锝(^(99)Tc)亚甲基二磷酸盐治疗难治性强直性脊柱炎临床疗效观察

Clinical observation on treatment of refractory ankylosing spondylitis by ^(99)Tc-methylene diphosphonate﹡

目的评价锝(^(99)Tc)亚甲基二磷酸盐(^(99)Tc-MDP)治疗难治性强直性脊柱炎(AS)的临床疗效和安全性。方法入选60例难治性AS患者根据随机数字表法分为治疗组和对照组。治疗组:原有的改善病情抗风湿药加^(99)Tc-MDP。对照组:继续使用原有的改善病情抗风湿药。主要疗效指标:达到AS疗效评价(ASAS)20%改善程度(ASAS 20)的受试者比例。次要疗效指标:达到AS疗效缓解50%(ASAS 50)、ASAS标准中6项改善5项(ASAS 5/6)、Bath AS疾病活动指数(BASDAI)改善50%(BASDAI 50)、ASAS部分缓解的受试者比例。结果 AS患者使用^(99)Tc-MDP治疗第4周时,有30%患者达到治疗反应,16周时80%患者达到治疗反应。次要疗效标准(ASAS 5/6、BASDAI 50、ASAS 50、ASAS部分缓解)也有改善,第16周时有72.5%患者达到ASAS 5/6,55.0%患者达到BASDAI 50、42.5%患者达到ASAS 50、35%患者达到ASAS部分缓解。不仅如此,在第8周时患者ESR、CRP均有所下降。而且^(99)Tc-MDP的耐受性好,不良反应少。结论 ^(99)Tc-MDP可有效缓解难治性AS患者临床症状,降低炎症指标,为治疗难治性AS提供了一种新的选择。

Objective To evaluate the efficacy and safety of 99Tc-methylene diphosphonate（99Tc-MDP） in the treatment of refractory ankylosing spondylitis（AS）. Methods Totally 60 patients with refractory AS were randomly assigned into 2 groups,pa- tients in the experimental group were treated with their present medication and 99 Tc-MDP,patients in the control group were trea- ted with their present medication. The primary endpoint was the percentage of patients achieving the 20% improvement in assess- ment in AS （ASAS 20）. Other outcomes included the percentage of patients achieving ASAS 5/6,bath AS disease activity index 50 （BASDAI 50）,the percentage of patients achieving a 50% improvement in ASAS（ASAS 50）,and the ASAS partial remission. Re- suits At 4 weeks,the percentage of patients achieving the ASAS 20 in the 99Tc-MDP group was 30%. At 16 weeks,the percentage of patients achieving the ASAS 20 was 80%. Furthermore, the secondary endpoints include ASAS 5/6, BASDAI 50, ASAS 50, ASAS partial remission were also improved. At 16 weeks,in experimental group, 72.5% patients achieved the ASAS 5/6,55.0% patients achieved the BASDAI 50,the percentage of patients achieving the ASAS 50 was 42.5 % and the percentage of patients a- chieving the ASAS partial remission was 35.0%. At 8 weeks,CRP and ESR were both decreased. 99Tc-MDP was tolerated well and had few side effects. Conclusion 99Tc-MDP can effectively alleviate the refractory AS patients clinical symptoms,decrease inflam- matory index,it may be a new effective drug for treating refractory AS.