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亲水性乳膏中芦荟提取物治疗银屑病:一项安慰剂对照双盲研究。

Management of psoriasis with Aloe vera extract in a hydrophilic cream: a placebo-controlled, double-blind study.

作者信息

Syed T A, Ahmad S A, Holt A H, Ahmad S A, Ahmad S H, Afzal M

机构信息

Department of Clinical Physiology, Malmö University Hospital, Sweden.

出版信息

Trop Med Int Health. 1996 Aug;1(4):505-9. doi: 10.1046/j.1365-3156.1996.d01-91.x.

Abstract

The purpose of this double-blind, placebo-controlled study was to evaluate the clinical efficacy and tolerability of topical Aloe vera extract 0.5% in a hydrophilic cream to cure patients with psoriasis vulgaris. Sixty patients (36M/24F) aged 18-50 years (mean 25.6) with slight to moderate chronic plaque-type psoriasis and PASI (Psoriasis Area and Severity Index) scores between 4.8 and 16.7 (mean 9.3) were enrolled and randomized to two parallel groups. The mean duration of the disease prior to enrollment was 8.5 years (range 1-21). Patients were provided with a precoded 100g tube, placebo or active (with 0.5% Aloe vera extract), and they self-administered trial medication topically (without occlusion) at home 3 times daily for 5 consecutive days per week (maximum 4 weeks active treatment). Patients were examined on a weekly basis and those showing a progressive reduction of lesions, desquamation followed by decreased erythema, infiltration and lowered PASI score were considered healed. The study was scheduled for 16 weeks with 12 months of follow-up on a monthly basis. The treatment was well tolerated by all the patients, with no adverse drug-related symptoms and no dropouts. By the end of the study, the Aloe vera extract cream had cured 25/30 patients (83.3%) compared to the placebo cure rate of 2/30 (6.6%) (P < 0.001) resulting in significant clearing of the psoriatic plaques (328/396 (82.8%) vs placebo 28/366 (7.7%), P < 0.001) and a decreased PASI score to a mean of 2.2. The findings of this study suggest that topically applied Aloe vera extract 0.5% in a hydrophilic cream is more effective than placebo, and has not shown toxic or any other objective side-effects. Therefore, the regimen can be considered a safe and alternative treatment to cure patients suffering from psoriasis.

摘要

这项双盲、安慰剂对照研究的目的是评估亲水性乳膏中0.5%的局部芦荟提取物治疗寻常型银屑病患者的临床疗效和耐受性。纳入了60名年龄在18至50岁(平均25.6岁)之间、患有轻度至中度慢性斑块型银屑病且银屑病面积和严重程度指数(PASI)评分在4.8至16.7之间(平均9.3)的患者(36名男性/24名女性),并将他们随机分为两个平行组。入组前疾病的平均病程为8.5年(范围1至21年)。为患者提供了预编码的100克管装药物,安慰剂或活性药物(含0.5%芦荟提取物),他们在家中自行局部使用试验药物(不封包),每周连续5天,每天3次(最长4周的积极治疗)。每周对患者进行检查,那些病变逐渐减轻、脱屑后红斑减少、浸润减轻且PASI评分降低的患者被视为治愈。该研究计划为期16周,并进行为期12个月的每月一次随访。所有患者对治疗耐受性良好,未出现与药物相关的不良症状,也没有患者退出研究。到研究结束时,芦荟提取物乳膏治愈了25/30名患者(83.3%),而安慰剂的治愈率为2/30(6.6%)(P < 0.001),导致银屑病斑块明显消退(328/396(82.8%)对比安慰剂28/366(7.7%),P < 0.001),PASI评分降至平均2.2。这项研究的结果表明,亲水性乳膏中局部应用0.5%的芦荟提取物比安慰剂更有效,且未显示出毒性或任何其他客观副作用。因此,该治疗方案可被视为治疗银屑病患者的一种安全且替代的治疗方法。

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