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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 investigate the relapse of ankylosing spondylitis (AS) and its related factors after etanercept withdrawal, and to evaluate the effect of Gu Ling Decoction on the recurrence of the disease. Methods Sixty ASA patients were randomly divided into two groups: 30 in treatment group 1 (Gu Ling Decoction combined with etanercept group) and 30 in treatment 2 group (etanercept group). All patients were given a nonsteroidal Anti-inflammatory drugs. Patients who achieved improvements in ASAS20 after 12 weeks of treatment discontinued etanercept and continued to receive baseline medications, followed up periodically every 2 to 4 weeks until relapse or up to 9 months. Cox proportional hazards model was used to evaluate the relapse-related factors. Log-rank test was used to compare the relapse status between the two groups. RESULTS: After 12 weeks, 53 patients achieved ASAS 20 improvement criteria and were followed up. There were 28 cases in treatment group 1 and 25 cases in treatment 2 group. There was no significant difference between the two groups in demographic information, baseline and 12 weeks (P> 0.05). By the end of the study, 81.1% of patients had a relapse. The recurrence rate of treatment group 1 was 71.4%, and the median time of recurrence was 20 weeks. The recurrence rate was 92.0% in treatment group 2 and 14 weeks. The difference between the two groups was statistically significant (P <0.05). Cox regression model analysis showed that baseline BASDAI and high CRP and hip involvement were risk factors for relapse (P <0.05), and treatment was protective (P <0.05). CONCLUSIONS: The majority of patients who relapse after maintaining etanercept with etanercept in AS patients have a relapse. The baseline high BASDAI, CRP and hip joint involvement are the unfavorable factors of disease recurrence. Early joint use of bone Ling Tang can effectively maintain the efficacy and delay relapse.