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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 observe the short-term treatment of patients with ankylosing spondylitis (AS) with recombinant human type Ⅱ tumor necrosis factor (TNF) receptor-antibody fusion protein (rhTNFR-Fc) in different doses and to compare their different clinical effects. Methods Twenty patients were randomly divided into two groups. The rats were given 25 mg, once a day, and once a day for 7 days, respectively. The rats were given 8 consecutive doses of ASAS20, ASAS50 and BASDAI50 at different time points. Results There was no significant difference in the ASAS20, ASAS50 and BASDAI50 between the first, the fourth and the eighth administration and on the 20th day after administration of the drug (P> 0.05). At the same dosage (200mg) Compared with the 50 mg group, there was no significant difference in the number of ASAS20, ASAS50 and BASDAI50 patients. There was no significant difference in other indexes at different time points. Conclusions There is no significant difference in the effective time and curative effect maintaining time between two doses of rhTNFR-Fc at different time intervals in patients with AS in our country. At the same time, there is no significant difference between the two doses at different time intervals when the total dose is the same, But 50 mg, 1 / 7d administration more convenient, can increase patient compliance.