清肠化湿方治疗溃疡性结肠炎活动期

目的观察清肠化湿方治疗溃疡性结肠炎(UC)活动期湿热内蕴证的临床疗效,并评价其安全性。方法 60例轻、中度初发或复发型UC活动期湿热内蕴证患者采用中央随机系统分为试验组(30例)和对照组(30例)。试验组给予清肠化湿方(由黄连6g黄芩10g白头翁10g煨木香10g炒当归10g炒白芍20g肉桂3g生甘草6g组成)口服,每日1剂,煎两次,共得300mL,分两次服用,并根据病情变化情况随证加减,配合灌肠方(由黄柏30g苦参10g地榆30g白及9g三七粉3g锡类散1.5g组成)灌肠,煎两次,混合浓缩至120mL,每晚睡前灌肠,每连续12天后停灌2天;对照组给予美沙拉嗪肠溶片(0.25g/片)口服,每次1g,每日4次。两组疗程8周。比较两组患者症状积分、肠镜及病理疗效、缓解率,并监测用药安全性。结果治疗结束时,试验组对症状的改善优于对照组(P<0.05)。两组患者肠镜及病理均有改善,但差异无统计学意义(P>0.05)。两组间黏膜愈合率(分别为50.0%及43.3%)、缓解率(分别为36.7%、30.0%)比较,差异均无统计学意义(P>0.05)。试验中仅对照组发生ALT轻度升高1例。结论清肠化湿方治疗UC活动期湿热内蕴证是有效而安全的,而且对症状的改善优于美沙拉嗪。

Observation of the Curative Effect of Qingchang Huashi Recipe for Treating Active Ulcerative Colitis of Inner-accumulation of Damp-heat Syndrome

Objective To observe the clinical effects of Qingchang Huashi Recipe （QHR） for treating active ulcerative colitis （UC） patients of inner-accumulation of damp-heat syndrome （IADHS）, and to evaluate its safety. Methods Using a central random system, 60 patients with mild-to-moderately initial onset or relapsed active UC of IADHS were assigned to the test group （30 cases） and the control group （30 cases）. Patients in the test group took QHR （ Rhizoma Coptidis 6 g, Radix Scutellariae 10 g, Radix Pulsatillae 10 g, Radix Aucklandiae 10 g, parched Radix Angelicae sinensis 10 g, Radix Paeoniae alba 20 g, Cortex Cinnamomi 3 g, Radix Glycyrrhizae 6 g, and so on）, 1 dose each time, decocted twice, mixed to 300 mL, taken in two portions. The components were modified according to the condition of illness. Enema of Guanchang Recipe （GCR） was combined （ Cortex Phellodendri 30 g, Radix Sophorae flavescentis 10 g, Radix Sanguisorbae 30 g, Rhizoma bletillae 9 g, Radix notoginseng3 g, Xilei powder 1.5 g）, decocted twice, mixed and concentrated to 120 mL, applied before sleep every evening, with an interval of 12 days after 12 successive days）. Those in the control group took Me- salazine Enteric-coated Tablet （MECT, 0.25 g/tablet）, 1 g each time, 4 times daily. The therapeutic course for all was 8 weeks. The symptom integral, the colonoscopic results, the pathological efficacy, and the remission rate were compared between the two groups. The medication safety was monitored. Results By the end of the treatment the improvement of symptoms was superior in the test group to that of the control group （ P 〈 0.05）. The colonoscopic and pathological results were improved in the two groups, but with no statistical difference（ P 〉 0.05）. There was no statistical difference in the mucosal healing rate （50.0% vs 43. 3% ） and the remission rate （36.7% vs 30.0% ） between the two groups. Only 1 patient of the control group had moderate increase of ALT during the whole test. Conclusions QHR was effective and safe in treating active UC patients of IADHS. Besides, its effect on improving the symptoms was better than that of MECT.