从真实世界数据看甲氨蝶呤用于治疗类风湿性关节炎

Use of Methotrexate in Treatment of Rheumatoid Arthritis According to Real World

目的分析甲氨蝶呤治疗类风湿性关节炎的真实世界数据,为甲氨蝶呤相关药品在国内的药品说明书中增加类风湿性关节炎的适应证提供参考。方法参考不同国家上市的甲氨蝶呤制剂的说明书及用法用量,从超说明书用药的角度收集国内已报道甲氨蝶呤用于治疗类风湿性关节炎的疗效及循证医学评估。结果甲氨蝶呤用于治疗类风湿性关节炎的适应证在欧美日等国家和地区均已获准,而相关药品在国内用于治疗类风湿性关节炎的真实世界数据足以支撑其在该领域的应用,虽均为超说明书用药但均符合循证医学逻辑。结论甲氨蝶呤在治疗中国人群类风湿性关节炎的锚定作用应该被重视,类风湿性关节炎的适应证理应写入甲氨蝶呤相关药品的说明书中。

OBJECTIVE To provide reference for the additional use of methotrexate-related drugs approved in China by analyzing the real-world data of methotrexate for rheumatoid arthritis.METHODS Based on various indications and usage of methotrexate marketed in different countries and regions.The efficacy and evidence-based medical evaluation of methotrexate for the treatment of rheumatoid arthritis in China were collected by off-label use in such drugs.RESULTS The indications of methotrexate for the treatment of rheumatoid arthritis had been approved in Europe and the United States,Japan and other countries and regions.The real-world data of methotrexate for the treatment of rheumatoid arthritis in China was enough to support its application in this field,although all of cases were off-label use but got support by evidence-based medical evidence.CONCLUSION The anchoring role of methotrexate in the treatment of rheumatoid arthritis in Chinese population should be emphasized,as well as the indications for rheumatoid arthritis should rightly be included in the label of methotrexate-related drugs.