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本文引用的文献

1
Efficacy and Safety of Sonidegib in Adult Patients with Nevoid Basal Cell Carcinoma Syndrome (Gorlin Syndrome): Results from a Phase 2, Double-Blind, Randomized Trial.索尼德吉治疗成年痣样基底细胞癌综合征(戈林综合征)患者的疗效和安全性:一项2期双盲随机试验的结果
Clin Cosmet Investig Dermatol. 2020 Feb 3;13:117-121. doi: 10.2147/CCID.S233097. eCollection 2020.
2
Sonidegib and vismodegib in the treatment of patients with locally advanced basal cell carcinoma: a joint expert opinion.索纳替尼和维莫德吉治疗局部晚期基底细胞癌患者:联合专家意见
J Eur Acad Dermatol Venereol. 2020 Sep;34(9):1944-1956. doi: 10.1111/jdv.16230. Epub 2020 Mar 4.
3
Sonic Hedgehog Pathway Inhibition in the Treatment of Advanced Basal Cell Carcinoma.Sonic Hedgehog 通路抑制在晚期基底细胞癌治疗中的应用。
Curr Treat Options Oncol. 2019 Nov 26;20(11):84. doi: 10.1007/s11864-019-0683-9.
4
Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study.索立德吉治疗晚期基底细胞癌的长期疗效和安全性:II 期随机、双盲 BOLT 研究的 42 个月分析。
Br J Dermatol. 2020 Jun;182(6):1369-1378. doi: 10.1111/bjd.18552. Epub 2019 Dec 8.
5
Long-Term Efficacy of Vismodegib After its Withdrawal and Patients' Health-Related Quality of Life Using the Dermatology Life Quality Index (DLQI).维莫德吉停药后的长期疗效以及使用皮肤病生活质量指数(DLQI)评估患者的健康相关生活质量。
Dermatol Ther (Heidelb). 2019 Dec;9(4):719-724. doi: 10.1007/s13555-019-00323-4. Epub 2019 Sep 10.
6
Real-Life Effectiveness of Vismodegib in Patients with Metastatic and Advanced Basal Cell Carcinoma: Characterization of Adverse Events and Assessment of Health-Related Quality of Life using the Dermatology Life Quality Index (DLQI) Test.维莫德吉在转移性和晚期基底细胞癌患者中的实际疗效:不良事件特征及使用皮肤病生活质量指数(DLQI)测试评估健康相关生活质量
Dermatol Ther (Heidelb). 2019 Sep;9(3):505-510. doi: 10.1007/s13555-019-0303-4. Epub 2019 Jun 4.
7
Reply to Woltsche N. et al. Managing adverse effects by dose reduction during routine treatment of locally advanced basal cell carcinoma with the hedgehog inhibitor vismodegib: a single-centre experience.回复Woltsche N.等人的文章《在使用刺猬信号通路抑制剂维莫德吉对局部晚期基底细胞癌进行常规治疗期间通过降低剂量来管理不良反应:一项单中心经验》
J Eur Acad Dermatol Venereol. 2019 Apr;33(4):e145-e147. doi: 10.1111/jdv.15469. Epub 2019 Mar 20.
8
Safety and Tolerability of Sonic Hedgehog Pathway Inhibitors in Cancer.癌症中 Sonic Hedgehog 通路抑制剂的安全性和耐受性。
Drug Saf. 2019 Feb;42(2):263-279. doi: 10.1007/s40264-018-0777-5.
9
Vismodegib treatment in a HIV positive patient on antiretroviral therapy.在接受抗逆转录病毒治疗的HIV阳性患者中使用维莫德吉进行治疗。
Indian J Dermatol Venereol Leprol. 2018 Nov-Dec;84(6):758-760. doi: 10.4103/ijdvl.IJDVL_92_18.
10
Efficacy, safety, and comparison of sonic hedgehog inhibitors in basal cell carcinomas: A systematic review and meta-analysis.索那替尼抑制剂治疗基底细胞癌的疗效、安全性及比较:系统评价和荟萃分析。
J Am Acad Dermatol. 2018 Dec;79(6):1089-1100.e17. doi: 10.1016/j.jaad.2018.07.004. Epub 2018 Jul 10.

索尼德吉:治疗晚期基底细胞癌的安全性与有效性

Sonidegib: Safety and Efficacy in Treatment of Advanced Basal Cell Carcinoma.

作者信息

Villani Alessia, Fabbrocini Gabriella, Costa Claudia, Scalvenzi Massimiliano

机构信息

Dermatology Unit, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

出版信息

Dermatol Ther (Heidelb). 2020 Jun;10(3):401-412. doi: 10.1007/s13555-020-00378-8. Epub 2020 Apr 15.

DOI:10.1007/s13555-020-00378-8
PMID:32297221
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7211768/
Abstract

Hedgehog inhibitors are promising alternative treatments for patients with advanced basal cell carcinomas. Sonidegib (Odomzo), an oral smoothened (SMO) antagonist, is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) who present recurrence following surgery or radiation therapy, or those who are not candidates for surgery or radiotherapy. Several studies and randomized controlled trials have been conducted to evaluate the efficacy, safety, and tolerability of this new molecule that has demonstrated a good response rate (44%). Grade 1-2 adverse events have also been reported. Further studies of real-world experiences are needed to better understand the correct management of the drug, alternative dosing regimens, and differences with other hedgehog inhibitors. This article provides a complete overview of the pharmacology and pharmacokinetics of sonidegib and a report of the trials and studies conducted. The most frequent adverse events and their correct management are also discussed.

摘要

刺猬信号通路抑制剂是晚期基底细胞癌患者很有前景的替代治疗方法。索尼德吉(Odomzo),一种口服的 smoothened(SMO)拮抗剂,适用于治疗成年局部晚期基底细胞癌(laBCC)患者,这些患者在手术或放疗后出现复发,或那些不适合手术或放疗的患者。已经进行了多项研究和随机对照试验来评估这种新分子的疗效、安全性和耐受性,其显示出良好的缓解率(44%)。也有1-2级不良事件的报告。需要进一步开展真实世界经验的研究,以更好地了解该药物的正确管理、替代给药方案以及与其他刺猬信号通路抑制剂的差异。本文全面概述了索尼德吉的药理学和药代动力学,并报告了所进行的试验和研究。还讨论了最常见的不良事件及其正确管理。