甲氨蝶呤片联合艾拉莫德片治疗类风湿关节炎的临床研究

Clinical trial of methotrexate tablets combined with iguratimod tablets in the treatment of rheumatoid arthritis

目的观察甲氨蝶呤片联合艾拉莫德片治疗类风湿关节炎(RA)的临床疗效及安全性。方法将93例RA患者随机分为对照组46例和试验组47例。对照组予以甲氨蝶呤每次15 mg,每周1次,口服;试验组在对照组治疗的基础上,予以艾拉莫德每次25 mg,bid,口服。2组患者均治疗24周。比较2组患者的临床疗效,类风湿因子(RF)和红细胞沉降率(ESR)水平和疾病活动性评分28(DAS28),以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为89. 36%(42例/47例)和73. 91%(34例/46例),差异有统计学意义(P <0. 05)。治疗后,试验组和对照组的RF分别为(36. 55±5. 15)和(58. 22±8. 19) U·mL^(-1),ESR分别为(27. 74±3. 81)和(34. 25±4. 63)mm·h^(-1),DAS28评分分别为(2. 62±0. 36)和(3. 77±0. 50)分,差异均有统计学意义(均P <0. 05)。试验组出现的药物不良反应主要有腹泻、头晕头痛和恶心呕吐,对照组出现的药物不良反应主要有腹泻和头晕头痛。试验组和对照组的总药物不良反应发生率分别为12. 77%和8. 70%,差异无统计学意义(P> 0. 05)。结论甲氨蝶呤片联合艾拉莫德片治疗RA的临床疗效确切,其能显著缓解患者的临床症状,下调RF和ESR水平,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of methotrexate tablets combined with iguratimod tablets in the treatment of rheumatoid arthritis( RA). Methods A total of 93 patients with RA were randomly divided into control group with 46 cases and treatment group with 47 cases. Control group received methotrexate 15 mg per time,once a week,orally. Treatment group received iguratimod 25 mg per time,bid,orally,on the basis of control group. Two groups were treated for 24 weeks. The clinical efficacy,serum C reactive protein( CRP),rheumatoid factor( RF),erythrocyte sedimentation rate( ESR),disease activity score 28( DAS28),and the incidence of adverse reactions were compared between 2 groups. Results After treatment,the total effective rates of treatment and control groups were 89. 36%( 42 cases/47 cases) and 73. 91%( 34 cases/46 cases) with significant difference( P < 0. 05). After treatment,the main indexes of treatment and controlgroups were compared: RF were( 36. 55 ± 5. 15) and( 58. 22 ± 8. 19) U · mL-1,ESR were( 27. 74 ± 3. 81) and( 34. 25 ± 4. 63) mm·h-1,DAS28 were( 2. 62 ± 0. 36) and( 3. 77 ± 0. 50) scores,the differences were statistically significant( all P < 0. 05). The adverse drug reactions of treatment group were diarrhea,dizziness and headache,nausea and vomiting,which in the control group were diarrhea,dizziness and headache. The total incidences of adverse reactions in treatment and control groups were 12. 77% and 8. 70% without significant difference( P > 0. 05).Conclusion Methotrexate tablets combined with iguratimod tablets have a definitive clinical efficacy in the treatment of patients with RA,which can significantly relieve the clinical symptoms of patients and reduce the levels of RF and ESR,without increasing the incidence of adverse drug reactions.