A randomized, multicenter, open-label study of poly-l-lactic acid for HIV-1 facial lipoatrophy
A randomized, multicenter, open-label study of poly-l-lactic acid for HIV-1 facial lipoatrophy
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DOI：
10.1097/qai.0b013e318158bec9
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发表时间：
2007-12-15
影响因子：
3.6
通讯作者：
Carr, Andrew
中科院分区：
文献类型：
--
作者：
Carey, Dianne L.;Baker, David;Carr, Andrew
背景：面部脂肪萎缩可使患者蒙受耻辱，降低生活质量、自尊和抗逆转录病毒治疗依从性。聚-L-乳酸（PLA）注射似乎是安全和有效的，但没有随机研究包括客观endpoints.Methods：HIV阳性的成年人中度/重度面部脂肪萎缩被随机分配到4个开放标签的PLA治疗，每2周从0周（立即组，n = 5 - 1）或24周后（延期组，n = 50）。主要终点是通过螺旋计算机断层扫描评估的面部软组织体积（FSTV）的平均变化。结果：在第24周，FSTV的平均变化在中间组为0 cm（3），在延迟组为-10 cm（3）（组间差异为10 [95%可信区间（0）：-7至28 cm 3; P = 0.24）。即刻组在上颌骨（2.2 mm [95% CI：1.6 - 2.9]; P < 0.000 1）和鼻中隔底部（1.0转[95% CI：03 - 1.6]; P = 0.003）水平的软组织深度平均变化更大。PLA对外周脂肪量、病毒载量或抗逆转录病毒依从性没有影响。患者和医生主观评估面部脂肪萎缩严重程度（P < 0.0001），8份健康调查简表中有2份和5份多维身体-自我关系量表中有2份评分显著改善。治疗相关不良事件的中位持续时间为2（四分位数范围：1至3）days.Conclusions：PLA并没有增加FSTV，虽然注射平面的组织厚度适度增加，患者观察到的改善。PLA安全且耐受性良好。面部脂肪萎缩的严重程度和一些生活质量领域得到改善。
Background: Facial lipoatrophy can stigmatize and can reduce quality of life, self esteem, and antiretroviral adherence. Poly-L-lactic acid (PLA) injections seem safe and effective, but no randomized study has included objective endpoints.Methods: HIV-positive adults with moderate/severe facial lipoatrophy were randomized to 4 open-label PLA treatments administered every 2 weeks from week 0 (immediate group, n = 5 1) or after week 24 (deferred group, n = 50). The primary endpoint was mean change in facial soft tissue volume (FSTV), as assessed by spiral computed tomography. Analyses were by intention to treat.Results: At week 24, mean changes in FSTV were 0 cm(3) in the intermediate group and -10 cm(3) in the deferred group (betweengroup difference of 10 [95% confidence interval (0): -7 to 28 cm 3; P = 0.24). The immediate group had a greater mean change in soft tissue depth at the maxilla (2.2 mm [95% Cl: 1.6 to 2.9]; P < 0.000 1) and base of the nasal septum (1.0 turn [95% CI: 03 to 1.6]; P = 0.003) levels. PLA did not have an impact on peripheral fat mass, viral load, or antiretroviral adherence. Patient and physician subjectively assessed facial lipoatrophy severity (P < 0.0001), 2 of 8 Short Form-36 Health Survey and 2 of 5 Multidimensional Body-Self Relations Questionnaire-Appearance Scales, scores improved significantly. The median duration of treatment-related adverse events was 2 (interquartile range: 1 to 3) days.Conclusions: PLA did not increase FSTV, although tissue thickness in injection planes increased modestly, an improvement observed by patients. PLA was safe and well tolerated. Facial lipoatrophy severity and some quality-of-life domains improved.