维得利珠单抗联合柳氮磺吡啶治疗中重度溃疡性结肠炎的临床研究

Clinical study on vedolizumab combined with sulfasalazine in treatment of moderate to severe ulcerative colitis

目的 探究维得利珠单抗联合柳氮磺吡啶治疗中重度溃疡性结肠炎的治疗效果。方法 选取2021年8月—2023年8月在北京市第六医院治疗的溃疡性结肠炎患者99例,随机将患者分成对照组(49例)和治疗组(50例)。对照组口服柳氮磺吡啶肠溶片,初始剂量为1 g/d,如耐受则提升至2 g,3次/d,病情缓解后降至每1 g/d,2次/d。治疗组在对照组基础上静脉滴注注射用维得利珠单抗,分别于0、2、6、14周用药1次,每次取300 mg本品加入生理盐水250 mL,滴注时长控制在30 min以上。两组患者治疗14周。观察两组患者临床疗效,比较治疗前后两组患者临床症状改善时间,溃疡性结肠炎内镜下严重程度指数(UCEIS)、疾病活动指数(DAI)和炎症性肠病生存质量问卷(IBDQ)评分,肠黏膜屏蔽功能指标二胺氧化酶(DAO)、细菌内毒素(BE)和β-防御素(β-DF)水平,及血清肠型脂肪酸结合蛋白(I-FABP)、单核细胞趋化蛋白-1(MCP-1)和热休克蛋白70(HSP70)水平。结果 治疗后,对照组和治疗组临床总有效率分别为81.63%和96.00%,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组患者症状的改善时间均要明显短于对照组(P<0.05)。治疗后,两组患者UCEIS评分和DAI评分均显著下降,而IBDQ评分均显著上升(P<0.05),且治疗组在所有评分的改善上表现更为突出(P<0.05)。治疗后,两组患者肠黏膜屏蔽功能指标DAO、BE、β-DF、I-FABP和MCP-1水平均显著降低,而血清HSP70水平均显著升高(P<0.05),且治疗组在这些指标的改善上表现更为突出(P<0.05)。结论 维得利珠单抗联合柳氮磺吡啶治疗中重度溃疡性结肠炎疗效显著,不仅能够显著改善患者临床症状、病情程度和生存质量,同时还能够改善患者肠黏膜屏蔽功能并促进血清学指标的恢复。

Objective To evaluate the clinical efficacy of vedolizumab combined with sulfasalazine in treatment of moderate to severe ulcerative colitis.Methods Patients(99 cases)with moderate to severe ulcerative colitis in Beijing No.6 Hospital from August 2021 to August 2023 were randomly divided into control(49 cases)and treatment(50 cases)group.Patients in the control group were po administered with Sulfasalazine Enteric-coated Tablets,the initial dose was 1 g/d,if tolerated,increased to 2 g,three times daily,and decreased to 1 g/d after remission,twice daily.Patients in the treatment group were iv administered with Vedolizumab for injection on the basis of the control group,once at weeks 0,2,6,and 14 respectively,300 mg was added into 250 mL of physiological saline,the infusion duration was controlled to more than 30 min.Patients in two groups were treated for 14 weeks.After treatment,the clinical evaluations were evaluated,the clinical symptom improvement time,the scores of UCEIS,DAI and IBDQ,the levels of intestinal mucosal shield function indicators DAO,BE andβ-DF,and the levels of serum I-FABP,MCP-1 and HSP70 in two groups before and after treatment were compared.Results Afer treatment,the total clinical effective rates in the control group and the treatment group were 81.63%and 96.00%,respectively,and the difference between the two groups was statistically significant(P<0.05).After treatment,the improvement time for patients in the treatment group was significantly shorter than that in the control group(P<0.05).After treatment,the UCEIS score and DAI score were significantly decreased significantly in two groups,while the IBDQ score was significantly increased(P<0.05),and the improvement of scores in the treatment group was more prominent(P<0.05).After treatment,the levels of intestinal mucosal shielding function indicators DAO,BE,β-DF,I-FABP and MCP-1 in two groups were significantly reduced,while the serum HSP70 levels were significantly increased(P<0.05),and the treatment group showed more prominent improvement in these indicators(P<0.05).Conclusion Vidlizumab combined with sulfasalazine has significant efficacy in the treatment of moderate to severe ulcerative colitis.It can not only significantly improve the patient's clinical symptoms,disease severity and quality of life,but also improve the patient's intestinal mucosa shielding function and promote serological indicators.