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与接受地舒单抗治疗的患者发生药物相关性颌骨坏死相关的风险因素。

Risk factors associated with onset of medication-related osteonecrosis of the jaw in patients treated with denosumab.

机构信息

Department of Oral and Maxillofacial Surgery and Facial Plastic Surgery, University Hospital, LMU Munich, Lindwurmstr. 2a, 80336, Munich, Germany.

Department of Oral and Maxillofacial Surgery, University of Halle, Ernst-Grube-Straße 40, 06120, Halle, Germany.

出版信息

Clin Oral Investig. 2022 Mar;26(3):2839-2852. doi: 10.1007/s00784-021-04261-4. Epub 2021 Nov 23.

Abstract

OBJECTIVES

While risk factors of bisphosphonate (BP) associated osteonecrosis of the jaw have been properly analyzed, studies focusing on risk factors associated with denosumab (DNO) are sparse. The purpose of this study was to identify risk factors influencing the onset of medication-related osteonecrosis of the jaw (MRONJ) in patients receiving antiresorptive treatment (ART) with DNO by comparing patients suffering from MRONJ and patients without MRONJ. Multiple variables were evaluated including the impact of a previous BP intake.

MATERIALS AND METHODS

A retrospective single-center cohort study with patients receiving DNO was conducted. One-hundred twenty-eight patients were included and divided into three groups: I (control, n = 40) receiving DNO with absence of MRONJ; group II (Test 1, n = 46), receiving DNO with presence of MRONJ; and group III (Test 2, n = 42) sequentially receiving BP and DNO with presence of MRONJ. Patients' medical history, focusing on the identification of MRONJ risk factors, was collected and evaluated. Parameters were sex, age, smoking habit, alcohol consumption, underlying disease (cancer type, osteoporosis), internal diseases, additional chemo/hormonal therapy, oral inflammation, and trauma.

RESULTS

The following risk factors were identified to increase MRONJ onset significantly in patients treated with DNO: chemo/hormonal therapy (p = 0.02), DNO dosage (p < 0.01), breast cancer (p = 0.03), intake of corticosteroids (p = 0.04), hypertension (p = 0.02), diabetes mellitus (p = 0.04), periodontal disease (p = 0.03), apical ostitis (p = 0.02), and denture use (p = 0.02). A medication switch did not affect MRONJ development (p = 0.86).

CONCLUSIONS

Malignant diseases, additional chemotherapy, DNO dosage, and oral inflammations as well as diabetes mellitus and hypertension influence MRONJ onset in patients treated with DNO significantly.

CLINICAL RELEVANCE

Patients receiving ART with DNO featuring aforementioned risk factors have a higher risk of MRONJ onset. These patients need a sound and regular prophylaxis in order to prevent the onset of MRONJ under DNO treatment.

摘要

目的

虽然双膦酸盐(BP)相关的颌骨骨坏死的风险因素已经得到了适当的分析,但针对地舒单抗(DNO)相关风险因素的研究却很少。本研究的目的是通过比较患有药物相关性颌骨骨坏死(MRONJ)的患者和没有 MRONJ 的患者,确定接受抗吸收治疗(ART)的患者中影响 DNO 治疗后发生 MRONJ 的风险因素。评估了多个变量,包括之前使用 BP 的影响。

材料和方法

进行了一项回顾性单中心队列研究,纳入了接受 DNO 治疗的患者。共纳入 128 例患者,分为三组:I 组(对照组,n=40)接受 DNO 治疗且无 MRONJ;II 组(Test1,n=46)接受 DNO 治疗且有 MRONJ;III 组(Test2,n=42)先后接受 BP 和 DNO 治疗且有 MRONJ。收集并评估了患者的病史,重点是确定 MRONJ 的风险因素。参数包括性别、年龄、吸烟习惯、饮酒、基础疾病(癌症类型、骨质疏松症)、内科疾病、附加化疗/激素治疗、口腔炎症和创伤。

结果

研究发现,以下风险因素显著增加了接受 DNO 治疗的患者发生 MRONJ 的风险:化疗/激素治疗(p=0.02)、DNO 剂量(p<0.01)、乳腺癌(p=0.03)、皮质类固醇(p=0.04)、高血压(p=0.02)、糖尿病(p=0.04)、牙周病(p=0.03)、根尖周炎(p=0.02)和义齿使用(p=0.02)。药物转换并不影响 MRONJ 的发展(p=0.86)。

结论

恶性疾病、附加化疗、DNO 剂量以及口腔炎症、糖尿病和高血压显著影响接受 DNO 治疗的患者的 MRONJ 发病。这些患者在接受 DNO 治疗时,需要进行良好且定期的预防,以防止发生 MRONJ。

临床意义

接受 DNO 治疗的 ART 患者具有上述风险因素时,发生 MRONJ 的风险更高。这些患者需要进行良好的定期预防,以防止在 DNO 治疗下发生 MRONJ。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c189/8898220/d4548218f198/784_2021_4261_Fig1_HTML.jpg

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