摘要
目的:观察艾拉莫德联合甲氨蝶呤治疗类风湿性关节炎的临床疗效及安全性。方法:选择2015年2月-2016年2月于我院接受治疗的82例类风湿性关节炎患者,采用随机数字表法分为观察组和对照组,各41例。对照组患者给予甲氨蝶呤片10 mg口服,每周1次,2周后逐渐增至15 mg,每周1次。观察组患者在对照组基础上给予艾拉莫德片25 mg餐后口服,bid。两组患者的疗程均为6个月。观察两组患者的临床疗效、不良反应发生情况和治疗前后的关节压痛数、关节肿胀数、晨僵时间;检测两组患者治疗前后的红细胞沉降率、C反应蛋白(CRP)、血小板计数、血清免疫球蛋白(IgG、IgA、IgM)和T淋巴细胞亚群(CD3^+、CD4^+、CD8^+)水平。结果:观察组患者临床总有效率为90.24%,明显高于对照组的78.05%,差异有统计学意义(P<0.05)。治疗前,两组患者上述指标水平比较,差异均无统计学意义(P>0.05)。治疗后,两组患者的关节压痛数、关节肿胀数明显少于治疗前,晨僵时间明显短于治疗前,红细胞沉降率、CRP、血小板计数、血清免疫球蛋白和T淋巴细胞亚群水平均明显低于治疗前,且观察组均明显低于对照组,差异均有统计学意义(P<0.05)。两组患者均未见严重的不良反应发生,组间不良反应发生率比较,差异无统计学意义(P>0.05)。结论:艾拉莫德联合甲氨蝶呤较单用甲氨蝶呤更能够提高疗效、缓解患者临床症状、抑制患者免疫功能,从而控制类风湿性关节炎的疾病进展,且安全性较好。
OBJECTIVE: To observe clinical efficacy and safety of iguratimod combined with methotrexate in the treatment of rheumatoid arthritis. METHODS: A total of 82 patients with rheumatoid arthritis selected from our hospital from Feb. 2015 to Feb. 2016 were randomly divided into observation group and control group, with 41 cases in each group. Control group was given Meth- otrexate tablets 10 mg orally, once a week, increasing to 15 mg 2 weeks later, once a week. Observation group was addtionally given Iguratimod tablets 25 mg orally after meal, bid, on the basis of control group. Treatment course of 2 groups lasted for 6 months. Clinical efficacies and the occurrence of ADR were observed in 2 groups. The joint tenderness count, joint swelling count and morning stiffness time were also observed before and after treatment. The erythrocyte sedimentation rate, CRP, platelet count, serum immunoglobulin (IgG, IgA and IgM) and T lymphocyte subsets (CD3+, CD4+ and CD8+) levels were detected in 2 groups before and after treatment. RESULTS: The total response rate of observation group was 90.24%, which was significantly higher than 78.05% of control group, with statistical significance (P〈0.05). Before treatment, there was no statistical significance in above indexes between 2 groups (P〉0.05). After treatment, the number of joint tenderness and joint swelling in 2 groups were sig- nificantly lower than before treatment, and the time of morning stiffness was significantly shorter than before treatment. The erythro- cyte sedimentation rate, CRP, platelet count, serum immunoglobulin and T lymphocyte subsets were significantly lower than before treatment. The observation group was significantly lower than the control group, with statistical significance (P〈0.05). No obvious ADR was found in 2 groups. There was no statistical significance in the incidence of ADR between 2 groups (P〉0.05). CONCLUSIONS: Compared with methotrexate alone, iguratimod with methotrexate can improve therapeutic efficacy, relieve clini- cal symptom and inhibit immune function so as to control the progression of rheumatoid arthritis with good safety.
出处
《中国药房》
CAS
北大核心
2017年第32期4530-4533,共4页
China Pharmacy