摘要
目的回顾性分析补充维生素D对乌司奴单抗(UST)治疗克罗恩病患者临床疗效的影响。方法通过检索温州医科大学附属第二医院临床资料数据库,收集2021年5月至2023年2月接受UST一线治疗的71例中、重度活动期克罗恩病患者资料。采用哈维-布拉德肖指数(HBI)评估克罗恩病疾病活动度,简化克罗恩病内镜评分(SES-CD)评估克罗恩病肠道炎症严重度。依据UST治疗的同时是否补充维生素D(400 U/d)将克罗恩病患者分为补充组(41例)和未补充组(30例)。再依据基线血清25-羟维生素D[25(OH)D]水平,将克罗恩病患者分为维生素D缺乏组(<20μg/L,42例)和不缺乏组(≥20μg/L,29例)。主要观察终点是UST治疗第24周时补充组与未补充组之间临床缓解(HBI评分≤4分)率和黏膜愈合(SES-CD评分≤2分)率的差异。次要观察终点是UST治疗第8周时补充组与未补充组之间临床应答(HBI评分较第0周下降≥3分)率和生物化学缓解[C反应蛋白(CRP)≤5 mg/L]率的差异。采用多元线性回归模型分析血清25(OH)D水平与克罗恩病患者临床病理特征的关系,采用多因素二元logistic回归分析第8周和第24周UST临床疗效的影响因素。两组间比较采用独立样本t检验、Mann-Whitney U检验、卡方检验。UST治疗前后计量资料的比较采用配对t检验。结果多元线性回归分析发现克恩罗病患者基线血清25(OH)D水平是基线CRP水平[β=-0.33,95%置信区间(95%CI)-0.41~-0.08,P=0.041]和基线HBI评分(β=-0.52,95%CI-0.68~-0.33,P=0.027)的独立影响因素。第8周与第0周比较,补充组血清25(OH)D水平升高[(17.18±5.46)μg/L比(13.71±7.73)μg/L],差异有统计学意义(t=-7.81,P<0.001);未补充组血清25(OH)D水平[(14.85±3.92)μg/L比(15.69±5.48)μg/L]差异无统计学意义(P>0.05)。第8周时,补充组的HBI评分和CRP均低于未补充组[(5.71±1.88)分比(8.34±2.27)分、10.83 mg/L(3.95 mg/L,21.07 mg/L)比16.17 mg/L(6.91 mg/L,35.48 mg/L),t=0.48、Z=2.87,P<0
Objective To retrospectively analyze the effects of vitamin D supplementation on the clinical efficacy of ustekinumab(UST)in treatment of patients with Crohn′s disease(CD).Methods Seventy-one patients with moderate to severe active CD who received the first-line treatment UST from May 2021 to February 2023 were collected by searching the clinical database of the Second Affiliated Hospital of Wenzhou Medical University.The disease activity of CD was evaluated by Harvey-Bradshaw index(HBI)and intestinal inflammation was assessed by simplified endoscopic score for Crohn′s disease(SES-CD).The CD patients were divided into supplementary group(n=41)and non-supplementary group(n=30)based on whether vitamin D supplementation(400 U/d)was performed during UST treatment.According to the baseline serum 25(OH)D level,the patients were divided into vitamin D deficiency group(<20μg/L,n=42)and non-deficiency group(≥20μg/L,n=29).The main end points were the differences in the clinical remission(HBI score≤4)rate and mucosal healing(SES-CD score≤2)rate between supplementary group and non-supplementary group at week 24 of UST treatment.The secondary end points were the differences in the clinical response(the reduction of HBI score≥3 compared to week 0)rate and biochemical remission(C-reactive protein(CRP)≤5 mg/L)rate between supplementary group and non-supplementary group at week 8 of UST treatment.A multiple linear regression analysis was performed to investigate the relation between serum 25(OH)D levels and the clinicopathological characteristics of CD patients.Multivariate binary logistic regression models were used to analyze the factors affecting the clinical efficacy of UST at week 8 and 24.Independent sample t test,Mann-Whitney U test,Chi-square test and Fisher′s exact test were used for comparisons between the two groups.Paired t test was used to analyze the differences before and after UST treatment.Results The results of multiple linear regression analysis for 71 CD patients showed that the baseline seru
作者
饶舜禹
胡定元
林道泼
曹曙光
吴昊
蒋益
Rao Shunyu;Hu Dingyuan;Lin Daopo;Cao Shuguang;Wu Hao;Jiang Yi(Department of Gastroenterology,the Second Affiliated Hospital of Wenzhou Medical University(Yuying Children′s Hospital),Wenzhou 325000,China)
出处
《中华消化杂志》
CAS
CSCD
北大核心
2023年第11期755-763,共9页
Chinese Journal of Digestion
基金
浙江省自然科学基金(LY23H030004)
浙江省医药卫生科技计划项目(2021KY802,2021KY803)
贺林院士工作站科研基金(19331101)。
