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[药物警戒更新]

[Pharmacovigilance update].

作者信息

Livio Françoise

机构信息

Service de pharmacologie clinique, Département des laboratoires, CHUV, 1011 Lausanne.

出版信息

Rev Med Suisse. 2018 Jan 10;14(588-589):81-84.

PMID:29337457
Abstract

The main pharmacovigilance updates in 2017 are reviewed. Denosumab : rebound-associated multiple vertebral fractures after discontinuation. Canagliflozine: increased risk of foot/leg amputations. Biologic and targeted cancer therapies, direct-acting antivirals for chronic hepatitis C: risk of hepatitis B reactivation. Checkpoint inhibitors : immune-related adverse events and graft rejection. Fingolimod : rebound-associated reactivation of MS following withdrawal. Daclizumab: risk of severe liver injury leading to restricted use in MS patients. Posaconazole: risk of overexposure when switching from oral suspension to tablets. Voriconazole: cutaneous squamous cell carcinoma under long-term therapy. Proton pump inhibitors : early exposure might increase fracture risk in young children.

摘要

回顾了2017年主要的药物警戒更新情况。地诺单抗:停药后与反弹相关的多发性椎体骨折。卡格列净:足部/腿部截肢风险增加。生物和靶向癌症治疗药物、慢性丙型肝炎直接作用抗病毒药物:乙型肝炎再激活风险。检查点抑制剂:免疫相关不良事件和移植排斥反应。芬戈莫德:撤药后与反弹相关的多发性硬化症再激活。达利珠单抗:严重肝损伤风险导致其在多发性硬化症患者中的使用受限。泊沙康唑:从口服混悬液转换为片剂时存在暴露过量风险。伏立康唑:长期治疗下的皮肤鳞状细胞癌风险。质子泵抑制剂:幼儿早期接触可能增加骨折风险。

相似文献

1
[Pharmacovigilance update].[药物警戒更新]
Rev Med Suisse. 2018 Jan 10;14(588-589):81-84.
2
[Multiple Vertebral Fractures after Denosumab Discontinuation: How to Avoid Them?].[地诺单抗停药后多发性椎体骨折:如何避免?]
Praxis (Bern 1994). 2018 Jun;107(12):649-654. doi: 10.1024/1661-8157/a002997.
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[How to manage the rebound effect at denosumab discontinuation and avoid multiple vertebral fractures?].[如何应对地诺单抗停药后的反跳效应并避免多发性椎体骨折?]
Rev Med Suisse. 2019 Apr 17;15(647):831-835.
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Rebound-associated vertebral fractures after discontinuation of denosumab-from clinic and biomechanics.地诺单抗停用后与反弹相关的椎体骨折——来自临床和生物力学研究
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Rebound vertebral fracture in the dental chair during a tooth extraction whilst on a treatment holiday from denosumab to avoid ONJ!在因使用地诺单抗治疗休假以避免颌骨坏死期间,于牙科椅上拔牙时发生椎体再发骨折!
Bone. 2018 Mar;108:43. doi: 10.1016/j.bone.2017.12.015. Epub 2017 Dec 16.
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[The denosumab dilemma: to be stopped after 5 years or to be continued in patients with osteoporosis?].[地舒单抗困境:骨质疏松症患者5年后停药还是继续用药?]
Ned Tijdschr Geneeskd. 2018 May 14;162:D2831.
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Rebound-associated vertebral fractures after discontinuation of denosumab for the treatment of maxillitis.地舒单抗治疗颌骨炎停药后与反跳相关的椎体骨折。
Osteoporos Int. 2018 Mar;29(3):769-772. doi: 10.1007/s00198-017-4334-3. Epub 2017 Dec 11.
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Rev Med Suisse. 2019 Jan 9;15(N° 632-633):92-95.
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Severe Rebound-Associated Vertebral Fractures After Denosumab Discontinuation: 9 Clinical Cases Report.地诺单抗停药后严重的反弹相关椎体骨折:9例临床病例报告
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引用本文的文献

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The Clinical Effectiveness of Denosumab (Prolia®) for the Treatment of Osteoporosis in Postmenopausal Women, Compared to Bisphosphonates, Selective Estrogen Receptor Modulators (SERM), and Placebo: A Systematic Review and Network Meta-Analysis.唑来膦酸(普罗力)治疗绝经后妇女骨质疏松症的临床疗效:与双膦酸盐、选择性雌激素受体调节剂(SERM)和安慰剂的系统评价和网络荟萃分析。
Calcif Tissue Int. 2023 Jun;112(6):631-646. doi: 10.1007/s00223-023-01078-z. Epub 2023 Apr 5.
2
The clinical effectiveness of denosumab (Prolia®) in patients with hormone-sensitive cancer receiving endocrine therapy, compared to bisphosphonates, selective estrogen receptor modulators (SERM), and placebo: a systematic review and network meta-analysis.地舒单抗(普罗力)对比双磷酸盐、选择性雌激素受体调节剂(SERM)和安慰剂用于接受内分泌治疗的激素敏感性癌症患者的临床疗效:系统评价和网络荟萃分析。
Arch Osteoporos. 2023 Jan 10;18(1):18. doi: 10.1007/s11657-023-01211-3.