恩替卡韦在韩国慢性乙型肝炎患者中的安全性和有效性的大

StephenW

Korean J Intern Med. 2017 Dec 13. doi: 10.3904/kjim.2016.111. [Epub ahead of print]
Large-scale surveillance study of the safety and effectiveness of entecavir in Korean patients with chronic hepatitis B.
Kim CW1, Kim CS2, Kim HY1, Lee CD1, Yu K3, Llamoso C4, Lee HJ5.
Author information
Abstract
Background/Aims:

Entecavir (ETV) is effective and safe antiviral agent against hepatitis B virus (HBV) in clinical and real-world setting but, most studies were performed in single institute or have limitation in patient's number. A large-scale nation-wide real-world surveillance study was carried out to investigate safety, efficacy and clinical effectiveness of ETV in Korean patients with chronic hepatitis B (CHB).
Methods:

Between 2006 and 2012, 3,444 patients were enrolled from 132 Korean institutions. For the safety assessment, investigators recorded the occurrence of observed and patient-reported adverse events (AEs), as well as laboratory abnormalities. Efficacy, which consisted of change in HBV DNA and alanine aminotransferase (ALT), was evaluated in patients who had received at least 16 weeks of ETV treatment. Overall clinical effectiveness, based on improvement of ALT, HBV DNA and patient's symptoms, was evaluated by physicians.
Results:

Of the patients, 3,367 were evaluated for safety and 3,115 for efficacy and clinical effectiveness. Three hundred and eighty AEs were reported in 255 cases (7.57%), and 67 adverse drug reactions in 54 cases (1.6%). Serious AEs (SAE) were 19 events in nine cases (0.27%). Serious adverse drug reactions (SADR) were three events in two cases (0.06%), and unexpected SAE/SADR were three events in two cases (0.06%). Medical history and concomitant medications were factors influencing incidence rates of AEs. Overall clinical effectiveness rate was 96.53%, which was clinically assessed as marked improved or improved state.
Conclusions:

This study showed that ETV was well tolerated and clinically effective in Korean patients with CHB in a real-world nation-wide setting.
KEYWORDS:

Drug-related side effects and adverse reactions; Entecavir; Hepatitis B, chronic; Product surveillance, postmarketing

PMID:
    29228519
DOI:
    10.3904/kjim.2016.111

StephenW

韩国J Intern Med。 2017 Dec 13。doi：10.3904 / kjim.2016.111。 [电子版提前打印]
恩替卡韦在韩国慢性乙型肝炎患者中的安全性和有效性的大规模监测研究
Kim CW1，Kim CS2，Kim HY1，Lee CD1，Yu K3，Llamoso C4，Lee HJ5。
作者信息
抽象
背景/目的：

恩替卡韦（ETV）在临床和现实环境中是有效且安全的抗乙型肝炎病毒（HBV）的抗病毒药物，但大多数研究是在单一研究所进行或对患者数量有限制。对韩国慢性乙型肝炎（CHB）患者进行ETV的安全性，有效性和临床有效性进行了大规模的全国范围的现实世界的监测研究。
方法：

从2006年到2012年，有132个韩国院校招收了3,444名患者。对于安全性评估，研究者记录了观察到的和患者报告的不良事件（AE）以及实验室异常的发生。在接受至少16周的ETV治疗的患者中评估了由HBV DNA和丙氨酸转氨酶（ALT）的变化组成的效力。基于ALT，HBV DNA和患者症状的改善的整体临床效果由医师评估。
结果：

其中3,367例安全性评估，3,115例评估疗效和临床有效性。 255例（7.57％）报告有380例AE，54例（1.6％）有67例药物不良反应。严重不良事件（SAE）共发生19起，其中9起（0.27％）。严重的药物不良反应（SADR）有2例发生3例（0.06％），2例发生意外的SAE / SADR 3例（0.06％）。病史和伴随药物是影响AE发病率的因素。整体临床有效率为96.53％，临床评估为显着改善或改善状态。
结论：

这项研究表明，ETV在韩国CHB患者中在全国范围内具有良好的耐受性和临床有效性。
关键词：

与药物有关的副作用和不良反应;恩替卡韦;乙型肝炎，慢性;产品监督，上市后

结论：
    29228519
DOI：
    10.3904 / kjim.2016.111

StephenW

http://kjim.org/journal/view.php?doi=10.3904/kjim.2016.111