初次与中断后再次启用肿瘤坏死因子-α拮抗剂短期治疗对强直性脊柱炎患者的安全性与疗效对比

Comparison of safety and efficacy of short-term treatment between re-use and initial use in patients with ankylosing spondylitis treated with tumor necrosis factor inhibitors

目的探讨对于使用肿瘤坏死因子拮抗剂(TNFi)治疗的AS患者,中断后再次启用与初次使用两者之间在安全性与疗效方面可能存在的差异。方法2016年10月至2017年10月就诊于兰州大学第二医院的AS患者82例,其中初次使用TNFi者57例,中断后再次启用者25例。在规范使用TNFi3个月后,比较2组患者的疗效指标[疼痛视觉模拟评分(VAS)、晨僵时间、BASDAI、BASFI、Bath测量指数(BASMI)、AS疾病活动度评分(ASDAS)、CRP、ESR]及安全事件,采用t检验和协方差进行分析。结果2组患者治疗后的各项疗效指标均有显著改善,与基线相比差异具有统计学意义(P<0.05)[初次使用组治疗前后:ESR(40±31)mm/1h和(8±8)mm/1h,CRP(28±35)mg/L和(5±9)mg/L,VAS(6.5±1.6)和(2.0±1.7),晨僵时间(0.6±0.4)h和(0.1±0.2)h,BASDAI(5.0±1.3)和(1.6±1.2),BASFI(4.1±2.3)和(1.3±1.3),BASMI(2.6±1.9)和(0.8±1.0),ASDAS(3.5±0.8)和(1.2±0.7);再次启用组治疗前后:ESR(39±33)mm/1h和(9±10)mm/1h,CRP(28±28)mg/L和(5±6)mg/L,VAS(6.6±1.9)和(1.6±1.0),晨僵时间(0.6±0.4)h和(0.1±0.1)h,BASDAI(5.1±0.8)和(1.4±1.4),BASFI(5.1±2.2)和(1.3±1.4),BASMI(3.4±1.8)和(1.0±0.9),ASDAS(3.6±0.8)和(1.2±0.4)]。2组患者治疗后各项疗效指标之间的差异无统计学意义(P>0.05)。结论中断后再次启用TNFi的AS患者能够获得与初次使用TNFi时相同的安全与疗效保障。

Objective To investigate the possible differences in safety and efficacy between re-use and initial use in patients with ankylosing spondylitis (AS) treated with tumor necrosis factor inhibitors (TNFi). Methods From October 2016 to October 2017, 82 patients with AS who were admitted to the Second Hospital of Lanzhou University were studied. Among them, 57 patients used TNFi for the first time and 25 patients reuse it after the interruption. After 3 months of standardized use of TNF-inhibitor, we compared the efficacy indicators [visual analogue scale/score (VAS), morning stiffness, bath ankylosing spondylitis disease activity index (BASDAI), Bath ankylosing spondylitis functional index (BASFI), Bath ankylosing spondylitis metroloty index (BASMI), ankylosing spondylitis disease activity score (ASDAS), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) 0 and safety events between the two groups. T test and covariance analysis were used. Results The efficacy indexes of the two groups after treatment were significantly improved, the difference was statistically significant (P<0.05) compared with the baseline [Before and after treatment in the first treatment group: ESR: (40±31) mm/1 h, (8±8) mm/1 h, CRP: (28±35) mg/L, (5±9) mg/L, VAS: (6.5±1.6),(2.0±1.7), Morning stiff time: (0.6±0.4) h, (0.1±0.2) h, BASDAI: (5.0±1.3) h, (1.6±1.2) h, BASFI: (4.1±2.3), (1.3±1.3), BASMI: (2.6±2.0), (0.8±1.0), ASDAS: (3.5±0.8), (1.2±0.7); Before and after treatment in the re-use group: ESR: (39±33) mm/1 h, (9±10) mm/1 h, CRP: (28±28) mg/L, (5±6) mg/L, VAS: (6.6±1.9), (1.6±1.0), Morning stiff time: (0.6±0.4) h, (0.1±0.1) h, BASDAI: (5.1±0.8), (1.4±1.4), BASFI (5.1±2.2), (1.3±1.4), BASMI: (3.4±1.8), (1.0±0.9), ASDAS: (3.6±0.8), (1.2±0.4)]. But there was no statistical significant difference between the two groups in patients after treatment (P>0.05). Conclusion Patients with AS who re-uses TNFi after discontinuation could achieve the same safety and efficacy as they first use it.