摘要:
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。
Abstract:
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.
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