Piquet M, Brignol L, Chatelain B, Rey D, Ricbourg B, Meyer C
Service de chirurgie maxillofaciale et stomatologie, CHU de Jean-Minjoz, boulevard Fleming, 25030 Besançon cedex, France.
Rev Stomatol Chir Maxillofac. 2007 Dec;108(6):496-504. doi: 10.1016/j.stomax.2007.04.005. Epub 2007 Aug 1.
The aim of the study was to evaluate the mean-term efficacy and tolerance of the polylactic acid injections (New-Fill) for the correction of facial lipoatrophy occurring in HIV-positive patients under tri-therapy.
The patients were managed at the University Hospitals of Besançon and Strasbourg (France) from January 2002 to December 2005 for a prospective study. The patients were consecutively included in this study once their consent was obtained. Patients not stabilized by their antiretroviral treatment were excluded. Facial lipoatrophy was classified in four clinical stages (stage I: mild, stage II: moderate, stage III: important, stage IV: severe) after a clinical examination. The polylactic acid solution was prepared according to the manufacturer's recommendations, and injected in a retrotracing manner in the hypoderm at the rate of one 5 ml flask per side, with an interval of one month. The number of sessions varied according to the severity of the stage. Treatment efficacy, assessed after a minimal follow-up of one year, was established clinically by comparing the initial and final photographs (changes in the clinical stage) and by the patient's and surgeon's satisfaction rate (from zero to ten). Treatment tolerance was established on the painfulness of injections and on socioprofessional constraints reported by the patients and made on a visual analogical scale. The occurrence of adverse-effects was checked. Finally, we compared the cost of the treatment with that of lipostructure.
Twenty-five patients were included (mean age: 44, sex-ratio: 23 male/2 female patients). The mean body mass index was 21. The mean CD4 cell count was 600/mm(3). The mean HIV-1 RNA was 276 copies/ml. The severity of the lipoatrophy was stage one in two patients (8%), stage two in 12 patients (48%), stage three in nine patients (36%), and stage four in two patients (8%). The mean number of sessions was 5.2. The mean follow-up time was 26 months. In 76% of the cases we observed a complete correction of lipoatrophy (100% of stages I, 92% of stages II, 66% of stages III, 0% of stages IV). However, among stages II, III, and IV that were incompletely corrected, an improvement was noticed in all patients (grading to an inferior stage, at least). The mean satisfaction rate was 8/10 by patients and 7.2/10 by surgeons. In six patients (24%) a renewal of the treatment was proposed because of inadequate results. The painfulness of injections was rated at 3.3/10 and constraints at 3/10 by patients. One single case of visible and palpable sub-cutaneous granuloma was noticed in a patient at the end of the follow-up period (18 months).
The use of polylactic acid is a safe and efficient procedure for the treatment of facial lipo-atrophy in HIV-infected patients, however severe the clinical stage may be, after a two-year follow-up period. We recommend hypodermic (and not dermic) injections to prevent adverse effects. This treatment is not more expensive then lipo-structure and the progressive correction is considered as an important advantage by patients. Considering our results, the simplicity of the procedure, and the low rate of complications observed, the injection of poly-lactic acid has become our first intention treatment for this condition.
本研究的目的是评估聚乳酸注射液（New-Fill）对接受三联疗法的HIV阳性患者面部脂肪萎缩的中期疗效和耐受性。
2002年1月至2005年12月，在法国贝桑松和斯特拉斯堡大学医院对患者进行前瞻性研究。一旦获得患者同意，便将其连续纳入本研究。排除抗逆转录病毒治疗未稳定的患者。临床检查后，将面部脂肪萎缩分为四个临床阶段（I期：轻度，II期：中度，III期：重度，IV期：极重度）。聚乳酸溶液根据制造商的建议配制，并以逆行方式皮下注射，每侧注射一瓶5毫升，间隔一个月。疗程数量根据阶段的严重程度而异。在至少随访一年后评估治疗效果，通过比较初始和最终照片（临床阶段的变化）以及患者和外科医生的满意率（从零到十）进行临床评估。根据注射的疼痛程度以及患者报告的社会职业限制，通过视觉模拟量表确定治疗耐受性。检查不良反应的发生情况。最后，我们将该治疗的成本与脂肪结构治疗的成本进行了比较。
纳入25例患者（平均年龄：44岁，性别比：23例男性/2例女性患者）。平均体重指数为21。平均CD4细胞计数为600/mm³。平均HIV-1 RNA为276拷贝/毫升。脂肪萎缩的严重程度为I期2例患者（8%），II期12例患者（48%），III期9例患者（36%），IV期2例患者（8%）。平均疗程数为5.2次。平均随访时间为26个月。在76%的病例中，我们观察到脂肪萎缩完全得到纠正（I期100%，II期92%，III期66%，IV期0%）。然而，在未完全纠正的II期、III期和IV期患者中，所有患者均有改善（至少降至较低阶段）。患者的平均满意率为8/10，外科医生的平均满意率为7.2/10。6例患者（24%）因效果不佳而建议再次治疗。患者对注射疼痛的评分是3.3/10，对限制的评分是3/10。在随访期结束时（18个月），一名患者出现一例可见且可触及的皮下肉芽肿。
经过两年的随访期，使用聚乳酸治疗HIV感染患者的面部脂肪萎缩是一种安全有效的方法，无论临床阶段多么严重。我们建议皮下（而非真皮内）注射以预防不良反应。这种治疗并不比脂肪结构治疗更昂贵，而且逐渐矫正被患者视为一个重要优势。考虑到我们的结果、操作的简单性以及观察到的低并发症发生率，聚乳酸注射已成为我们治疗这种情况的首选方法。
