摘要
目的探讨英夫利西单抗联合甲氨蝶呤治疗活动性类风湿关节炎(RA)的临床疗效及安全性。方法选取2009年1月—2012年4月绵阳市中心医院风湿科收治的39例活动性RA患者,将其随机分为试验组(19例)和对照组(20例)。试验组患者口服甲氨蝶呤10 mg,1次/周;同时静脉注射英夫利西单抗5 mg/kg,首次给药后的第2周和第6周及以后每隔8周各给予相同剂量的英夫利西单抗治疗,共5次,随访至24周。对照组患者仅口服甲氨蝶呤10 mg,1次/周,也随访至24周。(1)主要疗效评价指标:在治疗6、14、24周时达到ACR20的患者的比例。(2)次要疗效评价指标:在治疗14、24周时达到ACR50、ACR70的患者比例。结果 (1)在治疗6、14、24周时,试验组19例患者分别有7例(36.8%)、12例(64.2%)、14例(73.0%)达到ACR20,而对照组20例患者中分别有2例(10.0%)、6例(30.0%)、7例(35.0%)达到ACR20,两组比较差异有统计学意义(P<0.05)。(2)在治疗14、24周时,试验组患者分别有9例(42.8%)、12例(57.8%)达到ACR50,而对照组患者分别有4例(20.0%)、6例(30.0%)达到ACR50,两组比较差异有统计学意义(P<0.05);在治疗24周时,试验组和对照组分别有10例(57.1%)、3例(15.0%)达到ACR70,两组比较差异亦有统计学意义(P<0.05)。试验期间,两组未出现严重不良反应。结论英夫利西单抗联合甲氨蝶呤治疗活动性RA是安全、有效的,疗效优于单用甲氨蝶呤治疗。
Objective To observe the efficacy and safety of infliximab and methotrexate （MTX） in the treatment of active rheumatoid arthritis （RA） . Methods 39 cases of active RA admitted to our hospital from January 2009 to April 2012 were randomly divided into two groups, with 19 cases in treatment group and the other 20 in control group. The treatment group was treated with MTX 10 mg/week per os and intravenous drip of infliximab. Intravenous drip of infliximab was given at weeks of 0, 2, 6, 14 and 22 at a dose of 5 mg/kg. All patients were followed up for 24 weeks. The control group was given MTX 10 mg/ week per os for 24 weeks. Therapeutic evaluation： tender and swollen joint counts, erythrocyte sedimentation rate （ ESR）, C- reactive protein （CRP）, Health Assessment Questionnaire scores （HAQ） and ACR20, 50 and 70 were recorded at base- lineafter the treatment ofinffiximabt and MTXat6, 14 and24 weeks. Results （1） At6, 14 and 24 weeks , 7 （36.8%）, 12 （64.2%） and 14 cases （73.0%） in the treatment group reached ACR20, while 2 （10.0%）, 6 （30.0%） and 7 cases （35.0%） in the control group reached ACR20, the difference was statistically significant （P 〈 0. 05 ） . （2） At 14 and 24 weeks, 9 （42. 8% ） and 12 cases （57.8%） in the treatment group reached ACRS0, while in the control group, the number was 4 （20. 0% ） and 6 cases （ 30. 0% ）, the difference was statistically significant （ P 〈 0. 05 ） . At 24 week, 10 cases （57. 1% ） in the treatment group and 3 cases （ 15.0% ） in the control group reached ACR70, and the difference was statistically significant （P 〈 0. 05） . During treatment, no severe adverse reactions were found. Conclusion It is safe and effective to com- bine infliximab with MTX in the treatment of active RA.
出处
《中国全科医学》
CAS
CSCD
北大核心
2013年第15期1711-1714,共4页
Chinese General Practice
