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两种低剂量口服异维A酸方案治疗中度至重度寻常痤疮的随机对照试验。

A randomized comparative trial of two low-dose oral isotretinoin regimens in moderate to severe acne vulgaris.

作者信息

Dhaked Daulat Ram, Meena Ram Singh, Maheshwari Anshul, Agarwal Uma Shankar, Purohit Saroj

机构信息

Department of Skin, VD and Leprosy, Sawai Man Singh (SMS) Medical College, Jaipur, Rajasthan, India.

出版信息

Indian Dermatol Online J. 2016 Sep-Oct;7(5):378-385. doi: 10.4103/2229-5178.190505.

DOI:10.4103/2229-5178.190505
PMID:27730033
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5038098/
Abstract

BACKGROUND

Oral isotretinoin is highly effective in all forms and grades of acne, even in lower dosages (<0.5 mg/kg/day). There is a paucity of comparative data on the various low-dose regimens of oral isotretinoin in the Indian literature.

OBJECTIVES

To assess and compare the efficacy and tolerability of two low-dose oral isotretinoin treatment regimens (20 mg daily and 20 mg alternate days) in moderate to severe acne vulgaris.

MATERIALS AND METHODS

A total of 240 patients with moderate to severe acne vulgaris were selected and randomized into two groups and treated with a fixed dose of 20 mg of isotretinoin (Group A - daily and Group B - alternate days) for 24 weeks and followed up for 12 weeks post therapy.

RESULTS

A total of 234 patients completed the study. At the end of therapy, decrease in the total acne loads up to 98.99% (Group A) and 97.69% (Group B) was achieved from the baseline ( < 0.01), excellent response was observed in 98.3% (Group A) and 93.96% (Group B) patients ( = 0.166). In the severe acne, Group A performed significantly better than Group B until the end of 36 weeks. While in the moderate acne, significant difference in the response between both groups was observed only up to 12 weeks. No serious side effect was observed.

CONCLUSION

Both isotretinoin regimens were well tolerated and found to be an effective treatment for moderate to severe acne vulgaris. However, in moderate acne 20 mg alternate day regimen may be preferred. A 20 mg daily regimen is a better choice for severe acne in terms of response.

LIMITATION

Small sample size and short follow-up period.

摘要

背景

口服异维A酸对各种类型和分级的痤疮均非常有效,即使是低剂量(<0.5mg/kg/天)。印度文献中关于口服异维A酸各种低剂量方案的比较数据较少。

目的

评估和比较两种低剂量口服异维A酸治疗方案(每日20mg和隔日20mg)治疗中度至重度寻常痤疮的疗效和耐受性。

材料与方法

共选择240例中度至重度寻常痤疮患者,随机分为两组,给予固定剂量20mg异维A酸治疗(A组 - 每日,B组 - 隔日),疗程24周,并在治疗后随访12周。

结果

共有234例患者完成研究。治疗结束时,两组痤疮总负荷较基线分别下降了98.99%(A组)和97.69%(B组)(<0.01),A组98.3%、B组93.96%的患者获得了良好反应(P = 0.166)。在重度痤疮中,直到36周结束时A组的表现明显优于B组。而在中度痤疮中,两组间反应的显著差异仅在12周内观察到。未观察到严重副作用。

结论

两种异维A酸治疗方案耐受性良好,均被发现是治疗中度至重度寻常痤疮的有效方法。然而,对于中度痤疮,隔日20mg方案可能更可取。就反应而言,每日20mg方案对重度痤疮是更好的选择。

局限性

样本量小且随访期短。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/6015791891a7/IDOJ-7-378-g011.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/ed3290e3da7a/IDOJ-7-378-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/ab78464fcf1a/IDOJ-7-378-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/6f16f3dff84d/IDOJ-7-378-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/ff9956c3b836/IDOJ-7-378-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/b23514239737/IDOJ-7-378-g010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/6015791891a7/IDOJ-7-378-g011.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/ed3290e3da7a/IDOJ-7-378-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/ab78464fcf1a/IDOJ-7-378-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/6f16f3dff84d/IDOJ-7-378-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/ff9956c3b836/IDOJ-7-378-g009.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/b23514239737/IDOJ-7-378-g010.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f301/5038098/6015791891a7/IDOJ-7-378-g011.jpg

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