目的 探讨人免疫缺陷病毒(hiv)和丙型肝炎病毒(hcv)合并感染者高效抗反转录病毒治疗(haart)的疗效.方法 采用双盲法随机选择hiv/hcv合并感染者63例(a组),单纯hiv感染者62例(b组).其中a组通过spw-pb网络数据平台按1∶1∶1随机分为a1、a2和a3组,分别采用以奈韦拉平(nvp)、依非韦伦(efv)和洛匹那韦/利托那韦(lpv/r)为基础的三种haart方案治疗.观察免疫学、病毒学指标及不良反应发生率.采用spss 13.0软件进行统计学分析.多组间比较采用one-way anova,组间两两比较采用lsd-t检验.结果 治疗48周后,a组hiv rna转阴率为93.7％ (59/63),b组为98.4％( 61/62),两组间比较差异无统计学意义(x2=0.159,p＞0.05);a组cd4 +t淋巴细胞计数为(208±77)个/μl,明显低于b组(263±78)个/μl(t=-2.759,p =0.008);a组alt均值为(57±49) u/l,明显高于b组(31±14) u/l(t =2.027,p=0.047);a3组cd4 +t淋巴细胞计数明显高于a1组,差异有统计学意义(t=-2.191,p=0.045);a1组alt均值高于a2、a3组,差异有统计学意义(t=2.568和2.478,p值均＜0.05).hiv/hcv合并感染组治疗过程中药物性肝炎的发生率明显高于hiv单纯感染组(55.5％vs.27.4％),两组比较差异有统计学意义(x2= 10.182,p=0.001).结论 hiv/hcv合并感染不影响haart的病毒学疗效,但可能影响患者的免疫重建.hiv/hcv感染者haart期间肝脏毒性反应较常见,尤以nvp方案明显.推荐hiv/hcv感染者采用lpv/r的haart方案.; abstract：; objective to investigate the efficacy of highly active antiretroviral therapy (haart) for hiv/hcv co-infection patients. methods a randomized and double blinded trial was conducted in sixty-three hiv/hcv co-infected patients ( group a) and 62 hiv infected patients ( group b). the group a (study group) was further divided into a1, a2, a3 subgroups randomly by spw-pb network data system, and were given three different haart regimens based on nevirapine (nvp), efavirenz (efv) and lopinavir/ritonavir(lpv/r), respectively. cd4+ t lymphocyte counts, hiv virus load, glutamate-pyruvate transaminase (alt) were detected at baseline and at the endpoint of study (48 weeks). spss 13.0 was used for statistical analysis. one-way anova and lsd-t tests were performed. results after 48 weeks treatment, hiv rna became negative in 59 patients of group a (59/63, 93.7％ ), while that in group b was 61 (61/62, 98.4％ ) (x2 =0.159, p ＞ 0.05 ). cd4+ t lymphocyte count in group a was (208 ± 77 )/μl, which was significantly lower than that in group b (263 ± 78)/μl (t =-2. 759, p = 0.008 ).alt level in group a was (57 ±49)u/l, which was significantly higher than in group b (31 ± 14) u/l (t = 2. 027, p = 0.047). cd4 + t lymphocyte count in group a3 was significantly higher than that in a1 (t=-2. 191, p =0.045), while alt level in a1 was much higher than that in subgroups a2 and a3 ( t = 2.568 and 2.478, p ＜ 0.05 ). the incurrence of drug-induced hepatitis in hiv/hcv co-infected group was much higher than that in hiv infected group (55.5％ vs. 27.4％, x2 = 10.182, p = 0.001 ).conclusions hcv co-infection in hiv patients shows no impact on virological response to haart, but the immunological response is poorer. hepatotoxicity is common among patients receiving haart, especially those who are receiving nvp containing regimens. lpv/r based regimens are recommend for hiv/hcv coinfected patients.