罗格列酮治疗HIV相关脂肪代谢障碍综合征的安全性及疗效评估。

Evaluation of safety and efficacy of rosiglitazone in the treatment of HIV-associated lipodystrophy syndrome.

作者信息

Feldt T, Oette M, Kroidl A, Goebels K, Fritzen R, Kambergs J, Kappert G, Vogt C, Wettstein M, Häussinger D

机构信息

Clinic of Gastroenterology, Hepatology, and Infectious Diseases, Heinrich-Heine University, Moorenstr. 5, 40225 Düsseldorf, Germany.

出版信息

Infection. 2006 Apr;34(2):55-61. doi: 10.1007/s15010-006-5022-y.

DOI:10.1007/s15010-006-5022-y

PMID:16703293

Abstract

BACKGROUND

HIV-associated lipodystrophy syndrome (LDS) as a long-term side effect of HAART is becoming increasingly important and negatively affects adherence to medication. Currently, an effective therapy is not available. There is some evidence that the drug class of thiazolidindiones might be effective in the treatment of LDS.

PATIENTS AND METHODS

Prospective open-label study with 20 HIV-infected patients suffering from severe LDS. Patients received 4 mg rosiglitazone once daily for a 24-week study period. Efficacy was assessed by measurement of metabolic and anthropometric parameters, total body DXA scan, CT scan of the abdomen, photo documentation and self-assessment.

RESULTS

Rosiglitazone treatment was well tolerated. DXA scans demonstrated a highly significant increase in adipose tissue of the limbs (2644 +/- 1334 g vs 3380 +/- 1614 g, p < or = 0.001) without any change in total fat mass. Abdominal CT-scans revealed a significant increase in subcutaneous adipose tissue (113.7 +/- 82.4 cm(2) vs 125.3 +/- 83.7 cm(2), p = 0.04). Abdominal circumference decreased significantly (94.7 +/- 8.7 cm vs 92.2 +/- 8.45 cm, p = 0.03) without any relevant change of body weight or BMI. We observed an increase in serum cholesterol (248 vs 281 mg/dl, p = 0.006) and serum triglycerides (301 vs 351 mg/dl, p = 0.1). Furthermore, no side effects of clinical relevance were observed. The insulin sensitivity index improved without reaching statistical significance. Thirteen patients (65%) reported general improvement of LDS symptoms. Evaluation of photo documentation by five HIV-experts revealed poor concordance and no relevant change of LDS.

CONCLUSIONS

The results of this study suggest that rosiglitazone is safe in the treatment of HAART-associated lipodystrophy and has moderate clinical efficacy. We found a trend towards improved insulin sensitivity and as a possible limiting factor an unfavorable increase in serum cholesterol and triglycerides.

摘要

背景

作为高效抗逆转录病毒治疗（HAART）的长期副作用，HIV相关脂肪代谢障碍综合征（LDS）日益受到关注，且对药物依从性产生负面影响。目前尚无有效的治疗方法。有证据表明噻唑烷二酮类药物可能对LDS的治疗有效。

患者与方法

对20例患有严重LDS的HIV感染患者进行前瞻性开放标签研究。患者在为期24周的研究期间每天服用一次4毫克罗格列酮。通过测量代谢和人体测量参数、全身双能X线吸收测定（DXA）扫描、腹部CT扫描、照片记录和自我评估来评估疗效。

结果

罗格列酮治疗耐受性良好。DXA扫描显示四肢脂肪组织显著增加（2644±1334克对3380±1614克，p≤0.001），而总脂肪量无任何变化。腹部CT扫描显示皮下脂肪组织显著增加（113.7±82.4平方厘米对125.3±83.7平方厘米，p = 0.04）。腹围显著减小（94.7±8.7厘米对92.2±8.45厘米，p = 0.03），而体重或体重指数（BMI）无任何相关变化。我们观察到血清胆固醇升高（248对281毫克/分升，p = 0.006）和血清甘油三酯升高（301对351毫克/分升，p = 0.1）。此外，未观察到具有临床意义的副作用。胰岛素敏感性指数有所改善，但未达到统计学显著性。13例患者（65%）报告LDS症状总体有所改善。由五位HIV专家对照片记录进行的评估显示一致性较差，且LDS无相关变化。