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.

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.

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.

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.

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。

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。

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。

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。