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目的 观察依那西普对强直性脊柱炎(AS)肌腱端病变的疗效,同时寻找既方便易行,又能较好反映病情的肌腱端炎评分方法.方法 为期12周的随机、双盲、安慰剂对照的临床研究,前6周为双盲期.活动性AS患者分别接受依那西普和安慰剂注射,后6周为开放期,全部患者均接受依那西普治疗.分别在第0、2、4、6、8、10、12周记录患者的肌腱端压痛数.主要疗效观察指标为治疗后第6周时的Mander 肌腱端炎指数(EI) . 同时进行 MASES组织、SPARCC小组、Berlin小组、SanFrancisco小组提出的EI与Mander的相关性分析.结果 127例肌腱端炎压痛患者对照组35例,试验组92例.依那西普治疗第2周时试验组25例患者肌腱端炎消失,第4周时41例患并肌腱端压痛阴性,至第6 周时47例患者肌腱端压痛阴性,至12周时2组患者肌腱端炎阴性比例均达到70％以上依那西普治疗第6 周时Mander EI试验组降至0(0,2)分,对照组降至1(0,3)分,2组比较差异有统计学意义(P=0.0286).4种EI 中 San Francisco小组提出的EI与 Mander EI相关性最高(r=0.9328,P＜0.01).结论 依那西普可有效改善AS患者的肌腱端炎,在临床应用中可考虑使用简便易行的San Francisco小组提出的EI对患者的肌腱端炎症状进行评估.

Objective To evaluate the efficacy of etanercept in the treatment of active ankylosing spondylitis ( AS) with enthesitis and explore an easy and accurate scoring method.Methods We designed this 12-week double-blind,placebo-controlled,randomized clinical study in active AS patients.The first part was a 6-week placebo-controlled period that patients received etanercept or placebo,followed by a 6-week open-label period that all patients received etanercept. At week 0,2,4,6,8,10,12,the scores of enthesitis were recorded.The primary efficacy endpoint was the Mander Index in the two groups. We compared the Maastricht AS Enthesis Score ( MASFS) index,Spondyloarthritis Research Consortium of Canada ( SPARCC) index,Berlin index and San Francisco index with the Mander Index. Results A total of 127 patients were included with 92 in the etanercept group and 35 in the placebo group.In etanercept group there were 25,41,47 patients without enthesitis at week 2,4,6 separately. At week 12,more than 70％ patients' enthesitis in two groups turned negative.The primary endpoint,as the Mander Index at week 6,was achieved by 0(0,2) score in the etanercept group compared with 1 (0,3) score in the placebo group (P =0.0286). Among the four Indexes.the San Francisco Index was the one most COrrelated with the Mander Index.Conclusion Etanercept can improve the symptoms of enthesitis fast and significantly. In clinics,the San Francisco Index is easier to operate and more accurate for assessment.