调和肝脾核心汤治疗腹泻型肠易激综合征的随机对照临床试验

背景：肠易激综合征（irritable bowel syndrome, IBS）对患者生活质量影响较大且需花费高额医疗费用，其病因及发病机制迄今尚未完全明了，对本病的防治至今还缺乏足够有效的方法。 目的：观察在肝脾相关理论指导下自拟调和肝脾核心汤治疗腹泻型IBS的疗效。 设计、场所、对象和干预措施：纳入2007年9月至2009年3月在暨南大学第一附属医院、广州红十字会医院和广州中医药大学第一附属医院就诊的40例腹泻型IBS患者。将40例患者随机平均分为两组，治疗组给予调和肝脾核心汤，对照组给予匹维溴铵，疗程均为4周。 主要结局指标：评价治疗组和对照组治疗前后中医证候积分、临床总显效率、症状消失率和症状积分的变化。 结果：治疗后，治疗组和对照组中医证候积分均低于治疗前（P＜0.01），且治疗组中医证候积分亦低于对照组（P＜0.01）；治疗组和对照组临床总显效率分别为85%（17/20）和45%（9/20），两组比较，差异有统计学意义（P＜0.01）；治疗组腹痛、腹胀、排便不尽感、大便次数、大便性状和黏液便各症状消失率均高于对照组（P＜0.05）；治疗组腹痛、腹胀、排便不尽感、大便次数、大便性状和黏液便各症状积分均低于对照组（P〈0.05）。 结论：运用肝脾相关理论自拟调和肝脾核心汤治疗腹泻型IBS能明显改善患者的临床症状。

Tiaohe Ganpi Hexin Decoction in treatment of irritable bowel syndrome with diarrhea: a randomized controlled trial

Background： The quality of life has been greatly influenced and the cost of medical expenses is very high in patients with irritable bowel syndrome （IBS）. The etiology and pathogenesis of IBS are still unclear, and the prevention and treatment of this disease still lack of effective methods.
Objective： To explore and analyze the effects of Tiaohe Ganpi Hexin Decoction （TGHD）, a compound traditional Chinese herbal medicine for regulating the liver and spleen, on IBS patients with diarrhea.
Design, setting, participants and interventions： All 40 IBS patients came from the First Hospital of Jinan University, Guangzhou Red Cross Hospital, and the First Affiliated Hospital of Guangzhou University of Chinese Medicine, and were randomly divided into two groups. Patients in the treatment group （n=20） were given TGHD, while those in the control group （n=20） were prescribed oral pinaverium with a four-week treatment period.
Main outcome measures： Traditional Chinese medicine （TCM） syndrome score, total obviously effective rate, disappearance rate of symptoms, and clinical symptom score in the two groups were evaluated before and after four-week treatment.
Results： After the treatment, TCM syndrome scores in both groups were decreased （P〈0.01）, and the TCM syndrome score in the treatment group was significantly lower than that in the control group （P〈0.01）. There was a significant difference in the total obviously effective rate between the two groups （P〈0.01）, and the total obviously effective rates in the treatment and control groups were 85%（17/20） and 45%（9/20） respectively. The disappearance rates of abdominal pain, abdominal distention, poor stool output, stool frequency, stool character and mucous stool in the treatment group were higher than those in the control group （P〈0.05）. The symptom scores of abdominal pain, abdominal distention, poor stool output, stool frequency, stool character and mucous stool in the treatment group were lower than those in the control group （P〈0.05）.
Conclusion： TGHD can significantly improve the clinical symptoms in IBS patients with diarrhea.