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目的研究含洛匹那韦/利托那韦(LPV/r)的抗病毒治疗方案,治疗合并感染丙型肝炎病毒(HCV)的艾滋病病人(HIV/HCV合并感染)的疗效与安全性。方法 52例未接受过抗病毒治疗的HIV/HCV合并感染者,随机分为研究组(26人)和对照组(26人),研究组给予替诺福韦(TDF)+拉米夫定(3TC)+LPV/r方案治疗,对照组给予TDF+3TC+依非韦伦(EFV)方案治疗,随访48周。观察指标包括两组病毒载量、CD+4T淋巴细胞(简称CD4细胞)计数、丙氨酸转氨酶(ALT)、总胆固醇(TC)和甘油三酯(TG)水平,此外观察两组不良反应发生情况。结果48周后,研究组和对照组患者病毒载量均降至50拷贝/mL以下;两组ALT水平接近,差异无统计学意义[(72.8±16.4)U/L vs.(81.2±20.5)U/L,P=0.109];与对照组相比,研究组CD4细胞计数更高[(282.4±105.8)/μL vs.(187.6±110.2)/μL,P=0.003];同时TC和TG水平也明显增高,差异有统计学意义[TC:(6.24±1.83)mmol/L vs.(4.28±0.84)mmol/L,P=0.038;TG:(3.32±1.25)mmol/L vs.(1.55±0.78)mmol/L,P=0.011]。研究组共3例(11.54%)报告有不良反应,其中1例恶心、呕吐,2例腹泻;对照组共出现5例不良反应(19.23%),均为头晕。两组不良反应发生率差异无统计学意义(P>0.05)。结论含LPV/r方案与含EFV抗病毒方案对HIV/HCV合并感染者抗病毒效果接近;含LPV/r方案更有利于CD4细胞计数的提升,但可能引起血脂升高。
Objective To investigate the efficacy and safety of antiviral therapy with lopinavir / ritonavir (LPV / r) in the treatment of AIDS patients (HCV / HCV co-infection) with hepatitis C virus (HCV) infection. Methods Fifty-two HIV / HCV co-infected patients who were not treated with antiviral therapy were randomly divided into study group (26) and control group (26). The study group was given tenofovir (TDF) + lamivudine 3TC) + LPV / r regimen. The control group was treated with TDF + 3TC + EFV regimen for 48 weeks. Observed indicators included two groups of viral load, count of CD4 + T lymphocytes (CD4), ALT, TC and triglyceride (TG). In addition, two groups of adverse reactions were observed Happening. Results After 48 weeks, the viral load of study group and control group decreased to below 50 copies / mL. There was no significant difference in ALT between the two groups [(72.8 ± 16.4) U / L vs. (81.2 ± 20.5) (282.4 ± 105.8) / μL vs. (187.6 ± 110.2) / μL, P = 0.003]. The levels of TC and TG in the study group were significantly higher than those in the control group (TC: 6.24 ± 1.83 mmol / L vs. 4.28 ± 0.84 mmol / L, P = 0.038; TG: 3.32 ± 1.25 mmol / L vs. 1.55 ± 0.78) mmol / L, P = 0.011]. A total of 3 patients (11.54%) in the study group reported adverse reactions, including nausea and vomiting in 1 case and diarrhea in 2 cases. There were 5 adverse reactions (19.23%) in the control group, all of which were dizzy. There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05). Conclusions The anti-virus effect of LPV / r and EFV-containing antiviral programs are similar to that of HIV / HCV co-infected patients. The LPV / r regimen is more beneficial to the increase of CD4 cell count, but may lead to elevated blood lipids.