联合雷特格韦用于HIV-1初次治疗有效性和安全性的Meta分析

Efficacy and safety of raltegravir-based therapy in antiretroviral-naive patients with HIV-1 infection:A Meta-analysis

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)分别为: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：1.03-1.28,P =0.010）.The incidence rate of drug-related clinical common adverse events （including diarrhea,nausea,dizziness,headache,insomnia） 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） concentrations,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.