Maberry Mackenzie D, Smith Caleb J, Go Ronald S
Department of Medicine, Mayo Clinic, Rochester, MN, USA.
Division of Hematology, Mayo Clinic, Rochester, MN, USA.
J Gen Intern Med. 2025 May 16. doi: 10.1007/s11606-025-09528-0.
Peripheral neuropathy can be associated with certain monoclonal gammopathies; therefore, monoclonal protein testing is routinely performed in the evaluation of this symptom. However, limited data exist regarding the utility of monoclonal protein testing for this indication. Data suggest those receiving a new monoclonal gammopathy of undetermined significance (MGUS) diagnosis have similar rates of diagnosis-related anxiety when compared to those receiving a myeloma diagnosis (Maatouk et al., Blood Cancer J 9(2), 2019; Adami et al., Eur J Clin Invest 49(3), 2019; Rögnvaldsson et al., Blood Cancer J 11(5):1-13, 2021).
To quantify the utility of monoclonal protein testing with respect to early detection of malignancy or determining etiology of peripheral neuropathy.
DESIGN/PARTICIPANTS: We reviewed records of patients who received monoclonal protein testing for neuropathy as per ICD-10 codes at our institution during 2021 (n=1436). All those with previously diagnosed monoclonal gammopathies were excluded (n=37). Clinical utility was defined as finding a new lymphoplasmacytic neoplasm diagnosis, or if the neuropathy was ultimately attributed to the monoclonal gammopathy identified with testing.
Among 1399 patients receiving monoclonal protein testing, 148 (10.6%) were diagnosed with monoclonal gammopathy, the majority (98.6%) being MGUS. As a result of monoclonal gammopathy screening, neuropathy was ultimately attributed to monoclonal gammopathy in 12 patients (0.8% total), and two patients (0.1%) were diagnosed with a lymphoplasmacytic malignancy as a result of monoclonal protein testing.
In the evaluation of peripheral neuropathy, routine monoclonal protein testing has low clinical utility. In our study, greater than 1 in 10 patients screened were diagnosed with MGUS, while less than 1 in 100 patients were determined to have neuropathy attributable to monoclonal gammopathy. Our data suggest the test performance of monoclonal protein testing for the indication of peripheral neuropathy without other findings to suggest an underlying paraproteinemic process, such as bony pain, renal dysfunction, or unexplained anemia, is poor, and this test should be reserved for individuals in whom alternative diagnoses are first considered and excluded.
周围神经病变可能与某些单克隆丙种球蛋白病相关；因此，在评估该症状时通常会进行单克隆蛋白检测。然而，关于单克隆蛋白检测用于此适应症的效用的数据有限。数据表明，与那些被诊断为骨髓瘤的患者相比，那些新诊断为意义未明的单克隆丙种球蛋白病（MGUS）的患者有相似的诊断相关焦虑率（马图克等人，《血液癌症杂志》9(2)，2019年；阿达米等人，《欧洲临床研究杂志》49(3)，2019年；罗格瓦尔德松等人，《血液癌症杂志》11(5):1 - 13，2021年）。
量化单克隆蛋白检测在早期发现恶性肿瘤或确定周围神经病变病因方面的效用。
设计/参与者：我们回顾了2021年在我们机构根据国际疾病分类第十版（ICD - 10）编码接受神经病变单克隆蛋白检测的患者记录（n = 1436）。所有先前已诊断为单克隆丙种球蛋白病的患者被排除（n = 37）。临床效用定义为发现新的淋巴浆细胞性肿瘤诊断，或者神经病变最终归因于检测所确定的单克隆丙种球蛋白病。
在1399例接受单克隆蛋白检测的患者中，148例（10.6%）被诊断为单克隆丙种球蛋白病，其中大多数（98.6%）为MGUS。由于单克隆丙种球蛋白病筛查，12例患者（占总数的0.8%）的神经病变最终归因于单克隆丙种球蛋白病，并且有2例患者（0.1%）因单克隆蛋白检测被诊断为淋巴浆细胞性恶性肿瘤。
在评估周围神经病变时，常规单克隆蛋白检测的临床效用较低。在我们的研究中，每10名接受筛查的患者中就有超过1名被诊断为MGUS，而每100名患者中不到1名被确定患有可归因于单克隆丙种球蛋白病的神经病变。我们的数据表明，对于没有其他提示潜在副蛋白血症过程的发现（如骨痛、肾功能不全或不明原因贫血）的周围神经病变适应症，单克隆蛋白检测的测试性能较差，并且该检测应保留给首先考虑并排除其他诊断的个体。
