英夫利西单抗治疗克罗恩病的疗效分析

目的 探讨TNFα单克隆抗体英夫利西(infliximab,IFX)单抗治疗活动性克罗恩病(CD)的疗效与安全性.方法 对传统药物治疗后未能完全缓解、手术治疗后复发或对药物不耐受的CD患者,于0、2、6周时静脉输注IFX(5 mg/kg)诱导缓解治疗,并对第一次输注后14周内的临床疗效,包括疾病活动度、血生化指标及结肠镜表现作出评估.结果 10例患者接受了IFX治疗,其中男8例,女2例,中位年龄31.4岁.5例患者IFX治疗1周后即感症状得到改善,主观症状评分从2.2±0.6降为1.2±0.4(P<0.05);简化CD活动性指数(H-B指数)从6.6±1.6降为2.1±1.0(P<0.05);ESR、C反应蛋白、血清总蛋白及白蛋白也有明显改善;内镜下CD严重度指数也得到明显改善.治疗过程中未观察到输注反应;1例患者在第3次IFX输注后,血ALT及AST暂时性升高;1例患者输注后35周出现严重贫血(三系列均减少).结论 经3次IFX静脉输注方案治疗,本组患者的临床症状及结肠镜下表现可获得较快、较好的改善.IFX长期应用的安全性尚需进一步扩大样本的研究.

A study of efficiacy of infliximab treatment for Crohn's disease

Objective To investigated the potential and safety of the monoclonal antibody to TNFα infliximab(IFX)in the treatment of active Crohn's disease(CD).Methods Patients who were confirmed diagnosis of CD and were unresponsive to the conventional treatments,or recurred after surgeries,or discontinued treatment due to drug intolerance,were treated with IFX intravenously in a dose of 5 mg/kg at week 0.2,6(IFX infusion continued at an interval of every 8 weeks if respond to initial dosing).Clinical assessments,including disease activity,blood biological markers and colonoscopic findings,were performed at baseline(week O)and each week(4 weeks or later for colonoscopy)after IFX infusion were conducted until the week before 4~(th) infusion from initiated.Results Ten patients(8 male,2 female)with mean age of 31.4 years(ranged from 15 to 65 years old)were included in the analysis.The mean subjective score from baseline to week 14 was decreased from 2.2±0.6 to 1.2±0.4(P<0.05).The mean Harvey-Bradshaw index was 6.6±1.6 at baseline and 2.1±1.0 at week 14.The levels of ESR,CRP,serum total protein (TP)and albumin(Alb)were significantly improved during the 14-week period.Colonoscopy showed a remarkable improvement of Crohn's Disease Endoscopic Index of Severity(CDEIS).No infusion-related reaction was observed in all patients during the treatment.Mild or transient skin itching and headache were respectively reported in two Patients.Transient elevation of serum ALT and AST after 3rd infusion in one patient,and severe anemia including leucopenia and thrombocytopenia at week 35 after 1st infusion in one male patient were absenred.Conclusions Treatment with three infusions of IFX in a dose of 5 mg/kg was effective for induction of remission for active and complex CD patients who failed to respond to conventional treatment.Long-term safety of the therapy effect was warranted in further investigations.