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作 者:郝慧琴[1,2] 黄烽[1] 邓小虎[1] 张亚美[1]
机构地区:[1]中国人民解放军总医院风湿科,北京100853 [2]中华风湿病学杂志社
出 处:《中国药物与临床》2008年第6期432-436,共5页Chinese Remedies & Clinics
基 金:国家自然科学基金资助项目(30571726)
摘 要:目的观察不同用药方案依那西普[重组人Ⅱ型肿瘤坏死因子(TNF)受体-抗体融合蛋白,rhTNFR-Fc]治疗强直性脊柱炎(AS)患者的情况,并比较其不同的临床疗效。方法20例患者随机分成两组,分别给予25mg/次,2次/周和50mg/次,1次/周,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20dASAS20、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50mg组相比,达到ASAS20、ASAS50、BAS-DAI50改善的例数差异也无统计学意义,但是50mg组较早获得BASFI改善(P=0.0289)。其他指标在不同时间点差异均无统计学意义(P>0.05)。结论不同剂量rhTNFR-Fc、不同间隔时间治疗我国AS患者时疗效差异无统计学意义;50mg,1次/周的方法会给患者带来较早的功能方面(BASFI)的改善;50mg,1次/周给药更方便、经济。Objective To compare the outcomes of ankylosing spondylitis (AS) treated with different dosages of recombinant human tumor necrosis factor receptor: Fc fusion protein (rhTNFR-Fc). Methods Ten patients with active AS were randomly assigned to receive subcutaneous injections of rhTNFR-Fc 25 mg (twice a week) or 50 mg (once a week) for 8 weeks. At different time points, we evaluated ASAS20, ASAS50 and BASDAI50 in these patients. Results There was no significant difference in percentages of patients reaching ASAS20, ASAS50 and BASDAI50 after the first, fourth and eighth injections and 20 days after the last injection between the groups receiving 25 mg and 50 mg group (P〉0.05). Also, given different dosing intervals but the same accumulative dose (200 mg), there was no difference in number of patients who reached ASAS20, ASAS50 and BASDAI50 between the both groups, except that BASFI in 50 mg group was improved earlier (P=0.0289). Changes of other indices during injections were not found. Conclusion The two dosages and different dosing interval of rhTNFR-Fc appeared to resnh in similar curative efficacy. Meanwhile, medication with 50 mg once a week seemed to demonstrated earlier improvement in functions, easier use and more cost-effectiveness.
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