Law Matthew, Puls Rebekah, Cheng Andrew K, Cooper David A, Carr Andrew
National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia.
Antivir Ther. 2006;11(2):179-86.
To compare three versions of the objective HIV-associated lipodystrophy (HIVLD) case definition (LDCD) and derived severity scale to spontaneous clinical LD assessment in adults initiating antiretroviral therapy.
The LDCD versions were the 'primary' LDCD [which includes dual-energy X-ray absorptiometry (DXA) and computerized tomography (CT)], a simpler 'central' LDCD that omits CT data, and a simpler but probably less accurate 'non-imaging' LDCD. Physician LD assessments were passively reported. Two of the 10 parameters in the primary LDCD were not collected and were imputed. Setting, participants and interventions: Retrospective analysis of a randomized, placebo-controlled, 144-week study of tenofovir DF or stavudine (d4T) in 600 antiretroviral-naive adults.
Central LDCD and clinical assessment diagnosed LD in 27% and 19% of d4T recipients at week 144, respectively (P < 0.001), and 3% and 3% of tenofovir DF recipients, respectively (P = 0.248). The central LDCD performed at least as well as the primary LDCD; both were more sensitive than the non-imaging model. There was poor concordance between clinical and LDCD-based diagnosis (kappa 0.02-0.20); most clinical cases did not fulfill any LDCD. Using the central LDCD, most LD was grade 1; 6% of d4T recipients and no tenofovir DF recipient had grade 3-4 LD at week 144 (P = 0.007). Independent risk factors for LD using the central LDCD were d4T, increasing age, female sex and higher baseline triglycerides, whereas clinical assessment consistently identified only d4T. The LDCD score was more sensitive than DXA for assessing LD severity.
In this prospective study of a first antiretroviral regimen, the LDCD was more sensitive for LD diagnosis and identified more lipodystrophy risk factors than spontaneous clinical assessment or DXA, and also objectively quantified LD severity. The central LDCD should make objective LD assessment cheaper and simpler. Spontaneous clinical LD assessment of is of limited value, even in placebo-controlled trials.
比较三种版本的客观HIV相关脂肪代谢障碍（HIVLD）病例定义（LDCD）及其衍生的严重程度量表与成人开始抗逆转录病毒治疗时的自发临床脂肪代谢障碍评估结果。
LDCD的版本包括“主要”LDCD[其中包括双能X线吸收测定法（DXA）和计算机断层扫描（CT）]、一个省略CT数据的更简单的“中央”LDCD以及一个更简单但可能不太准确的“非影像学”LDCD。医生对脂肪代谢障碍的评估是被动报告的。主要LDCD中的10个参数中有2个未收集并进行了估算。研究背景、参与者和干预措施：对一项随机、安慰剂对照、为期144周的替诺福韦酯或司他夫定（d4T）治疗600例初治抗逆转录病毒治疗成人的研究进行回顾性分析。
在第144周时，中央LDCD和临床评估分别诊断出27%的d4T接受者和19%的替诺福韦酯接受者患有脂肪代谢障碍（P<0.001），以及分别为3%的替诺福韦酯接受者和3%的d4T接受者患有脂肪代谢障碍（P = 0.248）。中央LDCD的表现至少与主要LDCD一样好；两者都比非影像学模型更敏感。临床诊断与基于LDCD的诊断之间的一致性较差（kappa值为0.02 - 0.20）；大多数临床病例不符合任何LDCD标准。使用中央LDCD，大多数脂肪代谢障碍为1级；在第144周时，6%的d4T接受者有3 - 4级脂肪代谢障碍，而替诺福韦酯接受者中没有（P = 0.007）。使用中央LDCD时，脂肪代谢障碍的独立危险因素为d4T、年龄增加、女性以及更高的基线甘油三酯水平，而临床评估始终仅确定d4T为危险因素。LDCD评分在评估脂肪代谢障碍严重程度方面比DXA更敏感。
在这项关于首个抗逆转录病毒治疗方案的前瞻性研究中，LDCD在脂肪代谢障碍诊断方面比自发临床评估或DXA更敏感，识别出更多脂肪代谢障碍危险因素，并且还能客观量化脂肪代谢障碍的严重程度。中央LDCD应能使客观的脂肪代谢障碍评估更便宜、更简单。即使在安慰剂对照试验中，自发临床脂肪代谢障碍评估的价值也有限。
