Bone mineral density changes in protease inhibitor-sparing vs. nucleoside reverse transcriptase inhibitor-sparing highly active antiretroviral therapy: data from a randomized trial

Bone mineral density changes in protease inhibitor-sparing vs. nucleoside reverse transcriptase inhibitor-sparing highly active antiretroviral therapy: data from a randomized trial
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DOI:
10.1111/j.1468-1293.2010.00864.x
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发表时间:
2011-03-01
期刊:
影响因子:
3
通讯作者:
Gerstoft, J.
Gerstoft, J.
中科院分区:
医学4区
文献类型:
--
作者:
Hansen, A. B.;Obel, N.;Gerstoft, J.

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目的本研究的目的是比较开始保留核苷逆转录酶抑制剂 (NRTI) 或保留蛋白酶抑制剂高效抗逆转录病毒治疗 (HAART) 的 HIV 感染患者 144 周内骨矿物质密度 (BMD) 的变化。 方法 63 名未接受过 HAART 的患者被随机分为两组 齐多夫定/拉米夫定+依非韦伦或洛匹那韦/利托那韦+依非韦伦。我们在基线以及第 24、48、96 和 144 周进行了双能 X 射线骨密度测定 (DEXA),以评估腰椎和股骨颈(髋)BMD。 结果在基线时,33 名患者 (55.9%) 的 BMD 较低(T 分数 < -1.0),其中 8 名患者患有骨质疏松症(T 分数 < -2.5)。直到第 24 周,双臂脊柱 BMD 才趋于稳定。在保留 NRTI 组中,第 24 周时相对于基线的平均百分比变化为 -2.7% [95% CI -3.9 至 -1.4],第 144 周时为 -2.5% (95% CI -5.4 至 -0.3),而 -3.2% (95% CI -4.4 至 -2.1) 和 -1.9% (95% CI -3.5 至 -0.3)在蛋白酶中 保留抑制剂的臂。髋部 BMD 一直下降,直到第 48 周才趋于稳定。在保留 NRTI 组中,第 48 周时 BMD 下降了 -5.1%(95% CI -7.1 至 -3.1),第 144 周时下降了 -4.5%(95% CI -6.9 至 -2.1),而蛋白酶组中的 BMD 为 -6.1%(95% CI -8.2 至 -4.0)和 -5.0%(95% CI -6.8 至 -3.1)。保留抑制剂 手臂。手臂之间没有显着差异。低基线 CD4 细胞计数与脊柱 (P=0.007) 和髋部 (P=0.04) BMD 损失以及低体重指数与髋部 BMD 损失独立相关 (P=0.03)。 结论 开始 HAART 后 24 至 48 周,脊柱和髋部 BMD 迅速下降,与指定的药物类别无关,但此后 BMD 值保持稳定。
ObjectiveThe aim of the study was to compare changes in bone mineral density (BMD) over 144 weeks in HIV-infected patients initiating nucleoside reverse transcriptase inhibitor (NRTI)-sparing or protease inhibitor-sparing highly active antiretroviral therapy (HAART).MethodsSixty-three HAART-naive patients were randomized to zidovudine/lamivudine+efavirenz or lopinavir/ritonavir+efavirenz. We performed dual energy X-ray absorptiometry (DEXA) at baseline and at weeks 24, 48, 96 and 144 to evaluate lumbar spine and femoral neck (hip) BMD.ResultsAt baseline, 33 patients (55.9%) had low BMD (T-score < -1.0) and of these eight had osteoporosis (T-score < -2.5). Spine BMD declined in both arms until week 24, before stabilizing. In the NRTI-sparing arm, the mean percentage change from baseline was -2.7% [95% confidence interval (CI) -3.9 to -1.4] at week 24 and -2.5% (95% CI -5.4 to 0.3) at week 144, compared with -3.2% (95% CI -4.4 to -2.1) and -1.9% (95% CI -3.5 to -0.3) in the protease inhibitor-sparing arm. Hip BMD declined until week 48 before stabilizing. In the NRTI-sparing arm, BMD had decreased by -5.1% (95% CI -7.1 to -3.1) at week 48 and -4.5% (95% CI -6.9 to -2.1) at week 144, compared with -6.1% (95% CI -8.2 to -4.0) and -5.0% (95% CI -6.8 to -3.1) in the protease inhibitor-sparing arm. There were no significant differences between arms. Low baseline CD4 cell count was independently associated with spine (P=0.007) and hip (P=0.04) BMD loss and low body mass index with hip BMD loss (P=0.03).ConclusionSpine and hip BMD declined rapidly 24 to 48 weeks after initiating HAART, independent of the assigned drug class, but thereafter BMD values remained stable.