学应答率，HBsAg阴转率达8.5%。多项小样本研究同样表明拉米夫定(LAM)、阿德福韦((ADV)或ETV序贯联合干扰素治疗与单药治疗相比较可能获得更好的疗效，且安全性良好。ARES研究结果显示，CHB患者经ETV单药治疗24周后加用PEG-IFN联合治疗24周，与对照组ETV单药治疗相比，可能获得更高的停药后持久应答率。这些数据为长期使用核苷(酸)类似物治疗而难以停药的难治性CHB患者提供新的优化治疗策略，目前国内外正在进行多项临床研究或临床实践进一步验证。会议报道NEWSWITCH[经治患者以及PEG-IFN与TDF联合使用(初治患者)]的研究结果显示了与OSST相似的临床疗效，期待数据正式发表。

核苷(酸)类似物经治CHB患者干扰素序贯联合抗病毒治疗疗效的预测因素

修改建议建议增加：核苷(酸)类似物经治CHB患者，若HBeAg阴转且HBsAg<1500IU/ml，序贯联合PEG-IFN治疗，其治疗疗效更佳，尤其对于PEG-IFN治疗12周HBsAg者，有望获得较高水平的HBsAg清除率。

修改理由 HBsAg水平或变化能够预测PEG-IFN或核苷(酸)类似物抗病毒的治疗应答。OSST研究结果显示，ETV经治患者HBVDNA≤103copies/ml时，对HBeAg转阴且HBsAg<1500IU/ml患者予以PEG-IFN序贯治疗，HBsAg清除率达25%，PEG-IFN治疗12周HBsAg48周最佳治疗疗效，HBsAg清除率高达77.8%。相反，如果患者PEG-IFN治疗12周后其HBsAg>1500IU/ml，则仅有1.7%获得HBsAg清除，阴性预测值(NPV)为98%，建议终止干扰素治疗，考虑其他治疗策略。该研究结果已经被国内外临床实践验证实用且有效。综上，对于核苷(酸)类似物经治序贯联合使用PEG-IFN的患者，基线及治疗12周较低水平的HBsAg，可帮助预测更高水平的血清学应答。

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2016-08-24 doctorJiangchao

继续学习

52 0
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2016-08-23 医路开来

学习啦，很不错

56 0
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2015-09-13 bioon3

#防治指南#

27 0
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2016-07-15 okhuali

#乙型肝炎#

31 0
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2016-01-13 Lynee劲飞扬

学习啦

144 0
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2015-12-30 xyfg98

比之前的更明确些

76 0
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2015-12-30 xyfg98

有价值

40 0
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2015-10-15 ms7405317358118777

#肝炎防治#

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