Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Infectious Diseases Department, Spain.
AIDS. 2012 Feb 20;26(4):475-81. doi: 10.1097/QAD.0b013e32834f3507.
To compare 48-week changes in body fat distribution and bone mineral density (BMD) between patients switching from a ritonavir-boosted protease inhibitor (PI/r) to raltegravir (RAL) and patients continuing with PI/r.
Substudy of the prospective, randomized, open-label, multicenter SPIRAL study.
Patients were randomized (1 : 1) to continue with the PI/r-based regimen or switch to RAL, maintaining the rest of the treatment unchanged. Dual-energy X-ray absorptiometry and computed tomography scans were performed at baseline and after 48 weeks to measure body fat and bone composition, analyzing intragroup and intergroup differences.
Eighty-six patients were included and 74 patients (39 RAL, 35 PI/r) completed the substudy. Significant increases in median [interquartile range (IQR)] visceral adipose tissue (VAT) [20.7 (-2.4 to 45.6) cm(2), P = 0.002] and total adipose tissue (TAT) [21.4 (-1.3 to 55.4) cm(2), P = 0.013] were seen within the PI/r group. No significant changes in body fat were seen with RAL or between treatment groups. Regarding bone composition, total BMD [0.01 (0 to 0.02) g/cm(2), P = 0.002], total hip BMD [0.01 (0 to 0.03) g/cm(2), P = 0.015] and total hip T score [0.12 (-0.05 to 0.21) SD, P = 0.004] significantly increased with RAL, with no significant changes within the PI/r group. Differences between treatment groups were significant in femoral neck BMD [0.01 (-0.02 to 0.02) g/cm(2), P = 0.032] and T score [0.01 (-0.18 to 0.18) SD, P = 0.016].
Although there were no significant changes in body fat between groups, maintaining a PI/r-based regimen was associated with a significant increase in VAT and TAT. Switching to RAL led to a significant increase in femoral neck BMD when comparing between groups.
比较从利托那韦增强型蛋白酶抑制剂（PI/r）转换为拉替拉韦（RAL）的患者与继续接受 PI/r 治疗的患者在 48 周时身体脂肪分布和骨密度（BMD）的变化。
前瞻性、随机、开放标签、多中心 SPIRAL 研究的子研究。
患者被随机（1:1）分为继续接受 PI/r 为基础的方案或转换为 RAL，同时保持其余治疗不变。在基线和 48 周时进行双能 X 射线吸收法和计算机断层扫描，以测量身体脂肪和骨成分，分析组内和组间差异。
共纳入 86 例患者，其中 74 例患者（RAL 39 例，PI/r 35 例）完成了子研究。PI/r 组的内脏脂肪组织（VAT）[中位数（四分位距（IQR）]增加 20.7（2.4 至 45.6）cm2，P = 0.002]和总脂肪组织（TAT）[中位数（IQR）增加 21.4（1.3 至 55.4）cm2，P = 0.013]。RAL 组的体脂无显著变化，两组间无显著差异。关于骨成分，全骨密度[0.01（0 至 0.02）g/cm2，P = 0.002]、全髋关节骨密度[0.01（0 至 0.03）g/cm2，P = 0.015]和全髋关节 T 评分[0.12（-0.05 至 0.21）SD，P = 0.004]均显著增加，而 PI/r 组无显著变化。两组间的差异在股骨颈骨密度[0.01（-0.02 至 0.02）g/cm2，P = 0.032]和 T 评分[0.01（-0.18 至 0.18）SD，P = 0.016]上具有统计学意义。
虽然组间体脂无显著变化，但维持 PI/r 为基础的方案与 VAT 和 TAT 显著增加有关。与组内相比，转换为 RAL 时，股骨颈骨密度显著增加。
