聚乙二醇干扰素α联合利巴韦林治疗人类免疫缺陷病毒合并丙型肝炎病毒感染者最佳时机的探讨  

Discussion on optimal duration of pegylated interferon a combined with ribavirin for chronic hepatitis C in HIV-infected patients

作　　者：柯迎春[1] 李凌华[1] 胡凤玉[2] 兰芸[2] 何耀祖[1] 陈谐捷[1] 唐小平[2] 蔡卫平[1] 卢瑞朝 何艳[4] 李惠琴 Ke Yingchun;Li Linghua;Hu Fengyu;Lan Yun;He Yaozu;Chen Xiejie;Tang Xiaoping;Cai Weiping;Lu Ruichao;He Yan;Li Huiqin(Department of Infectious Diseases, Eighth People＇s Hospital, Guangzhou 510060, China;Research Institution, Eighth People＇s Hospital, Guangzhou 510060, Chin;Department of Infectious Diseases, Guangxi Zhuang Autonomous Region Longtan Hospital, Liuzhou 545005, Chin;Department of Infectious Disease, the Second Xiangya Hospital, Central South University, Changsha 410011, China;Yunnan Provincial Hospital of Infectious Diseases, Yunnan AIDS Care Center, Kunming 650301, China)

机构地区：[1]广州市第八人民医院感染科,510060 [2]广州市第八人民医院研究所,510060 [3]广西壮族自治区龙潭医院,柳州545005 [4]中南大学湘雅二医院,长沙410011 [5]云南省艾滋病关爱中心,昆明650301

出　　处：《中华肝脏病杂志》2018年第4期282-287,共6页Chinese Journal of Hepatology

基　　金：“十二”五国家科技支撑计划项目（2012ZX10001003）

摘　　要：目的探讨聚乙二醇干扰素α（Peg—INFα）联合利巴韦林（RBV）治疗人类免疫缺陷病毒（HIV）合并丙型肝炎病毒（HCV）感染者的最佳时机。方法为前瞻性多中心研究，A组：158例，HIV合并HCV感染者；B组：对照组，60例，单一HCV感染者，均接受Peg—INFα联合RBV标准治疗。A组根据CD4^＋T淋巴细胞计数分为3个亚组：A1组，79例，CD4^＋T淋巴细胞〉350个／μl，先抗HCV治疗再进行联合抗病毒治疗（cART）；A2组，45例，CD4^＋T淋巴细胞200～350个／μl，先给予cART，耐受后开始抗HCV治疗;A3组，34例，CD4^＋T淋巴细胞〈200个／μl，先给予cART，待CD4^＋T淋巴细胞〉200个／μl开始抗HCV治疗。比较各组及亚组问抗HCV的疗效。对于服从正态分布、方差齐性资料两组之间采用t检验，计数资料采用χ^2检验（或Fisher确切概率法），非正态数据采用Mann-Whitney U检验。多组均数比较采用单向方差分析，随后进行SNK检验。多组疗效比较采用多个独立样本非参数检验。结果各组及亚组年龄、基线HCVRNA水平，差异无统计学意义（P值均〉0．05）。两组意向性分析：A组完全早期病毒学应答率（cEVR）率75．3％（119／158），治疗结束时病毒学应答（eTVR）率68．4％（108／158），持续病毒学应答（SVR）率48．7％（77／158）；B组cEVR率93．3％（56／60），eTVR率90．0％（54／60），SVR率71．7％（43／60），A组各疗效指标明显低于B组，差异有统计学意义（P值均〈0．05）。经过符合方案分析，A组cEVR率仍低于B组（P〈0．05），但eTVR率及SVR率与B组比较，差异无统计学意义（P值均〉0．05）。A组各亚组间疗效比较，意向性分析：A1亚组cEVR率78．5％（62／79），eTVR率68．4％（54／79），SVR率41．8％（33／79）；A2亚组cEVR率75．6％（34／45）。eTVR率80．0％（36／45），SVR率64．4％（29／45）；A3亚组cEVR率67．6％（23／34Objective To investigate the optimal duration ofpegylated-alpha interferon （Peg-INFα） combined with ribavirin （RBV） in treating chronic hepatitis C infection in human immunodeficiency virus （HIV）-infected patients. Methods A multicenter prospective study was conducted. The study subjects were divided into two groups; HIV/HCV co-infections （Group A, n = 158） and control with HCV-monoinfections （Group B,n = 60）. All recruited patients received standard Peg-INFer plus RBV therapy. Group A was divided into 3 subgroups according to CD4^＋ cell counts： A1 subgroup, 79 cases, CD4^＋ counts 〉 350 cells/μl, who received anti-HCV before combination antiretroviral therapy（cART）; A2 subgroup, 45 cases, CD4^＋ counts between 200 and 350 cells/μl, who did not start anti-HCV until they could tolerate cART well; A3 subgroup, 34 cases, CD4^＋ counts 〈 200 cells/pl, cART was administered first, and anti-HCV therapy was started when CD4^＋ counts 〉 200 cells/μl. The anti-HCV efficacy of two groups and 3 subgroups were compared. Statistical analysis for normal distribution and homogeneity of variance data was calculated by t-test and the counting data was analyzed by χ^2 test. The Mann-Whitney Utest was used for non-normal data. A one-way analysis of variance （ANOVA） was used for the comparison of multiple groups, followed by SNK method. Multiple independent samples were used for non-parametric tests. Results There was no significant difference in age and baseline HCV RNA levels between groups and subgroups （P 〉 0.05）. By an intent-to-treat （ITT） analysis, in Group A, the ratio of complete early virological response （cEVR） rate was 75.3% （119/158）, the ratio of end of treatment virological response （eTVR） rate was 68.4% （108/158）, and the ratio of sustained virological response （SVR） rate was 48.7% （77/158）; in Group B, the ratio of cEVR rate was 93.3% （56/60）, the ratio of eTVR rate was 90.0% （54/60）, and the ratio of SVR rate was 71.7% （43/60

关 键 词：肝炎病毒 丙型 利巴韦林 人类免疫缺陷病毒 疗效 聚乙二醇干扰素Α CD4^+T淋巴细胞 

分 类 号：R512.63[医药卫生—内科学] R512.91[医药卫生—临床医学]