艾拉莫德片联合雷公藤多苷片治疗活动期老年类风湿关节炎的临床研究  

Clinical trial iguratimod tablets combined with tripterysium glycosides tablets in the treatment of elderly patients with active rheumatoid arthritis

作　　者：刘媛媛[1] 沈海丽[1] LIU Yuan-yuan;SHEN Hai-li(Department of Rheumatology and Immunology,Lanzhou University Second Hospital,Lanzhou 730030,China)

机构地区：[1]兰州大学第二医院风湿免疫科,兰州730030

出　　处：《中国临床药理学杂志》2018年第19期2283-2286,共4页The Chinese Journal of Clinical Pharmacology

基　　金：兰州市科学技术局基金资助项目(2017-4-89)

摘　　要：目的观察艾拉莫德片联合雷公藤多苷片治疗活动期老年类风湿关节炎(RA)的临床疗效及安全性。方法将90例活动期老年RA患者随机分为对照组和试验组,每组45例。对照组予以雷公藤多苷每次20 mg,tid,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,红细胞沉降率(ESR)、C反应蛋白(CRP)、类风湿因子(RF)的水平,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ACR20有效率分别为86.67%(39例/45例)和46.67%(21例/45例),ACR50有效率分别为68.89%(31例/45例)和31.11%(14例/45例),ACR70有效率分别为24.44%(11例/45例)和6.67%(3例/45例),差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的ESR分别为(16.42±9.87)和(23.36±10.16)mm·h^(-1),CRP分别为(6.59±4.05)和(11.42±6.64)mg·L^(-1),RF分别为(50.06±15.49)和(61.34±22.30)U·mL^(-1),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以白细胞减少、肝转氨酶升高和上腹部不适为主,试验组和对照组的总药物不良反应发生率分别为13.33%和11.11%,差异无统计学意义(P>0.05)。结论艾拉莫德片联合雷公藤多苷片治疗活动期老年RA患者的临床疗效明显优于雷公藤多苷片单药治疗,且不增加药物不良反应的发生率。Objective To observe the clinical efficacy and safety of iguratimod tablets combined with tripterysium glycosides tablets in the treatment of elderly patients with active rheumatoid arthritis（ RA）. Methods A total of 90 elderly patients with active RA were randomly divided into control and treatment groups with 45 cases per group. Control group was given tripterysium glycosides 20 mg per time,tid,orally. Treatment group was given iguratimod 25 mg per time,bid,orally,on the basis of control group. Two groups were treated for 24 weeks. The clinical efficacy,the levels of erythrocyte sedimentation rate（ ESR）,C-reactive protein（ CRP） and rheumatoid factor（ RF）,and adverse drug reactions were compared between two groups. Results Compared with treatment group and control groups after treatment,the effective rates of ACR20 were 86. 67%（ 39 cases/45 cases） and 46. 67%（ 21 cases/45 cases）,the effective rates of ACR50 were 68. 89%（ 31 cases/45 cases） and 31. 11%（ 14 cases/45 cases）,the effective rates of ACR70 were 24. 44%（ 11 cases/45 cases） and 6. 67%（ 3 cases/45 cases）,the differences were statistically significant（ all P〈0. 05）. After treatment,the main indexes of treatment and control groups were compared： ESR were（ 16. 42 ± 9. 87） and（ 23. 36 ± 10. 16） mm·h^-1,CRP were（ 6. 59 ± 4. 05） and（ 11. 42 ± 6. 64） mg·L^-1,RF were（ 50. 06 ± 15. 49） and（ 61. 34 ± 22. 30） U·mL^-1,the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions of two groups were leukopenia,elevated liver transaminase and epigastric discomfort. The total incidences of adverse drug reacions in treatment and control groups were 13. 33% and 11. 11% without significant difference（ P〉0. 05）. Conclusion Iguratimod tablets combined with tripterysium glycosides tablets have a definitive clinical efficacy in the treatment of elderly patients with active RA,which is better than tripterysium glycosides alone,without increasing the incidence o

关 键 词：艾拉莫德片 雷公藤多苷片 活动期老年类风湿关节炎 安全性评价 

分 类 号：R979.5[医药卫生—药品]