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痤疮治疗中,不同品牌异维 A 酸口服制剂的不良反应发生率存在差异:一项回顾性观察性研究。

Prevalence of adverse events varies with the different oral isotretinoin brands in acne treatment: a retrospective observational study.

机构信息

Dermatology Department, Faculté de Médecine, Université Saint-Joseph, Beirut, Lebanon.

Dermatology Department, Hôtel-Dieu de France University Hospital, Boulevard Alfred Naccache, Beirut, 16-6830, Lebanon.

出版信息

Arch Dermatol Res. 2023 Aug;315(6):1533-1539. doi: 10.1007/s00403-023-02532-6. Epub 2023 Jan 19.

DOI:10.1007/s00403-023-02532-6
PMID:36656385
Abstract

Oral isotretinoin remains the most effective treatment for acne. The aim of this retrospective single-center cohort study was to estimate the prevalence of adverse events with the different oral isotretinoin brands used in acne treatment. The population consisted of all patients who consulted for acne between January 2015 and January 2020. The inclusion criterion was the initiation of treatment with oral isotretinoin. The exclusion criteria were the use of two or more brands during the same course of treatment and previous treatment with oral isotretinoin. Statistical analysis was carried out using Chi-square and Mann-Whitney tests. We analyzed 468 patients of whom 68.6% were female. The median age was 21 years. The median weight was 65 kg. The treatment was Roaccutane, Curacné, Acnotren, Isosupra, Contracné, or Acnogen in 44.2%, 28%, 14.5%, 10.5%, 1.7% and 0.4% of cases, respectively. Xerosis was the most frequently reported side effect regardless of the brand. The highest frequencies of hypercholesterolemia (25.6%) and eczema (13%) were noted with Roaccutane; hypertriglyceridemia (16.8%), epistaxis (9.9%) and fatigue (3.1%) with Curacné; excessive sweating (4.1%) and headache (4.1%) with Isosupra; and abnormal liver function tests (11%) with Acnotren. We found a significant correlation mainly between abnormal ASAT and Acnotren (p = 0.009), hypercholesterolemia and Roaccutane [OR = 1.652 (95% CI 1.056-2.585)], hypertriglyceridemia and higher body weight (p = 0.004). Factors related to the drug brand and to characteristics of acne patients could explain the variability in the prevalence of some adverse events.

摘要

口服异维 A 酸仍然是治疗痤疮最有效的方法。本回顾性单中心队列研究旨在评估不同品牌口服异维 A 酸治疗痤疮的不良反应发生率。该人群包括 2015 年 1 月至 2020 年 1 月期间因痤疮就诊的所有患者。纳入标准为开始口服异维 A 酸治疗。排除标准为同一疗程使用两种或两种以上品牌以及既往口服异维 A 酸治疗。使用卡方检验和曼-惠特尼检验进行统计分析。我们分析了 468 名患者,其中 68.6%为女性。中位年龄为 21 岁。中位体重为 65 公斤。治疗药物分别为 Roaccutane、Curacné、Acnotren、Isosupra、Contracné 和 Acnogen,占比分别为 44.2%、28%、14.5%、10.5%、1.7%和 0.4%。无论品牌如何,干燥症都是最常报告的副作用。Roaccutane 组高胆固醇血症(25.6%)和湿疹(13%)的发生率最高;Curacné 组高甘油三酯血症(16.8%)、鼻出血(9.9%)和疲劳(3.1%)发生率最高;Isosupra 组多汗(4.1%)和头痛(4.1%)发生率最高;Acnotren 组肝功能异常(11%)发生率最高。我们发现主要有显著相关性异常 AST 与 Acnotren(p=0.009),高胆固醇血症与 Roaccutane [OR=1.652(95%CI 1.056-2.585)],高甘油三酯血症与体重较高(p=0.004)。药物品牌和痤疮患者特征相关的因素可以解释一些不良反应发生率的差异。

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本文引用的文献

1
Isotretinoin Laboratory Monitoring in Acne Treatment: A Delphi Consensus Study.异维 A 酸治疗痤疮的实验室监测:德尔菲共识研究。
JAMA Dermatol. 2022 Aug 1;158(8):942-948. doi: 10.1001/jamadermatol.2022.2044.
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Comprehensive review of reports of menstrual irregularities associated with isotretinoin.异维A酸相关月经不调报告的综合综述。
Int J Womens Dermatol. 2020 Jul 17;6(5):365-367. doi: 10.1016/j.ijwd.2020.07.004. eCollection 2020 Dec.
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Optimizing Isotretinoin Treatment of Acne: Update on Current Recommendations for Monitoring, Dosing, Safety, Adverse Effects, Compliance, and Outcomes.
优化异维 A 酸治疗痤疮:当前监测、剂量、安全性、不良反应、依从性和结局建议的更新。
Am J Clin Dermatol. 2020 Jun;21(3):411-419. doi: 10.1007/s40257-020-00508-0.
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The clinical utility of laboratory monitoring during isotretinoin therapy for acne and changes to monitoring practices over time.异维 A 酸治疗痤疮时实验室监测的临床实用性及监测实践随时间的变化。
J Am Acad Dermatol. 2020 Jan;82(1):72-79. doi: 10.1016/j.jaad.2019.06.025. Epub 2019 Jun 19.
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Oral isotretinoin for acne.口服异维A酸治疗痤疮。
Cochrane Database Syst Rev. 2018 Nov 24;11(11):CD009435. doi: 10.1002/14651858.CD009435.pub2.
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Effect of oral isotretinoin on the nucleo-cytoplasmic distribution of FoxO1 and FoxO3 proteins in sebaceous glands of patients with acne vulgaris.口服异维 A 酸对寻常痤疮患者皮脂腺中 FoxO1 和 FoxO3 蛋白核质分布的影响。
Exp Dermatol. 2018 Dec;27(12):1344-1351. doi: 10.1111/exd.13787. Epub 2018 Oct 17.
7
Practical management of acne for clinicians: An international consensus from the Global Alliance to Improve Outcomes in Acne.痤疮临床实用管理:来自改善痤疮结局全球联盟的国际共识。
J Am Acad Dermatol. 2018 Feb;78(2 Suppl 1):S1-S23.e1. doi: 10.1016/j.jaad.2017.09.078. Epub 2017 Nov 8.
8
Efficacy and adverse events of oral isotretinoin for acne: a systematic review.口服异维 A 酸治疗痤疮的疗效和不良反应:系统评价。
Br J Dermatol. 2018 Jan;178(1):76-85. doi: 10.1111/bjd.15668. Epub 2017 Dec 8.
9
Isotretinoin treatment for acne and risk of depression: A systematic review and meta-analysis.异维 A 酸治疗痤疮与抑郁风险:系统评价和荟萃分析。
J Am Acad Dermatol. 2017 Jun;76(6):1068-1076.e9. doi: 10.1016/j.jaad.2016.12.028. Epub 2017 Mar 11.
10
Guidelines of care for the management of acne vulgaris.寻常痤疮治疗的指南。
J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17.