目的 探討艾拉莫德片聯(lián)合注射用重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風(fēng)濕關(guān)節(jié)炎的臨床療效。方法 選取2015年4月-2016年4月在邢臺(tái)市人民醫(yī)院進(jìn)行治療的類風(fēng)濕關(guān)節(jié)炎患者96例為研究對(duì)象，根據(jù)入院先后將患者分為對(duì)照組和治療組，每組各48例。對(duì)照組皮下注射注射用重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白，25 mg/次，2次/周。治療組在對(duì)照組基礎(chǔ)上口服艾拉莫德片，25 mg/次，2次/d。兩組患者均連續(xù)治療12周。觀察兩組的臨床療效，比較兩組的關(guān)節(jié)癥狀、類風(fēng)濕關(guān)節(jié)炎患者病情評(píng)價(jià)（DAS-28）評(píng)分、健康評(píng)估問卷（HAQ）評(píng)分和血清學(xué)指標(biāo)。結(jié)果 治療后，對(duì)照組和治療組的總有效率分別為79.17%、93.75%，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，兩組關(guān)節(jié)疼痛數(shù)、關(guān)節(jié)壓痛數(shù)、關(guān)節(jié)腫脹數(shù)和晨僵時(shí)間均顯著降低，同組治療前后比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）；且治療組這些觀察指標(biāo)明顯低于對(duì)照組，兩組比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，兩組DAS-28評(píng)分、HAQ評(píng)分均顯著降低，同組治療前后比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）；且治療組這些觀察指標(biāo)明顯低于對(duì)照組，兩組比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，兩組血清腫瘤壞死因子-α（TNF-α）、白細(xì)胞介素-1β（IL-1β）、白細(xì)胞介素-37（IL-37）、類風(fēng)濕因子（RF）和血沉（ESR）水平均顯著降低，同組治療前后比較差異有統(tǒng)計(jì)學(xué)意義（P<0.05）；且治療組這些觀察指標(biāo)明顯低于對(duì)照組，兩組比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。結(jié)論 艾拉莫德片聯(lián)合注射用重組人Ⅱ型腫瘤壞死因子受體-抗體融合蛋白治療類風(fēng)濕關(guān)節(jié)炎具有較好的臨床療效，可改善患者臨床癥狀，降低機(jī)體炎癥反應(yīng)，改善患者生活質(zhì)量，具有一定的臨床推廣應(yīng)用價(jià)值。

Objective To investigate the clinical efficacy of Iguratimod Tablets combined with Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein for injection in treatment of rheumatoid arthritis. Methods Patients (96 cases) with rheumatoid arthritis in Xingtai People's Hospital from April 2015 to April 2016 were randomly divided into control and treatment groups, and each group had 48 cases. Patients in the control group were subcutaneous injection administered with Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein for injection, 25 mg/time, twice weekly. Patients in the treatment group were po administered with Iguratimod Tablets on the basis of the control group, 25 mg/time, twice daily. Patients in two groups were treated for 12 weeks. After treatment, the clinical efficacies were evaluated, and joint symptoms, DAS-28 scores, HAQ scores, and serological indexes in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 79.17% and 93.75%, respectively, and there was difference between two groups (P<0.05). After treatment, joint pain count, tender joint counts, joint swelling count, and morning stiffness time in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, DAS-28 scores and HAQ scores in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of TNF-α, IL-1β, IL-37, RF, and ESR in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). Conclusion Iguratimod Tablets combined with Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ:IgG Fc Fusion Protein for injection has clinical curative effect in treatment of rheumatoid arthritis, can improve clinical symptoms, decrease the body inflammatory reaction, and improve the quality of life, which has a certain clinical application value.

河北省醫(yī)學(xué)科學(xué)研究重點(diǎn)課題計(jì)劃項(xiàng)目（20171464）