Getov I, Dimitrova Z, Petkova V
Department of Social Pharmacy, Faculty of Pharmacy, Medical University-Sofia.
Boll Chim Farm. 2000 Jul-Aug;139(4):153-8.
Antineoplastic drugs caused various and frequent adverse drug reactions (ADR) in connection with their pharmacodynamics. Methotrexate (MTX) ADRs are preferably gastrointestinal disorders and hepatotoxicity (hepatic enzyme abnormalities). The aim of this study was to detect and analyse ADR induced by low-dose MTX treatment in rheumatology. We observed 94 patients, 63 with rheumatoid arthritis and 31 with psoriatic arthritis. All patients were co-medicated with nonsteroidal anti-inflammatory drugs (NSAID) as Diclofenacum, Indomethacinum, Piroxicamum and 51% with glycocorticosteroides. During the follow-up study we collected 18 case-reports with ADR for 17% of the patients. From the patients with registered ADR, 11 was treated with standard dose of 7.5 mg MTX for a week and 7 patients received from 10 to 15 mg for a week. The distribution of the cases according patients' gender was 9 females and 7 males. Prevail individuals in age groups' 41-50 and over 61 years. The most frequent adverse drug reactions were leucopenia, trombocytopenia, skin reactions and gastrointestinal disorders as vomiting, melaena, epigastrial pain, etc. The primary risk connected with long therapy of low doses MTX is hepatotoxicity that diagnose and treatment are painful and expensive. As a result of the appearance of ADR in 5 patients the therapy with MTX was not changed, in two cases MTX is stopped timely or the dosage is changed and in the rest 11 patients MTX was excluded from the therapeutic scheme.
抗肿瘤药物因其药效学特性会引发各种常见的药物不良反应(ADR)。甲氨蝶呤(MTX)的不良反应主要为胃肠道疾病和肝毒性(肝酶异常)。本研究旨在检测和分析低剂量MTX治疗风湿病时诱发的ADR。我们观察了94例患者,其中63例为类风湿性关节炎,31例为银屑病关节炎。所有患者均联合使用双氯芬酸、吲哚美辛、吡罗昔康等非甾体抗炎药(NSAID),51%的患者还使用了糖皮质激素。在随访研究中,我们收集了18例ADR病例报告,占患者总数的17%。在报告有ADR的患者中,11例接受标准剂量7.5mg MTX治疗一周,7例接受10至15mg MTX治疗一周。病例按患者性别分布为9名女性和7名男性。年龄组中41 - 50岁和61岁以上的患者居多。最常见的药物不良反应为白细胞减少、血小板减少、皮肤反应以及胃肠道疾病,如呕吐、黑便、上腹部疼痛等。与低剂量MTX长期治疗相关的主要风险是肝毒性,其诊断和治疗既痛苦又昂贵。由于5例患者出现ADR,MTX治疗方案未改变;2例中MTX及时停药或改变剂量;其余11例患者的MTX被排除在治疗方案之外。