Pappalardo A, Sallì L, Compagno M
Cattedra di Reumatologia, Università degli Studi di Palermo, Italia.
Clin Ter. 1998 Mar-Apr;149(2):109-14.
To verify, in an open study, the efficacy and safety of long-term administration of low weekly doses (5 mg) of methotrexate (MTX) i.m. in different stage rheumatoid arthritis patients.
The study has been performed for 24 months in 42 patients (37 females and 5 males), fulfilling the ARA criteria for rheumatoid arthritis. Main functional parameters, main serological data and some immunology indexes were periodically monitored (after 1, 3, 6, 12 and 24 months of therapy); moreover, some instrumental exams (X-ray of involved joints, liver ultrasound, respiratory function tests) have been performed.
Thirty of 42 enrolled patients completed the whole 24 month therapy, and 22 are still using methotrexate. Results were as follows: therapeutic remission in one patient, marked improvement in 12 cases, moderate improvement in 16 and worsening in 1. Among the 12 remaining patients, 2 refused further treatment; 6 and 4 patients were withdrawn from the study because of inefficacy and toxicity, respectively. A significant improvement was observed in all of the main efficacy parameters taken into consideration. Moderate and reversible side effects were registered in 23 patients.
Our results confirm the value of MTX in the treatment of rheumatoid arthritis. In our opinion this drug is very effective even in a relatively early stage of the disease, mainly in patients whose genetic and clinical markers may predict a more aggressive and severe outcome.
在一项开放性研究中，验证长期每周小剂量（5毫克）甲氨蝶呤（MTX）肌肉注射对不同阶段类风湿关节炎患者的疗效和安全性。
该研究对42例符合美国风湿病学会（ARA）类风湿关节炎标准的患者（37例女性，5例男性）进行了24个月的观察。定期监测主要功能参数、主要血清学数据和一些免疫学指标（治疗1、3、6、12和24个月后）；此外，还进行了一些器械检查（受累关节X线检查、肝脏超声检查、呼吸功能测试）。
42例入组患者中有30例完成了整个24个月的治疗，22例仍在使用甲氨蝶呤。结果如下：1例患者达到治疗缓解，12例显著改善，16例中度改善，1例病情恶化。其余12例患者中，2例拒绝进一步治疗；6例和4例患者分别因无效和毒性退出研究。所有考虑的主要疗效参数均有显著改善。23例患者出现中度且可逆的副作用。
我们的结果证实了甲氨蝶呤在类风湿关节炎治疗中的价值。我们认为，即使在疾病相对早期，该药也非常有效，主要适用于那些遗传和临床指标可能预示病情更具侵袭性和严重性的患者。
