英夫利西单抗联合硫唑嘌呤治疗中重度克罗恩病的疗效研究

Efficacy of Infliximab Combined with Azathioprine for Moderate to Severe Crohn's Disease

背景:激素和免疫抑制剂是克罗恩病(CD)的传统治疗药物,然而部分CD患者对传统药物耐药或依赖。目的:评价英夫利西单抗联合硫唑嘌呤治疗中重度CD的有效性和安全性。方法:24例CD患者随机分为英夫利西单抗组、硫唑嘌呤组、英夫利西单抗联合硫唑嘌呤组(联合治疗组)。英夫利西单抗组于第0、2、6周给予英夫利西单抗5mg/kg,随后每隔8周给予英夫利西单抗5 mg/kg;硫唑嘌呤组给予硫唑嘌呤2.5 mg/kg qd;联合治疗组给予硫唑嘌呤2.5 mg/kg qd,并于第0、2、6周给予英夫利西单抗5 mg/kg,随后每隔8周给予英夫利西单抗5 mg/kg。治疗第26周末以CD疾病活动指数(CDAI)和内镜检查评价治疗疗效。治疗期间记录患者不良反应发生情况。结果:治疗第26周末,联合治疗组的临床总有效率和内镜下总有效率较英夫利西单抗组和硫唑嘌呤组均显著升高(P<0.05);治疗第26周末联合治疗组血红蛋白水平较治疗前显著升高(P<0.05),ESR和CRP水平治疗前均显著降低(P<0.05);治疗期间联合治疗组无严重不良反应发生。结论:对于激素抵抗或依赖的中重度CD患者,英夫利西单抗联合硫唑嘌呤的疗效优于单用英夫利西单抗或硫唑嘌呤。

Glucocorticoids and immune depressants are the traditional medicines for the treatment of Crohn＇ s disease （CD）. However, some CD patients showed resistant and dependent to these traditional medicines. Aims： To assess the efficacy and safety of infliximab combined with azathioprine for the treatment of moderate to severe CD. Methods： A total of 24 CD patients were randomly assigned into infliximab group, azathioprine group and infliximab combined with azathioprine group （ combination group）. Patients in infliximab group were given infliximab 5 mg/kg at week 0, 2, 6, and then infliximab 5 mg/kg every 8 weeks. Patients in azathioprine group were given azathioprine 2.5 mg/kg qd. Patients in combination group were given azathioprine 2.5 mg/kg qd combined with infliximab 5 mg/kg at week 0, 2, 6, and then infliximab 5 mg/kg every 8 weeks. CD activity index （CDAI） assessment and endoscopic examination were performed at week 26 to evaluate treatment efficacy. Adverse effects during the course of treatment were recorded. Results： At week 26, clinical overall effective rate and endoscopic overall effective rate in combination group were significantly higher than those in infliximab group and azathioprine group （P 〈 0.05）. In con^bination group, hemoglobin level measured at week 26 was significantly higher than that before treatment （ P 〈 0. 05 ）, ESR and CRP levels measured at week 26 were significantly lower than those before treatment （ P 〈 0.05 ）. No serious adverse effects were seen in combination group. Conclusions： Compared with infliximab or azathioprine monotherapy, azathioprine combined with infliximab therapy is more effective for the treatment of moderate to severe CD with glucocorticoids resistance or dependence.