乌司奴单抗双静脉诱导治疗复杂性肛瘘型克罗恩病的疗效分析  

Analysis on the efficacy of dual vein induction therapy of Ustekinumab in complex perianal fistulizing Crohn′s disease

作　　者：张顶力 邵晓晓[1] 胡定元[1] 林道泼 吴昊[1] 蒋益[1] Zhang Dingli;Shao Xiaoxiao;Hu Dingyuan;Lin Daopo;Wu Hao;Jiang Yi(Department of Gastroenterology,the Second Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China)

机构地区：[1]温州医科大学附属第二医院消化内科,温州325000

出　　处：《中华医学杂志》2023年第41期3301-3306,共6页National Medical Journal of China

基　　金：浙江省自然科学基金(LY23H030004);浙江省医药卫生科技计划(2021KY802,2021KY803)

摘　　要：目的分析乌司奴单抗(UST)双静脉诱导治疗复杂性肛瘘型克罗恩病(PFCD)的疗效。方法回顾性分析2022年1月至2023年3月就诊于温州医科大学附属第二医院并确诊为复杂性PFCD患者的临床资料。所有患者分别于第0、8周给予足量UST(6 mg/kg)单次静脉输注后,每隔8周单次皮下注射UST 90 mg维持治疗。第8、16、22~26周采用肛周疾病活动指数(PDAI)评估肛瘘临床结局,Harvey-Bradshaw指数(HBI)评估整体活动度。第22~26周采用Van Assche指数(VAI)评估肛瘘影像结局,简化克罗恩病内镜评分(SES-CD)评估肠道结局事件。比较UST治疗前后上述指标的差异。依据是否采用UST一线治疗将PFCD患者分为一线UST治疗组与非一线UST治疗组,比较两组之间肛瘘应答率和缓解率、肠道应答率和缓解率以及整体活动度应答率和缓解率的差异。结果共纳入60例PFCD患者,男46例,女14例,年龄[M(Q_(1),Q_(3))]25.0(20.8,30.0)岁。第8、16、22~26周的肛瘘临床应答率[41.7%(25/60)、55.0%(33/60)、63.3%(38/60),P=0.056]和肛瘘临床缓解率[21.7%(13/60)、31.7%(19/60)和43.3%(26/60),P=0.002]逐渐增高;整体活动度应答率[53.3%(32/60)、70.0%(42/60)、83.3%(50/60),P=0.040]和整体活动度缓解率[41.7%(25/60)、61.7%(37/60)、75.0%(45/60),P=0.001]亦逐渐增高。第22~26周时,肛瘘影像学部分应答率和瘘管愈合率分别为45.0%(27/60)和38.3%(23/60);内镜应答率和内镜缓解率分别为73.7%(44/60)和45.0%(27/60)。一线UST治疗组[男23例,女8例,年龄22.0(21.0,39.0)岁]的内镜应答率高于非一线UST治疗组[男23例,女6例,年龄26.5(20.0,30.0)岁](87.1%比58.6%,P=0.013)。结论UST双静脉诱导治疗能有效改善复杂性PFCD患者的临床疗效。Objectives To analyze the efficacy of dual vein induction therapy of Ustekinumab(UST)in complex perianal fistulizing Crohn′s disease(PFCD).Methods Clinical data of patients diagnosed with complex PFCD in the Second Affiliated Hospital of Wenzhou Medical University from January 2022 to March 2023 were retrospectively analyzed.After sufficient single intravenous infusion of UST(6 mg/kg)at week 0 and 8,every patient received single subcutaneous injection of UST 90 mg every 8 weeks for maintenance treatment.At week 8,16,and 22-26,clinical outcomes of anal fistula were evaluated using perianal disease activity index(PDAI),and overall activity of the patients was evaluated using Harvey Bradshaw index(HBI).At week 22-26,Van Assche Index(VAI)was used to evaluate imaging outcome of anal fistula,and simplified endoscopic score of Crohn′s disease(SES-CD)was employed to assess intestinal outcome events.The above indexes were compared in the patients before and after UST treatment.PFCD patients were divided into first-line UST treatment group and non first-line UST treatment group according to whether first-line UST treatment was used,the differences in anal fistula response rate and remission rate,intestinal response rate and remission rate as well as overall activity response rate and remission rate were compared between the two groups.Results A total of 60 PFCD patients were included,including 46 males and 14 females,aged[M(Q_(1),Q_(3))]25.0(20.8,30.0)years old.The clinical response rates of anal fistula[41.7%(25/60),55.0%(33/60)and 63.3%(38/60),respectively,P=0.056]and the clinical remission rates of anal fistula[21.7%(13/60),31.7%(19/60)and 43.3%(26/60),respectively,P=0.002]gradually increased at week 8,16,22-26.The overall activity response rates[53.3%(32/60),70.0%(42/60),83.3%(50/60),respectively,P=0.040]and the overall activity response rates[41.7%(25/60),61.7%(37/60),75.0%(45/60),respectively,P=0.001]also gradually increased at week 8,16,22-26.At week 22-26,the partial response rate and fistula healing rate of an

关 键 词：炎性肠疾病 乌司奴单抗 复杂性肛瘘型克罗恩病 双静脉诱导治疗 疗效 

分 类 号：R574.62[医药卫生—消化系统]