目的 探讨肿瘤坏死因子受体-抗体融合蛋白依那西普(Etanercept)联合来氟米特(LEF)治疗强直性脊柱炎(AS)的临床疗效及应用的安全性.方法 将45例AS患者随机分为3组,每组15例,分别给予依那西普(A组)、依那西普联合来氟米特(B组)和双氯芬酸联合来氟米特(C组)治疗.8周后,A组继续应用依那西普;B组停用依那西普,继续应用来氟米特;C组停用双氯芬酸,继续应用来氟米特.于治疗开始前和治疗后第4周、8周、12周根据患者的临床表现及实验室检查结果,进行临床疗效及安全性评估.结果 3组治疗前临床资料比较,差异均无统计学意义(P＞0.05).治疗后第8周,A、B两组强直性脊柱炎评估(ASAS),ASAS 20和ASAS 50的改善率均高于C组(P＜0.05),而A、B两组的改善率比较,差异均无统计学意义(P＞0.05).治疗后第12周,3组患者ASAS 20的改善率比较,差异无统计学意义(P＞0.05);A、B两组ASAS 50的改善率均高于C组(P＜0.05),而A、B两组改善率比较,差异无统计学意义(P＞0.05).A、B两组的不良反应主要有皮疹、肝功能异常、上呼吸道感染,两组不良反应发生率比较,差异无统计学意义(P＞0.05).C组的不良反应主要有胃肠道反应、肝功能异常,其不良反应发生率高于A、B两组(P＜0.05).结论 应用依那西普治疗AS起效快,且不良反应少.短期应用依那西普联合来氟米特治疗与长期单独应用依那西普疗效相当,不良反应无差异,故可考虑缩短依那西普的疗程,减少患者的经济负担.%Objective To investigated the clinical efficacy and safety of etanercept combined with leflunomide in treating ankylosing spondylitis ( AS ) . Methods Forty - five patients with AS were randomly divided into 3 groups: group A received etanercept treatment, group B received etanercept combined with leflunomide and group C received diclofenac combined with leflunomide. Eight weeks later, etanercept and diclofenac were withdrawn in group B and group C respectively. At week 0,4,8 and 12, efficacy and safety were assessed according to the clinical manifestations and lahoratory measurements. Results Clinical data at haseline showed no statistic differences among the 3 groups ( P ＞ 0.05 ) . Assessment of Ankylosing Spondylitis ( ASAS ) showed that ASAS 20 and ASAS 50 improvement rates in group A and B were higher than those in group C ( P ＜ 0.05 ),while no difference was seen between group A and B ( P ＞ 0.05 ) . At the end of study, no difference among the ASAS 20 improvement rates among the three groups was seen (P＞0.05) . ASAS 50 improvement rates in group A and B were higher than that in group C, while no difference was observed between group A and B ( P＞0.05 ) . Adverse reactions in group A and B showed no significant differences in incidence rates ( P＞0.05 ) and included erythra, liver disfunction and upper respiratory infections. Adverse reactions in group C included gastrointestinal illness and liver disfunction with higher incidence rates than those of group A and B ( P ＜ 0.05 ) . Conclusion Etanercept shows a quick effect and few adverse reaction in the treatment of AS. Short - term therapy of etanercept combined with leflunomide shows comparable curative effects and similar adverse reaction rates compared with long - term therapy of etanercept alone. Therefore it might be reasonable to shorten the therapeutic duration of etanercept so as to relieve the economic burden of the patients.
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