CAJ | 학술논문

目的观察英利西单抗治疗活动性类风湿关节炎(RA)的临床疗效和安全性.方法 30例活动性RA患者分为研究组和对照组,各15例.研究组在每周口服甲氨蝶呤(MTX)10～15 mg基础上联合应用英利西单抗,在第0、2、6周接受3 mg/kg的英利西单抗静脉滴注;对照组口服相同剂量的MTX,联合应用其他改善病情抗风湿药(DMARDs),如柳氮磺吡啶、来氟米特或羟氯喹.疗程均为12周.结果治疗6周后,研究组和对照组的临床症状和实验室指标均有改善,美国风湿病学会(ACR)20有效率分别为40%(6/15)和20%(3/15),差异有统计学意义(P＜0.05);ACR50有效率分别为27%(4/15)和6%(1/15),差异有统计学意义(P＜0.05).治疗12周后各项指标进一步改善.研究组和对照组的ACR20有效率分别为60%(9/15)和33%(5/15),差异有统计学意义(P＜0.05);ACR50有效率分别为40%(6/15)和13%(2/15),差异有统计学意义(P＜0.05).治疗6周后,研究组和对照组的临床症状和实验室指标均有改善.结果表明,研究组在治疗12周后休息痛、关节肿胀和关节压痛改善明显,红细胞沉降率、C反应蛋白和类风湿因子改善情况也明显优于对照组.研究组和对照组治疗前简明疾病活动评分分别为(5.8±2.5)和(5.9±2.2)分,差异无统计学意义(P＞0.05).治疗6周后2组分别为(2.4±1.6)和(4.7±1.9)分,差异有统计学意义(P＜0.05).治疗12周后2组分别为(1.8±1.1)和(4.2±1.8)分,差异有统计学意义(P＜0.05).研究组共有2例患者出现不良反应,1例注射局部出现皮疹或红斑,未见局部溃疡和坏死.上述不良反应均自行消失,未中断治疗.1例患者出现上呼吸道感染,对症处理后症状消失,亦未中断治疗.结论英利西单抗是安全有效的治疗RA的药物,可以更早期达到诱导缓解病情的目的.
목적 관찰영리서단항치료활동성류풍습관절염(RA)적림상료효화안전성.방법 30례활동성RA환자분위연구조화대조조,각15례.연구조재매주구복갑안접령(MTX)10～15 mg기출상연합응용영리서단항,재제0、2、6주접수3 mg/kg적영리서단항정맥적주;대조조구복상동제량적MTX,연합응용기타개선병정항풍습약(DMARDs),여류담광필정、래불미특혹간록규.료정균위12주.결과 치료6주후,연구조화대조조적림상증상화실험실지표균유개선,미국풍습병학회(ACR)20유효솔분별위40%(6/15)화20%(3/15),차이유통계학의의(P＜0.05);ACR50유효솔분별위27%(4/15)화6%(1/15),차이유통계학의의(P＜0.05).치료12주후각항지표진일보개선.연구조화대조조적ACR20유효솔분별위60%(9/15)화33%(5/15),차이유통계학의의(P＜0.05);ACR50유효솔분별위40%(6/15)화13%(2/15),차이유통계학의의(P＜0.05).치료6주후,연구조화대조조적림상증상화실험실지표균유개선.결과 표명,연구조재치료12주후휴식통、관절종창화관절압통개선명현,홍세포침강솔、C반응단백화류풍습인자개선정황야명현우우대조조.연구조화대조조치료전간명질병활동평분분별위(5.8±2.5)화(5.9±2.2)분,차이무통계학의의(P＞0.05).치료6주후2조분별위(2.4±1.6)화(4.7±1.9)분,차이유통계학의의(P＜0.05).치료12주후2조분별위(1.8±1.1)화(4.2±1.8)분,차이유통계학의의(P＜0.05).연구조공유2례환자출현불량반응,1례주사국부출현피진혹홍반,미견국부궤양화배사.상술불량반응균자행소실,미중단치료.1례환자출현상호흡도감염,대증처리후증상소실,역미중단치료.결론 영리서단항시안전유효적치료RA적약물,가이경조기체도유도완해병정적목적.
Objective To investigate the clinical efficacy and safety of the infliximab in the treatment of patients with active rheumatoid arthritis(RA). Methods Thirty cases of RA were retrospectively analyzed. In infliximab treatment group,15 patients were treated with infliximab 3mg/kg, week 0,2,6, combined with weekly oral methotrexate(MTX) 10-15 mg per week for 12 weeks. Fifteen patients receiving the same dosage MTX combined with Disease modifying antirheumatic drugs (DMARDs): salicylazosulfapyridine (SASP), leflunomide (LEF) or hydroxychloroquine(HCQ)for 12 weeks were observed as a control group. Results All patients completed treatment. As compared with the control group, the infliximab treatment group had a more rapid improvement in ACR20 and ACR50 in disease activity during the first 6 weeks(40% vs 20%, 27% vs 6%, P ＜0.05 respectively). At the end of 12 week, the infliximab treatment group also had significant improvement in ACR20 and ACR50 when compared with the control group(60% vs 33%, 40% vs 13%, P ＜0.05 respectively). Compared with the control group, the infliximab treatment group had a more significant decrease of the DAS28 score, and there was also significant difference between the infliximab group and the control group after 12 weeks (P ＜ 0.05). The most common adverse events of infliximab included injection site reaction and respiratory infection. Conclusion Infliximab is a safe and effective drug for RA patients.