来氟米特治疗活动性强直性脊柱炎临床观察

Clinical trial of Leflunomide in active ankylosing spondylitis

目的探讨来氟米特治疗活动性强直性脊柱炎的疗效及安全性。方法选择40例活动性强直性脊柱炎(年龄16～50岁,平均病程0.5～8.0年),全部病例均符合1984年修订的纽约标准。来氟米特分别按体重>50kg或<50kg,在治疗开始的3d给予负荷剂量50mg/d或40mg/d,在此之后的维持量分别是50mg/周或40mg/周。柳氮磺胺吡啶0.75日3次口服。分别于治疗前,治疗后3、6、12及18个月,做Bath强直性脊柱炎活动性指数(BASDAI)及Bath强直性脊柱炎测量指数(BASMI)评分。同时测定血常规、血沉、肝功、肾功及尿沉渣。在治疗前、治疗后6个月、10个月、18个月做骶髂关节CT及其它受累关节的X线平片检查。结果共36例随访至18个月。在3个月与治疗前,6个月与3个月、12个月与6个月、18个月与12个月的比较中,BAS-DAI、BASMI及ESR均明显下降(P<0.01)。CT及X线平片未发现加重。不良反应包括短暂的、轻度的口腔溃疡(n=2)、白细胞减少(n=3)、高血压(n=2)、转氨酶升高(n=6),不适(n=1)。结论来氟米特治疗活动性强直性脊炎疗效明显,不良反应少。

[Objective] To assess the efficacy and safety of Leflunomide in active ankylosing spondylitis. [Methods] 40 cases of active ankylosing spondylitis （6-50 years old, disease duration 0.5-8.0 years） meeting the 1984 modified New York criteria were included. The patients received a Leflunomide loading dose of 50 mg or 40 mg once daily for the first 3 days followed by a maintenance dose of 50 mg or 40 mg once weekly, according to whether the bodyweight is more than 50 kg or less than 50 kg, respectively. Sulfasalazine was prescribed 0.75 three times daily. The Bath Ankylosing Spondylitis Disease Activity Index （BASDAI） and The Bath Ankylosing Spondylitis Metrology Index （BASIM） scoring instruments have been used to assess the responsiveness of Leflunomide therapy at study entry, three months, six months, twelve months and eighteen months after treatment, respectively. Laboratory data including peripheral blood counts （WBC, HGB, RBC）, erythrocyte sedimentation rates （ESR）, liver enzymes, serum creatinine, urinary sediments were detected at the same time. Sacroiliac joints CT scan and other involved joints x-ray radiograph examinations were taken at study entry, six months, twelve months, eighteen months after treatment, respectively. [Results] 36 cases were followed up to eighteen months. At three months, six months, twelve months and eighteen months, BASDAI, BASMI and ESR were all lower significantly （P 〈0.01） compared with study entry, three months, six months, twelve months, respectively. No deterioration with sacroiliac joints on CT scan and the involved joints on x-ray raidographs was found. Adverse events were monitered as transient and mild oral ulcer, leukocytopenia, hypentension, elevated transaminase （ALT, GGT）, and a case of severe malaise. [Conclusion] Leflunomide shows good efficacy and safety in active ankylosing spondylitis.