依那西普治疗强直性脊柱炎的安全性研究  

Studies on safety of etanercept in treatment of ankylosing spondylitis

作　　者：张红[1] 邓小虎[1] 张亚美[1] 张江林[1] 黄烽[1] 

机构地区：[1]中国人民解放军总医院风湿科,北京100853

出　　处：《药物不良反应杂志》2008年第6期396-399,共4页Adverse Drug Reactions Journal

摘　　要：目的:观察依那西普治疗强直性脊柱炎(ankylosing spondylitis,AS)出现的不良反应。方法:本研究采用随机、双盲、安慰剂平行对照的方案,2005年4月至2006年1月对52例活动性AS患者随机分入依那西普组及安慰剂组,每组患者各26例,依那西普组平均年龄(27.7±8.5)岁,安慰剂组平均年龄(29.7±8.1)岁。整个研究持续12周,前6周为双盲治疗期,后6周为开放治疗期。在双盲期,依那西普组给予依那西普25mg/次,皮下注射,每周2次,连续用药6周;安慰剂组给予非活性物质25mg/次,皮下注射,每周2次,连续用药6周。开放治疗期,2组均使用依那西普25mg/次,皮下注射,每周2次,连续用药6周。于第0、1、2、4、6、7、8、10、12周进行血常规检查,观察分析注射部位皮肤反应、其他的皮肤及附属器官的反应、感染的发生情况、血液系统反应、肝酶水平、自身抗体反应及其他不良反应。结果:依那西普组和安慰剂组的不良反应发生率分别为23%和38%,差异无统计学意义(P>0.05);无严重不良事件发生。双盲期内依那西普组有26.9%的患者出现注射部位皮肤红肿、硬结和瘙痒反应,安慰剂组无1例出现该反应,2组差别有统计学意义(P<0.05)。试验期间注射部位皮肤反应的发生率为34.6%。双盲期依那西普组有6例患者(23.1%)出现中性粒细胞减少,而安慰剂组无1例发生该反应,2组之间差异有统计学意义(P<0.05)。依那西普组和安慰组的其他不良反应如上呼吸道感染(分别为5例与7例)、皮肤及附属器官反应(分别为6例和3例)、肝酶升高(分别为5例和8例)等,差异均无统计学意义(均P>0.05)。结论:依那西普是一种较为安全的治疗AS的药物。Objective： To observe the adverse reactions of etanercept in the treatment of ankylosing spondylitis （AS）. Methods： A randomized, double-blind, placebo-controlled parallel study was conducted. From April 2005 to January 2006, 52 patients with active ankylosing spondylitis were enrolled in the study, and randomly divided into the etanercept and placebo groups （26 patients in each group）. The patients average age in the etanercept group was （27.7 ± 8.5 ） years, and in the placebo group was （29.7 ± 8.1 ） years. The trial duration was 12 weeks. The first 6 weeks were a double-blind phase and the second 6 weeks were an open-label phase. During the double-blind phase, the patients in the etanercept group received etanercept subcutaneously in a dose of 25 mg twice a week for 6 weeks and the patients in the placebo group received inactive substance subcutaneously in a dose of 25 mg twice a week for 6 weeks. During the open-label phase, all the patients in both groups received etanereept subcutaneously in a dose of 25 mg twice a week for 6 weeks. Routine blood test was performed at week 0, 1, 2, 4, 6, 7, 8, 10, and 12, meanwhile the dermal lesion at the site of injections, the skin and its appendages reactions, infections, hematological disorders, liver enzyme levels, auto-antibody response, and other adverse reactions were observed and analysed. Results： The incidence of adverse reactions in the etanercept and placebo groups was 23% and 38%, respectively; the difference was not statistically significant （P 〉 0.05）; no serious adverse reaction occurredl During the double-blind phase, 26.9% of the patients in the etanercept group developed local dermal lesions characterized by redness and swelling, induration, and pruritus at the site of injections, and no case of such local dermal lesions was found in the placebo group; the difference between both groups was statistically significant （ P 〈 0.05 ）. During the trial period, the incidence of the reactions at the site of injections was 34.6

关 键 词：依那西普 强直性脊柱炎 安全性 

分 类 号：R593.23[医药卫生—内科学]