CAJ | 학술논문

目的了解Telaprevir联合聚乙二醇干扰素(Peg-IFN)α、利巴韦林对基因Ⅰ型HCV感染慢性丙型肝炎患者的疗效及安全性. 方法采用Meta分析方法对国外2009-2011年发表的Telaprevir、Peg-IFN α及利巴韦林三联疗法治疗慢性丙型肝炎的相关研究结果进行合并效应值和异质性相关因素分析.共收集相关文献6篇,累计病例2677例.其中,Telaprevir、Peg-IFN α、利巴韦林治疗组(TPR组)1850例,干扰素α、利巴韦林治疗组(PR组)827例.用Meta分析方法合并OR值或RR值及其95％可信区间.采用基于x2检验的Q检验法分析各研究的组间异质性.通过去除任意一个研究进行敏感性分析,以进一步证实研究结果的可信性. 结果 1850例TPR组患者中,获得快速病毒学应答(RVR)者1041例,占56.3％；获得持续病毒学应答(SVR)者1235例,占66.8％；复发率为12.1％(176/1460).827例PR组患者中,获得RVR者58例,占7.0％；获得SVR者296例,占35.8％；复发率为32.3％ (145/449).TPR组RVR、SVR均明显高于PR组(合并OR值分别为29.83和3.97,95％ CI分别为16.16 ～ 55.05和2.58 ～ 6.11,P值均＜0.01),复发率明显低于PR组(合并RR值为0.36,95％ CI为0.24 ～ 0.56,P＜0.01).结论 Telaprevir联合Peg-IFNα、利巴韦林治疗对HCV基因Ⅰ型的慢性丙型肝炎患者的疗效显著,但要注意防治不良反应.
목적 료해Telaprevir연합취을이순간우소(Peg-IFN)α、리파위림대기인Ⅰ형HCV감염만성병형간염환자적료효급안전성. 방법 채용Meta분석방법대국외2009-2011년발표적Telaprevir、Peg-IFN α급리파위림삼련요법치료만성병형간염적상관연구결과진행합병효응치화이질성상관인소분석.공수집상관문헌6편,루계병례2677례.기중,Telaprevir、Peg-IFN α、리파위림치료조(TPR조)1850례,간우소α、리파위림치료조(PR조)827례.용Meta분석방법합병OR치혹RR치급기95％가신구간.채용기우x2검험적Q검험법분석각연구적조간이질성.통과거제임의일개연구진행민감성분석,이진일보증실연구결과적가신성. 결과 1850례TPR조환자중,획득쾌속병독학응답(RVR)자1041례,점56.3％；획득지속병독학응답(SVR)자1235례,점66.8％；복발솔위12.1％(176/1460).827례PR조환자중,획득RVR자58례,점7.0％；획득SVR자296례,점35.8％；복발솔위32.3％ (145/449).TPR조RVR、SVR균명현고우PR조(합병OR치분별위29.83화3.97,95％ CI분별위16.16 ～ 55.05화2.58 ～ 6.11,P치균＜0.01),복발솔명현저우PR조(합병RR치위0.36,95％ CI위0.24 ～ 0.56,P＜0.01).결론 Telaprevir연합Peg-IFNα、리파위림치료대HCV기인Ⅰ형적만성병형간염환자적료효현저,단요주의방치불량반응.
Objective To evaluate the efficacy and safety oftelaprevir combined with peginterferon alfa (Peg-IFNα) plus ribavirin (RBV) (collectively,TPR therapy) in patients with chronic hepatitis C (CHC) using a meta-analysis approach.Methods The Pubmed literature database was searched for randomized controlled trials of TRP therapy in CHC patients published between 2009 and 2011.The following outcome data was extracted for meta-analysis of efficacy:sustained virological response (SVR),defined as serum HCV RNA of＜ 1000 copies/ml at end-of-treatment (week 24); rapid virological response (RVR),defined as serum HCV RNA of ＜ 1000 copies/ml at treatment week 4; recurrence,defined as serum HCV RNA of ＜ 1000 copies/ mL at end-of-treatment and ＞ 1000 copies/ml at follow-up (week 24 after treatment completion).The pooled odds ratio (OR) or relative risk (RR) were calculated,with 95％ confidence interval (CI).Heterogeneity was assessed by the Chi-squared test based on the Q statistic.Results Six studies of TPR triple therapy,representing a total of 2677 CHC patients,were included in the meta-analysis.Among the 1850 patients who received TPR,56.3％ (n =1041) achieved RVR,66.8％ (n =1235) achieved SVR,and 12.1％ (n =176/1460)experienced recurrence.Among the 827 patients who received PR double-therapy,7.0％ (n =58) achieved RVR,35.8％ (n =296) achieved SVR,and 32.3％ (n =145/449) experienced recurrence.The TRP group had significantly higher rates of RVR (OR =29.83,95％ CI:16.16 ～ 55.05) and SVR (OR =3.97,95％ CI:2.58 ～ 6.11)than the PR group (both P ＜ 0.01),and significantly lower rate of recurrence (RR =0.36,95％ CI:0.24 ～ 0.56,P ＜ 0.01).Conclusion The therapeutic effect of research group is better than that of control group,suggesting that omithine aspartate combined with naloxone treatment in hepatic encephalopathy is worthy of promoting.