中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2008年
20期
1408-1411
,共4页
盘晓燕%李娟%庞捷%戴森华%陈卫国
盤曉燕%李娟%龐捷%戴森華%陳衛國
반효연%리연%방첩%대삼화%진위국
脊柱炎,强直性%肿瘤坏死因子%放射学
脊柱炎,彊直性%腫瘤壞死因子%放射學
척주염,강직성%종류배사인자%방사학
Spondylitis,ankylosing%Tumor necrosis factor%Radiology
目的 评价注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rh TNFR:Fc)对强直性脊柱炎(AS)患者活动性及影像学表现的影响.方法 采用临床开放性研究,对68例既往接受多种免疫抑制剂规范治疗(包括甲氨蝶呤)≥3个月,仍处于活动期的AS患者予rh TNFR:Fc治疗,rhTNFR:Fc 25 mg皮下注射,2次/周,疗程≥24周.评价指标为2、6、12、24周达到As疗效评价标准20(ASAS20)的患者百分比;达到AS疗效评价标准50、70(ASAS50、70)的患者百分比;独立ASAS参数、Bath AS疾病活动性指数(BASDAI)、急性期血中炎性反应物水平、Bath AS脊柱功能评分(BASMI);并对0、12和24周的骶髂关节、髋关节x线片进行Bath AS放射学评分(BASRI).结果 68例患者治疗后评价指标均较基线改善,12周达到ASAS20的改善者为64.7%(44例),24周时为85.0%(58例);24周达到ASAS50的改善者为60.3%(41例),达到ASAS70的改善者为50.0%(34例).其他各项疗效指标也反映出相似的改善程度及趋势,急性期血中反应物水平、BASMI在2周即出现明显改善(P＜0.01),在12、24周改善差异有统计学意义(P＜0.01);影像学BASRI评分显示,骶髂关节在治疗12、24周改善差异无统计学意义(P＞0.05),髋关节影像学BASRI评分在治疗12周改善差异无统计学意义(P＞0.05),治疗24周时的改善与基线相比差异有统计学意义(P＜0.05).结论 rhTNFR:Fc治疗2周即可改善AS患者的症状、体征及AS患者的功能和活动范围,而这些改善在24周的疗程内均处于稳定的上升趋势;rh TNFR:Fc 24周的疗程内对骶髂关节的影像学改善不明显,但对髋关节有明显改善.
目的 評價註射用重組人Ⅱ型腫瘤壞死因子受體-抗體融閤蛋白(rh TNFR:Fc)對彊直性脊柱炎(AS)患者活動性及影像學錶現的影響.方法 採用臨床開放性研究,對68例既往接受多種免疫抑製劑規範治療(包括甲氨蝶呤)≥3箇月,仍處于活動期的AS患者予rh TNFR:Fc治療,rhTNFR:Fc 25 mg皮下註射,2次/週,療程≥24週.評價指標為2、6、12、24週達到As療效評價標準20(ASAS20)的患者百分比;達到AS療效評價標準50、70(ASAS50、70)的患者百分比;獨立ASAS參數、Bath AS疾病活動性指數(BASDAI)、急性期血中炎性反應物水平、Bath AS脊柱功能評分(BASMI);併對0、12和24週的骶髂關節、髖關節x線片進行Bath AS放射學評分(BASRI).結果 68例患者治療後評價指標均較基線改善,12週達到ASAS20的改善者為64.7%(44例),24週時為85.0%(58例);24週達到ASAS50的改善者為60.3%(41例),達到ASAS70的改善者為50.0%(34例).其他各項療效指標也反映齣相似的改善程度及趨勢,急性期血中反應物水平、BASMI在2週即齣現明顯改善(P＜0.01),在12、24週改善差異有統計學意義(P＜0.01);影像學BASRI評分顯示,骶髂關節在治療12、24週改善差異無統計學意義(P＞0.05),髖關節影像學BASRI評分在治療12週改善差異無統計學意義(P＞0.05),治療24週時的改善與基線相比差異有統計學意義(P＜0.05).結論 rhTNFR:Fc治療2週即可改善AS患者的癥狀、體徵及AS患者的功能和活動範圍,而這些改善在24週的療程內均處于穩定的上升趨勢;rh TNFR:Fc 24週的療程內對骶髂關節的影像學改善不明顯,但對髖關節有明顯改善.
목적 평개주사용중조인Ⅱ형종류배사인자수체-항체융합단백(rh TNFR:Fc)대강직성척주염(AS)환자활동성급영상학표현적영향.방법 채용림상개방성연구,대68례기왕접수다충면역억제제규범치료(포괄갑안접령)≥3개월,잉처우활동기적AS환자여rh TNFR:Fc치료,rhTNFR:Fc 25 mg피하주사,2차/주,료정≥24주.평개지표위2、6、12、24주체도As료효평개표준20(ASAS20)적환자백분비;체도AS료효평개표준50、70(ASAS50、70)적환자백분비;독립ASAS삼수、Bath AS질병활동성지수(BASDAI)、급성기혈중염성반응물수평、Bath AS척주공능평분(BASMI);병대0、12화24주적저가관절、관관절x선편진행Bath AS방사학평분(BASRI).결과 68례환자치료후평개지표균교기선개선,12주체도ASAS20적개선자위64.7%(44례),24주시위85.0%(58례);24주체도ASAS50적개선자위60.3%(41례),체도ASAS70적개선자위50.0%(34례).기타각항료효지표야반영출상사적개선정도급추세,급성기혈중반응물수평、BASMI재2주즉출현명현개선(P＜0.01),재12、24주개선차이유통계학의의(P＜0.01);영상학BASRI평분현시,저가관절재치료12、24주개선차이무통계학의의(P＞0.05),관관절영상학BASRI평분재치료12주개선차이무통계학의의(P＞0.05),치료24주시적개선여기선상비차이유통계학의의(P＜0.05).결론 rhTNFR:Fc치료2주즉가개선AS환자적증상、체정급AS환자적공능화활동범위,이저사개선재24주적료정내균처우은정적상승추세;rh TNFR:Fc 24주적료정내대저가관절적영상학개선불명현,단대관관절유명현개선.
Objective To evaluate the efficacy of recombinant human tumor necrosis factor receptor-Fc fusion protein(rh TNFR:Fc)in the treatment of active ankylosing spondylitis(AS).Methods 68 patients with active AS underwent subcutaneous injection of rh TNFR:Fc 25 mg twice a week for 24 weeks.The following indexes were observed:improvement of at least 20%of reported symptoms,based on the multicomponent Assessments in AS(ASAS)response criteria(ASAS 20)at weeks 2,6,12 and 24,ASAS 50 and ASAS 70 responses,and improved scores on individual components of ASAS,including Bath AS disease activity index(BASDAI),acute phase reactants,and Bath AS metrology index(BASMI).And the X-ray images of patient's pelvis at weeks 0,12.and 24 were graded based on BASRI.Resuits After treatment of rh TNFR:Fc the primary and secondary efficacy end points of the 68 patients were all improved compared with the baseline values.During the process of treatment,the number of patients with the efficacy achieving ASAS20 was gradually rising:44 cases(64.7%)at week 12 and 58(85.0%)at week 24.The efficacy of 41 cases(60.3%)reached ASAS50 and that of 34 cases reached ASAS70 at week 24.Other efficacy end points also reflected the similar effect and were improved significantly compared with the baseline values at different time points(all P＜0.01).BASRI showed that the radiological improvement of sacroiliac jpint was not significant(P＞0.05)and that the radiological improvement of hip was not obvious at week 12(P＞0.05)but significant at week 24(P＜0.05).Conclusion rh TNFR:Fc rapidly improves the signs and symptoms of active AS.
