兰州大学机构库 >第一临床医学院
难治性慢性丙型肝炎初治患者优化治疗后的病毒学应答率研究
2015
Source Publication中华肝脏病杂志   Impact Factor & Quartile Of Published Year  The Latest Impact Factor & Quartile
ISSN1007-3418
Volume23Issue:6Pages:412-417
Abstract目的通过前瞻性、开放性、多中心、随机临床研究,利用早期病毒学应答(EVR)对疗效的预测作用,建立适合我国难治性慢性丙型肝炎(RHC)初治患者的优化治疗方案。方法通过18个临床中心纳入438例患者资料,先统一进行聚乙二醇干扰素α联合利巴韦林治疗12周,然后根据完全早期病毒学应答(cEVR)情况分组,获得cEVR的患者进A组继续进行标准治疗至48周;未获得cEVR的患者进入B组:随机进入B1组(继续治疗至72周)和B2组(继续治疗至96周)。随访24周。检测患者治疗前后、治疗中和随访中的HCV RNA水平作为疗效评价的指标。用CMH检验或Fisher检验分析各组病毒学应答率的比较。结果总的持续病毒学应答(SVR)率为85.1%。其中91.0%的患者获得cEVR进入A组,A组SVR率高达90.8%。B1、B2组间SVR率差异无统计学意义(29.4% 比25.0%,P > 0.05)。感染基因1型HCV患者的SVR率为83.3%。感染IL28B CC型患者的SVR率为89.8%。本研究中快速病毒学应答(RVR)、cEVR和延迟病毒学应答(DVR)对SVR的阳性预测率分别为93.4%、90.8%和77.8%; RVR, EVR和DVR对SVR的阴性预测率分别为28%、93.3%和100%。治疗过程中,不良反应发生率为66.9%,但严重不良反应发生率仅为1.9%。结论中国RHC 初治患者中绝大部分(91.0%)可获得cEVR,而通过cEVR分组对RHC初治患者进行个体化治疗的疗效很好,这一治疗方案具有较好的安全性和耐受性。
Other AbstractObjective To perform a prospective, multicenter, open, randomized study to determine a treatment regimen for treatment-naive patients with refractory chronic hepatitis C (RHC) using the predictive value (PV) of early virological response (EVR). Methods A total of 438 patients from 18 hospitals were recruited between December 2008 and December 2010 and administered peg-interferon/ribavirin treatment for 12 weeks. Patients who achieved complete EVR (cEVR) were assigned to group A for a 48-week course of treatment, while patients without cEVR were randomly allocated to either group Bl for a 72-week course of treatment or to group B2 for a 96-week course of treatment. Serum hepatitis C virus RNA levels at baseline, treatment weeks 4, 12 and 24, end of treatment, and post-treatment week 24 were measured and used to evaluate the efficiency of therapy. Results The overall sustained virological response (SVR) rate was 85.1%. In all, 91.0% of patients achieved cEVR and were assigned to group A,which had an SVR rate of 90.8%. There was no statistically significant difference in the SVR rates of groups B1 and B2 (29.4% vs. 25.0%, P > 0.05). The positive PV of rapid virological response (RVR), cEVR and delayed virological response (DVR) for SVR was 93.4%, 90.8% and 77.8% respectively, and the negative PV of RVR, EVR and DVR for SVR was 28.0%, 93.3% and 100% respectively. Overall, 66.9% of the patients experienced adverse events (AEs), but only 1.9% of patients experienced severe AEs. Conclusion The majority of Chinese RHC treatmentnaive patients (91.0%) can achieve cEVR and a high SVR rate with a low rate of severe AEs using the cEVR guided personal treatment regimen.
Keyword肝炎,丙型,慢性 干扰素α-2a 利巴韦林 初治患者
DOI10.3760/cma.j.issn.1007-3418.2015.06.004
Publication PlaceCHONGQING
Indexed ByPubMed ; MEDLINE ; CSCD
Language中文
First Inst
Funding Project国家科技重大专项
Host of Journal中华医学会
Project Number国家“十二五”科技重大专项 ; 国家“十一五”科技重大专项 ; 国家“十二五”科技重大专项
CSCD IDCSCD:5451135
Funding OrganizationMOST
PMID 26236925
IRIDCSCD2284
Department
首都医科大学附属北京佑安医院;
河南省人民医院;
北京大学人民医院;
上海交通大学医学院附属瑞金医院;
中山大学附属第三医院;
北京大学第一医院;
中国医科大学盛京医院;
中南大学附属湘雅二医院;
解放军第三0二医院;
南京医科大学第一附属医院...更多
Citation statistics
Cited Times:5[CSCD]   [CSCD Record]
Document Type期刊论文
Identifierhttps://ir.lzu.edu.cn/handle/262010/186955
Collection第一临床医学院
Recommended Citation
GB/T 7714
陈新月,尚佳,杨瑞锋,等. 难治性慢性丙型肝炎初治患者优化治疗后的病毒学应答率研究[J]. 中华肝脏病杂志,2015,23(6):412-417.
APA 陈新月.,尚佳.,杨瑞锋.,谢青.,高志良.,...&魏来.(2015).难治性慢性丙型肝炎初治患者优化治疗后的病毒学应答率研究.中华肝脏病杂志,23(6),412-417.
MLA 陈新月,et al."难治性慢性丙型肝炎初治患者优化治疗后的病毒学应答率研究".中华肝脏病杂志 23.6(2015):412-417.
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