他克莫司在中国多发性大动脉炎患者中的疗效分析

The efficacy of tacrolimus on the treatment of Takayasu arteritis

目的探究他克莫司在中国多发性大动脉炎患者中的治疗效果。方法本研究为单中心、前瞻性的临床研究。记录患者治疗前后临床症状及实验室指标变化情况。采用彩色多普勒超声和计算机断层血管造影评价患者病变血管受累，他克莫司治疗期间每6个月复查影像学变化。采用SPSS 20.0软件进行统计分析，数据比较采用2独立样本t检验以及Fisher确切概率检验或Kruskal-Wallis H检验。结果共19例患者纳入本研究，平均年龄（26±6）岁，女性16例。无脉、乏力、双侧血压不对称是最常见的临床表现；颈动脉和锁骨下动脉是最常受累的血管；最常见的血管受累模式为Numano Ⅰ型。他克莫司中位治疗剂量为2（2，3）mg。19例患者中，他克莫司治疗方案对9例患者有效，总有效率为47.4%。与他克莫司治疗有效的患者相比，他克莫司治疗无效的患者平均ESR[（33±29）mm/1 h和（42±20）mm/1 h，t=-0.776，P=0.448]和平均hs-CRP[（20±31）mg/L和（54±45）mg/L，t=-1.758，P=0.099）]水平高，但差异无统计学意义。治疗期间未出现药物相关不良反应。结论他克莫司可用于多发性大动脉炎治疗，对部分患者有效。

ObjectiveTo explore the efficacy and safety of tacrolimus among Chinese Takayasu arteritis （TAK） patients.MethodsThis was a single center, prospective study of active TAK patients treated with tacrolimus. Clinical manifestations, white blood cell count, hemoglobin level, erythrocyte sedimentation rate （ESR）, hypersensitivity C reactive protein （hsCRP）, alanine and aspartate aminotransferase and serum creatinine were recorded before and during tacrolimus treatment. Vascular changes were repeated every 6 months during tacrolimus treatment. All data were analyzed by statistical product and service solutions （SPSS） 20.0 statistical software, unpaired t test and Fisher exact probability and Kruskal-Wallis H test were used for statistical analysis.ResultsA total of 19 consecutive patients with an average age of （26±6） years were analyzed in this study. Sixteen of them were women. Pulselessness, fatigue, asymmetric blood pressure and fever were the most common clinical findings. Cervical and subclavian artery were more vulnerable. The most common artery involvement pattern was Numano type Ⅰ, followed by type Ⅱa and type Ⅴ. The median tacrolimus dosage was 2（2, 3） mg. Tacrolimus was effective in 9 out of the 19 patients. Patients who responded to tacrolimus tended to have lower mean ESR[（33±29） mm/1 h vs （42±20） mm/1 h, t=-0.776, P=0.448] and hsCRP [（20±31） mg/L vs（54±45） mg/L, t=-1.758, P=0.099] levels. However, no statistical significance was observed. During tacrolimus treatment, no drug related side effect was observed.ConclusionTacrolimus is an alternative and effective therapy for some of the TAK patients.