Efficacy and safety of raltegravir-based therapy in antiretroviral-naive patients with HIV-1 infection: A Meta-analysis
- 公共卫生－已发表论文 
目的评价联合雷特格韦治疗方案用于人类免疫缺陷病毒-1 human immunodeficiency virus; 1,HIV-1)初次抗病毒治疗的安全性和有效性。方法检索联合雷特格韦用于HIV-1感染者初次抗病毒治疗的临床随机对照试验(randomized; controlled trial,RCT),采用Rev Man 5.2软件和Stata; 12.0进行Meta分析。结果纳入17个RCT,Meta分析结果:以血浆病毒载量<50拷贝/ml为治疗有效。在治疗48周及96周,试验组有效率分; 别为84.21%、87.30%,与对照组相比差异均无统计学意义(均有P; >0.05);治疗240周,试验组有效率高于对照组(70.2%和61.5%),合并效应量(RR = 1.15,95% CI: 1.03 ~; 1.28,P = 0.010)。试验组与对照组在腹泻、恶心、头晕、头痛、失眠等常见不良反应差异均无统计学意义(均有P; >0.05);其中96周及144/156周时脂质代谢异常增高合并效应量RR(95%; CI)分别低密度脂蛋白0.16(0.05~0.49)、0.20(0.08~0.48),甘油三酯0.12(0.02~; 0.59)、0.12(0.03~0.59),总胆固醇0.04(0.00~0.40)、0.04(0.00 ~; 0.34)。脂质代谢指标异常增高发生率,试验组均少于对照组,差异均有统计学意义(均有P<0.05)。结论雷特格韦联合核苷类逆转录酶抑制剂、非核苷; 类逆转录酶抑制剂或蛋白酶抑制剂可以作为HIV-1/艾滋病初次抗病毒治疗的可选方案,与目前推荐的抗病毒治疗方案疗效相当,且安全性较好,其中脂质代谢; 异增高常明显减少,但受纳入研究对象的限制,需要更多研究进一步证验证。Objective To systematically review the efficacy and safety of; raltegravir-based therapy in antiretroviral-naive patients with HIV; infection. Methods The data on randomized controlled trial (RCT) of; raltegravir-based therapy in antiretroviral-naive patients with HIV-1; infection were collected, and analyzed using Rev Man 5.2 and Stata 12.0; software. Results A total of 17 RCTs were included. At weeks 48, 96,; there were no significant differences (all P > 0.05) between the; raltegravir group and control group, proportion of patients with; virological response (plasma viral load < 50 copies/ml) in raltegravir; group were 84.2% and 87.3%, respectively. At weeks 240,70.2% versus; 61.5% achieved plasma viral load <50 copies/m in the raltegravir group; and control group (RR = 1.15, 95% CI: l.03-1.28, P=0.010). The incidence; rate of drug-related clinical common adverse events (including diarrhea,; nausea,dizziness, headache, in-somnia)in both groups were not; significantly different (all P > 0.05) at weeks 48 and 96, respectively.; At weeks 96,144/156, the mean changes from baseline in LDL-cholesterol; (LDL) 0.16(0.05-0.49), 0.20 (0.08-0.48), triglyceride (TG); 0.12(0.02-0.59), 0.12(0.03-0.59) and total cholesterol (TC),; 0.04(0.00-0.40), 0.04(0.00-0.34) concen-trations, the raltegravir-based; regimens group had a lower incidence rate than the control group (all P; < 0.05). Conclusions Current evidence shows that the raltegravir-based; therapy had long-term and well tolerated antiretroviral activity, which; was non-inferior to current regimens recommended for; antiretroviral-native adults and adolescents with HIV-infection. Due to; limited quality and quantity of the included studies, more high quality; studies would be needed to verify the above conclusion.