基于数据挖掘的沈洪教授治疗湿瘀互结型克罗恩病核心处方分析及临床疗效研究

Analysis of Core Prescription and Clinical Efficacy of Professor Shen Hong’s Treatment of Crohn’s Disease with Dampness-Stasis Interjunction Syndrome Based on Data Mining

目的运用数据挖掘方法分析沈洪教授治疗克罗恩病(Crohn’s disease,CD)的用药规律并形成核心处方,回顾性分析该核心处方联合乌司奴单克隆抗体(UST)治疗湿瘀互结型CD的临床疗效。方法收集沈洪教授诊治CD患者门诊记录,通过数据挖掘技术,对药物性味归经、用药频次、复杂网络分析、聚类和关联规则等进行总结,梳理形成核心处方。纳入中医辨证为湿瘀互结证的回结肠型CD患者62例进行回顾性分析,其中观察组30例,对照组32例。对照组给予UST治疗,观察组在对照组治疗基础上加服核心处方,2组疗程均为8周,治疗前后观察2组患者中医证候积分变化情况并分析临床有效率,检测2组患者炎症指标[粪便钙卫蛋白(FC)、血沉(ESR)、C反应蛋白(CRP)]变化情况。结果综合药物频次、关联规则和聚类分析得到核心处方,药物组成包括黄芩、苦参、土茯苓、当归、白芷、白术、陈皮、白芍、防风、薏苡仁、山药、蜂房、徐长卿、木香、神曲和甘草,并由沈洪教授命名为清肠通络方。回顾性临床研究显示:治疗后,2组患者中医证候积分均显著降低(P<0.05,P<0.01),观察组中医证候总积分优于对照组(P<0.01),观察组中医临床疗效显愈率优于对照组(P<0.05);2组患者ESR、CRP、FC水平均显著降低(P<0.01),观察组优于对照组(P<0.05)。治疗期间2组患者均未见明显药物相关不良反应。结论沈洪教授辨治CD以清肠燥湿,通络止痛,健脾益气为要,核心处方联合UST治疗能够有效改善患者临床症状和炎症水平,可作为回结肠型辨证属湿瘀互结型CD的有效治疗手段,值得临床推广应用。

OBJECTIVE To analyze the medication rules of Professor Shen Hong’s TCM treatment of Crohn’s disease(CD)and form the core prescription using data mining technology,and to retrospectively analyze the clinical efficacy of the core prescription combined with ustekinumab in the treatment of CD with dampness-stasis interjunction syndrome.METHODS CD patient outpatient records treated by Professor Shen Hong were collected,and the property,taste and meridian tropism,drug frequency,association rules and complex network analysis of drugs were summarized,in order to sort out the core prescription.62 cases of active ileocolic CD with TCM syndrome of dampness-stasis interjunction were retrospectively included,with 32 patients in the control group and 30 patients in the observation group.The control group was only given ustekinumab,and the observation group was given the core prescription oral treatment on the basis of the treatment in the control group.The observation course was 8 weeks.The improvement of clinical symptoms and changes of inflammatory indicators[erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),fecal calprotectin(FC)]before and after treatment were analyzed.RESULTS The core prescription was obtained by combining drug frequency,association rules and cluster analysis,which included scutellaria baicalensis,radix sophorae flavescentis,smilax glabr,angelicae sinensis,angelica dahurica,atractylodes,tangerine peel,paeoniae alba,saposhnikovia,coicis semen,yam,nidus vespae,cynanchum paniculatum,radix aucklandiae,massa medicata fermentata,glycyrrhiza uralensis,and was named Qingchang Tongluo Formula by Professor Shen Hong.Retrospective clinical research showed that after treatment,the TCM syndrome scores of the 2 groups of patients were significantly reduced(P<0.05,P<0.01),the total TCM syndrome score of the observation group was better than that of the control group(P<0.01),and the TCM clinical significant recovery rate of the observation group was better than the control group(P<0.05);the ESR,CRP,and FC levels of patients in both groups were significantly reduced(P<0.01),and the improvement in the observation group was better than that in the control group(P<0.05).No obvious drug-related adverse reactions were found in the 2 groups of patients during treatment.CONCLUSION Professor Shen Hong distinguishes the treatment of CD by clearing heat and removing blood stasis,strengthening spleen and healing lesions.The core prescription Qingchang Tongluo prescription,combined with ustekinumab can improve clinical symptoms and inflammation levels.It can be used clinically as an effective treatment for ileocolonic Crohn’s disease with dampness-stasis interjunction syndrome.