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口服核苷(酸)类似物长期安全治疗慢性乙型肝炎的53,500受 [复制链接]

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发表于 2015-8-25 15:44 |只看该作者 |倒序浏览 |打印
Long-term safety of oral nucleos(t)ide analogs for patients with chronic hepatitis B: A cohort study of 53,500 subjects

    Grace Lai-Hung Wong1,2,3, Yee-Kit Tse1,2, Vincent Wai-Sun Wong1,2,3, Terry Cheuk-Fung Yip4, Kelvin Kam-Fai Tsoi5 andHenry Lik-Yuen Chan1,2,3,*

Article first published online: 28 JUL 2015

DOI: 10.1002/hep.27894

© 2015 by the American Association for the Study of Liver Diseases


Hepatology

Volume 62, Issue 3, pages 684–693, September 2015
Article has an altmetric score of 5


    1    Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong
    2    Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong
    3    State Key Laboratory of Digestive Disease, The Chinese University of Hong Kong, Hong Kong
    4    Department of Statistics, The Chinese University of Hong Kong, Hong Kong
    5    Big Data Decision Analytics Research Center, The Chinese University of Hong Kong, Hong Kong

*Address reprint requests to: Henry L.Y. Chan, M.D., Department of Medicine and Therapeutics, 9/F Prince of Wales Hospital, 30-32 Ngan Shing Street, Shatin, Hong Kong. E-mail: [email protected]; fax: +1-852-2637-3852.

    Potential conflict of interest: Dr. Grace Wong advises, is on the speakers’ bureau, and received grants from Otsuka. She is on the speakers’ bureau and received grants from Bristol-Myers Squibb, Echosens, and Furui. She advises AbbVie and Gilead. Dr. Vincent Wong advises and is on the speakers’ bureau for Roche and Novartis. He advises Otsuka, Gilead, and AbbVie. He is on the speakers’ bureau for Bristol-Myers Squibb, Abbott, and Echosens. Dr. Chan consults, is on the speakers’ bureau, and received grants from Roche. He consults and is on the speakers’ bureau for Abbott, Bristol-Myers Squibb, Gilead, Merck, and Novartis. He is on the speakers’ bureau for Echosens and GlaxoSmithKline.



Widespread and long-term use of oral nucleos(t)ide analogs (NAs) to treat chronic hepatitis B (CHB) brings about safety data in a real-life setting. We aimed to determine the risks of renal and bone side effects in patients receiving or who have received NAs as CHB treatment. A territory-wide cohort study using the database from Hospital Authority, the major provider of medical services in Hong Kong, was conducted. We identified CHB patients by International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes, diagnosed between 2000 and 2012. The primary events were renal (incident renal failure and renal replacement therapy [RRT]) and bone events (incident hip, vertebral, and all fractures). A 3-year landmark analysis was used to evaluate the relative risk of primary outcome in patients with or without NA treatment. A total of 53,500 CHB patients (46,454 untreated and 7,046 treated), who were event free for 3 years, were included in the analysis. At a median follow-up of 4.9 years, chronic renal failure, RRT, all fractures, hip fractures, and vertebral fractures occurred in 0.6%, 0.2%, 0.7%, 0.1%, and 0.1% of untreated subjects and 1.4%, 0.7%, 1.3%, 0.2%, and 0.2% of treated subjects. After propensity score weighting, NA therapy did not increase the risk of any of the events (hazard ratios [HRs] ranged from 0.79 to 1.31; P = 0.225-0.887). Exposure to nucleotide analogues, compared with nucleoside analogs, increased the risk of hip fracture (HR = 5.69; 95% confidence interval: 1.98-16.39; P = 0.001), but not other events (HR = 0.58-1.44; P = 0.202-0.823). Conclusions: NA treatment does not increase the risk of renal and bone events in general. Nucleotide analogs may increase the risk of hip fracture, but the overall event rate is low. (Hepatology 2015;62:684–693)

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发表于 2015-8-25 15:44 |只看该作者
口服核苷(酸)类似物长期安全治疗慢性乙型肝炎的53,500受试者进行的队列研究

    格雷斯来红Wong1,2,3,绮套件Tse1,2,文森特惠荪Wong1,2,3,特里焯丰Yip4,开尔文鉴辉Tsoi5 andHenry沥-源Chan1,2,3,*

文章首次在网上公布:2015年7月28日

DOI:10.1002 / hep.27894

©2015年肝病研究的美国协会


肝病

第62卷,第3期,页684-693,2015年九月
文章的altmetric比分5


    消化疾病香港的中国大学1研究所,香港
    内科及药物治疗,香港中国大学,香港2部
    消化疾病,香港的中国大学,香港3个国家重点实验室
    统计的4系,中国香港大学,香港
    5大数据决策分析研究中心,香港中国大学,香港

*地址转载请:亨利L.Y。陈医师,内科及药物治疗,9系/˚F威尔斯亲王医院,银城街30-32,沙田,香港。电子信箱:[email protected];传真:+ 1-852-2637-3852。

    的利益冲突:格蕾丝黄医生建议,是对发言者的电信局,从大冢的赠款。她是对的演讲“从施贵宝,Echosens,以及古井局,并获得资助。她建议艾伯维和基列。王浩信博士建议,并在扬声器的罗氏和诺华局。他建议大冢,基列,和艾伯维。他是发言者对百时美施贵宝,雅培,和Echosens局。陈博士咨询,是对扬声器的局,并从罗氏获得资助。他咨询,并在扬声器的雅培,百时美施贵宝,Gilead公司,默克,诺华和局。他对说话者的为Echosens和葛兰素史克局。



广泛和长期使用口服核苷(酸)类似物(NAS)治疗慢性乙型肝炎(CHB)带来的现实生活环境的安全性数据。我们的目的是确定接收或谁收到来港为慢性乙肝治疗的肾和骨骼的副作用的患者的风险。使用来自医院管理局,香港医疗服务的主要提供者的数据库中的全港性队列研究,进行。我们确定了慢性乙肝患者通过国际疾病分类第9版,临床修正诊断代码,诊断为2000年和2012年的主要事件是肾脏之间(事件肾功能衰竭和肾脏替代疗法[RRT])和骨事件(事件发生髋部,脊椎,和所有的骨折)。为期3年的具有里程碑意义的分析来评估主要结果的患者有无NA治疗的相对风险。共有53,500例慢性乙型肝炎患者(46454未处理和7046处理),谁是事件的分类为3年,被列入分析。在一个位随访4.9年,慢性肾功能衰竭,RRT,所有骨折,髋部骨折,和椎骨骨折发生在0.6%,0.2%,0.7%,0.1%,和未处理的受试者的0.1%和1.4%,0.7 %,1.3%,0.2%,和治疗的受试者的0.2%。经过倾向评分权重,NA治疗并没有增加任何事件风险(风险比[的HR]介于0.79至1.31; P = 0.225-0.887)。曝光到核苷酸类似物,核苷类似物相比,增加的髋部骨折的风险(HR = 5.69; 95%置信区间:1.98-16.39,P = 0.001),但不是其他事件(HR = 0.58-1.44,P = 0.202- 0.823)。结论:NA治疗不会增加总体肾和骨事件的风险。核苷酸类似物可增加髋部骨折的风险,但整体事件率低。 (肝病2015; 62:684-693)

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发表于 2015-8-25 17:14 |只看该作者
服核苷的又一有力佐证,可是没有服核苷对肾功能影响的数据

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发表于 2015-8-25 17:45 |只看该作者
那0.6%和0.7%是什么?
说明对肾影响差别不大。

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发表于 2015-8-25 18:58 |只看该作者
感谢楼主分享
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