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在巴西人群中使用0.015% 斑蝥素乳膏治疗面部和头皮的光化性角化病及癌变区域：安全性、耐受性及患者观点

Treatment of actinic keratoses and cancerization field of the face and scalp with 0.015% ingenol mebutate gel in Brazilian individuals: safety, tolerability and patients' perspectives.

作者信息

Gameiro Luiz, Tovo Luis Fernando Requejo, Sanches Júnior José Antonio, Aprahamian Ivan

机构信息

Department of Internal Medicine, Faculdade de Medicina de Jundiaí, Jundiaí (SP), Brazil.

Discipline of Dermatology, Faculdade de Medicina de Jundiaí, Jundiaí (SP), Brazil.

出版信息

An Bras Dermatol. 2019 Jul 29;94(3):313-319. doi: 10.1590/abd1806-4841.20197938.

DOI:10.1590/abd1806-4841.20197938
PMID:31365660
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6668952/
Abstract

BACKGROUND

Actinic keratosis (AK) represents a risk of progression to squamous cell carcinoma. Ingenol mebutate gel is a novel therapeutic option for field-directed treatment.

OBJECTIVES

To evaluate the safety, tolerability and patients' perspectives, related to the therapeutic success of managing AKs on the face and scalp with ingenol mebutate gel in Brazilian individuals.

METHODS

This was an observational, retrospective and descriptive study of 68 areas of actinic keratosis on the face and scalp treated with Ingenol mebutate gel involving a total of 37 patients. The drug was applied for three consecutive days on an area of of 25 cm2 and documentation was performed on baseline and days 4, 8, 15, 60 and 180. On day 4, the composite local skin reaction score was calculated. At the end, a questionnaire was applied to evaluate patients' perspectives about the treatment.

RESULTS

Adherence was 100%, no serious adverse events were recorded and the mean composite local skin reaction score (standard deviation) was 8.61±4.22. The treatment was considered optimum by 75.68% of the patients.

STUDY LIMITATIONS

Calculation of composite local skin reaction score performed only on the fourth day.

CONCLUSIONS

Treatment with ingenol mebutate gel was considered safe and tolerable in Brazilian subjects. Patients had a maximum adherence rate and a great improvement in self-esteem. The results of this research reproduce the findings of the literature.

摘要

背景

光化性角化病（AK）有进展为鳞状细胞癌的风险。咪喹莫特凝胶是一种用于区域定向治疗的新型治疗选择。

目的

评估在巴西人群中，使用咪喹莫特凝胶治疗面部和头皮光化性角化病的安全性、耐受性及患者对治疗成功的看法。

方法

这是一项观察性、回顾性和描述性研究，共纳入37例患者，其面部和头皮的68个光化性角化病区域接受了咪喹莫特凝胶治疗。药物连续三天涂抹于25平方厘米的区域，并在基线以及第4、8、15、60和180天进行记录。在第4天计算局部皮肤综合反应评分。最后，应用一份问卷来评估患者对治疗的看法。

结果

依从率为100%，未记录到严重不良事件，局部皮肤综合反应评分均值（标准差）为8.61±4.22。75.68%的患者认为治疗效果最佳。

研究局限性

仅在第4天计算局部皮肤综合反应评分。

结论

在巴西受试者中，咪喹莫特凝胶治疗被认为是安全且可耐受的。患者依从率最高，自尊得到极大改善。本研究结果重现了文献中的发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/0c4eccdc9cf4/abd-94-03-0313-g06.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/3babba18825d/abd-94-03-0313-g05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/e685b81070db/abd-94-03-0313-g01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/3c8c4cf4aa2d/abd-94-03-0313-g02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/13633db7ca25/abd-94-03-0313-g03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/c9e5ff95f2b0/abd-94-03-0313-g04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/0c4eccdc9cf4/abd-94-03-0313-g06.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/3babba18825d/abd-94-03-0313-g05.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/e685b81070db/abd-94-03-0313-g01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/3c8c4cf4aa2d/abd-94-03-0313-g02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/13633db7ca25/abd-94-03-0313-g03.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/c9e5ff95f2b0/abd-94-03-0313-g04.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fb0/6668952/0c4eccdc9cf4/abd-94-03-0313-g06.jpg

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本文引用的文献

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British Association of Dermatologists' guidelines for the care of patients with actinic keratosis 2017.英国皮肤科医师协会2017年光化性角化病患者护理指南。
Br J Dermatol. 2017 Jan;176(1):20-43. doi: 10.1111/bjd.15107.
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Real-World Evidence - What Is It and What Can It Tell Us?真实世界证据——它是什么以及能告诉我们什么？
N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216.
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Italian expert consensus for the management of actinic keratosis in immunocompetent patients.意大利免疫功能正常患者光化性角化病管理专家共识。
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Real-life efficacy and safety of ingenol mebutate for the treatment of actinic keratosis of the face and scalp: A single arm retrospective study.鬼臼毒素治疗面部和头皮光化性角化病的真实疗效和安全性：一项单臂回顾性研究。
J Dermatolog Treat. 2016 Nov;27(6):525-530. doi: 10.3109/09546634.2016.1161162. Epub 2016 Apr 4.
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Safety and tolerability of ingenol mebutate in the treatment of actinic keratosis.咪喹莫特治疗光化性角化病的安全性和耐受性。
Expert Opin Drug Saf. 2015;14(12):1969-78. doi: 10.1517/14740338.2015.1108962. Epub 2015 Nov 2.
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Efficacy and safety of follow-up field treatment of actinic keratosis with ingenol mebutate 0·015% gel: a randomized, controlled 12-month study.疗效和安全性的随访领域治疗光化性角化病与 ingenol 咪喹莫特 0·015%凝胶:一项随机、对照 12 个月的研究。
Br J Dermatol. 2016 Mar;174(3):505-13. doi: 10.1111/bjd.14222. Epub 2016 Jan 9.
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Cosmetic Effects of Ingenol Mebutate Gel in the Treatment of Field-Cancerized Photodamaged Skin.咪喹莫特凝胶治疗光损伤皮肤原位癌的美容效果
Dermatol Surg. 2015 Nov;41(11):1328-9. doi: 10.1097/DSS.0000000000000503.
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Evidence- and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis - International League of Dermatological Societies in cooperation with the European Dermatology Forum - Short version.基于证据和共识的（S3）光化性角化病治疗指南 - 国际皮肤科学会联盟与欧洲皮肤病学会联盟合作 - 简版。
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