柴枳和胃胶囊治疗功能性消化不良餐后不适综合征肝郁脾虚证疗效研究

Clinical effect on Chaizhi Hewei capsule in the treatment of functional dyspepsia postprandial distress syndrome of Ganyu Pixu

目的:评价柴枳和胃胶囊治疗功能性消化不良餐后不适综合征肝郁脾虚证的临床疗效及相关机制。方法:采用随机、双盲和安慰剂平行对照临床试验,纳入30例功能性消化不良餐后不适综合征肝郁脾虚证患者,随机分为试验组、安慰剂组,每组15例。两组分别给予柴枳和胃胶囊和安慰剂柴枳和胃模拟胶囊,两组均饭后口服,5粒/次,3次/d,疗程2周。比较两组治疗前后患者视觉模拟评分(VAS)、功能性消化不良餐后不适综合征单项症状VAS评分、疾病总体评价有效率(7点Likert)、尼平消化不良生存指数(NDI)、焦虑抑郁量表(HAD)、血清胃动素。结果:治疗后试验组治疗应答率高于安慰剂组(P<0.05)。治疗后试验组患者胃胀、打嗝、腹胀3项症状的消失率均高于安慰剂组(P<0.05)。治疗后试验组7点Likert总体评价应答率高于安慰剂组(P<0.05)。治疗后试验组患者NDI评分低于安慰剂组(P<0.05)。治疗后试验组患者焦虑、抑郁评分均低于安慰剂组(P<0.05)。治疗后试验组患者胃动素水平明显升高(P<0.05)。结论:柴枳和胃胶囊可有效改善功能性消化不良餐后不适综合征肝郁脾虚证的临床症状,提高患者生存质量,改善焦虑抑郁状态,总体疗效较好,这可能与胃动素水平升高相关。

Objective:To evaluate the clinical efficacy and mechanism of Chaizhi Hewei capsule in treatment of functional dyspepsia postprandial distress syndrome Ganyu Pixu.Methods:Randomized double-blind and placebo-controlled clinical trial was conducted.30 patients with functional dyspepsia postprandial distress syndrome Ganyu Pixu were included and randomly divided into experimental group and control group each for 15 patients.The experimental group were given Chaizhi Hewei capsule.The control group were given placebo Chaizhi Hewei capsule.Both groups were given 5 tablets/time after meal,3 times/day,and the course of treatment was 2 weeks.Visual analogue scale(VAS),VAS scores for single symptom of functional dyspepsia postprandial discomfort syndrome,7-point Likert,NDI,HAD,serum motilin level were used as observation.Results:After treatment,treatment response rate in the experimental group was significantly higher than that in the control group(P<0.05).After treatment,the disappearance rate of three symptoms of stomach distention,hiccups and abdominal distension in the experimental group were significantly higher than those in the control group(P<0.05).After treatment,the 7-point Likert overall evaluation response rate in the experimental group was significantly higher than that in the control group(P<0.05).After treatment,the NDI score of the experimental group was significantly lower than that in the control group(P<0.05).After treatment,the scores of anxiety and depression in the experimental group were better than those in the control group(P<0.05).After treatment,the motilin level of the traetment group was significantly increased(P<0.05).Concluson:Chaizhi Hewei capsule can effectively relieve clinical symptoms of patients with functional dyspepsia postprandial distress syndrome Ganyu Pixu and improve the anxiety and depression state.The overall effect was better,which might be related to the increase of motilin level.