大剂量甲基强的松龙与生物制剂治疗强直性脊柱炎的短期临床疗效观察

目的评价大剂量甲基强的松龙（MP）与生物制剂治疗强直性脊柱炎（AS）患者的临床疗效和安全性。方法48例难治性AS患者随机分为两组,激素组27例分别给予MP250～500mg/d,静脉冲击治疗,连用3d,其余4d停用激素,每周重复1次,治疗3次,同时继续给予NSAIDs和DMARDs,MP治疗结束后用小剂量醋酸泼尼松20mg/d维持,6周后开始减量,20周后撤除激素。生物制剂类克组21例患者分别在第0、2周每周静脉输注1次英夫利昔单抗（infliximab）0.2g,同时继续给予NSAIDs和DMARDs。两组分别在治疗前及治疗第3周后进行评估。主要疗效指标为达到AS疗效评价标准20（ASAS20）的患者比例,次要疗效指标为达到ASAS40的患者比例。结果激素组和类克组治疗后其他各项疗效指标和实验室指标均有显著改善,且两组之间差异无统计学意义（p〉0.05）。达到ASAS20的患者比例分别为81.48%（22例）和80.95%（17例）（p〉0.05）。达到ASAS40的患者比例分别为59.26%（16例）和66.67%（14例）（p〉0.05）。治疗期间激素组9例（33.33%）类克组5例（23.8%）患者发生与治疗相关的不良反应,所有不良事件均为轻中度、暂时性的,均给予对症治疗或治疗结束后好转。结论短期大剂量的MP和生物制剂治疗均可作为快速改善AS症状体征炎性指标及活动范围和生活质量的药物,且激素可以弥补生物制剂用药的禁忌及价格昂贵等问题,作为一种价格相对廉价的药物,但能否真正控制病情进展有待更多的研究证实。

The short-term clinical observation of intravenous methylprednisolone pulses and biological agent infliximab in the management of ankylosing spondylitis

Objective To assess the clinical efficacy and safety of high-dose methylprednisolone （MP） and biological agent infliximab in ankylosing spondylitis （AS）. Methods We retrospectively analyzed 48 cases of AS. In MP treatment group, 27 patients were treated with 250-500mg per day, intravenous for 3-4 days a week, repeated a times, treated for 3 times, then given prednisone 20mg per day to maintain. After 6 weeks, prednisone was gradually reduced and finally removed the prednisone 20 weeks later. In infliximab treatment group, 21 patients were given intravenous infliximab 0.2 on the zero and second week. We assessed patients respectively before treatment and on the third week after treatment. We considered the proportion of ASAS20 as the primary efficacy endpoint, and ASAS40 as the secondary efficacy endpoint. Results All patients completed treatment. The MP treatment group and the infliximab treatment group had a more rapid improvement in other indexes of the efficacy and laboratory （p 〉0.05）. The groups had a more rapid improvement in ASAS20 and ASAS40 after the 3 weeks （81.48% Vs 80.95%, 59.26% Vs 66.67%, p〉0.05, respectively）. During the treatment 9 patients （33.33%） in the glucocorticoid treatment group and 5 patients （23.8%） occurred adverse events with treatment-related. All adverse events were moderate, temporary, and gradually appeared with symptomatic treatment. Conclusion High-dose MP and infliximabcan improved the symptoms, signs, inflammatory indexes, home range and quality of life of AS short-term significantly and rapidly, MP can make up some questions such as taboo and expensive about treatment using infliximab, and is a cheap medicine relatively. But we still need further study about MP improving the condition of AS.