CAJ | 학술논문

目的评估一种新型重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTN FR: Fc,商品名:安佰诺)治疗活动性AS的短期疗效与安全性.方法纳入180例活动性AS患者,随机接受新型及已上市的2种rhTNFR:Fc,每周2次,25 mg治疗12周.主要疗效指标为12周达到ASAS20的受试者比例,次要疗效指标为不同时点达到ASAS20、ASAS40、BASDAI50、ASAS5/6应答的受试者比例,以及强直性脊柱炎病情活动度评分(ASDAS)、BASDAI、晨僵时间、Bath AS测量指数(BASMI)、BASFI、胸廓扩张度、肿胀关节数、疼痛关节数、总背痛、夜间痛、疾病活动性的受试者整体评价、ESR、CRP、强直性脊柱炎健康评价问卷(HAQ-S)等单项指标.所有受试者均进行安全性评价.统计学处理采用t检验和x2检验.结果用药12周后试验组ASAS20为88％(89例);对照组ASAS20为88％(90例)(x2=0.001,P=0.978).次要疗效指标2组间差异亦无统计学意义.2组不良事件和不良反应发生率差异均无统计学意义.结论 2种重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白对活动性AS均具有显著疗效和良好的安全性.
목적 평고일충신형중조인Ⅱ형종류배사인자수체-항체융합단백(rhTN FR: Fc,상품명:안백낙)치료활동성AS적단기료효여안전성.방법 납입180례활동성AS환자,수궤접수신형급이상시적2충rhTNFR:Fc,매주2차,25 mg치료12주.주요료효지표위12주체도ASAS20적수시자비례,차요료효지표위불동시점체도ASAS20、ASAS40、BASDAI50、ASAS5/6응답적수시자비례,이급강직성척주염병정활동도평분(ASDAS)、BASDAI、신강시간、Bath AS측량지수(BASMI)、BASFI、흉곽확장도、종창관절수、동통관절수、총배통、야간통、질병활동성적수시자정체평개、ESR、CRP、강직성척주염건강평개문권(HAQ-S)등단항지표.소유수시자균진행안전성평개.통계학처리채용t검험화x2검험.결과 용약12주후시험조ASAS20위88％(89례);대조조ASAS20위88％(90례)(x2=0.001,P=0.978).차요료효지표2조간차이역무통계학의의.2조불량사건화불량반응발생솔차이균무통계학의의.결론 2충중조인Ⅱ형종류배사인자수체-항체융합단백대활동성AS균구유현저료효화량호적안전성.
Objective To evaluate the efficacy and safety of tumor necrosis factor-α receptor Ⅱ : Fc fusion protein (TNFR Ⅱ : Fc), a new recombinant human TNFR Ⅱ : Fc fusion protein in Chinese patients with active ankylosing spondylitis (AS).Methods 180 patients with active AS were treated 1:1 with two kinds of recom-binant human TNFRI Ⅱ : Fc fusion proteins for 12 weeks.The primary efficacy endpoint was the percentage of patients meeting the Assessment in Spondylo-arthritis International Society response criteria (ASAS20) at week 12.The secondary endpoints included ASAS40, BASDAI50, ASAS5/6, Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spond-ylitis Disease Activity Index (BASDAI), Morning stiffness, Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Functional Index (BASFI), Chest expansion.Swollen joint count, Tender joint count, Patient Global Assessment of disease activity, Erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP) and the Health Assessment Questionnaire modified for the spondyloarthro-pathies (HAQ-S) total score.All patients were evaluated for safety.T test and x2 test were used for statistical analysis.Results After 12 weeks of treatment, ASAS20 achieved 88％ in the experimental group (n=89), and 88％ in the control group (n=90), the difference was not statistically significant (x2=0.001, P＞0.05).The secondary endpoints were not significantly different between the two groups.The number of adverse events was not different between the two groups.Common adverse drug reactions included elevated liver enzymes, upper respiratory tract infection and injection site reactions.Conclusion The two kinds of Etanercepts appears to be fast-acting, effective and well tolerated in Chinese patients with active AS.