反应停治疗强直性脊柱炎的临床研究

Effect of thalidomide in the treatment of ankylosing spondylitis patients

目的 评价反应停治疗强直性脊柱炎 (AS)的有效性与安全性 ,探讨反应停治疗AS的价值。方法 采用队列研究方法 ,选用柳氮磺吡啶 (SASP)和单用非甾体抗炎药 (NSAIDs)作为对照。三组共治疗AS患者 98例 ,其中反应停治疗 2 9例 (反应停组 ) ,SASP治疗 37例 (SASP组 ) ,单用非甾体抗炎药 (NSAIDs)治疗 32例(NSAIDs组 ) ,疗程均为 6个月 ,三组患者的病情相似 ,其中反应停组的AS患者 ,是自愿而且排除孕妇及未婚未育者。结果 治疗 6个月 ,晨僵时间、关节疼痛数和血沉 (ESR)在三组均显著改善 (P <0 0 1和P <0 0 5 ) ,而C反应蛋白 (CRP)的显著下降仅见于反应停组和SASP组 (P均 <0 0 1)。三组间比较 ,关节疼痛数、ESR和CRP在反应停组及SASP组改善程度显著高于NSAIDs组 (P <0 0 5 )。临床缓解、显效、有效和无效率在反应停组分别为4 1%、2 8%、2 1%和 10 % ;在SASP组分别为 38%、2 7%、2 2 %和 13% ;在NSAIDs组分别为 10 %、34%、31%和2 5 %。对比三组疗效 ,反应停组与SASP组疗效相当 ,均优于NSAIDs组 (P <0 0 5 )。不良反应在反应停组主要是嗜睡和胃肠道不适 ,多为一过性 ,其发生率为 5 5 % ,明显高于SASP组 19%和NSAIDs组 16 % (P <0 0 5 ) ;反应停组无 1例出现白细胞减低和转氨酶升高 ,而在SASP组各有

Objective To evaluate the clinical efficacy and safety of thalidomide in the treatment of ankylosing spondylitis (AS).Methods Ninety eight AS patients were divided into 3 groups by pairs studying:thalidomide group 29 patients,SASP group 37 patients,and NSAIDs group 32 patients.The course of all the groups was 6 months.Results After six months′treatment clinical and laboratory parameters such as morning stiffness time,number of painful joints and ESR were improved in all three groups ( P <0 01 or 0 05),while decrease of CRP happened in thalidomide group and SASP group ( P <0 01).Morning stiffness time,number of painful joints and ESR all took a favorable turn significantly in thalidomide group and SASP group compared with NSAIDs group ( P <0 05).In thalidomide group 41% of patients were in clinical remission,28% had outstanding effect,21% had effect,and 10% had no effect.In SASP group,38%, 27%,22% and 13% respectively;in NSAIDs group,10%,34%,31% and 25% respectively.Curative effect of the thalidomide group was equivalent to that of the SASP group ( P >0 05),but was better than that of the NSAID group ( P <0 05) .Incidence of side effects in thalidomide group was 55%,much higher than in SASP group (19%) or in NSAID group (16%) ( P <0 05) .The most frequent were drowsiness and abdominal distention,but they were not serious. Conclusion Like SASP,thalidomide is shown to be effective in the treatment of AS patients.Though its side effects are rather more,they are not serious.Thalidomide can be used as an alternative drug in the treatment of AS patients.