摘要
目的 探讨环磷酰胺联合沙利度胺治疗难治性CD患者的有效性和安全性.方法 本研究为前瞻性、开放性的研究,共纳入15例难治性CD患者.采用环磷酰胺隔天静脉注射200 mg,持续治疗2周,继以400 mg每周1次静脉注射,至累积剂量达6～8 g.环磷酰胺治疗开始即同时开始口服沙利度胺,根据患者耐受程度,每晚予25～75 mg.治疗前、治疗后2周、环磷酰胺累积剂量达到6～8 g时,记录患者克罗恩病活动指数（CDAI）、Hb、WBC计数、ESR和超敏CRP的变化;治疗前及环磷酰胺累积剂量达到6～8 g时进行内镜检查,观察患者黏膜愈合情况,并进行简要克罗恩病内镜评分（SES-CD）.监测所有患者的不良反应.统计学处理采用配对t检验.结果 治疗前,15例难治性CD患者的CDAI为（235.87±59.87）分,治疗后2周降为（135.33±29.23）分,差异有统计学意义（t=7.50,P＜0.01）.治疗前,ESR和超敏CRP分别为（42.13±22.80） mm/1 h和（13.73±2.18） mg/L,治疗后2周分别降为（23.80±16.63）mm/1 h和（5.77±4.77） mg/L,差异均有统计学意义（t=2.43,6.17;P均＜0.05）.在完成了2周的治疗后,10例患者获得临床缓解.在完成了环磷酰胺累积剂量达到6～8 g的联合治疗后,患者的CDAI为（108.14±47.10）分,较治疗前下降,差异有统计学意义（t=6.30,P＜0.01）;ESR,超敏CRP和WBC计数分别为（19.35±19.18）mm/1 h、（6.16±5.02）mg/L和（6.28±3.42）×109/L,较治疗前下降,差异均有统计学意义（t=5.90,5.40,3.71;P均＜0.01）;12例患者达到临床缓解.12例患者内镜下的病变好转,4例患者达到黏膜愈合;治疗前SES-CD为（9.14±5.39）分,治疗后降为（5.07±4.58）分,差异有统计学意义（t=3.14,P＜0.01）.在治疗过程中,5例患者出现不良反应,3例ALT升高,1例WBC计数降低,1例出现严重的泌尿系统感染.结论 环磷酰胺联合沙利度胺的治疗方案使难治性CD患者获得临床缓解和内镜下黏膜愈合,有较好的疗效.但�
Objective To investigate the efficacy and safety of the combined therapy of cyclophosphamide and thalidomide in the treatment of refractory Crohn＇s disease （CD）.Methods This study was a prospective and open study.A total of 15 patients with refractory CD were enrolled.All patients received intravenous cyclophosphamide 200 mg every other day for two weeks,then followed by intravenous 400 mg once a week until the cumulative dose reached 6 to 8 g.when the cyclophosphamide treatment started,at the same time thalidomide was taken 25 to 75 mg every night according to the tolerance of patients.Before the treatment,two weeks＇ after the treatment and at the time when the cumulative dose of cyclophosphamide reached 6 to 8 g,Crohn＇s disease activity index （CDAI）,hemoglobin （Hb）,white blood cell （WBC） count,erythrocyte sedimentation rate （ESR） and high-sensitivity C-reactive protein （hs-CRP） were recorded.Endoscopy examination was conducted before the treatment and at the time when the cumulative dose of cyclophosphamide reached 6 to 8 g.The condition of mucosa healing was observed and scored by simple endoscopic score for crohn＇s disease （SES-CD）.Adverse effects of all patients were monitored.Paired t test was performed for statistical analysis.Results Before the treatment,the CDAI of 15 patients with refractory CD was 235.87±59.87,two weeks after the treatment the CDAI declined to 135.33 ± 29.23,and the difference was statistically significant （t=7.50,P＜0.01）.Before the treatment,ESR and hs-CRP was （42.13±22.80） mm/1 h and （13.73± 2.18） mg/L.Two weeks after treatment they declined to （23.80±16.63） mm/1 h and （5.77±4.77） mg/L,and the differences were statistically significant （t=2.43 and 6.17,both P＜0.05）.After two-week treatment,10 patients achieved clinical remission.After the cumulative dose of cyclophosphamide reached 6 to 8 g combined therapy,CDAI of patients was 108.14 ± 47.10,which decreased significantly compared with that before treatment （t=6
出处
《中华消化杂志》
CAS
CSCD
北大核心
2014年第11期721-725,共5页
Chinese Journal of Digestion
基金
广东省科技社会发展计划（2011B031800097）
