停用依那西普后强直性脊柱炎病情复发相关因素分析及骨灵汤对其病情复发的影响

Analysis of the Factors Causing Ankylosing Spondylitis Recurring after Discontinuing the Treatment of Etanercept and the Effects of Gulingtang on the Relapse

目的探讨停用依那西普后强直性脊柱炎(AS)病情复发情况及其相关因素,评价骨灵汤对病情复发的影响。方法 60例活动性AS随机分为两组,治疗1组(骨灵汤合依那西普组)30例,治疗2组(依那西普组)30例,基线均合用一种非甾体类抗炎药。治疗12周后达到ASAS20改善的患者,停用依那西普,基线药物继续使用,每2～4周定期随访,直至病情复发或至9个月。采用Cox比例风险模型评价与复发有关的因素,Log-rank检验比较两组之间的复发情况。结果 12周后共53例患者达到了ASAS20改善标准并进入随访研究。其中治疗1组28例,治疗2组25例,两组人口统计学资料、基线及12周时病情特征比较差异无统计学意义(P>0.05)。至研究结束时,有81.1%的患者病情复发。治疗1组复发率为71.4%,复发时间中位数为20周;治疗2组复发率为92.0%,复发时间中位数为14周,两组差异有统计学意义(P<0.05)。Cox回归模型分析显示,基线BASDAI和CRP高及髋关节受累是病情复发的危险因素(P<0.05),治疗方法为保护因素(P<0.05)。结论 AS停用依那西普后维持原药物治疗多数患者病情会复发,基线高BASDAI、CRP和髋关节受累是疾病复发的不利因素。早期联合使用骨灵汤能够有效维持疗效,延缓复发。

Objective To explore the clinical or laboratory parameters predictive of flare and determine whether Gulingtang can maintain remission after discontinuation of etanercept therapy in ankylosing spondylitis.Methods Sixty patients with ankylosing spondylitis（AS） were randomly divided into two groups.Treatment group 1（30 cases） received etanercept and Gulingtang.Treatment group 2（30 cases） received etanercept.After 12 weeks,patients stopping using etanercept,were followed up until relapse or 9 month after not using etanercept.The statistical tools used were the Cox proportionate hazard model and the logrank method.Results 53 patients who attained an improvement of ASAS20 at week 12 were followed using a definition of relapse.81.1% of these patients relapsed within 36 weeks afterwards.The duration of relapse of group1 was 20 weeks,however that in the group 2 was 14 weeks.The rates of relapse in the group1 and group 2 were 71.4%,92%,respectively.The differents betweent the two groups were significantly（P0.05）.Higher BASDAI,CRP and hip joint damaged at baseline were the risk factors for the AS patients,and the therapeutic method was the protective factor（P0.05）.Conclusion After discontinuing the etanercept keeping the initial medications almost patients completed disease relapsed within short times.Higher BASDAI,CRP and hip joint damaged were the risk factors for the relapse.Gulingtang could prolong the duration of remission.