健脾清热化湿方联合美沙拉秦治疗脾虚湿热型缓解期溃疡性结肠炎的单病例随机对照试验

背景缓解期溃疡性结肠炎（UC）患者病程长，需长期维持治疗，中医药治疗缓解期UC具有一定的疗效。健脾清热化湿方治疗缓解期UC的疗效还不确切。目的采用单病例随机对照试验，评价健脾清热化湿方联合美沙拉秦对比美沙拉秦治疗脾虚湿热型缓解期UC患者的疗效和安全性。方法于2020年6月至2021年3月，在广州中医药大学第一附属医院门诊纳入1例缓解期UC患者。采取自身对照的方式，共进行4轮次无洗脱期的随机对照试验，每一轮次包括试验期和对照期两个治疗期，每个治疗期干预1个月，共8个治疗期。受试者在试验期服用健脾清热化湿方颗粒与美沙拉秦，在对照期服用美沙拉秦。比较两个治疗期的中医证候评分（TCMSS）、Bristol粪便性状量表（BSFS）、腹痛和腹泻视觉模拟评分（VAS）、炎症性肠病简明健康量表（SHS）评分及安全性。结果4轮次试验后，试验期腹泻、腹胀、肢体倦怠评分及TCMSS总分的改善程度优于对照期（P<0.05）。4轮次试验后，试验期BSFS评分和腹泻VAS评分的改善程度优于对照期，腹痛VAS评分的改善程度劣于对照期（P<0.05）。4轮次试验后，试验期SHS评分的改善程度优于对照期（P<0.05）。患者在4个周期均无不良反应发生。结论健脾清热化湿方联合美沙拉秦可改善脾虚湿热型缓解期UC患者的临床症状，且安全性较高。

N-of-1 Trial of Jianpiqingrehuashi Granular Decoction with Mesalamine in the Treatment of Ulcerative Colitis in Remission with Spleen Deficiency-induced Damp-heat Syndrome

Background The patient with ulcerative colitis(UC)in remission has a long course of disease,and needs a long-term maintenance treatment.Traditional Chinese medicine(TCM)has proved to be partially effective in treating UC in remission,but the efficacy of Jianpiqingrehuashi granular decoction(JPQRHSGD)against UC in remission is not yet clear.Objective To evaluate the efficacy and safety of JPQRHSGD with mesalamine versus mesalamine in the treatment of UC in remission using an N-of-1 trial.Methods An N-of-1 trial was conducted between June 2020 and March 2021.Participant was an outpatient with UC in remission with spleen deficiency-induced dampness-heat syndrome who was selected from the First Affiliated Hospital,Guangzhou University of Chinese Medicine.The patient received a treatment program,namely four rounds of treatment without washout consisting of eight cycles〔each round includes two cycles,that was,one-month intervention treatment(use of JPQRHSGD with mesalamine)alternating with one-month control treatment(taking mesalamine only)〕.Efficaciesof two types of treatment were evaluated by of the TCM Syndrome Score(TCMSS),Bristol Stool Form Scale(BSFS),visual analogue scale(VAS)for abdominal pain and diarrhea,and Short Health Scale(SHS).Safety was also compared between the two treatments.Results The total TCMSS in intervention period was significantly lower than that in control period(P<0.05).In particular,the symptoms of diarrhea,abdominal distension and fatigue of the limbs were improved more obviouslyin intervention period(P<0.05).The improvements of total BSFS score,and diarrhea VAS score in intervention period were better than those in control period(P<0.05).However,abdominal pain VAS score in intervention period was worse than that in control period(P<0.05).The improvement of SHS score in intervention period was better than those in control period(P<0.05).No treatment-related adverse events were reported.Conclusion The JPQRHSGD with mesalamine improved the clinical symptoms of the UC patient in remission with spleen deficiency-induced dampness-heat syndrome,with relatively high safety.