Sierocinski Elizabeth, Angelow Aniela, Mainz Armin, Walker Jochen, Chenot Jean-François
Abteilung Allgemeinmedizin, Institut für Community Medicine, Universitätsmedizin Greifswald, Fleischmannstr. 6, 17485, Greifswald, Deutschland.
Hausarztpraxis Korbach, Korbach, Deutschland.
Z Rheumatol. 2021 Jun;80(5):418-424. doi: 10.1007/s00393-021-00976-7. Epub 2021 Mar 11.
Methotrexate (MTX) is the most commonly prescribed disease-modifying drug in the treatment of rheumatic diseases. Regular laboratory testing is recommended to recognize side effects, such as hepatotoxicity and myelotoxicity as well as decreases in renal function that may cause toxic MTX accumulation. Additionally, folic acid is recommended as prophylaxis against specific side effects. In this study we investigated whether laboratory monitoring and prescription of folic acid took place according to published recommendations.
Claims data from the statutory health insurance from 1 January 2009 to 31 December 2013 were retrospectively analyzed. A total of 40,087 adults with a rheumatic diagnosis (ICD10 codes M05-M18), no malignant disease and no previous MTX prescription within 12 months were extracted from the InGef (Institute for Applied Health Research in Berlin, formerly Health Risk Institute) research database. The frequency of recommended laboratory testing, appointments with rheumatologists and the prescription of folic acid prophylaxis were investigated.
Of the patients 12,451 began treatment with MTX in the observation period. Between 42% and 46% of recommended blood counts, liver values and kidney function tests and 14% of urinalyses were performed according to recommendations. Of the patients 84% were seen regularly by a rheumatologist and 74% received a prescription for prophylactic folic acid. Serious conditions potentially resulting from MTX treatment were observed in 0.7-3.5 cases/1000 person years.
Laboratory monitoring in the context of MTX treatment is carried out less frequently than recommended in the literature. Potential MTX-associated serious complications are rare from a practice perspective. On the one hand solutions are needed for a better coordination of laboratory monitoring. On the other hand more empirical evidence is needed regarding the benefits of laboratory monitoring and the appropriate intervals thereof.
甲氨蝶呤（MTX）是治疗风湿性疾病时最常用的改善病情药物。建议定期进行实验室检测以识别副作用，如肝毒性、骨髓毒性以及可能导致MTX毒性蓄积的肾功能下降。此外，建议补充叶酸以预防特定副作用。在本研究中，我们调查了实验室监测和叶酸处方是否按照已发表的建议进行。
对2009年1月1日至2013年12月31日法定医疗保险的理赔数据进行回顾性分析。从InGef（柏林应用健康研究所，前身为健康风险研究所）研究数据库中提取了40,087名患有风湿性疾病诊断（ICD10编码M05 - M18）、无恶性疾病且在12个月内未接受过MTX处方的成年人。调查了建议的实验室检测频率、与风湿病学家的预约情况以及叶酸预防用药的处方情况。
在观察期内，12,451名患者开始接受MTX治疗。根据建议进行的血常规、肝功能和肾功能检测的比例在42%至46%之间，尿常规检测的比例为14%。84%的患者定期就诊于风湿病学家，74%的患者接受了预防性叶酸处方。每1000人年中观察到0.7 - 3.5例可能由MTX治疗导致的严重情况。
MTX治疗中的实验室监测频率低于文献建议。从实践角度来看，与MTX相关的潜在严重并发症很少见。一方面，需要更好地协调实验室监测的解决方案。另一方面，需要更多关于实验室监测的益处及其合适间隔的实证证据。
