血竭散联合英夫利西单抗治疗克罗恩病的临床疗效观察

Effect of Combination of Xue Jie San and Infliximab in Treating Crohn's Disease

目的:观察血竭散联合英夫利西单抗(IFX)治疗克罗恩病(CD)的临床疗效。方法:回顾性分析2017年1月—2021年5月苏州市中医医院肛肠科确诊的CD患者59例,根据内科治疗方案分为治疗组(血竭散联合IFX)27例和对照组(IFX)32例。观察两组治疗14周时腹痛症状及评分、内镜缓解率、克罗恩病简化内镜评分(SES-CD)、临床缓解率、克罗恩病活动指数(CDAI)、IFX谷浓度、肿瘤坏死因子-α(TNF-α)浓度、粪钙卫蛋白(FC)含量、血小板(PLT)计数、D-二聚体(D-D)和纤维蛋白原(FIB)浓度。结果:治疗后,两组腹痛评分、SES-CD评分、CDAI评分、FC含量、PLT计数、D-D和FIB浓度均低于治疗前,差异有统计学意义(P<0.05)。两组患者临床缓解率(96.3%vs 93.8%)和CDAI评分(108.3±11.4 vs 106.9±10.2)差异无统计学意义(P>0.05);治疗组腹痛缓解率(82.4%vs 45.0%)、内镜缓解率(88.9%vs 59.4%)、IFX谷浓度[(4.2±1.1)μg/mL vs(2.4±0.7)μg/mL]均高于对照组,差异有统计学意义(P<0.05);腹痛评分(0.4±0.1 vs 1.2±0.3)、SES-CD评分(1.7±0.6 vs 2.9±1.1)、TNF-α浓度[(47.8±6.2)pg/mL vs(106.4±8.9)pg/mL]、FC含量[(34.8±5.3)μg/g vs(72.5±6.2)μg/g]、PLT计数[(184.4±12.8)×10^(9)/L vs(266.4±15.3)×10^(9)/L]、D-D[(0.3±0.1)mg/L vs(0.8±0.1)mg/L]和FIB[(2.6±0.3)g/L vs(3.9±0.2)g/L]浓度均显著低于对照组,差异有统计学意义(P<0.05)。结论:血竭散联合IFX比IFX单药能更好地改善CD患者高凝状态,缓解腹痛,提高IFX谷浓度,促进肠黏膜溃疡愈合。

Objective To observe the efficacy of combination of Xue Jie San and infliximab(IFX)for the treatment of Crohn's disease(CD).Methods The prospectively collected data of CD patients who were admitted at Suzhou Hospital of Traditional Chinese Medicine between January 2017 and May 2021 were retrospectively analyzed.The patients were divided into treatment group and control group based on medical regimen.In treatment group(27 cases),patients were treated with combination of Xue Jie San and IFX as well as 32 patients in control group received IFX alone.Symptom and score of abdominal pain,endoscopic remission rate,the simplified endoscopic score for Crohn's disease(SES-CD)score,clinical remission rate,the Crohn's disease activity index(CDAI)score,IFX trough level,expressions of tumor necrosis factor-α(TNF-α),platelet(PLT)count,and concentrations of fecal calprotectin(FC),D-dimer(D-D)and fibrinogen(FIB)were recorded.Results There were statistical differences in abdominal pain,SES-CD and CDAI scores,PLT counts,and concentrations of FC,D-D and FIB before and after treatment in both groups(P<0.05).After treatment,there was no statistical difference in clinical remission rates(96.3%vs 93.8%)and CDAI scores(108.3±11.4 vs 106.9±10.2)between two groups(P>0.05).The remission rates of abdominal pain(82.4%vs 45.0%)and endoscopy(88.9%vs 59.4%),and IFX trough levels[(4.2±1.1)μg/mL vs(2.4±0.7)μg/mL]in treatment group were significantly higher than those in control group(P<0.05).The abdominal pain(0.4±0.1 vs 1.2±0.3)and SES-CD(1.7±0.6 vs 2.9±1.1)scores,PLT counts[(184.4±12.8)×10^(9)/L vs(266.4±15.3)×10^(9)/L],and concentrations of TNF-α[(47.8±6.2)pg/mL vs(106.4±8.9)pg/mL],FC[(34.8±5.3)μg/g vs(72.5±6.2)μg/g],D-D[(0.3±0.1)mg/L vs(0.8±0.1)mg/L]and FIB[(2.6±0.3)g/L vs(3.9±0.2)g/L]in treatment group were significantly lower than those in control group(P<0.05).Conclusion Compared with using IFX alone,Xue Jie San combined with IFX could ameliorate hypercoagulable state,relieve abdominal pain,increase IFX trough levels,and promote healing of intestinal mucosal ulcer in CD patients.