韩国研究人员对慢性乙型肝炎患者进行了一项大型上市后监测研究，以探讨恩替卡韦（ ETV ）的安全性和疗效并分析影响恩替卡韦（ ETV ）安全性和有效性的因素。研究结果在第64届美国肝病研究学会（AASLD）年会公布。

研究方法

132家医疗机构的3444例患者入选，并收集了2006年5月至2012年5月的数据。研究者记录了观察到的及患者报告的不良事件（AE）发生率以进行安全性评估。对ETV治疗16周以上的患者进行实验室检测与总疗效评价。进行统计分析，确定影响ETV安全性和有效性的因素。

研究结果 

3444例患者中，3367例进行了安全性评估，3115例进行了疗效评估。255例（ 7.57％ ）例病例报告了380次不良事件，胃肠道系统不良事件如胃灼热，消化不良，恶心，上腹疼痛较常见。54例（1.6％）患者出现67次药品不良反应（ADR ），无法排除与恩替卡韦治疗的因果关系。188 例（ 5.58％ ）病例出现253次意外不良事件。9例（ 0.27％ ）出现19次严重不良事件，如肝癌、腹水、腹腔出血、胃肠道出血、胆管炎、败血症和肝性脑病。根据医生的评估，所有这些报告可能与 ETV 无关。 “治疗史”和“合并用药”因素影响AE的发生率。疗效评估显示，总有效率为96.53％（3007例/ 3115例）。ETV治疗后，肝功生化指标如白蛋白和胆红素得到改善。

结论

这项大型上市后恩替卡韦治疗患者监测研究表明，韩国现实生活中的慢性乙型肝炎患者对恩替卡韦耐受性良好且临床有效。

原文摘要

BACKGROUND/AIM: A large-scaled post marketing surveillance study was carried out to investigate safety and efficacy profile and to analyze the factors which are considered to affect safety and efficacy of entecavir (ETV) in Korean patients with chronic hepatitis B in real life setting. 

METHODS: From 132 institutions, 3,444 patients were enrolled from May 2006 to May 2012 and collected data. For the safety assessment, investigators recorded the occurrence of observed and patient-reported adverse events(AEs). Laboratory test and overall efficacy were evaluated for efficacy assessment in patients treated with ETV more than 16 weeks. Statistical analyses were conducted to identify the factor affecting on safety and efficacy of ETV.

RESULTS: Of the 3,444 patients, 3,367 patients were evaluated for safety and 3,115 patients for efficacy assessment. Totally 380 AEs were reported in 255 (7.57%) cases and events associated with gastrointestinal system such as heartburn, dyspepsia, nausea and epigastric pain were commonly observed AEs. 67 adverse drug reactions (ADRs) which cannot be excluded the causality with ETV therapy were reported in 54 (1.6%) cases. Unexpected AEs were 253 events in 188 (5.58%) case. 19 serious AEs such as hepatoma, ascites, intraabdominal hemorrhage, gastrointestinal bleeding, cholangitis, sepsis and hepatic encephalopathy were reported in 9 (0.27%) patients and all of those were reported as ‘probably not related to ETV’ according to physician’s evaluations. The factors of ‘medical history’ and ‘concomitant medication’ influence on the incidence rate of AE. In efficacy evaluation, overall efficacy rate was 96.53% (3,007/3,115 patients). Liver function markers such as albumin and bilirubin were improved after ETV therapy.

CONCLUSIONS: This large-scaled post marketing surveillance study of patients treated with entecavir showed that entecavir was well tolerated and clinically effective in Korean patients with chronic hepatitis B in real life. 

更多阅读

[AASLD2013]NA治疗成功的患者或可安全停药

[AASLD2013]TDF和拉米夫定均可预防HBV围产期传播

【专家视点】乙肝长期抗病毒治疗优选恩替卡韦

(本网站所有内容，凡注明来源为“医脉通”，版权均归医脉通所有，未经授权，任何媒体、网站或个人不得转载，否则将追究法律责任，授权转载时须注明“来源：医脉通”。本网注明来源为其他媒体的内容为转载，转载仅作观点分享，版权归原作者所有，如有侵犯版权，请及时联系我们。)