异维a酸Lidose®的有效性和安全性

L. S. Kruglova, N. V. Gryazeva, A. V. Tamrazova
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摘要

介绍。痤疮是一种常见的慢性炎症性疾病,伴随着严重的社会压力,降低了患者的生活质量。异维甲酸是治疗严重和中度痤疮的黄金标准,也用于有痤疮后症状复杂的风险和以前的治疗方法无效的情况。研究目的:探讨不同异维甲酸方案在0.4 ~ 0.8 mg/kg剂量下对中重度寻常痤疮患者和成人痤疮患者的有效性和安全性。材料和方法。本研究采用单中心、前瞻性、平行对照研究方法,将139例普通痤疮和成人痤疮患者分为3组。根据IGA量表,72例中度寻常性痤疮患者(A1组)和37例成人痤疮患者(B组)接受异维甲酸(Accutane)治疗,剂量为0.4 mg/kg/天(累积剂量为100 mg/kg),疗程8个月。30例重度寻常型痤疮患者(A1组)接受阿库坦治疗,剂量为0.8 mg/kg/天(累积剂量为120 mg/kg),疗程8个月。这项研究持续了24个月。共4次就诊(第1次就诊、第4次就诊、第8次就诊和第24个月就诊),每次就诊时进行光控,计算炎症和非炎症因子的数量,测定DAI指数和IGA量表上的程度。结果。治疗8个月后,所有139例患者的IGA评分均达到“透明”或“几乎透明”。4个月和8个月后,各组非炎症因子和炎症因子均有统计学意义的下降。(p & lt;0.001)。8个月后,A1组DIA总分下降89.2%,A2组下降83.78%,B组下降80.3%。5例患者24个月后痤疮复发。结论。对于中度和重度寻常性痤疮,以及成人痤疮的各种方案,已经证明了高疗效和良好的安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy and safety of isotretinoin Lidose®
Introduction. Acne is a common chronic inflammatory disease, which is accompanied by severe social stress and reduces the quality of life of patients. Isotretinoin is the gold standard for the treatment of severe and moderate forms of acne, and is also used when there is a risk of developing a post-acne symptom complex and when previous treatment methods are ineffective. Purpose of the study. To determine the effectiveness and safety of various isotretinoin regimens at a dose of 0.4–0.8 mg/kg in patients with moderate to severe acne vulgaris and in patients with adult acne. Materials and methods. A single-center, prospective, parallel, controlled study involved 139 patients with acne vulgaris and adult acne, who were divided into 3 groups. 72 patients with acne vulgaris of moderate severity according to the IGA scale (group A1) and 37 patients with adult acne (group B) received isotretinoin (Accutane) at a dose of 0.4 mg/kg/day (cumulative dose 100 mg/kg) for 8 months. 30 patients with severe forms of acne vulgaris (group A1) received Accutane at a dose of 0.8 mg/kg/day (cumulative dose 120 mg/kg) for 8 months. The study lasted 24 months. and consisted of 4 visits (1st visit, 4, 8 and 24 months), at each visit photocontrol was performed, the number of inflammatory and non-inflammatory elements was calculated, the DAI index and the degree on the IGA scale were determined. Results. All 139 patients achieved ‘clear’ or almost ‘clear’ skin according to the IGA scale after 8 months of therapy. There was also a statistically significant decrease in non-inflammatory and inflammatory elements in all groups after 4 and 8 months. (p < 0.001). The total DIA score after 8 months was reduced in group A1 by 89.2%, in group A2 by 83.78% and in group B by 80.3%. Acne recurrence after 24 months was determined in five patients. Conclusions. Various regimens of Accutane for moderate and severe acne vulgaris, as well as adult acne, have demonstrated high efficacy and a favorable safety profile.
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