多拉韦林联合NRTIs治疗成人初治HIV感染者有效性和安全性研究

    Study on the efficacy and safety of Dolavirin combined with NRTIs in the treatment of newly diagnosed adult HIV infection

    • 摘要:
      目的: 探究多拉韦林联合核苷酸类逆转录酶抑制剂(NRTIs)在感染人类免疫缺陷病毒(HIV)病人治疗中的有效性和安全性。
      方法: 将88例成人初治HIV感染者随机分为观察组和对照组,各44例。所有受试者均口服恩曲他滨替诺福韦片500 毫克/次,1次/天。在此基础上,对照组联合依非韦伦治疗,口服依非韦伦片600 毫克/次,1次/天;观察组联合多拉韦林治疗,口服多拉韦林片100 毫克/次,1次/天。治疗48周后,检测病人血浆HIV RNA、低密度脂蛋白胆固醇(LDL–C)、非高密度脂蛋白胆固醇(Non–HDL–C)、总胆固醇和甘油三酯水平,并记录治疗期间的药物不良反应。
      结果: 治疗第48周时,36例(81.82%)观察组和35例(79.55%)对照组病人的血浆HIV RNA < 50 copies/mL,2组比较差异无统计学意义(P > 0.05)。治疗前(基线),2组病人的LDL–C、Non–HDL–C、总胆固醇和甘油三酯表达量比较差异均无统计学意义(P > 0.05)。自基线至治疗第48周,对照组病人的LDL–C、Non–HDL–C、总胆固醇和甘油三酯水平均升高,观察组病人的LDL–C、Non–HDL–C、总胆固醇和甘油三酯水平均降低;且2组间比较差异均有统计学意义(P < 0.05 ~ P < 0.01)。2组病人的不良反应以腹泻、头晕等发生率较高,组间比较差异均无统计学意义(P > 0.05)。
      结论: 多拉韦林联合NRTIs治疗成人初治HIV感染者,疗效确切且安全性良好,具有更好的血脂谱表现。

       

      Abstract:
      Objective To explore the efficacy and safety of Dolavirin combined with nucleotides reverse transcriptase inhibitors (NRTIs) in the treatment of patients infected with Human Immunodeficiency Virus (HIV).
      Methods A total of 88 newly diagnosed adult HIV infected patients were randomly divided into the observation group and control group (44 cases each group). All the subjects were orally given Entracabine-Tenofovir tablets 500 mg·time–1, 1 time·day–1. On this basis, the control group were treated with Efeviren, taking Efeviren tablets 600 mg·time–1, 1 time·day–1; The observation group were treated with Dolavirin, oral Dolavirin tablets 100 mg·time–1, 1 time·day–1. After 48 weeks of treatment, the plasma levels of HIV RNA, LDL cholesterol, non-HDL cholesterol, total cholesterol and triglyceride were measured, and the adverse drug reactions during treatment were recorded.
      Results At the 48th week of treatment, the plasma HIV RNA of 36 patients (81.82%) in the observation group and 35 patients (79.55%) in the control group were less than 50 copies·mL–1, with no statistically significant difference (P > 0.05). Before treatment, there was no statistical significance in the expression levels of LDL-C, Non-HDL-C, total cholesterol and triglycerides between two groups (P > 0.05). From baseline to the 48th week of treatment, the levels of LDL-C, Non-HDL-C, total cholesterol and triglycerides in the control group increased, while those in the observation group decreased. Moreover, there were statistically significant differences between two groups (P < 0.05 to P < 0.01). The incidence of adverse reactions such as diarrhea and dizziness was relatively high in the two groups, and there was no statistical significance between the groups (P > 0.05).
      Conclusions Dolavirin combined with NRTIs in the treatment of newly diagnosed adult HIV infection has a definite effect and good safety, with better blood lipid profile.

       

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