不同剂量重组人Ⅱ型肿瘤坏死因子受体-Fc融合蛋白治疗强直性脊柱炎疗效比较  

The comparison of efficacy of different dosage regimen of recombinant human tumor necrosis factor receptor-Fc fusion protein in Chinese ankylosing spondylitis patients

作　　者：郝慧琴[1] 黄烽[1] 唐捷[2] 邓小虎[1] 张亚美[1] 索塔林[2] 方显峰[2] 

机构地区：[1]解放军总医院风湿科,北京100853 [2]中国科学院生物物理研究所

出　　处：《中华风湿病学杂志》2007年第4期202-205,共4页Chinese Journal of Rheumatology

基　　金：国家自然科学基金(30571726)

摘　　要：目的观察短期不同剂量重组人Ⅱ型肿瘤坏死因子(TNF)受体-抗体融合蛋白(rhTNFR-Fc)治疗我国强直性脊柱炎(AS)患者,并比较其不同的临床疗效。方法20例患者随机分成2组,分别给予25 mg,1次/3d和50mg,1次/7d,连续给药8次,在不同时间点评价ASAS20、ASAS50、BASDAI50等指标。结果两组在第1、4、8次给药及停药后20d ASAS20、ASAS50、BASDAI50差异无统计学意义(P>0.05);在总剂量相同(200mg)但是不同用药间隔情况下,25mg组患者与50 mg组相比,达到ASAS20、ASAS50、BASDAI50改善的例数差异也无统计学意义。其他指标在不同时间点差异均无统计学意义。结论rhTNFR-Fc两种剂量不同时间间隔治疗我国AS患者时,见效时间、疗效维持时间上差异无统计学意义;同时,总剂量相同时,两种剂量不同时间间隔用药差异也无统计学意义,但50 mg,1次/7d给药更方便,可增加患者的依从性。Objective To compare the efficacy of different dosage regimen of recombinant human tumor necrosis factor receptor-Fc fusion protein （rhTNFR-Fc） in Chinese ankylosing spondylitis （AS） patients. Methods Twenty active AS patients were randomly assigned to receive subcutaneous injections of rhTNFR-Fc 25 mg （1/3 d） or 50 mg （1/7 d） for 8 times. ASAS20, ASAS50, BASDA150 etc were evaluated at different time pionts. Results There was no significant difference in patients reaching ASAS20, ASAS50 and BASDA150 after the first, fourth and eighth injection and 20 days after injection completion comparing the patients in the 25 mg group with that in the 50 mg group （P〉0.05）. In addition, in different medication intervals and the same total dosage （200 mg）, there was no difference in the number of patients who reached ASAS20, ASAS50 and BASDA150 in both groups. The changes of other parameters were not observed. Conclusion Two dosages and different medication interval of rhTNFR-Fc have similiar efficacy onset time and maintence period. Meanwhile, at the same total dosage, there is no significant difference in therapeutic effect in the two dosage groups. However, 50 mg（1/7 d） regimen has better compliance than 25 mg （1/3 d）.

关 键 词：脊柱炎 强直性 肿瘤坏死因子Α 治疗结果 

分 类 号：R593.23[医药卫生—内科学]