Lafaurie Matthieu, Dolivo Marc, Porcher Raphäel, Rudant Jérémie, Madelaine Isabelle, Molina Jean-Michel
Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Paris, France.
J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):393-8. doi: 10.1097/01.qai.0000152834.02912.98.
This study assessed the safety and efficacy of intradermal injections of polylactic acid (PLA) in patients with facial lipoatrophy under antiretroviral therapy.
In a prospective open-label study, PLA was injected in both cheeks every 2 weeks. The primary efficacy endpoint was the patient's self-perception of improvement as assessed by a visual analogue scale (VAS). Secondary endpoints included 3-dimensional photographs (3DP) to measure dermal thickness, quality of life (QoL) scores, and adverse events.
Ninety-four patients received a median of 5 sets of injection in both cheeks. Median age was 43 years, and median CD4 cell count was 500/mm3. Median VAS score significantly increased from 3.4/10 at baseline to 6.8/10 at the end of the treatment procedure and was sustained at 7/10 at the end of follow-up (P < 0.0001 vs. baseline). Median dermal thickness increase was 2.3 mm at the end of follow-up. QoL scores remained unchanged. Seventeen patients needed further injections of PLA during a median follow-up of 12 months. Injections were well tolerated with only 1 serious adverse event (anaphylactic reaction) that necessitated treatment interruption.
Injections of PLA improved patients' self-perception of facial lipoatrophy, with a good safety profile. The benefit of the procedure, however, decreased with time.
本研究评估了在抗逆转录病毒治疗下,皮内注射聚乳酸(PLA)对面部脂肪萎缩患者的安全性和有效性。
在一项前瞻性开放标签研究中,每2周在双侧脸颊注射PLA。主要疗效终点是通过视觉模拟量表(VAS)评估患者对改善情况的自我感知。次要终点包括三维照片(3DP)以测量真皮厚度、生活质量(QoL)评分和不良事件。
94例患者双侧脸颊接受注射的中位数为5次。中位年龄为43岁,中位CD4细胞计数为500/mm³。VAS评分中位数从基线时的3.4/10显著增加至治疗结束时的6.8/10,并在随访结束时维持在7/10(与基线相比,P < 0.0001)。随访结束时真皮厚度增加的中位数为2.3 mm。QoL评分保持不变。在中位随访12个月期间,17例患者需要进一步注射PLA。注射耐受性良好,仅发生1例严重不良事件(过敏反应),需要中断治疗。
注射PLA改善了患者对面部脂肪萎缩的自我感知,安全性良好。然而,该治疗的益处随时间降低。