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目的:观察应用益赛普(rhTNFR-Fc)治疗强直性脊柱炎(AS)的临床疗效,并对其安全性进行评估。方法:益赛普25mg+1ml灭菌注射用水,上臂皮下注射,2次/W,疗程为12周。病情控制后可加用抗风湿药物(DMARDs)持续治疗。结果:37例AS患者经过12周治疗后,患者总体评价(PGA)、BASDAI及BASFI评分平均值均明显下降,晨僵时间、夜间背痛(VAS)、脊柱痛(VAS)、指-地距等临床症状及体征均有明显改善,以上指标与治疗前比较差异具有显著性均有统计学意义(P<0.05),而枕-墙距与治疗前比较有所改善,但差异无统计学意义(P>0.05),治疗后患者的红细胞沉降率(ESR)、C-反应蛋白(CRP)等实验室指标均有明显下降,差异显著有统计学意义(P<0.05),治疗期间有7例患者发生了与治疗相关的不良事件,发生率18.92%,所有患者均未出现肝、肾功能异常,未发生严重的不良反应,安全性评估较好。结论:应用益赛普(rhTNFR-Fc)治疗活动期AS可以迅速改善或缓解患者的临床症状和体征,临床疗效显著,不良反应少,有较高的安全性和良好的耐受性。
Objective: To observe the clinical efficacy of rhTNFR-Fc in the treatment of ankylosing spondylitis (AS) and evaluate its safety. Methods: Iprap 25mg + 1ml sterile water for injection, arm subcutaneous injection, 2 times / W, treatment for 12 weeks. After the disease can be controlled with anti-rheumatic drugs (DMARDs) continued treatment. Results: The average score of PGA, BASDAI and BASFI decreased significantly in 37 patients with AS after 12 weeks of treatment. The morning stiffness, VAS, VAS, And other clinical symptoms and signs were significantly improved, the above indicators compared with the pre-treatment difference was statistically significant (P <0.05), and pillow-wall distance compared with before treatment, but the difference was not statistically significant (P> 0.05). After treatment, the laboratory indexes of erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) were significantly decreased, the difference was statistically significant (P <0.05) Patients with treatment-related adverse events, the incidence of 18.92%, all patients did not appear liver and kidney dysfunction, no serious adverse reactions, safety assessment is better. Conclusion: The treatment of active phase AS with imatinib (rhTNFR-Fc) can rapidly improve or relieve the clinical symptoms and signs of patients. The clinical efficacy is significant, with fewer adverse reactions, higher safety and better tolerability.