体重减轻可改善中重度慢性斑块状银屑病肥胖患者对低剂量环孢素治疗的反应：一项随机、对照、研究者设盲的临床试验。

Weight loss improves the response of obese patients with moderate-to-severe chronic plaque psoriasis to low-dose cyclosporine therapy: a randomized, controlled, investigator-blinded clinical trial.

作者信息

Gisondi Paolo, Del Giglio Micol, Di Francesco Vincenzo, Zamboni Mauro, Girolomoni Giampiero

机构信息

Section of Dermatology and Venereology, Department of Biomedical and Surgical Science, University of Verona, Verona, Italy.

出版信息

Am J Clin Nutr. 2008 Nov;88(5):1242-7. doi: 10.3945/ajcn.2008.26427.

DOI:10.3945/ajcn.2008.26427

PMID:18996858

Abstract

BACKGROUND

Chronic plaque psoriasis is frequently associated with obesity. The effect of a hypoenergetic diet on psoriasis has not been investigated.

OBJECTIVE

The objective was to investigate whether moderate weight loss (ie, 5-10% of body weight) increases the therapeutic response to a low dose of cyclosporine in obese patients with moderate-to-severe chronic plaque psoriasis.

DESIGN

A 24-wk randomized, controlled, investigator-blinded clinical trial was conducted in 61 patients. The efficacy of 2.5 mg x kg(-1)d(-1) cyclosporine combined with a low-calorie diet (intervention group) was compared with cyclosporine alone (control group) in obese patients [body mass index (in kg/m(2)) > 30] with moderate-to-severe psoriasis. The primary endpoint was an improvement from baseline of >or=75% in the Psoriasis Area and Severity Index (PASI 75 response) at week 24.

RESULTS

At week 24, the mean (+/- SD) reduction in body weight was 7.0% +/- 3.5 in the intervention group and was 0.2% +/- 0.9 in the control group (P < 0.001). The PASI 75 response was achieved by 20 of 30 patients (66.7%) treated with cyclosporine plus a low-calorie diet and by 9 of 31 (29.0%) patients treated with cyclosporine alone (P < 0.001). Four patients (13.3%) from the intervention group and 14 (45.1%) from the control group withdrew prematurely from the study (P < 0.001).

CONCLUSIONS

Obese patients with moderate-to-severe psoriasis increase their response to low-dose cyclosporine if a calorie-controlled diet is included in the treatment regimen. Lifestyle modifications, including a low-calorie diet, may supplement the pharmacologic treatment of obese psoriasis patients. This trial was registered at clinicaltrials.gov as NCT00512187.

摘要

背景

慢性斑块状银屑病常与肥胖相关。低能量饮食对银屑病的影响尚未得到研究。

目的

旨在研究中度体重减轻（即体重的5 - 10%）是否能增加中度至重度慢性斑块状银屑病肥胖患者对低剂量环孢素的治疗反应。

设计

对61例患者进行了一项为期24周的随机、对照、研究者盲法临床试验。将2.5 mg·kg⁻¹·d⁻¹环孢素联合低热量饮食（干预组）与单独使用环孢素（对照组）在中度至重度银屑病肥胖患者[体重指数（kg/m²）> 30]中的疗效进行比较。主要终点是第24周时银屑病面积和严重程度指数（PASI 75反应）较基线改善≥75%。

结果

在第24周时，干预组体重平均（±标准差）减轻7.0%±3.5%，对照组为0.2%±0.9%（P < 0.001）。30例接受环孢素加低热量饮食治疗的患者中有20例（66.7%）达到PASI 75反应，31例接受单独环孢素治疗的患者中有9例（29.0%）达到该反应（P < 0.001）。干预组有4例患者（13.3%）和对照组有14例患者（45.1%）提前退出研究（P < 0.001）。