不同剂量甲氨蝶呤联合不同剂量叶酸治疗活动期类风湿关节炎的临床研究

Clinical Study of Different Doses of Methotrexate Combined with Different Doses of Folic Acid in the Treatment of Active Rheumatoid Arthritis

目的:探讨不同剂量甲氨蝶呤(MTX)联合不同剂量的叶酸治疗活动期类风湿关节炎(RA)的疗效与安全性。方法:选取100例符合纳入、排除标准的RA患者,按照28关节疾病活动指数(DAS28)分为高疾病活动度组(使用MTX 15 mg每周1次)50例和低疾病活动度组(使用MTX 10 mg每周1次)50例。高疾病活动度组按叶酸使用10 mg每周1次或5 mg每周1次随机分为两组。低疾病活动度组按叶酸使用5 mg每周1次或不使用随机分为两组,对比治疗6个月后的临床疗效和安全性。结果:治疗后,高疾病活动度叶酸5 mg组DAS28评分、视觉模拟评分量表(VAS)评分、血沉(ESR)、超敏C反应蛋白(hs-CRP)以及总有效率均优于叶酸10 mg组(P<0.05),但是两组健康评定问卷(HAQ)评分、不良反应发生率和MTX浓度比较无明显差异(P>0.05)。低疾病活动度叶酸5 mg组与无叶酸组患者治疗后hs-CRP、ESR、MTX浓度比较差异有统计学意义(P<0.05),但是两组总有效率和不良反应发生率比较无明显差异(P>0.05)。结论:RA高疾病活动时,使用MTX 15 mg每周1次联合叶酸5 mg每周1次疗效更优,且不良反应发生率及MTX浓度变化不明显。RA低疾病活动时,MTX 10 mg每周1次,与是否使用叶酸在疗效和安全性上无显著差异,但未使用叶酸患者的MTX浓度更高。

Objective:To study the efficacy and safety of different doses of methotrexate(MTX)combined with different doses of folic acid in the treatment of active rheumatoid arthritis(RA).Methods:A total of 100 RA patients meeting the inclusion and exclusion criteria were selected.According to the 28 joint disease activity index(DAS28),50 patients in the high disease activity group(MTX15 mg once a week)and 50 patients in the low disease activity group(MTX 10 mg once a week)were divided.The high disease activity group was randomly divided into two groups according to folic acid administration of 10 mg once a week or 5 mg once a week.The low disease activity group was randomly divided into two groups according to folic acid administration of 5 mg once a week or no use,and the clinical efficacy and safety were compared at 6 months after treatment.Results:6 months after treatment,the DAS28 score,visual analogue scale(VAS)score,blood sedimentation(ESR),hypersensitive C-reactive protein(hs-CRP)and total effective rate in the high disease activity folic acid 5 mg group were better than those in the 10 mg folic acid group(P<0.05),but the health assessment questionnaire(HAQ),the incidence rate of adverse reactions and MTX concentration change no difference between the two groups(P>0.05).After treatment,the hs-CRP,ESR and MTX concentrations of patients with low disease activity folic acid 5 mg group and the patients without folic acid group showed statistically significant differences(P<0.05),and the total effective rate and the incidence rate of adverse reactions were not significantly different between the two groups(P>0.05).Conclusion:When RA is in high disease activity,MTX 15 mg once a week combined with folic acid 5 mg once a week is more effective,but there is no difference in adverse reactions and MTX concentration.MTX 10 mg once a week has no significant difference in efficacy and safety with or without folic acid when RA is low in disease activity,but MTX concentrations is higher in patients without folic acid.