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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。
Objective To evaluate the clinical efficacy and safety of high-dose methylprednisolone (MP) and biological agents in the treatment of ankylosing spondylitis (AS). Methods Forty-eight patients with refractory AS were randomly divided into two groups. 27 patients in the hormone group were given MP250 ~ 500mg / d intravenously for 3 days, and the other 4 days were discontinued. The patients were treated once a week for 3 times, Continue to give NSAIDs and DMARDs, MP after treatment with a small dose of prednisone acetate 20mg / d maintenance, began to reduce after 6 weeks, 20 weeks after the withdrawal of hormones. In the biologic preparation group, 21 patients were infused with 0.2g of infliximab intravenously once a week on the 0th and 2th week, meanwhile NSAIDs and DMARDs were continued. The two groups were evaluated before treatment and after the third week of treatment. The primary outcome measure was the proportion of patients who achieved AS AS 20 and the secondary outcome measure was the proportion of patients who achieved AS AS 40. Results After treatment, other curative effect indexes and laboratory indexes of hormone group and type g group were significantly improved, and there was no significant difference between the two groups (p> 0.05). The proportion of patients who reached ASAS20 was 81.48% (22 cases) and 80.95% (17 cases) (p> 0.05). The proportion of patients who reached ASAS40 was 59.26% (16 cases) and 66.67% (14 cases) (p> 0.05). During the treatment period, 9 cases (33.33%) of Gram group were treated with 5 adverse reactions (23.8%) in the steroid group and all the adverse events were mild to moderate and temporary. All patients were given symptomatic treatment or after the treatment was over . Conclusions Both short-term and high-dose MP and biological agents can be used as drugs to rapidly improve the inflammatory indexes, range of activities and quality of life of AS symptoms. And hormones can make up for the taboo and expensive of biological agents, Cheap drugs, but whether the disease can really control the progress to be confirmed by more studies.