Ka M M, Diallo S, Ka E F, Diop B M, Pouye A, Mbengue M, Leye A, Diouf B, Diop T M
CHU A.-Le Dantec, BP 6237, Dakar, Sénégal.
Sante. 2000 Jan-Feb;10(1):65-8.
Methotrexate (MTX), which has been used for years in cancer treatment, is now being proposed as a first-line treatment for rheumatoid arthritis (RA), despite its potential side effects. The aim of this study was to investigate the short-term efficacy, safety and relative cost of low-dose MTX for the treatment of RA. We carried out an open, nonrandomized trial in which patients received a 7 mg injection of MTX once per week, with clinical and biological follow up. A single physician performed the weekly assessments, which involved evaluation of the duration of morning stiffness, the number of night awakenings, the number of painful and swollen joints and Ritchie's index. Blood cell count and erythrocyte sedimentation rate were determined monthly. Twelve RA patients were enrolled in the trial, over a mean treatment period of 356 +/- 175 days. A significant improvement was observed in all variables except the number of swollen joints. Ritchie's index decreased from a mean of 31.8 +/- 11.85 to 6.5 +/- 8.98 (p<1.6 x 10- 4). Minor adverse reactions were observed but none indicated treatment withdrawal: 6 cases of nausea, 2 of a moderate increase in transaminase activity, 1 of bronchitis, in which the responsibility of MTX was not definitely established and 3 cases in which hemoglobin levels decreased. The monthly cost of the treatment, including the drug itself and laboratory tests, is lower than that of gold salt injection. Three issues of key importance in our region were investigated in this study: 1) the possible desire to become pregnant of female patients undergoing MTX treatment. In addition, some of the young and unmarried patients did not understand or appreciate the contraceptive effects of the treatment; 2) poor compliance with the treatment due to limited financial resources. Many patients did not regularly attend for their follow-up appointments and many stopped taking the medication. One third of the patients were lost to follow-up during this study; 3) the prevalence of chronic hepatitis, which may limit the use of MTX in our region. Serological tests should be performed before the treatment is started and a liver biopsy is recommended for patients with chronic hepatitis B or C.
甲氨蝶呤（MTX）多年来一直用于癌症治疗，尽管有潜在副作用，但目前被提议作为类风湿性关节炎（RA）的一线治疗药物。本研究的目的是调查低剂量MTX治疗RA的短期疗效、安全性和相对成本。我们进行了一项开放性、非随机试验，患者每周接受一次7毫克MTX注射，并进行临床和生物学随访。由一名医生每周进行评估，包括评估晨僵持续时间、夜间觉醒次数、疼痛和肿胀关节数量以及里奇指数。每月测定血细胞计数和红细胞沉降率。12名RA患者参与了试验，平均治疗期为356±175天。除肿胀关节数量外，所有变量均有显著改善。里奇指数从平均31.8±11.85降至6.5±8.98（p<1.6×10⁻⁴）。观察到轻微不良反应，但均未表明需停药：6例恶心，2例转氨酶活性中度升高，1例支气管炎（MTX的责任未明确确定），3例血红蛋白水平下降。治疗的每月成本，包括药物本身和实验室检查，低于金盐注射。本研究调查了我们地区三个至关重要的问题：1）接受MTX治疗的女性患者可能有怀孕的意愿。此外，一些年轻未婚患者不理解或不重视治疗的避孕效果；2）由于经济资源有限，治疗依从性差。许多患者未定期参加随访预约，许多人停止服药。在本研究期间，三分之一的患者失访；3）慢性肝炎的患病率，这可能限制MTX在我们地区的使用。在开始治疗前应进行血清学检查，对于慢性乙型或丙型肝炎患者，建议进行肝活检。
