短期应用依那西普联合小剂量沙利度胺及柳氮磺吡啶维持治疗强直性脊柱炎的研究

Outcome of Patients with Ankylosing Spondyloarthritis Continuing Treated with Thalidomide and SASP after a Short Course of Etanercept Therapy

目的了解强直性脊柱炎(AS)患者接受依那西普治疗3个月后联合、持续应用沙利度胺及柳氮磺吡啶维持治疗的疗效。方法采用前瞻性、非随机、对照、开放研究。纳入自2007年3月—2010年3月桂林医学院附属医院首诊AS患者。根据患者经济情况分别分为3组。试验组的给药方案为依那西普应用3个月,同时给予应用沙利度胺及柳氮磺吡啶治疗1年;依那西普对照组的给药方案为仅用依那西普应用3个月后停药;沙利度胺对照组仅予应用沙利度胺及柳氮磺吡啶治疗1年。于1,3,6,12个月对患者的强直性脊柱炎病情活动性指数(BASDAI)、巴氏强直性脊柱炎功能指数(BASFI)、BASDAI及BASFI改善百分比、血沉(ESR)、C反应蛋白(CRP)、ASAS20、ASAS50进行评价。结果治疗第1个月后试验组及依那西普对照组与沙利度胺对照组BASDAI评分相比有统计学差异,而BASFI评分相比无统计学差异;治疗第3个月后试验组及依那西普对照组与沙利度胺对照组BASFI评分相比有统计学差异,而3组BASDAI评分相比无统计学差异;治疗第6个月和12个月后试验组及沙利度胺对照组与依那西普对照组BASDAI评分及BASFI评分相比均有统计学差异;ESR、CRP在试验组及依那西普对照组1个月后即出现下降,试验组呈持续下降,而在依那西普对照组于停药后3个月出现再次升高;沙利度胺对照组在用药6个月后出现持续下降。结论联合、持续应用沙利度胺及柳氮磺吡啶对接受短期3个月依那西普治疗后的AS患者能达到持续改善。

OBJECTIVE To evaluate the outcome of patients with ankylosing spondyloarthritis continuing on SASP and thalidomide after a short course of etanercept therapy.METHODS With prospective,unrandomized,controlled evaluation and open design,the patients,who were first diagnosed ankylosing spondyloarthritis in affiliated hospital of Guilin medical university from March 2007 to March 2010,were divided into 3 groups.The patients of experimental group were treated with 25mg etanercept hypodermic injection twice a week for 4 months.SASP and thalidomide were given for 12 months since treatment begin.The patients of etanercept group were only given the same dose of etanercept for 3 months.The patients of thalidomide group were treated with 50 mg thalidomide every night and 1.5 g·d-1 SASP continuously for 12 months.Clinical features,Bath Ankylosing Spondylitis Disease Activity Index（BASDAI）,Bath Ankylosing Spondylitis Functional Index（BASFI）,C-reactive protein（CRP） and erythrocyte sedimentation rate（ESR） were noted at baseline（pre-etanercept）,1 month,3 months,6 months and 12months.RESULTS 79 patients were included in this study.Compared with thalidomide group,reduction of BASDAI of the other groups were significant at first month.At the third month,BASDAI were no appreciable distinction in three groups.At sixth month,BASDAI decreased significantly in experimental group and thalidomide group,comparing with etanercept group.The reduction of BASDAI was continuous in experimental group and thalidomide group at the end of the experiment.Rudction in BASFI were significant in experimental group and etanercept group in third months.In 6 months,BASFI decreased in experimental group and thalidomide group.At the end of the experiment,BASFI continuously decreased in experimental group and thalidomide group.Fall in ESR and CRP occured since 1 month to the end in experimental group.In etanercept group,ESR and CRP descended until 3 months after the last injection of etanercept.Descend of ESR and CRP was significant in thalidomide group after 6 month.CONCLUSION Continuing SASP and thalidomide after short course of etanercept results in sustained improvement in our patients with Ankylosing spondylitis.